(151 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. 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 maX Low Temperature Sterilization System Flexible Cycle.
The SterilContainer" S is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the Amsco® V-PRO" maX Flexible Cycle. The SterilContainer" S rigid 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 proof locks.
Here's an analysis of the acceptance criteria and study information provided for the SterilContainer™ S device, as described in the FDA 510(k) submission K151242:
This document primarily focuses on the performance data used to support substantial equivalence for a medical device (sterilization container system), not on an AI/ML powered device, which is indicated by the type of testing performed (e.g., sterilization efficacy, microbial challenge, material compatibility). Thus, many of the requested fields related to AI/ML studies (like expert consensus, adjudication methods, MRMC studies, or training set details) are not applicable or cannot be answered from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML study would (e.g., "sensitivity must be >90%"). Instead, it presents performance properties that were evaluated, and the results demonstrate the device met the necessary standards for sterilization and sterility maintenance.
| Performance Property | Reported Device Performance |
|---|---|
| Sterilization Efficacy | Achieved a 6 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Whole Package Microbial Aerosol Challenge | Contents maintained sterility after exposure to a defined amount of aerosol microorganisms. |
| Event Related Sterility Maintenance | Demonstrated an effective barrier for maintaining sterility of contents after processing, followed by 180 days of event-related storage under simulated hospital sterile package handling and storage conditions. |
| Material Compatibility | No visible or functional changes were observed after 100 cycles of processing. |
| Simulated Use | A worst-case dual-channel flexible endoscope was reproducibly sterilized under worst-case simulated use testing conditions in the Flexible Cycle. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical "sample size" in terms of number of containers or tests for each performance property. It refers to "testing," "validations," and "studies" being conducted. For example, "100 cycles of processing" for material compatibility suggests a sample size of at least one container subjected to 100 cycles.
- Data Provenance: The studies were "conducted by a qualified testing laboratory." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the testing was performed to U.S. standards or by a lab recognized by the FDA. The studies are prospective in nature, as they involve actively performing tests (sterilization cycles, microbial challenges, material cycling).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is Not Applicable (N/A). This device is a sterilization container, not an AI/ML diagnostic system that requires expert interpretation for establishing ground truth. The "ground truth" for this device revolves around objective measurements of sterility, material integrity, and functionality based on standardized testing protocols.
4. Adjudication Method for the Test Set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations, which is not relevant for testing a physical sterilization device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This section is Not Applicable (N/A). MRMC studies are specific to evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a sterilization container, not an imaging or diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This is not an algorithm or AI device. The device itself (the SterilContainer S and its components) is being evaluated for its standalone performance in sterilization and sterility maintenance. The performance data is standalone performance of the device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective scientific and microbiological standards.
- Sterilization Efficacy: Measured by biological indicators (BI) overkill method and the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶. This is a quantitative, laboratory-based measurement.
- Microbial Aerosol Challenge: Measured by the absence of microorganisms in the contents after exposure to a defined aerosol challenge.
- Sterility Maintenance: Measured by maintaining sterility over a 180-day period under simulated conditions.
- Material Compatibility: Measured by visual and functional assessment after repeated cycles.
- Simulated Use: Measured by the reproducible sterilization of a worst-case endoscope under defined conditions.
8. The Sample Size for the Training Set
This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device information.
§ 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).