(169 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.
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The provided text is a 510(k) premarket notification from the FDA regarding the "Instru-Safe® Instrument Protection System." This document is primarily concerned with regulatory approval and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of a "study" related to AI device performance.
The device in question, the "Instru-Safe® Instrument Protection System," is classified as a "Sterilization Wrap" (21 CFR 880.6850). This is a physical medical device used to organize and protect other medical devices during pre-vacuum steam sterilization cycles.
Therefore, the requested information for an AI-related study (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this document.
The document states the Intended Use of the device, which acts as the de facto acceptance criteria in terms of functionality. These are:
- To organize and protect other medical devices.
- To allow sterilization of the enclosed medical devices during pre-vacuum steam sterilization cycles.
- To be used in conjunction with a legally marketed wrap or Aesculap rigid container.
- Not intended on their own to maintain sterility.
The document also specifies the validated sterilization parameters:
- Cycle: Pre-vacuum
- Temperature: 270°F (132°C)
- Exposure Time: 4 minutes
- Minimum Dry Time: 30 minutes
And for certain models used with Aesculap containers:
- Sterilization: Steam prevacuum sterilizers ONLY operating at 270°F (132°C) for 4 minutes exposure time.
And specific lumen size validations:
- Minimum Inside Diameter: 1mm, 3mm, 5mm
- Maximum Length: 65mm, 76mm, 177mm, 200mm, 241mm, 400mm
- Number of Lumens: 1, 2, 4, 17
This information pertains to the physical and functional characteristics of the sterilization cassettes, ensuring they are compatible with the specified sterilization processes and can hold certain instruments. It does not involve any AI or software validation.
In summary, none of the requested AI-related study information can be extracted from this document because the device described is a physical medical device (sterilization wrap/cassette), not an AI/software as a medical 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).