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510(k) Data Aggregation
(197 days)
The UroLift System Procedure Kit Sterilization Tray is intended to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer.
The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray:
- UL-SCOPE / UL-SCOPE-FE Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view
- UL-SHEATH / UL-SHEATH-FE Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock)
- UL-VO / UL-VO-FE Visual obturator, 20 Fr.
The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed. validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following pre-vacuum steam sterilization cycles:
132 °C Pre-vacuum Steam Cycle Exposure temperature: 270 °F (132 °C) Exposure time: 4 minutes Vacuum dry time: 30 minutes
134 ℃ Pre-vacuum Steam Cycle Exposure temperature: 273 °F (134 °C) Exposure time: 3 minutes Vacuum dry time: 20 minutes
The maximum weight of the tray is 1.8kg / 4lbs.
The UroLift System Procedure Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of the surgical instruments used in the UroLift System Procedure.
The UroLift® System Procedure Kit Sterilization Tray is a rigid containment device for surgical instruments, intended for storage and sterilization in a pre-vacuum steam sterilizer. The device was evaluated through non-clinical testing including usability, biocompatibility, cleaning, and sterilization testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of test | Purpose of test | Acceptance Criteria / Source of references | Results |
|---|---|---|---|
| Usability Testing | Assured that the user could perform the steps of the Instructions for Use to meet the intended use of the sterilization tray and that the tray performed as intended to securely store and sterilize the instruments. | The user is able to load and unload the tray, perform the reprocessing workflow (clean the tray, inspect the tray, clean and inspect the instruments, and load the tray and sterilize), and determine the end of the serviceable life of the tray. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cytotoxicity Testing | Evaluated the cytotoxicity of a test article extract using an in vitro mammalian cell culture test. | The test sample meets the requirements of the test if the biological response is less than or equal to grade 2 (mild). Cytotoxicity testing per ISO 10993-5:2009 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. | Pass |
| Sensitization Testing | Evaluated the potential of the test article to cause delayed dermal contact sensitization in the guinea pig maximization test. | Grades of 1 or greater observed in the test group generally indicate sensitization, provided that grades of less than 1 are observed on the control animals. If grades of 1 or greater are noted on control animals, then the reactions of test animals that exceeded the most severe control reaction will be considered to be due to sensitization. Sensitization testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Intracutaneous Reactivity Testing | Evaluated the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | The difference of overall mean of the test group to the control group on erythema and edema score must be less than 1. Intracutaneous Reactivity testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Useful Life Testing | Determined the serviceable lifespan of the tray by subjecting it to 100 cleaning and sterilization cycles. | The tray must pass the inspection criteria on the IFU after 100 reprocessing cycles. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cleaning Validation | Validated that the cleaning instructions in the Instructions for Use appropriately clean the tray to ensure the sterilization cycle will be effective. | Per the protocol, there were three acceptance criteria: protein residual analysis, hemoglobin residual analysis, and visual inspection. The protein residual benchmark level was 6.4µg/cm², and the hemoglobin benchmark level was 2.2µg/cm². The tray must pass the visual inspection in the IFU. AAMI TIR30: 2011/(R)2016 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff issued 17 March 2015. | Pass |
| Sterilization Validation | Validated that the sterilization instructions in the Instructions for Use appropriately sterilize the tray and contents. | The minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the IFU were followed. ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the exact sample sizes for each test in the test set (e.g., number of units tested for usability, number of samples for biocompatibility). The testing is described as non-clinical in nature. The provenance of the data is manufacturer-generated (NeoTract, Inc.) through non-clinical design verification testing. It is retrospective in the sense that the testing was conducted on the device to demonstrate conformance to pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not explicitly provided. Non-clinical studies like these generally rely on established scientific protocols and standards (e.g., ISO, AAMI) rather than expert consensus on interpretation for ground truth. For "Usability Testing," the evaluation would typically involve trained users or human factors engineers, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
The document does not detail specific adjudication methods as would be typical for clinical studies involving multiple reviewers or subjective assessments. The results are reported as "Pass" or "Fail" based on whether the acceptance criteria were met according to established laboratory methods and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This device is a sterilization tray, not a diagnostic or therapeutic device evaluated for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical device (sterilization tray), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was based on:
- Established scientific and regulatory standards: e.g., ISO 10993 for biocompatibility, AAMI ST77 and TIR30 for sterilization and cleaning.
- Predefined acceptance criteria: Specific quantitative (e.g., protein residual levels, SAL) and qualitative (e.g., visual inspection, user performance steps) benchmarks derived from these standards and industry best practices.
- Performance of the device itself through repeated cycles (for useful life testing).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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