(150 days)
The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen, Flexible, and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be:
- wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization . Systems or
- placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate Sterilization Trav (K160912) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are also described as accessories.
The provided text is a 510(k) Premarket Notification for a medical device (PRO-LITE™ Sterilization Trays). It describes the device's intended use, its technical characteristics, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Demonstration of Effective Sterilant Penetration | |||
| V-PRO maX 2 Sterilizer Fast Non Lumen Cycle | Worst case test article packaged in the trays shall be reproducibly sterilized under worst case 1/2 cycle conditions for Fast Non Lumen Cycle. | N/A (implied by "PASS") | PASS |
| V-PRO maX 2 Sterilizer Fast Non Lumen Cycle | Diffusion-restricted spaces (stainless steel and titanium) and sterilization tray/medical device contact points shall be reproducibly sterilized under worst case 1/2 cycle conditions for Fast Non Lumen Cycle. | N/A (implied by "PASS") | PASS |
| V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, titanium surface claims | Diffusion-restricted spaces (titanium) shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Non Lumen Cycle. | N/A (implied by "PASS") | PASS |
| Package Integrity | Not applicable. The Sterilization tray meets the definition of a "tray" in ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization, therefore package integrity and maintenance of package integrity testing are not applicable. | N/A | Not Applicable |
| Demonstration of Effective Drying and Aeration | Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions. | N/A (implied by "PASS") | PASS |
| Demonstration of Material Compatibility | After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality. | N/A (implied by "PASS") | PASS |
| Demonstration of Biocompatibility | Component materials shall be non-cytotoxic after exposure to worst case Sterilizer Cycle conditions. | N/A (implied by "PASS") | PASS |
| Demonstration of Effective Cleaning | Clean following automated and manual cleaning. | N/A (implied by "PASS") | PASS |
Note: The document only states "PASS" for the performance. It does not provide specific quantitative results (e.g., actual residual hydrogen peroxide levels or specific functionality test results after cycles).
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "worst case test article" and "multiple worst case sterilization cycles" but not the number of units or cycles.
The data provenance is not specified in terms of country of origin. The studies appear to be pre-market, non-clinical tests conducted by the manufacturer, STERIS Corporation, for regulatory submission to the FDA. The tests are designed to demonstrate the device's performance under simulated "worst-case" conditions for sterilization. It's not a retrospective or prospective study on patient data, but rather a laboratory-based performance validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests described are non-clinical, performance-based, not involving interpretation by human experts. The "ground truth" for these tests relates to defined sterilization efficacy (e.g., absence of viable microorganisms after sterilization) and material integrity standards.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication processes like those in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images and their performance with and without AI assistance is evaluated. The PRO-LITE™ Sterilization Trays are a medical device accessory for sterilization, not a diagnostic or AI-powered device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not performed in the context of an algorithm. This device is not an algorithm or AI. The performance tests conducted are standalone in the sense that they evaluate the device's physical and functional properties without human intervention during the sterilization process itself.
7. Type of Ground Truth Used
The ground truth for these tests is based on defined standards for sterilization efficacy and material properties.
- For sterilant penetration, the ground truth is the complete and reproducible sterilization of test articles, likely verified through biological indicators or other validated methods to confirm the absence of viable microorganisms.
- For drying/aeration, the ground truth is the acceptable level of residual hydrogen peroxide, measured against predefined safety limits.
- For material compatibility, the ground truth is the retention of functionality and structural integrity after multiple sterilization cycles, and for biocompatibility, it's the demonstration of non-cytotoxicity according to established standards.
- For cleaning, the ground truth is the device being clean per established protocols.
8. Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).