(267 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 hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.
Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.
The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.
The SterilContainer S System 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 STERRAD 100NX EXPRESS Cycle. 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-evident locks.
This document describes a 510(k) premarket notification for a medical device, the "SterilContainer S System", and focuses on demonstrating its substantial equivalence to a predicate device. This is a regulatory filing, not a clinical study, and therefore the acceptance criteria and study data provided are for performance validation rather than clinical efficacy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Property) | Reported Device Performance (Results) |
|---|---|
| Sterilization Efficacy | Achieved 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, the contents maintained sterility. |
| Event Related Sterility Maintenance | For the full-size container: Maintained sterility for 360 days following successful sterilization. For the ½ size container: Maintained sterility for 30 days following successful sterilization. This was achieved after processing and subsequent storage under simulated hospital sterile package handling and storage conditions. After 100 cycles of processing, no visible or functional changes were observed. |
| Material Compatibility | After 100 cycles of processing, no visible or functional changes were observed (this is included under Event Related Sterility Maintenance in the document, but is a distinct material compatibility aspect). |
| Biocompatibility | Cytotoxicity: No evidence of causing cell lysis or toxicity (per ISO 10993-5). Hemolysis: Results were non-hemolytic (per ASTM F756 and ISO 10993-4). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific numerical sample sizes for each test. For example, it doesn't say "X number of containers were tested for sterilization efficacy." However, it describes the type of testing performed:
- Sterilization Efficacy: "a half cycle validation."
- Whole Package Microbial Aerosol Challenge: "exposure to a defined amount of aerosol microorganisms."
- Event Related Sterility Maintenance: Mentions "30 or 360 day event related storage" and "100 cycles of processing."
- Biocompatibility: Mentions "Cytotoxicity testing" and "A Hemolysis study."
The data provenance is not specified regarding country of origin. The studies are prospective in nature, as they involve performing tests on the device to validate its performance according to defined protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a technical performance validation of a sterilization container, not a diagnostic device requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists) is not applicable here. The "ground truth" for these tests would be established by the adherence to recognized industry standards (e.g., ISO, ASTM) and microbiology principles for sterility and biological safety, as performed by a "qualified testing laboratory."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a technical device validation following standardized protocols, not a clinical study involving human interpretation that would require an adjudication method for ground truth.
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
Not applicable. This device is a sterilization container, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device validation is based on accepted scientific and industry standards for sterility, microbial barrier performance, material durability, and biocompatibility.
- Sterilization Efficacy: No microbial growth after sterilization and challenge, achieving a specified sterility assurance level (SAL).
- Whole Package Microbial Aerosol Challenge: No microbial ingress or contamination of contents.
- Event Related Sterility Maintenance: Maintenance of sterility for specified durations (30 or 360 days) and no degradation after repeated use (100 cycles).
- Biocompatibility: Meeting the criteria for non-cytotoxicity (per ISO 10993-5) and non-hemolysis (per ASTM F756 and ISO 10993-4).
These are objectively verifiable measurements and observations against established benchmarks, not subjective expert consensus or pathology.
8. The sample size for the training set
Not applicable. This device does not utilize machine learning or AI algorithms, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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).