ML24206A038

Akesis Galaxy 35.1000 Consolidated Technical Analysis

ML24206A038
Person / Time
Issue date:	08/23/2024
From:	NRC/NMSS/DMSST/MSEB
To:
References
Download: ML24206A038 (1)

Text

Appendix

Consolidated Technical Analysis

The following table provides a list of 10 CFR Part 35 regulations and conditions the NRC has determined are applicable for use of Akesis Galaxy RTi. Licensees shall comply with all regulations which address use of Akesis Galaxy RTi. The table also provides specific regulations and conditions which the NRC has determined are necessary for the medical use of Akesis Galaxy RTi.

Applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis by NRC staff.

Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis Subpart A - General Information 35.1 Purpose and scope Yes No N/A 35.2 Definitions Yes No N/A 35.5 Maintenance of records Yes No N/A 35.6 Provisions for the protection of human research Yes No N/A subjects 35.7 FDA, other Federal, and State requirements Yes No N/A 35.8 Information collection requirements: OMB approval Yes No N/A 35.10 Implementation Yes No N/A 35.11 License required Yes No N/A 35.12 Application for license, amendment, or renewal Yes No N/A 35.13 License amendments Yes No N/A 35.14 Notifications Yes No N/A 35.15 Exemptions regarding Type A specific licenses of broad Yes No N/A scope 35.18 License issuance Yes No N/A 35.19 Specific exemptions Yes No N/A Subpart B - General Administrative Requirements

1 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.24 Authority and responsibilities for the radiation protection Yes No N/A program 35.26 Radiation protection program changes Yes No N/A Standard 10 CFR 35.1000 language will be added.

35.27 Supervision Yes No N/A 35.40 Written directives (WDs) Yes No N/A A written directive (WD) is required to be followed but the specifications of the WD are different as provided in the guidance. The WD will contain the patient or human research subject's name; the total dose; the treatment site; dose per fraction; number of fractions; and the X, Y, Z target coordinate values; gamma angle; beam rotation start and stop angle and collimator size for each treatment shot within an anatomically distinct treatment site.

35.41 Procedures for administrations requiring a WD Yes No N/A Requirements in 10 CFR 35.41 can be followed but additional commitments should be included as listed in the guidance. For the Akesis Galaxy RTi GSR unit, procedures that provide high confidence that each administration is in accordance with the WD will address verification that any computer-generated dose calculations are correctly transferred into the Akesis Galaxy RTi control system.

2 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.49 Suppliers for sealed sources or devices for medical use Yes No N/A SS&D to be issued by CDPH.

35.50 Training for Radiation Safety Officer (RSO) and Yes No N/A Will mirror regulations but updated for Associate RSO 10 CFR 35.1000.

35.51 Training for an authorized medical physicist (AMP) Yes No N/A Will mirror regulations but updated for 10 CFR 35.1000.

35.55 Training for an authorized nuclear pharmacist (ANP) Yes No N/A 35.57 Training for experienced RSO, teletherapy or medical Yes No N/A Member(s) must have device specific physicist, AMP, authorized user (AU), nuclear training per 10 CFR 35.690(c).

pharmacist, and ANP 35.59 Recentness of training Yes No N/A Subpart C - General Technical Requirements 35.60 Possession, use, and calibration of instruments used to Yes No N/A measure the activity of unsealed byproduct material 35.61 Calibration of survey instruments Yes No N/A 35.63 Determination of dosages of unsealed byproduct Yes No N/A.

material for medical use 35.65 Authorization for calibration, transmission, and Yes No N/A reference sources 35.67 Requirements for possession of sealed sources and Yes No N/A brachytherapy sources 35.69 Labeling of vials and syringes Yes No N/A 35.70 Surveys of ambient radiation exposure rate Yes No N/A 35.75 Release of individuals containing unsealed byproduct Yes No N/A material or implants containing byproduct material 35.80 Provision of mobile medical service Yes No N/A 35.92 Decay-in-storage Yes No N/A The licensee will not be allowed to have decay in storage for unused Akesis Co-60 material.

3 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis Subpart D - Unsealed Byproduct Material - Written Directive Not Required 35.100 Use of unsealed byproduct material for uptake, dilution, Yes No N/A and excretion studies for which a WD is not required 35.190 Training for uptake dilution, and excretion studies Yes No N/A 35.200 Use of unsealed byproduct material for imaging and Yes No N/A localization studies for which a WD is not required 35.204 Permissible Mo-99, Sr-82, Sr-85 concentrations Yes No N/A 35.290 Training for imaging and localization studies Yes No N/A Subpart E - Unsealed Byproduct Material - WD Required 35.300 Use of unsealed byproduct material for which a WD is Yes No N/A required 35.310 Safety instruction Yes No N/A 35.315 Safety precautions Yes No N/A 35.390 Training for use of unsealed byproduct material for Yes No N/A which a WD is required 35.392 Training for the oral administration of NaI I-131 Yes No N/A requiring a WD in quantities <= 1.22 GBq (33 mCi) 35.394 Training for the oral administration of NaI I-131 Yes No N/A requiring a WD in quantities > 1.22 GBq (33 mCi) 35.396 Training for the parenteral administration of unsealed Yes No N/A byproduct material requiring a WD Subpart F - Manual Brachytherapy 35.400 Use of sources for manual brachytherapy Yes No N/A 35.404 Surveys after source implant and removal Yes No N/A 35.406 Brachytherapy sources accountability Yes No N/A 35.410 Safety instruction Yes No N/A 35.415 Safety precautions Yes No N/A

4 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.432 Calibration measurements of brachytherapy sources Yes No N/A 35.433 Sr-90 sources for ophthalmic treatments Yes No N/A 35.457 Therapy-related computer systems Yes No N/A 35.490 Training for use of manual brachytherapy sources Yes No N/A 35.491 Training for ophthalmic use of Sr-90 Yes No N/A Subpart G - Sealed Sources for Diagnosis 35.500 Use of sealed sources and medical devices for Yes No N/A diagnosis 35.590 Training for use of sealed sources and medical devices Yes No N/A for diagnosis Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery (GSR) Units 35.600 Use of a sealed source in a remote afterloader unit, Yes No N/A Same intent of regulation but will be teletherapy unit, or GSR unit licensed under 10 CFR 35.1000.

35.604 Surveys of patients and human research subjects Yes No N/A treated with a remote afterloader unit 35.605 Installation, maintenance, adjustment, and repair Yes No N/A.

35.610 Safety procedures and instructions for remote Yes No N/A SOPs shall be generated and provided afterloader units, teletherapy units, and GSR units to NRC for review during the application process as required by 10 CFR 35.610 for all GSR units.

35.615 Safety precautions for remote afterloader units, Yes No N/A Some requirements in 10 CFR 35.615 teletherapy units, and GSR units can be followed as described in the guidance. However, due to engineering changes, some requirements are not applicable and additional safety precautions should be added as described in the guidance.

5 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis Therefore, Akesis Galaxy RTi unit licensees should confirm they are meeting the requirements in 10 CFR 35.615(f)(3) or the following:

1) An AU and an AMP will be physically present during the initiation of all patient treatments involving the Akesis Galaxy RTi unit;

2) An AMP and either an AU or a physician, under the supervision of an AU, 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 Akesis Galaxy RTi unit; and

3) An AU will return to the Akesis 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 directive prior to re-initiation of the treatment.

6 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.630 Dosimetry equipment Yes No N/A 35.632 Full calibration measurements on teletherapy units Yes No N/A 35.633 Full calibration measurements on remote afterloader Yes No N/A units 35.635 Full calibration measurements on GSR units Yes No N/A Some requirements in 10 CFR 35.635 can be followed as described in the guidance. However, due to engineering changes, most measurements will not apply.

10 CFR 35.635 requires full calibration measurement procedures to be performed in accordance with published protocols accepted by nationally recognized bodies.

The guidance provides a condition to use manufacturer full calibration procedures for components and features of the Akesis Galaxy RTi unit as nationally recognized bodies have not yet published calibration procedures for the unit.

The Licensee will follow the applicable full calibration requirements of 10 CFR 35.635 and the spot-check requirements in 10 CFR 35.645 and retain the information described in 10

7 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis CFR 35.2632 for each full calibration and 10 CFR 35.2645 for each check except for those involving helmets, helmet factors, helmet micro-switches, trunnions, and hydraulic backup of the treatment table retraction system.

Licensees will keep each record of the full calibration and spot-checks for 3 years.

35.642 Periodic spot-checks for teletherapy units Yes No N/A 35.643 Periodic spot-checks for remote afterloader units Yes No N/A 35.645 Periodic spot-checks for GSR units Yes No N/A Spot-check required in 10 CFR 35.645 are applicable except for those involving helmets, helmet factors, helmet micro-switches, trunnions, and hydraulic backup of the treatment table retraction system. Therefore, some requirements in 10 CFR 35.645 can be followed as described in the guidance.

However, due to engineering changes, some requirements will not apply and additional spot check commitments should be added as described in the guidance.

35.647 Additional technical requirements for mobile remote Yes No N/A afterloader units 35.652 Radiation surveys Yes No N/A 35.655 Full-inspection servicing for teletherapy and GSR units Yes No N/A

8 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.657 Therapy-related computer systems Yes No N/A 35.690 Training for use of remote afterloader units, teletherapy Yes No N/A The recommended training and units, and GSR units experience criteria is listed in the guidance. This criterion is similar to that listed in 10 CFR 35.690 for other GSR units, but updated to be specific to the Akesis as AU of the Akesis should have training in this unit prior to use.

Subpart L - Records 35.2024 Records of authority and responsibilities for radiation Yes No N/A protection programs 35.2026 Records of radiation protection program changes Yes No N/A 35.2040 Records of WDs Yes No N/A 35.2041 Records for procedure for administrations requiring a Yes No N/A WD 35.2060 Records of calibrations of instruments used to measure Yes No N/A the activity of unsealed byproduct materials 35.2061 Records of radiation survey instrument calibrations Yes No N/A 35.2063 Records of dosages of unsealed byproduct material for Yes No N/A medical use 35.2067 Records of leaks tests and inventory of sealed sources Yes No N/A and brachytherapy sources 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 35.2075 Records of the release of individuals containing Yes No N/A unsealed byproduct material or implants containing byproduct material 35.2080 Records of mobile medical services Yes No N/A

9 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.2092 Records of decay-in-storage Yes No N/A 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 35.2310 Records of safety instruction Yes No N/A 35.2404 Records of surveys after source implant and removal Yes No N/A 35.2406 Records of brachytherapy source accountability Yes No N/A 35.2432 Records of calibration measurements of brachytherapy Yes No N/A sources 35.2433 Records of decay of Sr-90 sources for ophthalmic Yes No N/A treatments 35.2605 Records of installation, maintenance, adjustment, and Yes No N/A repair of remote afterloader units, teletherapy units, and GSR units 35.2610 Records of safety procedures Yes No N/A 35.2630 Records of dosimetry equipment used with remote Yes No N/A afterloader units, teletherapy units, and GSR units 35.2632 Records of teletherapy, remote afterloader, and GSR Yes No N/A Updated to reflect the 10 CFR Part full calibrations 35.635 calibration tests completed and those that cannot be completed due to engineering design.

35.2642 Records of periodic spot-checks for teletherapy units Yes No N/A 35.2643 Records of periodic spot-checks for remote afterloader Yes No N/A units 35.2645 Records of periodic spot-checks for GSR units Yes No N/A Updated similar to 10 CFR 35.645.

35.2647 Records of additional technical requirements for mobile Yes No N/A remote afterloader units 35.2652 Records of surveys of therapeutic treatment units Yes No N/A

10 Section Description Regulation Deviation Explanation and Specifics Applicable to for Licensing Guidance Akesis 35.2655 Records of full-inspection servicing for teletherapy and Yes No N/A GSR units Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 35.3047 Report and notification of a dose to an embryo/fetus or Yes No N/A a nursing child 35.3067 Report of a leaking source Yes No N/A 35.3204 Report and notification for an eluate exceeding Yes No N/A permissible Mo-99, Sr-82, and Sr-85 concentrations Subpart N - Enforcement 35.4001 Violations Yes No N/A 35.4002 Criminal penalties Yes No N/A

11