ML20022A313
| ML20022A313 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/2020 |
| From: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| To: | Heather Gepford, Donna Janda, Robert Orlikowski NRC Region 1, NRC/RGN-III, NRC Region 4 |
| Katherine Tapp, NRC/NMSS | |
| Shared Package | |
| ML20022A311 | List: |
| References | |
| Download: ML20022A313 (3) | |
Text
January 24, 2020 MEMORANDUM TO: Donna M. Janda, Chief Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I Bob J. Orlikowski, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region III Heather U. Gepford, Chief Licensing and Decommissioning Branch Division of Nuclear Materials Safety Region IV FROM: Chris E. Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State /RA/
and Tribal Programs Office of Nuclear Materials Safety and Safeguards
SUBJECT:
NOTIFICATION OF ISSUANCE OF XCISION GAMMAPODTM LICENSING GUIDANCE The Xcision GammaPod Licensing Guidance was published on January 22, 2020.
On December 22, 2017, the GammaPod' received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use as a non-invasive stereotactic radiotherapy system utilizing 36 or 25 Cobalt-60 (Co-60) sources to treat breast cancer. The GammaPod' system is different from traditional gamma stereotactic radiosurgery units as it uses a vacuum-assisted breast cup immobilization and stereotactic localization system, rotating source and collimator CONTACT: Katherine Tapp, NRC/NMSS 301-415-0236
D. Janda, et al. 2 carriers, and table motion during treatment. A joint Organization of Agreement States and U.S.
Nuclear Regulatory Commission (NRC) working group was created to: (1) confirm the need to license the Xcision GammaPod under Title 10 Code of Federal Regulations (CFR)
Part 35.1000 rather than 10 CFR Part 35, Subpart H, and (2) develop an associated 10 CFR Part 35.1000 licensing guidance document if necessary.
Although GammaPod' is a gamma stereotactic radiosurgery device, the working group concluded that it includes a number of engineering changes that make its components and operation significantly different from the gamma stereotactic radiosurgery units currently regulated in 10 CFR Part 35, Subpart H. These engineering changes include the elimination of helmets, relative helmet factors, helmet microswitches, hydraulic backups, trunnions, and a trunnion centricity point, all of which are described in 10 CFR Part 35, Subpart H. In addition, the GammaPods several new engineering features described above were not included in 10 CFR Part 35, Subpart H. As a result, the working group concluded the Gammapod will need to be licensed under 10 CFR Part 35, Subpart K, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material, and developed associated licensing guidance.
This licensing guidance revision is available at http://www.nrc.gov/materials/miau/med-use-toolkit.html.
ML20022A313 (memo) *via email OFFICE NMSS/ MSST NMSS/MSST NMSS/MSST NAME KTapp* LDimmick CEinberg DATE 01/22/2020 01/24/2020 01/24/2020 Package No. ML20022A311