(94 days)
The Medtronic Transportation Cassettes are intended for use in healthcare facilities to organize, enclose, sterlize, transport, and store medical devices and other instrumentation between surgical uses. The Medtronic Transportation/Sterilization Cassettes are not intent own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices, which meet national or international standards. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation / Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components if the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA-cleared wrap must be used for sterilization and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the Medtronic Transportation/Sterilization Cassettes are effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is a 510(k) summary for a medical device (Medtronic Transportation/Sterilization Cassettes) that states no changes were made to the device itself, only to the labeling to add manual cleaning instructions.
Therefore, the document explicitly states that the original biocompatibility and verification/validation data still applies, and it does not provide new, detailed acceptance criteria and performance data for the device's primary function of sterilization and transport. It mentions a cleaning validation study was performed for the new manual cleaning instructions, but provides no details on its methodology, sample size, or specific acceptance criteria and results beyond stating it was "effective."
Without specific acceptance criteria and reported device performance (e.g., sterilization efficacy rates, barrier properties, mechanical durability under specific tests), and details on the study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, etc.), I cannot fulfill your request.
§ 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).