(280 days)
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used 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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The SterilContainer™ S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer" S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
This documentation describes the regulatory clearance of the SterilContainer™ S System by Aesculap, Inc. as a reusable sterilization container system. The validation studies demonstrate its effectiveness and safety.
Here's an analysis of the provided text in the context of acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate table. However, the "Performance Properties" table (page 7) implicitly outlines the performance requirements that the device needed to meet for clearance.
| Acceptance Criterion (Inferred from "Performance Properties") | Reported Device Performance |
|---|---|
| Sterilization Efficacy/Lethality Study: Achieve a certain sterility assurance level (SAL). | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using the biological (BI) overkill method and half-cycle validation. This was achieved by placing at least 1.0 x 10^6 spores of Geobacillus stearothermophilus in the worst-case sterilization location through the containers. The full cycle results in a 12-log reduction of spores and produces a 10-6 SAL, reflecting a one-in-a-million chance of a non-sterile item. |
| Bacterial Filtration Efficiency: Maintain microbial barrier properties after processing. | The evaluation of the microbial barrier properties of the Aesculap® polypropylene filters demonstrates that the bacterial filtration efficiency is maintained by the filter after being processed in Cycle 1 of the STERIZONE® Sterilizer. |
| Event Related Sterility Maintenance: Maintain sterility of contents for a specified period after processing. | Testing 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 which simulate hospital sterile package handling and storage conditions. |
| Material Compatibility/Reuse Test: Withstand repeated processing cycles without visible or functional changes. | After 100 cycles of processing, no visible or functional changes were observed for the device materials. |
| Biocompatibility: Polypropylene filters must be biocompatible. | The Aesculap® polypropylene filters have been proven to be biocompatible when processed in Cycle 1 of the STERIZONE® VP4 Sterilizer. |
| Aerosol Microbial Challenge: Prevent microbial ingress in challenging conditions. | The contents of the container were negative for growth following exposure of the containers to aerosolized microbial challenge test conditions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sterilization Efficacy/Lethality Study: Performed in triplicate on the Aesculap rigid container. The specific number of containers per replicate is not stated. The data provenance is not explicitly mentioned as country of origin but is implied to be from a "qualified testing laboratory" (page 7) in support of US FDA clearance. It is a prospective study as tests were conducted specifically for this clearance.
- Bacterial Filtration Efficiency: The "evaluation" suggests a test set, but the sample size for filters or test runs is not specified.
- Event Related Sterility Maintenance: Not specified for individual containers, but the study simulated "hospital sterile package handling and storage conditions" over 180 days.
- Material Compatibility/Reuse Test: The device was subjected to 100 cycles of processing.
- Biocompatibility: The "study" evaluated the polypropylene filters, but the sample size of filters tested is not specified.
- Aerosol Microbial Challenge: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document describes the mechanical and biological performance of a medical device (sterilization container), not a diagnostic or AI-based device that relies on human interpretation for "ground truth". Therefore, the concept of "experts used to establish ground truth" based on interpretation is not applicable in this context. The "ground truth" for these tests is based on objective, standardized laboratory measurements and methods (e.g., microbial growth, visual inspection, filtration efficiency).
4. Adjudication Method for the Test Set:
Not applicable, as "adjudication method" often refers to resolving discrepancies among human readers or interpreters. The tests here are objective performance measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can be evaluated for its impact on their performance. This document is about a sterilization container system, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
Not applicable. This device is a physical container and doesn't involve any algorithm or AI for "standalone performance."
7. Type of Ground Truth Used:
The ground truth for the performance tests relies on:
- Microbial Challenge Testing: Demonstrating a log reduction of Geobacillus stearothermophilus spores and achieving a specific Sterility Assurance Level (SAL).
- Physical and Functional Testing: Visual inspection for material integrity, flow rate/filtration measurements for barrier function, and functional checks after repeated cycles.
- Chemical Testing: Biocompatibility assessment of materials.
- Time-based Stability: Maintaining sterility over a defined storage period.
These are all objective, laboratory-based measurements defined by established standards for medical device sterilization.
8. Sample Size for the Training Set:
Not applicable. This document describes the validation of a physical medical device. There is no AI or machine learning component that would require a "training set." The listed studies are for device validation, not model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML model for this 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).