(144 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 flexible endoscopes and accessories, cables, and camera heads. 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 STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.
Validation testing for event related sterility maintenance has been conducted for up to 365 days.
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 STERRAD 100NX DUO Sterilization System. The SterilContainer" S System rigid containers are made from nonanodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
The provided document is a 510(k) summary for the SterilContainer S System for use in the STERRAD 100NX DUO Cycle. It describes non-clinical performance data to demonstrate substantial equivalence to a predicate device.
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
| Performance Testing | Acceptance Criteria (Implied / Demonstrated) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy / Lethality | A 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ | Achieved a 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Maintenance of Sterility | Effective barrier for maintaining sterility of contents after sterilization for 365 days event-related storage under simulated hospital sterile package handling and storage conditions. | Continues to provide an effective barrier for maintaining sterility of the contents after sterilization for 365 days event related storage under conditions which simulate hospital sterile package handling and storage conditions. |
| Simulated Use | A 6-log reduction of G. stearothermophilus suspended in artificial soil medium for the containers when processed through a full cycle in the STERRAD 100NX DUO Cycle. | Demonstrated a 6-log reduction of G. stearothermophilus suspended in artificial soil medium for the Aesculap, Inc. SterilContainer S Containers when processed through a full cycle in the STERRAD 100NX DUO Cycle in healthcare facilities. |
| Inactivation Kinetics | No growth. | No growth was observed from three different injection doses for load configurations 1, 2, and 3 respectively. |
| Aerosol Challenge | (Implied: similar performance to predicate device, effective barrier) | The Aerosol challenge remains unchanged from the predicates as the container as well as the gaskets of the container remain the same as cleared in predicates. Predicate device data is still relevant for the proposed device. |
| Material Compatibility | (Implied: similar to predicate device) | Material Compatibility test data has not changed and remains the same as cleared in predicate. |
| Biocompatibility | (Implied: similar to predicate device) | The biocompatibility of the container remains unchanged from the predicates as the materials of the container remains the same as cleared in the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test in the non-clinical performance data section. However, it indicates that:
- "Testing demonstrated a 12 log reduction..." for Sterilization Efficacy.
- "No growth was observed from three different injection doses for load configuration 1, 2 and 3 respectively" for Inactivation Kinetics. This suggests at least three instances were tested.
- "Validation testing for event related sterility maintenance has been conducted for up to 365 days."
The data provenance is presented as "Non-Clinical Performance Data" and states that "These validations were conducted by a qualified testing laboratory." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but clinical trials are not mentioned, which typically implies laboratory-based, prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical performance testing of a medical device (sterilization container system) rather than an AI/ML-driven diagnostic or therapeutic. The "ground truth" here is based on quantitative microbiological and physical performance metrics, not expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
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 is not applicable as the device is not an AI/ML-driven system nor is it related to image interpretation or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device described is a physical sterilization container system, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on objective, quantitative measurements and established scientific principles for sterilization and sterility maintenance, including:
- Microbiological assays: Such as measuring log reduction of G. stearothermophilus (biological indicator) to establish a Sterility Assurance Level (SAL).
- Physical integrity testing: To assess the container's ability to maintain a sterile barrier over time.
- Chemical compatibility: Ensuring materials do not degrade or interfere with the sterilization process.
This is distinct from expert consensus, pathology, or outcomes data which are relevant for diagnostic or therapeutic devices.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML system requiring a training set. The "testing" in this context refers to validation studies for the physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable 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).