(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.
§ 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.