ML25087A147
| ML25087A147 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/2025 |
| From: | Maryann Ayoade NRC/NMSS/DMSST/MSEB |
| To: | |
| References | |
| Download: ML25087A147 (14) | |
Text
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 1
Emerging Medical Technology (EMT): LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Guidance Version: Original / Revision 0 Determination: 35.1000 Completed by: Maryann Ayoade Reviewed by: Maryann Ayoade Date: 03/26/2025 The following table provides a list of 10 CFR Part 35 regulations and conditions the NRC has determined are applicable for use of the LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System. Licensees shall comply with all regulations which address use of the LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System. The table also provides specific conditions which the NRC has determined are necessary for the medical use of the LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System. In addition, the table lists where licensees and applicants can find additional guidance. Applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis by NRC staff.
Section Description EMT Use Addressed in Regulation Guidance
[LV Guidance]
Guidance Section Comment 35.1 Purpose and scope Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2 Definitions Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.5 Maintenance of records Yes No N/A 1566 Vol 9
[LV Guidance]
Other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 2
35.6 Provisions for the protection of human research subjects Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.7 FDA, other Federal, and State requirements Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.8 Information collection requirements: OMB approval Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 9
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 3
35.10 Implementation Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.11 License required Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.12 Application for license, amendment, or renewal Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.13 License amendments Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.14 Notifications Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.18 License issuance Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.19 Specific exemptions Yes No N/A 1566 Vol 9
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 4
[LV Guidance]
Other Subpart B - General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.26 Radiation protection program changes Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.2 Parts of 10 CFR 35.26 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
The guidance may be revised as the regulator, manufacturer, and industry gains more experience more about the technology.
35.27 Supervision Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.1 This is a new technology that requires additional operational experience.
Precedence with NeoVista Epi-Rad90TM System and Intravascular Brachytherapy System Licensing Guidance that both have consultation and physical presence criteria.
ACMUI recommended physician presence of both the AU and AMP.
35.40 Written directives (WDs)
Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.3 Parts of 10 CFR 35.40 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
10 CFR 35.40(b)(7) describes written directive requirements for all other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 5
brachytherapy. This requirement does not include the source activity as part of the written directive, which is essential for determining the treatment times, similar to the requirement for Sr-90 sources in accordance with 10 CFR 35.433.
35.41 Procedures for administrations requiring a WD Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.49 Suppliers for sealed sources or devices for medical use Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 5.2 Parts of 10 CFR 35.50 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
Similar criteria are needed for training in the use of the LV Y-90 Disc source for the AU.
35.51 Training for an authorized medical physicist (AMP)
Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 5.2 Parts of 10 CFR 35.51 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
Similar criteria are needed for training in the use of the LV Y-90 Disc source for the AU.
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 6
35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user (AU),
nuclear pharmacist, and ANP Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.59 Recentness of training Yes No N/A 1566 Vol 9
[LV Guidance]
Other Subpart C - General Technical Requirements 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.61 Calibration of survey instruments Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.65 Authorization for calibration, transmission, and reference sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 7
35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.69 Labeling of vials and syringes Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.70 Surveys of ambient radiation exposure rate Yes No N/A 1566 Vol 9
[LV Guidance]
Other Parts of 10 CFR 35.70 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
The requirement for surveys related to unsealed byproduct materials use is not needed as the LV Liberty Vision Y-90 Disc source is not unsealed materials.
35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.80 Provision of mobile medical service Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.92 Decay-in-storage Yes No N/A 1566 Vol 9
[LV Guidance]
Other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 8
Subpart F - Manual Brachytherapy 35.400 Use of sources for manual brachytherapy Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.404 Surveys after source implant and removal Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.5 Parts of 10 CFR 35.404 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
10 CFR 35.404(a) is not needed. 10 CFR 35.404(b) is needed. The licensee needs only to perform surveys following removal of the implant to confirm that the source has been removed. The licensee does not need to perform surveys to locate and account for sources not implanted as this is a temporary brachytherapy treatment that uses a single source for a one-time/single use.
35.406 Brachytherapy sources accountability Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.410 Safety instruction Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.415 Safety precautions Yes No N/A 1566 Vol 9
[LV
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 9
Guidance]
Other 35.432 Calibration measurements of brachytherapy sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.4 Includes commitment for the licensee to commit to following 10 CFR 35.432 and 35.2432.
Also includes recommendation that the licensee should in alignment with manufacturer recommendation and published protocols by American Association of Physicists in Medicine, perform measurements to confirm the manufacturer measurements of source activity. Any discrepancies should be resolved according to the AAPM guidelines related to source calibration and manufacturers recommendations.
35.433 Sr-90 sources for ophthalmic treatments Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 6.4 Parts of 10 CFR 35.433 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
Similar to 10 CFR 35.433, but specific for use of the LV Y-90 Disc source.
Similar criteria are needed for use of Y-90 sources for ophthalmic treatments and to allow for the AMP or ophthalmic physicist to perform the required calculations for a Y-90 source to determine treatment times and for the development of written directive procedures for the LV Y-90 Disc.
35.457 Therapy-related computer systems Yes No N/A 1566 Vol 9
[LV
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 10 Guidance]
Other 35.490 Training for use of manual brachytherapy sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 5.2 Parts of 10 CFR 35.490 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
Similar criteria are needed for training in the use of the LV Y-90 Disc source for the AU.
35.491 Training for ophthalmic use of Sr-90 Yes No N/A 1566 Vol 9
[LV Guidance]
Other Section 5.2 Parts of 10 CFR 35.491 can be met with modifications provided in the guidance.
The guidance document provides additional information specific to LV Liberty Vision use.
Similar criteria are needed for training in the use of the LV Y-90 Disc source for the AU.
Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2026 Records of radiation protection program changes Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2040 Records of WDs Yes No N/A 1566 Vol 9
[LV Guidance]
Other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 11 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct materials Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2061 Records of radiation survey instrument calibrations Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1566 Vol 9
[LV Guidance]
Other
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 12 35.2080 Records of mobile medical services Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2092 Records of decay-in-storage Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2404 Records of surveys after source implant and removal Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2406 Records of brachytherapy source accountability Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A 1566 Vol 9
[LV Guidance]
Other Although use of the LV Y-90 Disc is not addressed in this requirement (because it is specific for Sr-90 sources and not Y-90 sources), this requirement is not needed.
This requirement to maintain records of activity for the life of the source is not
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 13 needed for use of the LV Y-90 Disc.
Due to the much shorter half-life of Y-90
- 64.2hrs as compared to Sr 28.8yrs (10 half-lives is about 26 days for Y-90 vs. 290 years for Sr-90) and the single use of the source, the requirement to maintain records of activity for the life of the source will be a much shorter timeframe, and is not needed.
Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.3067 Report of a leaking source Yes No N/A 1566 Vol 9
[LV Guidance]
Other 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1566 Vol 9
[LV Guidance]
Other Subpart N - Enforcement 35.4001 Violations Yes No N/A 1566 Vol 9
[LV
Appendix LV Liberty Vision Corporation Yttrium-90 Disc and iWand Ophthalmic System Consolidated Technical Analysis 14 Guidance]
Other 35.4002 Criminal penalties Yes No N/A 1566 Vol 9
[LV Guidance]
Other Additional Considerations