(250 days)
The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time).
When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used.
The system has been validated with devices with working channels >= 0.2mm and a maximum length of 240mm.
The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization. the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.
The tray configurations are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware.
The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.
The document describes the acceptance criteria and the results of non-clinical testing for the KARL STORZ Metal Sterilization Trays. It does not describe a study involving a medical device that uses artificial intelligence or machine learning. Therefore, many of the requested elements of the response (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for the training set) are not applicable or cannot be extracted from the provided text.
However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Type of Testing | Purpose | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|---|
| Pre-vacuum sterilization efficacy AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products Moist Heat Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | Demonstrate sterilization capabilities. | 10-6 SAL (Sterility Assurance Level) | PASSED |
| Pre-vacuum dry time AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products Moist Heat Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | To establish minimum dry time. | Pre and Post Sterilization weight difference |
§ 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).