CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features a stylized atom symbol to the left of the text "IsoRay MEDICAL". The text is in a bold, sans-serif font, with "MEDICAL" in a smaller font size below "IsoRay". KB32996 Page 1 of 2 DEC 1 7 2013 - 3.0 510(k) Summary Required by 21 CFR § 807.92(c): - 3.1. Submitter: IsoRay Medical, Inc. - 3.2. Address: 350 Hills Street, Suite 106 Richland, WA 99354-5411 - 3.3. Telephone and Fax Numbers: 509-375-1202 (Fax) 509-375-3473 - 3.4. Contact Person: Fredric Swindler - fswindler@isoray.com - 3.5. Date of preparation of this Summary: 09/06/2013 - 3.6. Device Name, Requlatory and Classification Information: - 3.6.1. Trade Name: GliaSite® RTS Cesitrex - 3.6.2. Common Name: Radionuclide source and radionuclide applicator - 3.6.3. Classification Name: Radionuclide Brachytherapy Source, (Per 21 CFR §892.5730), and Radionuclide Manual Applicator System, (Per 21 CFR 8892.5650). - 3.7. Marketed device to which equivalence is claimed: The modified GliaSite RTS that is the subject of this submission is substantially equivalent to the GliaSite RTS as described in 510(k) #K111931 (SE 08/05/11). - Product Description: The GliaSite® RTS is a radiation therapy system that 3.8. includes the GliaSite Catheter Tray, GliaSite Access Tray, and lotrex®, (125)-HBS) or Cesitrex, (liquid 131CsCI) Radiotherapy Solutions. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS Catheters are provided in three balloon sizes: 2 cm, 3 cm, and 4 cm. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex or Cesitrex. Iotrex and Cesitrex radiotherapy solutions are the radiation sources that can be used with the GliaSite RTS. - 3.9. Statement of intended use compared to the currently marketed predicate device: The intended use of modified device is as follows: The GliaSite RTS with Cesitrex is intended to deliver intracavity radiation . therapy (brachytherapy) in patients with malignant brain tumors following resection surgery. This is identical to the legally marketed predicate device, lotrex, Reference No. 8150, (1231)HBS, which is a component of the GliaSite RTS as described in 510(k) No. K111931 (SE 08/05/2011). {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features an atom-like symbol on the left, followed by the text "IsoRay" in a bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller font size. K132996 Page 2 of 2 - 3.10. Patient Population: Patients requiring radiation therapy for malignant diseases of the brain. - 3.11. Statement of Technological Characteristics: The intended use and technological characteristics of the proposed radiation source, (Cesitrex), for-GliaSite RTS are identical to the GliaSite RTS with lotrex predicate as described in 510(k) No. K111931. Both the proposed Cesitrex and the predicate, lotrex, are radionuclides which have similar energies and are used for low dose brachytherapy. Both Cesitrex and lotrex have been shown to be able to deliver the same radiation dose to the Planned treatment Volume. - 3.12. Assessment of Non-Clinical Performance Data: Based on the results of bench testing, both Cesitrex and lotrex comply with identical acceptance criteria including simulated clinical use testing, balloon and catheter leak testing, infusion port to catheter shaft tensile strength testing, characterization of the radionuclide source, and diffusion testing of amount of radioactive material that diffused from the GliaSite RTS Catheter's balloons. - 3.13. Conclusion Drawn from Testing: Based on the results of the analysis and testing performed on the proposed device it has been demonstrated that Cesifrex when used as the radiation source for the GliaSite RTS is safe and effective and exhibits equivalent performance to the predicate device, GliaSite RTS with lotrex. - 3.14. Safety and Effectiveness: To ensure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, pyrogens, and labeling. The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for the GliaSite RTS is detailed in the Device Master Record. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 17, 2013 IsoRay Medical, Inc. % Mr. Fredric Swindler Vice President, Regulatory Affairs and Quality Assurance 350 Hills Street, Suite 106 RICHLAND WA 99354 Re: K132996 Trade/Device Name: Cesitrex to be used with GliaSite® Radiation Therapy System (RTS) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: September 6, 2013 Received: September 24, 2013 Dear Mr. Swindler: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Mr. Swindler 1. 14. 1. 3. forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Sincerely yours, Michael D. O'Hara for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Section 2.0 ## Indications for Use Page 1 of 1 ## 510(k) Number: K132996 Device Name: GliaSite Radiation Therapy System (RTS) ## Indications for Use: The GliaSite RTS with Cesitrex, (Liquid 131CsCl), is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery. Prescription Use × (Per 21 CFR § 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Michael D. O'Hara (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K 132996 510(k) ======================================================================================================================================================================= Page 25 of 70