(72 days)
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper 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 has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks.
The Flash compatible Aesculap Sterilcontainer 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 "Flash" prevacuum steam sterilization. The container is made from anodized aluminum and utilizes a disposable (single use) paper filter. The container system consists of a solid bottom, a perforated lid w/ filter retention plate, and disposable paper filter. Accessories such as trays, baskets, and racks can be used with it.
This 510(k) summary provides information on the Aesculap Sterilcontainer System (Flash Indication). The device is a reusable sterilization container system intended for use with "Flash" prevacuum steam sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statement that the validation was conducted in accordance with "FDA quidance and available AAMI standards" and that the testing demonstrated "similar performance characteristics and prove efficacy of the Aesculap container" compared to a predicate device. Specific numerical acceptance criteria are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In accordance with FDA guidance and AAMI standards for flash sterilization. | "fully validated for the additional indication of flash sterilization in a prevacuum steam cycle." |
| Efficacy of the Aesculap container for flash sterilization. | "comparative testing was done on a predicate device to demonstrate similar performance characteristics and prove efficacy of the Aesculap container." |
| Maintain sterility of enclosed device until used. | Device is "intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used." |
| Compatibility with specific instrument types (stainless steel lumens, hinged, knurled). | "validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length)." |
| Compatibility with prevacuum (steam) flash sterilization. | "compatible for use in pre-vacuum (steam) flash sterilization." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the performance studies. It mentions that "The Aesculap Sterilcontainer system was fully validated... Additionally comparative testing was done on a predicate device." The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The validation was conducted "by a qualified testing laboratory," but details about expert involvement or qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. The study focused on the performance of the device itself rather than human reader performance with or without AI assistance, as this is a physical medical device (sterilization container), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense, the performance study conducted for the sterilization container can be considered a standalone assessment of the device's ability to sterilize and maintain sterility. The device itself (the container) is the primary subject of the performance evaluation. There's no AI algorithm involved, so "standalone" here refers to the device's intrinsic mechanical/sterilization performance.
7. The Type of Ground Truth Used
The ground truth for this type of device would typically be established through microbiological testing (e.g., sterility testing using biological indicators or culture methods) to confirm the complete inactivation of microorganisms, and physical/chemical integrity testing to ensure the container maintains sterility under various conditions. While not explicitly detailed, the statement "fully validated... in accordance with FDA quidance and available AAMI standards" implies the use of such established scientific methods for ground truth.
8. The Sample Size for the Training Set
This information is not applicable. Sterilization containers are not "trained" in the way AI models are. Their performance is inherent in their design and manufacturing, and validated through physical and microbiological testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 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).