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510(k) Data Aggregation
(81 days)
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: · UL-SCOPE4-0 / UL-SCOPE4-0-FE* - Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle - · UL-GRASP-R Optical Graspers, double action jaws - · UL-SCI-R Optical Scissors, double action jaws * Factory Exchange: Devices with a part number ending in "FE" have been repaired to meet product specifications. 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 prevacuum steam sterilization cycles: Prevacuum Steam Temperature: 132°C (270°F) Sterilization time: 4 minutes Minimum dry time: 30 minutes Maximum weight: 5 lbs (2.7 kg)
The UroLift System Rigid Retrieval Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of surgical instruments that are optionally used in the UroLift System Procedure.
The document describes the acceptance criteria and the results of non-clinical studies for the UroLift® System Rigid Retrieval Kit Sterilization Tray.
1. Table of Acceptance Criteria and Reported Device Performance:
| Title of Test | Purpose of Test | Acceptance Criteria / Source of References | Reported Device Performance |
|---|---|---|---|
| Usability Testing | Assured that the user could perform the steps of the Instructions for Use (IFU) 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 | Evaluate 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 | Evaluate 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 | Evaluate 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 | Determine the serviceable life span of the tray after being subject to 100 cleaning and sterilization cycles per the IFU reprocessing directions. | 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 | Validate that the cleaning instructions listed in the IFU 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, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices revised 15 December 2016 | |||
| 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 | Validate that the sterilization instructions listed in the IFU 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 document does not explicitly state the sample sizes for each test in terms of the number of devices or data points beyond "100 cleaning and sterilization cycles" for Useful Life Testing. The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (NeoTract, Inc.), so the data provenance would be from internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in a way that is applicable to typical "ground truth" establishment for AI/ML devices. The tests described are engineering/performance validations, not clinical studies requiring expert interpretation of results for ground truth. The "acceptance criteria" themselves serve as the standard by which the device's performance is judged.
4. Adjudication Method for the Test Set:
Not applicable to these non-clinical performance and biocompatibility tests. The "Pass" results are based on meeting predefined quantitative and qualitative acceptance criteria specified by relevant standards (e.g., ISO, AAMI).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a non-clinical device (sterilization tray) and does not involve AI or human readers for diagnostic purposes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a non-AI medical device.
7. Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on:
- Predefined performance specifications and acceptance criteria derived from established industry standards (e.g., ANSI/AAMI ST77:2013, ISO 10993 series, AAMI TIR30: 2011/(R)2016).
- Laboratory measurements (e.g., protein and hemoglobin residuals, biological responses in cell cultures/animals).
- Visual inspection criteria.
8. Sample Size for the Training Set:
Not applicable. This is a non-AI medical device and does not involve machine learning models with training sets.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, this is a non-AI device.
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