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510(k) Data Aggregation
(304 days)
The Aesculap(R) SterilContainer™ S2 System is a reusable rigid sterilization container system 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 in the following sterilization modalities:
- Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time)
- Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)
- STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles
- STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.
The Aesculap SterilContainer S2 System includes accessories such as sillcone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.
The attached table identifies the validated load configurations for each of the modalities.
The Aesculap SterilContainer S2 System is a reusable rigid container system that will allow for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:
- Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time)
- Gravity Steam (250°F for 30-60 minutes with 15 minute dry time)
- STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles
- STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex cycles
The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
The document provided is a 510(k) premarket notification for a medical device, the Aesculap® SterilContainer™ S2 System. It details the device's intended use, compatibility with various sterilization modalities, and comparisons to predicate devices. Crucially, it includes a "Summary of Non-Clinical Testing" which outlines performance tests, acceptance criteria, and results.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Testing | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | To determine sterilization effectiveness of test device after processing in a sterilization cycle. | A sterility assurance level (SAL) of 10⁻⁶ will be achieved post sterilization using the BI overkill method and half cycle validation. Biological indicators must be negative for growth after incubation period. | Pass |
| Simulated Use | To determine the effective sterilization of flexible scopes when used with the test device. | A minimum of 1.0 x 10⁶ spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle. Biological indicators must be negative for growth after incubation period. | Pass |
| Microbial Aerosol Challenge | To analyze the package integrity and microbial barrier properties of the test device. | Post sterilization, the container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Maintenance of Sterility | To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time | Sterility of container contents is maintained after processing for 360 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period. | Pass |
| Reusable Filter | To demonstrate sterilization effectiveness after determined number of sterilization and wash cycles. | Sterility Assurance Level (SAL) of 10⁻⁶ will be achieved after 2200 sterilization and washing cycles using half cycle testing with biological indicators to demonstrate a 6 log reduction. | Pass |
| Material Compatibility | To assess effects of full use cycles on device components and their intended functionality. | No degradation or impact to functionality at the completion multiple sterilization cycles. | Pass |
| Cytotoxicity | To determine the potential of a test device to cause cytotoxicity. | Testing completed in accordance with ISO 10993-5: 2009 to demonstrate no significant cytotoxic reaction after exposure to sterilant. Using the ISO Elution Method, the response to the article is not greater than 2 (mild reactivity). | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes (e.g., number of container units, number of test cycles) for each non-clinical test. It indicates that "Non-clinical testing was conducted to verify the performance of the subject device," implying that these tests were performed experimentally. The data provenance is implied to be from laboratory testing as part of the device's premarket submission, likely conducted by the manufacturer (Aesculap, Inc.) or a contracted testing facility. The nature of these tests suggests they are prospective, designed specifically to validate the device's performance. There is no information regarding the country of origin of the data beyond the manufacturer's location in Pennsylvania, USA.
For tests like "Sterilization Efficacy," "Simulated Use," and "Reusable Filter," the acceptance criteria mention specific biological indicator (BI) outcomes (e.g., "Biological indicators must be negative for growth") and log reductions, which imply a certain number of biological indicators and test cycles would have been used to statistically ensure the SAL. However, the concrete numbers are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes technical performance testing of a sterilization container, not a diagnostic or AI-driven device that requires human expert interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" as it would apply to, for example, a medical imaging AI, is not relevant here. The ground truth for these tests (e.g., "sterility," "no degradation," "no cytotoxicity") is established through objective, quantifiable laboratory methods and established standards (like SAL of 10⁻⁶, ISO 10993-5: 2009).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As this is not a study involving human reader interpretation or subjective assessments, there is no mention of an adjudication method. The test results are based on objective, measured outcomes and pass/fail criteria.
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:
No, an MRMC study was not done. This device is a physical medical device (sterilization container), not an AI-driven diagnostic tool or imaging software that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the device described. The device is a sterilization container, not an algorithm. The tests performed are "standalone" in the sense that they assess the device's inherent physical and functional properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for these performance tests is based on:
- Microbiological Standards: Demonstrated sterility (e.g., SAL of 10⁻⁶) measured by the absence of biological indicator growth.
- Physical/Functional Integrity: Observation of no degradation, impact on functionality, or maintenance of barrier properties after challenging conditions.
- Biocompatibility Standards: Adherence to ISO standards for cytotoxicity, measured by the reactivity level.
These are objective, empirical measures defined by scientific and regulatory standards for medical device sterilization and material safety.
8. The sample size for the training set:
This question is not applicable. The device is a physical product and does not involve AI or machine learning models that require training sets. All tests described are performance validation tests.
9. How the ground truth for the training set was established:
This question is not applicable, as there is no training set for this type of device.
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