(84 days)
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.
The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, GliaSite Access Tray, and Iotrex®, (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 Iotrex or Cesitrex. Iotrex and Cesitrex radiotherapy solutions are the radiation sources that can be used with the GliaSite RTS.
The provided text is a 510(k) summary for the GliaSite® RTS Cesitrex, a medical device used for intracavity radiation therapy in brain tumor patients. The submission claims substantial equivalence to a previously marketed device, the GliaSite RTS with Iotrex, and therefore focuses on demonstrating that Cesitrex is safe and effective and exhibits equivalent performance to the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Simulated clinical use testing | Complies (per bench testing results) |
| Balloon and catheter leak testing | Complies (per bench testing results) |
| Infusion port to catheter shaft tensile strength testing | Complies (per bench testing results) |
| Characterization of the radionuclide source | Complies (per bench testing results) |
| Diffusion testing of amount of radioactive material that diffused from the GliaSite RTS Catheter's balloons | Complies (per bench testing results) |
| Ability to deliver same radiation dose to Planned Treatment Volume (compared to Iotrex) | Shown to be able to deliver the same radiation dose (per technological characteristics statement) |
| Meeting required release specifications for finished products (including leak testing, eternal contamination, apparent activity, sterility, pyrogens, and labeling) | All finished products are tested and must meet all required release specifications before distribution, defined by written and approved procedures conforming to product design specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for the "bench testing" mentioned. It refers to "results of bench testing" in a general sense.
The data provenance is non-clinical bench testing. The information does not specify a country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects. For bench testing, it would generally be prospective testing conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the bench testing. The evaluation is based on compliance with predefined engineering and performance specifications, not on expert interpretation of results in a clinical context.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the testing described is primarily objective bench testing (e.g., measuring leak rates, tensile strength) against predetermined specifications, rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned. The device is a radiation therapy system component (radionuclide source), not an imaging or diagnostic device that typically involves human readers interpreting results.
6. Standalone Performance:
The "bench testing" described in section 3.12, conducted on both Cesitrex and Iotrex, represents a form of standalone performance evaluation for the radionuclide source and its interaction with the GliaSite RTS catheter. The equivalence claim is based on both sources complying with identical acceptance criteria. This testing evaluates the device's inherent characteristics and performance without human interaction for interpretation of results.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on engineering specifications and predefined performance criteria. For example, the acceptable leak rate or tensile strength would be established engineering parameters that the device must meet to be considered safe and effective. In the context of radiation dose, the ground truth is the established radiation dose delivery capabilities of the predicate device (Iotrex).
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of an algorithm or AI model, as this device is a physical medical device (radionuclide source and applicator system), not a software or AI-driven system.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable to the information provided, as there is no mention of a training set for an algorithm or AI. The "ground truth" for the device's performance is established through direct physical and radiometric measurements against design specifications and comparison to the predicate device's established performance.
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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).
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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.
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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
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Page 2 - Mr. Swindler
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
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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) =======================================================================================================================================================================
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§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.