(148 days)
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
Optional instrument organizers are accessories to the trays and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.
Optional sterilization mats are accessories to the trays and are intended to be used in conjunction with the V-PRO Sterilization Trays to cushion and stabilize instruments within the trays.
The V-PRO Sterilization Tray is available in various sizes, 10"x 10" x 27" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with clamping mechanisms for securing to the trav. There are numerous holes in the tray and larger holes in the lids for sterilant penetration. The purpose of this premarket submission is to modify the trays by adding a longer tray to the existing product line (10' x 27"), to increase the vent area of the tray lid, and to extend indications for use of the tray to include the V-PRO 60 Low Temperature Sterilization System.
Optional instrument organizers are provided as accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attaches to the V-PRO Sterilization Trav. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device that requires stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock. The organizers are identical to those previously cleared under K070769.
Sterilization mats are provided as optional accessories to the trav and are identical to those previously cleared under K103226 for use in V-PRO Low Temperature Sterilizers' Lumen, Non Lumen and Flexible Cycles. A larger mat sized to fit into the new 10" x 27" tray has been added to the existing product line. The sterilization mats are intended to cushion and stabilize devices placed into the V-PRO. Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Sterilization Trays.
Here's a breakdown of the acceptance criteria and study information for the STERIS V-PRO Sterilization Tray, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Worst case test article packaged in the trays shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Demonstration of Biocompatibility | Component materials shall be non cytotoxic after exposure to worst case V-PRO 60 Sterilizer Cycle conditions. Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case V-PRO 60 Sterilizer Cycle conditions. | PASS |
| Demonstration of Sterilant Compatibility | After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the performance studies. It refers to "worst case test article" and "multiple worst case sterilization cycles" but doesn't provide numerical details.
The data provenance is not explicitly stated in terms of country of origin. The document is a 510(k) summary submitted to the FDA in the USA, implying testing was conducted to meet US regulatory requirements. The studies appear to be prospective, specifically designed to demonstrate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies are performance tests related to sterilization efficacy and material compatibility, not studies involving expert interpretation of medical images or diagnoses.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and therefore not provided. The studies are laboratory-based performance tests, not clinical evaluations requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided. This is a medical device for sterilization, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided. This is a physical medical device, not an algorithm. The "standalone" performance here would refer to the device's ability to sterilize effectively by itself, which is what the "Demonstration of Effective Sterilant Penetration" test addresses. The study confirms that the device, in conjunction with the sterilizer, achieves sterilization.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance studies would be based on sterility assurance levels and material integrity measurements.
- For "Demonstration of Effective Sterilant Penetration": The ground truth is the absence of viable microorganisms after sterilization, typically confirmed using biological indicators (BIs) or other microbiological assays. The "reproducibly sterilized" criterion implies a defined sterility assurance level (SAL).
- For "Demonstration of Biocompatibility": The ground truth is confirmed absence of cytotoxicity (e.g., cell viability assays) and acceptable levels of chemical residues (e.g., hydrogen peroxide concentration measurements).
- For "Demonstration of Sterilant Compatibility": The ground truth is the continued functionality of the trays and accessories (e.g., visual inspection, mechanical performance tests) after exposure to sterilization cycles.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, 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).