(75 days)
The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- . Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100 NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
- wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above. or
- . placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
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 and the following STERRAD Sterilizers and cycles. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K222440) 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 describes the PRO-LITE Sterilization Tray, which is a device used to contain medical instruments for sterilization. The submission aims to add or expand claims for the use of these tray models specifically in the V-PRO maX 2 Specialty Cycle.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cycle specific test articles shall be reproducibly sterilized under ½ cycle conditions for the V-PRO maX 2 Specialty Cycle | All tested articles were reproducibly sterilized under ½ cycle conditions for the V-PRO maX 2 Specialty Cycle. |
| Conclusion: PASS | Conclusion: PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set (number of trays or instruments tested).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given this is an FDA 510(k) submission, it's customary for such performance data to be collected specifically for the submission, implying a prospective study conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. For sterilization validation, the ground truth is typically established through direct microbial inactivation (sterilization) testing using biological indicators or test articles inoculated with specific microorganisms, rather than expert consensus on images or observations.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set. This is consistent with the nature of sterilization efficacy testing, which relies on objective measurements of microbial kill.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or similar AI applications where human interpretation is involved. For a sterilization tray, the primary performance is objective sterilant penetration and microbial inactivation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable to the device described. The device is a physical sterilization tray, not an algorithm. The "performance" being evaluated is the ability of the tray to facilitate sterilization in specific cycles, which is a standalone performance of the device in conjunction with a sterilizer, without any human-in-the-loop "algorithm" performance.
7. Type of Ground Truth Used
The ground truth used for this type of sterilization study is typically:
- Microbial Inactivation/Sterility: This is established by demonstrating a specific sterility assurance level (SAL), often through the successful inactivation of highly resistant biological indicators (e.g., Geobacillus stearothermophilus spores) placed within the test articles. The "½ cycle conditions" mentioned indicate a stringent test designed to challenge the sterilization process.
8. Sample Size for the Training Set
The document does not describe a "training set" as this term primarily applies to the development of AI/ML algorithms. This device is a physical product, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for a physical sterilization tray.
§ 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).