(119 days)
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid container. The Instru-Safe System cassettes are not intended on the own to maintain sterility.
Not Found
The provided text is a 510(k) premarket notification decision letter from the FDA regarding "INSTRU-SAFE Instrument Protection Systems" (K051157). It confirms substantial equivalence to predicate devices for device sterility. However, it does not contain any information about acceptance criteria, device performance, validation study details, or ground truth as requested in the prompt.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document primarily focuses on:
- Device identification: INSTRU-SAFE Instrument Protection Systems.
- Regulatory classification: Class II, Product Code KCT, Regulation Number 21 CFR 880.6850 (Sterilization wrap).
- Indications for Use: Used to organize and protect medical devices during pre-vacuum steam or ethylene oxide sterilization cycles, in conjunction with legally marketed wraps or rigid containers.
- Sterilization methods and configurations: Specific times for steam and ethylene oxide sterilization cycles with different wrap/container types (140 count woven wrap, non-woven wrap, Genesis Container).
- FDA's determination: The device is substantially equivalent to legally marketed predicate devices.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or the actual study report submitted with the 510(k) application, which would detail the validation studies conducted to demonstrate the device's performance against established criteria for sterility.
§ 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).