(151 days)
The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes).
The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.
KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.
The KARL STORZ-ENDOSCOPE RADEL 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, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat.
The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray.
The provided text describes a 510(k) premarket notification for Karl Storz Radel Sterilization Trays and details non-clinical testing performed to demonstrate the device's safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents a "Summary of Non-Clinical Testing" which acts as the study proving the device meets the acceptance criteria. The table below excerpts the relevant information:
Table 1: Acceptance Criteria and Reported Device Performance
| Type of Testing | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1) | Demonstrate sterilization capabilities. | 10^-6 Sterility Assurance Level (SAL) | PASSED |
| Pre-vacuum dry time (AAMI ST77, ISO 17665-1) | 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).