(167 days)
The Aesculap Sterilcontainer S is a reusable 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 with the V-PRO 1 and V-PRO Plus Systems.
The Sterilcontainer S is recommended for surface and lumens:
≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and
The Aesculap Sterilcontainer S is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the V-PRO 1 and V-PRO 1 Plus sterilization systems. The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.
The provided text describes the Aesculap Sterilcontainer S, a reusable sterilization container system. However, it does not contain the detailed acceptance criteria or the specific study data that comprehensively demonstrates the device meets acceptance criteria in the format requested.
The document is a 510(k) summary and FDA communication, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report.
Here's a breakdown of what can be extracted and what information is missing based on your request:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The provided document, a 510(k) summary and FDA clearance letter, confirms that the Aesculap Sterilcontainer S was validated for use with V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards, implying that the device met the performance requirements outlined in those standards for sterilization containers. However, the exact acceptance criteria and detailed performance results are not explicitly stated in this document.
For example, a sterilization container system would typically need to demonstrate:
- Sterilization Efficacy: The container must allow for effective sterilization of enclosed devices (e.g., achieving a sterility assurance level (SAL) of $10^{-6}$ for specified cycles).
- Maintenance of Sterility: The container must maintain the sterility of the enclosed devices for a specified period (e.g., 6 months, 1 year).
- Material Compatibility: The container materials must be compatible with the sterilization process (e.g., V-PRO hydrogen peroxide plasma) without degradation or leaching.
- Physical Integrity: The container must maintain its physical integrity after repeated sterilization cycles.
- Filter Performance: The single-use polypropylene filter must effectively facilitate gas exchange while maintaining the sterile barrier.
The document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap Sterilcontainer S was completed. The Aesculap Sterilcontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory."
This indicates a study was performed, but the specifics are not provided. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
Missing Information:
The provided text does not contain the following information required for your detailed request:
- A table of acceptance criteria and the reported device performance: The document only generally states that "All required testing...was completed" and the device was "fully validated," implying it met relevant criteria, but no specific values or thresholds are given.
- Sample size used for the test set and the data provenance: There is no mention of the number of containers or cycles tested, nor the country of origin of the data or whether it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of study (related to physical sterilization efficacy) typically does not rely on human experts for ground truth in the same way an AI diagnostic device would. Ground truth would be established through biological indicator testing, chemical indicator evaluation, and sterility testing performed by qualified microbiology labs. The number and qualifications of such laboratory personnel are not mentioned.
- Adjudication method for the test set: Not applicable for this type of device performance testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device, not an AI diagnostic system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: While the text doesn't specify, for sterilization validation, ground truth would typically come from:
- Biological Indicator (BI) testing: Using highly resistant spores to confirm killing.
- Chemical Indicator (CI) changes: To visually confirm that sterilant conditions were met.
- Sterility Testing: Incubation of processed items to ensure no microbial growth.
- Physical Parameter Monitoring: Recording and verification of cycle parameters (temperature, pressure, time, sterilant concentration).
The document only states "fully validated," which implies these methods were used but does not detail them.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI system that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text confirms that performance testing and validation were conducted for the Aesculap Sterilcontainer S to demonstrate its compatibility and efficacy with V-PRO 1 and V-PRO 1 Plus sterilization systems, in accordance with FDA guidance and AAMI standards. However, it does not offer the granular detail concerning specific acceptance criteria, study sizes, methodologies, or ground truth establishment that your request specifies for an AI/diagnostic 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).