ML19270H129

Draft Xcision Gammapod Licensing Guidance for ACMUI, State and Regional Comments

ML19270H129
Person / Time
Issue date:	10/01/2019
From:	Katherine Tapp Office of Nuclear Material Safety and Safeguards
To:
Katherine Tapp, NRC/NMSS
References
Download: ML19270H129 (16)

Text

Note: This is the draft guidance that was sent to ACMUI, Agreement States, and regions for their comments and recommendations. This licensing guidance may change as it is being finalized and should not be used for licensing at this time.

Draft: Xcision GammaPod' Licensing Guidance MONTH DAY, 2019 U.S. Nuclear Regulatory Commission Contact Katherine Tapp (301) 415-0236 MedicalQuestions.Resource@nrc.gov

Table of Contents

1. 10 CFR 35.1000 Use...................................................................................................... 1

2. Licensing Guidance..................................................................................................... 1

3. General.......................................................................................................................... 1 3.1. Sensitive Security Related Information................................................................... 1 3.2. 10 Part 37................................................................................................................ 2 3.3. Radionuclides, Form, Possession Limits, and Purpose of Use............................... 2 3.4. Facility Address and Description............................................................................. 2

4. Training and Experience.............................................................................................. 2 4.1. Authorized Individuals............................................................................................. 2 4.1.1. Authorized Users.......................................................................................... 3 4.1.2. Authorized Medical Physicists.. 4 4.1.3. Radiation Safety Officers... 5

5. Licensing Commitments.............................................................................................. 6 5.1. Written Directives.................................................................................................... 6 5.2. Specific Information on Radiation Safety Precautions and Instructions 7 5.3. Physical Calibration Measurements and Periodic Spot-checks and Full 8 Calibration Measurements....

5.4. Physical Presence Required by 35.615(f)(3).............................. 11 5.5. Published Protocols Accepted by Nationally Recognized Bodies.......................... 11

6. Notes to Licensees....................................................................................................... 12 6.1. Alterations to GammaPod' Units........................................................................... 12 6.2. Change in Physical Conditions of Use 12 6.3. Notifications for AUs and AMPs................................................................... 12 6.4. Revisions to Existing GammaPod' Radiation Safety Programs to Conform to Future Changes in Licensing Guidance and Additional Safety Recommendations from the Manufacturer... 14

7. Note to Regulators... 14 7.1. Inspection Frequency.............................................................................................. 14 7.2. Program Code......................................................................................................... 14

8. Paperwork Reduction Act Statement......................................................................... 14

9. Public Protection Notification..................................................................................... 14

1. 10 CFR 35.1000 Use The Xcision GammaPod' (hereafter the GammaPod') is a gamma stereotactic radiosurgery unit dedicated to non-invasive stereotactic delivery of a therapeutic dose to a partial volume of the breast as a component of Breast Conserving Therapy for breast cancer. Although GammaPod' is a gamma stereotactic radiosurgery device, it includes a number of engineering changes that make its components and operation significantly different from the gamma stereotactic radiosurgery units currently regulated in Title 10 Code of Federal Regulations (10 CFR) Part 35, Subpart H, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units. These engineering changes include the elimination of helmets, relative helmet factors, helmet microswitches, hydraulic backups, trunnions, and a trunnion centricity point which are described in 10 CFR 35, Subpart H. In addition, GammaPodTM has several new engineering features that were not included in 10 CFR Part 35, Subpart H, including its vacuum-assisted breast cup immobilization and stereotactic localization system, rotating source and collimator carriers, and table motion during treatment.

As a result, the GammaPod' is regulated under 10 CFR Part 35, Subpart K, Other Medical Uses of Byproduct Material or Radiation From Byproduct Material.

2. Licensing Guidance This guidance provides applicants with an acceptable means of satisfying the requirements for a license for the use of the GammaPod' and is not intended to be the only means of satisfying requirements for a license. The applicant must submit the information required by 10 CFR 30.33 and 35.12 as described below. The applicant must submit additional information and commitments requested below or may, unless the information is specifically required by regulation, submit alternative commitments for review by the U.S. Nuclear Regulatory Commission (NRC) staff to determine whether the regulatory requirements are met. The commitments incorporated into the applicants license by license condition will be reviewed during routine inspections. Applicants are reminded that licenses issued pursuant to 10 CFR 35.10001 must still meet the general requirements in 10 CFR Part 35, Subparts A, B, C, L and M, except as specified in this guidance. Additionally, applicants must meet applicable requirements of 10 CFR Parts 19, 20, 30 and 37.

3. General 3.1. Sensitive Security-Related Information:

Following the events of September 11, 2001, the NRC changed its procedures to avoid the release of information that terrorists could use to plan or execute an attack against facilities or citizens in the U.S. As a result, certain types of information are no longer routinely released and are treated as sensitive unclassified information. For example, certain information about the quantities and locations of radioactive material at licensed facilities, and associated security measures, are no longer released to the public. Therefore, a cover letter should clearly state that the attached documents contain security-related sensitive information and the top of every page of a document that contains such information should be clearly marked: Security Related InformationWithhold Under 10 CFR 2.390. For the pages having security-related sensitive information, an additional marking should be included (e.g., an editorial note box) adjacent to 1

Medical Uses of Byproduct Material Licensed under 10 CFR 35.1000 are designated as Compatibility Category D. Agreement States are not required to adopt these regulations for purposes of compatibility.

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that material. For further information, see Regulatory Issues Summary 2005-31, Revision 1, Control of Security-Related Sensitive Unclassified Non-Safeguards Information Handled by Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, Byproduct, and Special Nuclear Material, available at https://www.nrc.gov/docs/ML1619/ML16196A237.pdf .

Additional information on procedures and any updates are available in the NRC Library on the Witholding of Sensitive Information page at http://www.nrc.gov/reading-rm/sensitive-info.html.

3.2. 10 CFR Part 37 Applicants requesting authorization for the GammaPod' unit must comply with 10 CFR Part 37 before installing sources for this unit. Note that individuals who are servicing or inspecting (i.e.,

NRC or Agreement State inspectors) the GammaPod' unit must be escorted at all times unless they fall under the relief granted under 10 CFR 37.29. For more information, see NUREG-1556, Volume 9, Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Medical Use Licenses; NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material; and NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.

3.3. Radionuclides, Form, Possession Limits, and Purpose of Use:

The applicant shall identify the radionuclides, chemical/physical form, requested maximum possession limit, and purpose of use. NRC Form 313, Application for Materials License, may be used to submit this information. For example, the following provides the format for an acceptable request:

Radionuclides, Form, Possession Limits Radionuclides: A. Cobalt-60 (NRC Form 313 Item 5)

Chemical/Physical Form: B. Sealed sources (Manufacturer and Model Number, e.g.

(NRC Form 313 Item 5) Xcision Model GammaPod Model A)

Maximum Possession Limit: C. 198 curies per source not to exceed 4,950 curies total (NRC Form 313 Item 5) (or 10000 curies during source exchange)

Purpose:

For 10 CFR 35.1000 medical use in the Xcision (NRC Form 313 Item 6) GammaPod' gamma stereotactic radiosurgery unit.

3.4. Facility Address and Description [10 CFR 30.33(a)(2) and 10 CFR 35.12(b)(1)]:

Provide an address of use, submit a facility diagram and description of the location where the GammaPod' gamma stereotactic radiosurgery unit will be used or stored. For more information, see the section entitled Facilities Diagrams in NUREG-1556, Volume 9, Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Medical Use Licenses.

4. Training and Experience 4.1 Authorized Individuals [10 CFR 30.33(a)(3), § 35.12(b)(1), § 35.50, § 35.51, and § 35.690]

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The NRC has determined that individuals meeting the guidance provided below will be considered qualified and authorized for the GammaPod' gamma stereotactic radiosurgery unit.

Applicants may also submit alternative training and experience commitments to be reviewed on a case-by-case basis by the NRC staff. The alternative information should include an explanation of why the applicant believes the alternative information demonstrates that the individuals are qualified to be authorized individuals.

Because there are a limited number of GammaPod' units approved for medical use in the United States at the time this licensing guidance was published in 2019, there are a limited number of preceptors available to sign attestations. Therefore, the NRC is postponing requiring a written attestation until [2 years from the issuance of this guidance] for authorized users (AU) and authorized medical physicists (AMP). At that time, attestations will be required for individuals who do not hold certification by a recognized specialty board2 or are not already authorized for use of other gamma stereotactic radiosurgery units. The NRC will continue to review the availability of preceptors and may revise this guidance if it determines that sufficient preceptors have not become available. In addition, all individuals seeking authorization for use of the GammaPod' unit must submit documentation of successful completion of required training.

4.1.1. Authorized Users Applicants and licensees should identify each AU of the GammaPod' gamma stereotactic radiosurgery unit and provide documentation of his/her training and experience in the use of the GammaPod' unit. The NRC Form 313A (AUS), Authorized User Training, Experience and Preceptor Attestation, or other formats may be used to document this training and experience.

The physician will be considered qualified for use of the GammaPod' gamma stereotactic radiosurgery unit if the individual meets the following:

1) Is listed on a license or permit (NRC, Agreement State, Broad Scope License or NRC Master Materials License) as an AU for medical use of a gamma stereotactic radiosurgery unit under 10 CFR 35.600 or 10 CFR 35.1000; or is certified by a recognized board listed on the NRCs Web site2 under 10 CFR 35.690, Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units; or meets the criteria in 10 CFR 35.690(b)(1) and (2);

AND

2) Received documented training in hands-on device operation, safety procedures, and clinical use, which includes preparing treatment plans and calculating treatment doses and times, for the GammaPod' gamma stereotactic radiosurgery unit. If the individual is already an AU for another gamma stereotactic radiosurgery unit, in accordance with 10 CFR 35.690(c), this training must also include the differences in the device operation, safety procedures, and clinical use, of the GammaPod' compared to the other gamma stereotactic radiosurgery unit(s). This training requirement may be satisfied by satisfactory completion of a training program provided by the GammaPod' vendor or by receiving training supervised by an AU or authorized medical physicist (AMP), as appropriate, who is authorized for the GammaPod' use; AND 2

https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html 3

3) As of [2 years from the issuance of this guidance], for proposed AU demonstrating training and experience who is not certified by a recognized board listed on the NRCs Web site2 under 10 CFR 35.690(a) or not already authorized for use of GammaPod' or another gamma stereotactic radiosurgery unit; Obtained a written attestation that the individual has satisfactorily completed the training requirements above, and is able to independently fulfill the radiation safety-related duties as an AU for the GammaPod' unit. The written attestation must be signed by a preceptor AU who is authorized for the GammaPod' unit or a residency program director, in accordance with 10 CFR 35.690(b)(3)(ii), who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an AU for GammaPod', who concurs with the attestation provided by the residency program director.

4.1.2 Authorized Medical Physicists Applicants and licensees should identify each AMP for the GammaPod' gamma stereotactic radiosurgery unit and provide documentation of his/her training and experience in the use of the GammaPod' unit. The NRC Form 313A (AMP), Authorized Medical Physicist and Ophthalmic Physicist Training, Experience and Preceptor Attestation, or other formats may be used to document this training and experience. The medical physicist shall be considered qualified for use of the GammaPod' gamma stereotactic radiosurgery unit if the individual meets the following:

1) Is listed on a license or permit (NRC, Agreement State, Broad Scope License or NRC Master Materials License) as an AMP for gamma stereotactic radiosurgery unit use; or is certified by a recognized board listed on the NRCs Web site2 under 10 CFR 35.51, Training for an authorized medical physicist; or meets the criteria in 10 CFR 35.51(b)(1) for gamma stereotactic radiosurgery unit use; AND

2) Received documented training in hands-on device operation, safety procedures, clinical use, and the operation of the treatment planning system used with the GammaPod' unit. If the individual is already an AMP for another gamma stereotactic radiosurgery unit, in accordance with 10 CFR 35.51(c), this training must also include the differences in the device operation, safety procedures, clinical use, and operation of the treatment planning system used with the GammaPod' unit compared to the other gamma stereotactic radiosurgery unit(s). This training requirement may be satisfied by satisfactory completion of a training program provided by the GammaPod' vendor or by receiving training supervised by an AMP authorized for GammaPod' use; AND

3) As of [2 years from the issuance of this guidance], for proposed AMP who is not certified by a recognized board listed on the NRCs Web site2 under 10 CFR 35.51 or who is not already authorized for use of GammaPod' or another gamma stereotactic radiosurgery unit; Obtained a written attestation that the individual has satisfactorily completed the training requirements above, and is able to independently fulfill the radiation safety-related duties as an AMP for the GammaPod' unit. The written attestation must be signed by a preceptor AMP who is authorized for the GammaPod' unit.

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4.1.3 Radiation Safety Officers:

Identify the Radiation Safety Officer (RSO) with responsibility for the GammaPod' gamma stereotactic radiosurgery unit and provide documentation of his/her training and experience in radiation safety for the GammaPod' unit. If desired, identify an individual who will be assigned duties and tasks as an Associate RSO for the GammaPod' unit in accordance with 10 CFR 35.24(b). For both the RSO and Associate RSO, NRC Form 313A (RSO), Radiation Safety Officer or Associate Radiation Safety Officer Training, Experience and Preceptor Attestation, or other formats may be used to document this training and experience. The NRC recognizes that some applicants with new installations could have an individual who will have RSO responsibilities or Associate RSO duties for the unit but may not have access to an operational GammaPod' unit at the time of the radiation safety, regulatory issues, and emergency procedures training. For this reason, the applicant may commit that the individual(s) will complete supplemental hands-on radiation safety and emergency procedure training before first patient treatment using the GammaPod' unit. The individual(s) shall be considered qualified to be the RSO or Associate RSO, if applicable, for the GammaPod' gamma stereotactic radiosurgery unit if the individual(s) meet the following:

1) Is listed as an RSO or Associate RSO on a license or permit (NRC, Agreement State, Broad Scope License or NRC Master Materials License) authorizing gamma stereotactic radiosurgery unit medical use; or is certified by a recognized board listed on the NRCs Web site2 under 10 CFR 35.50, Training for Radiation Safety Officer and Associate Radiation Safety Officer; or meets the criteria in 35.50(b)(1) or (c) for gamma stereotactic radiosurgery unit use; AND

2) Received documented training in the radiation safety, regulatory issues, and emergency procedures for the GammaPod' gamma stereotactic radiosurgery unit in accordance with 10 CFR 35.50(d). If the individual is already an RSO or Associate RSO for another gamma stereotactic radiosurgery unit, in accordance with 10 CFR 35.50(d), this training must also include the differences in the radiation safety, regulatory issues, and emergency procedures for the GammaPod' unit compared to the other gamma stereotactic radiosurgery unit(s). This training requirement may be satisfied by satisfactory completion of a training program provided by the GammaPod' vendor or by receiving training supervised by an RSO, Associate RSO, AMP, or AU, as appropriate, who is authorized for the GammaPod' unit. If the applicants facility does not currently have access to an operational GammaPod' unit at the time of licensing, the applicant may commit that the individual(s) will complete supplemental hands-on radiation safety and emergency procedure training before first patient treatment using the GammaPod' unit; AND

3) For proposed RSO or ARSO who is not certified by a recognized board listed on the NRCs Web site under 10 CFR 35.50(a) or 10 CFR 35.51(a) or who is not already listed on a license or permit as the RSO or ARSO for the GammaPod' or another gamma stereotactic radiosurgery unit; Obtained a written attestation in accordance with 10 CFR 35.50 (b)(2) that the individual has satisfactorily completed the training requirements in 10 CFR 35.50 5

(b)(1) and (d), and is able to independently fulfill the radiation safety-related duties as a RSO or as an Associate RSO, if applicable, for the GammaPod' gamma stereotactic radiosurgery unit. The written attestation must be signed by a preceptor RSO or Associate RSO who has experience with the radiation safety aspects of similar types of use of byproduct material, generally the GammaPod' unit, or another GSR unit. The written attestation is not required for individuals who hold a certification by a recognized specialty board under 10 CFR 35.50(a) or 10 CFR 35.51(a); or who are currently listed on a license or permit for another gamma stereotactic radiosurgery unit where their training in accordance with 10 CFR 35.50, including preceptor attestation, was already evaluated.

5. Licensing Commitments:

5.1. Written Directive [10 CFR 35.40]

The GammaPod' gamma stereotactic radiosurgery unit and under 10 CFR 35.40 requires a written directive. Unlike earlier gamma stereotactic radiosurgery units licensed under 10 CFR 35.600, dose is delivered to the treatment site dynamically with the GammaPod' as the source and collimator carrier and patient table move during treatment and GammaPod' treatments are not controlled by distinct target coordinate settings, which are required to be in the written directive for gamma radiosurgery under 10 CFR 35.40. In addition, some GammaPod' treatment protocols use fractions. Therefore, to assure the dose is delivered in accordance with the AUs direction, the written directive should provide the following commitment in place of 10 CFR 35.40(b)(3):

For the GammaPod' gamma stereotactic radiosurgery unit use, the written directive will contain the patient or human research subject's name; the total dose; the treatment site, including the planning target volume; dose per fraction; number of fractions; and breast cup size/type.

Licensees should additionally commit to following 10 CFR 35.40(a), (c), and (d).

Licensees are required under 10 CFR 35.41(a)(2) to have procedures that provide high confidence that each administration is in accordance with the written directive. Under 10 CFR 35.41(b)(4) these procedure are required to address, among other things, verification that any computer-generated dose calculations are correctly transferred into the console of gamma stereotactic radiosurgery medical units authorized by 10 CFR 35.600. This verification is also applicable to gamma stereotactic radiosurgery units regulated under 10 CFR 35.1000.

The GammaPod' treatment is delivered via a series of movements through a series of control points designed to match the treatment plan. For this reason, the applicant should provide the following commitment in addition to 10 CFR 35.41:

For the GammaPod' unit, procedures that provide high confidence that each administration is in accordance with the written directive will address verification that the control points are consistent with the treatment control systems displayed target volume.

In addition, proper localization and immobilization is necessary for a successful treatment.

Therefore, the applicant should confirm the following for the GammaPod':

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Our program to provide high confidence that the administration is in accordance with the written directive will include written procedures for: (1) verification proper pump pressure and appropriate breast cup size and type, (2) verification that the proper plan has been selected, (2) pausing treatment and checking the patient set-up if a patient is observed to move such that delivery of the treatment would be effected, and (4) visually checking the patient set up at the initiation, re-initiation, and end of treatment.

5.2. Specific Information on Radiation Safety Precautions and Instructions

[10 CFR 35.12(d)(1)(i)]

The applicant must submit the information required by 10 CFR 35.12(b)(2), including procedures required in 10 CFR 35.610 and 10 CFR 35.645. In addition, the applicant must submit the information required by 10 CFR 35.12(d). Because the GammaPod' is a gamma stereotactic radiosurgery unit, the applicant may simplify its submission by confirming the following:

The applicant must provide a copy of:

Safety procedures and instruction for the GammaPod' unit and spot-check procedures for the GammaPod' unit.

For use of the Xcision GammaPod', we will meet the following requirements for a gamma stereotactic radiosurgery unit in 10 CFR Part 35, Subpart H:

Section 35.600, Section 35.605 (and retain records of the information described in Section 35.2605 for 3 years),

Section 35.610 (and retain procedures described in Sections 35.610(a)(4) and (d)(2) until the licensee no longer possesses the unit),

Section 35.615(a) through (d), (g), 35.615(f)(4),

Section 35.615(f)(3) (with modifications discussed below),

Section 35.630 (and retain a copy of the information described in Section 35.2630 for the period stated in Section 35.2630),

Section 35.635 (with modifications discussed below and retain a copy of the information described in Section 35.2632 with modifications discussed below for the period stated in Section 35.2632),

Section 35.645 (with modifications discussed below and retain a copy of the information described in Section 35.2645 with modifications discussed below for the period stated in Section 35.2645), and Section 35.652 Section 35.655 7

Section 35.657 (with modifications listed below).

For more information on these regulations, see sections on Operating and Emergency Procedures and Emergency Procedures for Therapy Devices Containing Sealed Sources, in NUREG-1556, Volume 9.

5.3. Full Calibration Measurements and Periodic Spot-checks [10 CFR 35.635 and 35.645]

Due to the design of the GammaPod', there are some required spot-checks and calibrations in 10 CFR 35.635 and 35.645 which cannot be performed, and associated required records described in 10 CFR 35.2632 and 35.2645 which cannot be completed. For example, the GammaPod' does not have a helmet for localization. Therefore spot-checks on helmet microswitches and trunnions and calibration on relative helmet factors, trunnions, and helmet microswitches cannot be performed. Further, the GammaPod' has unique features which were not considered during the development of 10 CFR 35, Subpart H, that require additional spot-checks and calibrations to ensure proper operations and functioning of the system to minimize risks of a potential medical events. These features include a breast immobilization and localization system; treatment table, sources, and collimators which move during treatment; and the function of the uninterrupted power supply during a power failure event. Refer to the Sealed Source and Device registration certificate for more information about these design features.

Due to these GammaPod' design features, the applicant should commit to the following for the GammaPod' in place of 10 CFR 35.635, 35.645, 35.2632, and 35.2645.

We will follow the applicable spot-check requirements in 10 CFR 35.645 and retain the information described in 10 CFR 35.2645 for each spot-check except for those requirements which are not applicable. We shall perform spot-check measurements as specified in 10 CFR 35.645(a). We shall arrange for the repair of any system identified in paragraph (c) of this section that is not operating properly as soon as possible. We will keep each record of the spot-checks for 3 years.

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The applicable spot-check requirements for the GammaPod' unit are:

• 10 CFR 35.645 o (b) o (c)(1)(i), and (1)(iii);

o (c)(2)(i), (ii), (iii), (iv), and (v);

o (d)(1), (3), (4), (5), and (6);

o (e), as applicable o (f), as applicable Before each patient use, and when the patient is immobilized, we will confirm the breast immobilization and localization system is working appropriately. At a minimum, we will confirm the negative pressure pump maintains an air-tight vacuum and the pump is functioning correctly and visually inspect the outer cup prior to treatment. In addition, we will ensure the cup lock switch is checked before the first use of the unit on a given day as specified by the manufacturer. This test and the description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

As part of spot-check measurements completed at intervals as specified in 10 CFR 35.645(a), we will confirm the geometric accuracy is in accordance with manufacturer tolerance limits. If the results of the checks indicate the malfunction, we shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. This test and the description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

As part of spot-check measurements completed at intervals as specified in 10 CFR 35.645(a), we will confirm proper functioning of the source exposure indicator light on the treatment room wall, in the facility prior to the treatment room, and on the console. If the results of the checks indicate the malfunction, we shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. This test and the description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

On a monthly basis, in addition to daily QA, we will verify no discoloration on the outer breast cups and the stereotactic frame is intact; manual operability of the treatment room door open/close, source close, and top shielding door close; congruence between the dosimetric isocenter and mechanical isocenter; dosimetric accuracy; and dose linearity of the timer are within the manufacturer specified tolerance limits. If the results of these checks indicate the malfunction of any system, we will lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the 9

malfunctioning system. We will also check the safety/emergency related items are present. This test and the description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

We will follow the applicable full calibration requirements of 10 CFR 35.635 and retain the information described in 10 CFR 35.2632 for each full calibration except for those requirements which are not applicable. We will keep each record of the full calibration 3 years. We shall perform full calibration measurements as specified in 10 CFR 35.635(a). In addition, we shall perform full calibration measurements following any repair of the GammaPod' unit that includes major repair of the components associated with the collimator assembly or equipment, such as motors, associated with localization during patient treatment.

The applicable full calibration requirements for the GammaPod' unit are 10 CFR 35.635

• (b)(1), (3), (4), (5) , and (9)

• (c), (e), (f), (g)

We will perform full calibration measurement procedures in accordance with published protocols accepted by nationally recognized bodies, except when nationally recognized bodies have not published required full calibration procedures for components and features of the GammaPod' unit. In the absence of published protocols for the GammaPod' unit accepted by nationally recognized bodies, we will use procedures developed by the manufacturer.

As part of full calibration measurements completed at intervals as specified in 10 CFR 35.635(a), we will perform comprehensive routine quality check that includes all safety, dosimetry accuracy and geometry accuracy tests and the end-to-end plan verification that is not performed during monthly QA checks. We will verify the proximity sensor ensuring proper docking is in working order. Also, we will perform area surveys in both non-treating and treating conditions and check the integrity of the uninterruptible power supply (UPS) system, including verification of collimator closure in event of power failure.

These tests will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

Approximately every six months (with exact date subject to vendor service availability),

we will confirm that speed of the table motion and collimator and source rotation are within appropriate tolerance limits. This test and the description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

During installation and approximately every six months (with exact date subject to vendor service availability), we will confirm that the vendor will verify that the location of the radiation isocenter, with respect to the table position, is within the specifications using measurements conducted in an off-centered position. This test and the 10

description of the record of the test will be included in the spot-check procedures. The test will also be performed during the full calibration measurements of the GammaPod' unit. We will keep each record of the results of this test performed during the full calibration measurement and spot-check for 3 years.

We confirm that if the localization system (i.e. breast cups, flange, and suction pump) fails to perform as designed, we will remove the defective part from service until repaired.

We confirm that if the docking devices (i.e. clamp, table loader, etc.), source and collimator movement, or table movement or positioning fail to perform as designed, we will lock the control console in the off position and not use the unit except as necessary to repair, replace, or check the malfunctioning system.

We confirm that if QA survey instruments, the Podscope or other QA test tool fails to function as specified by the manufacturer, we will have the tool repaired or replaced before the next patient treatment requiring the proper function of that tool.

5.4. Physical Presence Required by 35.615(f)(3)

As defined in 10 CFR 35.615(f)(3), an AU and an AMP are required to be physically present throughout all patient treatments involving gamma stereotactic radiosurgery units. However, unlike older models of gamma stereotactic radiosurgery units, GammaPod' have additional safety features including the pump suction interlock which will terminate the treatment if suction is lost and thereby providing adequate assurance that the treatment would be terminated following patient movement. In addition, the system utilizes a completely automated treatment system to delivery dose which eliminates the need to manually reposition patients following initiation of the treatment. As such, the physical presence of the AU throughout all patient treatments required by 10 CFR 35.615(f)(3) is unnecessary for the GammaPod' units, provided an AMP and a physician, under the supervision of an AU, are present during continuation of all treatments.

Therefore, the applicant should confirm to meeting the requirements in 10 CFR 35.615(f)(3) or the following:

1) An authorized user and an authorized medical physicist will be physically present during the initiation of all patient treatments involving the GammaPod' unit;

2) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, will be physically present during continuation of all patient treatments involving the GammaPod' unit; and

3) An authorized user will return to the GammaPod' unit console if there is an interruption of treatment to evaluate the patient, to review any information related to an abnormal situation, and to ensure that the treatment is being delivered in accordance with the treatment plan and written direction prior to re-initiation of the treatment.

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5.5. Published Protocols Accepted by Nationally Recognized Bodies Full calibration measurement procedures for gamma stereotactic radiosurgery units required by 10 CFR 35.635(d) and acceptance testing on the treatment planning system of therapy-related computer systems required by 10 CFR 35.657 must be in accordance with published protocols accepted by nationally recognized bodies. However, the GammaPod' unit contain components and features that are not addressed in the full calibration and acceptance testing procedures accepted and published by nationally recognized bodies. In this case, the applicant may use procedures developed by the manufacturer.

The applicant should confirm the following:

We will perform full calibration measurement procedures in accordance with published protocols accepted by nationally recognized bodies, except when nationally recognized bodies have not published required full calibration procedures for components and features of the GammaPod' unit. In the absence of published protocols for the GammaPod' unit accepted by nationally recognized bodies, we will use procedures developed by the manufacturer.

We will perform acceptance testing on treatment planning systems in accordance with published protocols accepted by nationally recognized bodies, except when nationally recognized bodies have not published procedures for acceptance testing on the treatment planning system for the GammaPod' System. In the absence of published protocols accepted by nationally recognized bodies, we will use procedures developed by the manufacturer, if available, or equivalent procedures.

6. Notes to Licensees 6.1. Alterations to GammaPod' Units This licensing guidance is based on the Sealed Source and Device (SS&D) safety evaluation in Registration Sheet MD-1362-D-101-S. Modification of the sources, the device, or the source-device combination will require a new or amended SS&D certificate (or safety evaluation by the broad scope medical use licensee) that addresses the conditions of use and safety of the modified GammaPod' unit.

6.2. Changes in Physical Conditions of Use If the physical conditions of use exceed those reported in the SS&D certificate, the limited specific medical use licensee should request an amendment for the new conditions, and a broad scope licensee should perform its own engineering and radiation safety evaluation addressing those differences.

6.3. Notification for AUs and AMPs The NRC recognizes that if an AU or AMP satisfies the training and experience listed in the NRCs licensing guidance for the GammaPod' unit and is currently listed on a Commission or Agreement State medical use license or permit for the GammaPod' unit, the AU or AMP should be allowed to work under a different license for the medical use of the GammaPod' unit. A limited specific medical use applicant initially applying for authorization for the medical use of the GammaPod' unit or an existing licensee applying for an amendment may request 12

authorization to notify the NRC in the future that it has permitted an AU to work at its facility without the need to request an additional license amendment, provided the following conditions are met:

1) the AU or AMP meets the training and experience criteria listed in NRCs licensing guidance for the GammaPod' unit; and

2) the AU or AMP is currently listed for the GammaPod' unit use on a Commission or Agreement State license, a permit issued by a Commission Master Material License, a permit issued by a Commission or Agreement State licensee of a broad scope, or a permit issued by a Commission master material license broad scope permittee; and

3) the licensee provides NRC a copy of the license or permit on which the AU or AMP was originally listed for the GammaPod' unit; and

4) the licensee provides documentation to NRC for each AU or AMP of the above listed conditions no later than 30 days after the date that the licensee allows the AU or AMP to work as an AU or AMP for the GammaPod' unit.

If this authorization is approved, these notification conditions will be incorporated as license conditions in the licensees license.

6.4. Revisions to Existing GammaPod' Radiation Safety Programs to Conform to Future Changes in Licensing Guidance and Additional Safety Recommendations from the Manufacturer Requesting authorization in accordance with the following guidance will permit a licensee to make certain changes under 10 CFR 35.26, Radiation protection program changes, to the GammaPod' gamma stereotactic radiosurgery unit safety program that might otherwise require a license amendment.

The above licensing guidance and safety recommendations from the manufacturer may be revised as additional experience is gained regarding medical use of the GammaPod' gamma stereotactic radiosurgery unit by the regulator and manufacturer. In contrast with 10 CFR 35.26, a licensee already authorized to use the GammaPod' gamma stereotactic radiosurgery unit and committed by license condition to follow the provisions in the guidance and Operators Manual existing at the time of commitment must apply for and receive an amendment to its license prior to making changes to conform to the revised guidance and additional radiation safety recommendations.

An applicant initially applying for authorization for medical use of the GammaPod' gamma stereotactic radiosurgery unit (or a licensee applying later for an amendment to conform to revisions in this guidance) may request authorization to allow future changes to radiation safety program, provided the following conditions are met:

1) The revision is in compliance with the regulations of the NRC or Agreement State;

2) The revision is based on the current guidance for the GammaPod' and/ gamma stereotactic radiosurgery unit medical use under 10 CFR 35.1000 use posted on the NRC Web site or the current operators manual and additional safety recommendations from the manufacturer; 13

3) The revision has been reviewed and approved by the licensees Radiation Safety Officer and management;

4) The affected individuals are instructed on the revised program before the change is implemented;

5) The licensee will retain a record of each change for 5 years; and

6) The record will include a copy of the appropriate Web site guidance, the old procedure, the new procedure, the effective date of the change, and the signature of the licensees management representative who reviewed and approved the change.

If this authorization is approved, these conditions will be incorporated as license conditions in the licensees license. This may be done by incorporating the commitments in the tie down condition.

7. Note to Regulators 7.1. Inspection Frequency Licenses authorizing GammaPod' units should be inspected every two years. Per Enclosure 1 to Inspection Manual Chapter 2800, licenses authorizing emerging technology in 10 CFR 35.1000 are assigned a Priority 2 inspection code.

7.2. Program Code The NRC regions should use program code 02310.

8. Paperwork Reduction Act Statement The information collections contained in this guidance are covered by the requirements of 10 CFR Parts 30, 32 and 35, which were approved by the Office of Management and Budget (OMB), approval numbers 3150-0017, 3150-0001, and 3150-0010, as well as, 3150- 0120 for filling out the NRC Form 313.

9. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement, unless the requesting document displays a currently valid OMB control number.

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