(232 days)
The SterilContainer S is a reusable sterilization container system (consisting of perforated lids with filter retention plates, and single use polypropylene filters) intended to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 60 Low Temperature Sterilization System's Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The Steril Container S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization.
The SterilContainer S is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the Steris V-PRO 60 Sterilization System. The SterilContainer Srigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks.
The provided text describes the acceptance criteria and the study results for the SterilContainer™ S sterilization container system.
Here's the breakdown of the information requested:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Property | Reported Device Performance (SterilContainer™ S) |
|---|---|
| Sterilization Efficacy | Demonstrated a 6 log reduction to no growth in a half-cycle validation, supporting a sterility assurance level (SAL) of 10-6 in a full cycle validation. |
| Whole Package Microbial Aerosol Challenge | After exposure to a defined amount of aerosol microorganisms, contents maintained sterility. |
| Event Related Sterility Maintenance | Demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing, followed by a 180-day event-related storage under conditions simulating hospital sterile package handling and storage. |
| Material Compatibility | After 100 cycles of processing, no visible or functional changes were observed. |
| Simulated Use | A worst-case dual channel flexible endoscope was reproducibly sterilized under worst-case simulated use testing conditions in the Flexible Cycle. |
| Sterility Maintenance Duration | 180 days (explicitly stated in the "Indications for Use" and "510(k) Summary"). |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for each performance test (e.g., number of containers tested for sterilization efficacy, or event-related sterility maintenance). It uses terms like "a defined amount of aerosol microorganisms" or "a worst case dual channel flexible endoscope."
The data provenance is nonclinical testing performed by a "qualified testing laboratory." It does not provide information on the country of origin of the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies involving human or animal subjects, not for device performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as this is a nonclinical performance study of a sterilization container, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is determined by objective measures (e.g., microbial growth, physical changes, sterility tests).
4. Adjudication method for the test set:
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for this type of nonclinical device performance testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and therefore not provided. The device described is a sterilization container, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical sterilization container, not a software algorithm.
7. The type of ground truth used:
The ground truth used in this study is based on objective laboratory measurements and tests designed to assess:
- Microbial reduction and absence of growth: For sterilization efficacy and microbial aerosol challenge.
- Maintenance of sterility: For event-related sterility maintenance.
- Absence of visible or functional changes: For material compatibility.
- Successful sterilization under specified conditions: For simulated use.
This is not expert consensus, pathology, or outcomes data in the traditional sense, but rather defined physical and biological endpoints.
8. The sample size for the training set:
This information is not applicable as the device is a physical sterilization container and does not involve machine learning or a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above (no training set for a physical 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).