(227 days)
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System 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, available in various sizes, are designed to encase specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes.
The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes.
The provided text describes the acceptance criteria and a summary of non-clinical testing for the KARL STORZ UDEL Sterilization Trays. The device is a medical device sterilization tray, and the testing focuses on its efficacy in various sterilization methods and its material stability.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Type of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (STERRAD 100S, STERRAD NX Standard & Advanced, STERRAD 100NX Flex, Pre-vacuum Steam, Gravity Steam) | 10^-6 Sterility Assurance Level (SAL) | PASSED |
| Pre-vacuum Dry Time | Establish Minimum Dry Time | ESTABLISHED |
| Gravity Dry Time | Establish Minimum Dry Time | ESTABLISHED |
| Manual Cleaning – Protein, Hemoglobin |
§ 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).