(338 days)
The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:
- · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
- · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.
The trays are not intended for sterilization of non-porous loads.
The trays are recommended not to be stacked during sterilization.
The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).
Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.
The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.
The lid, base and insert are made of Radel R-5000. This material is a polymer resin.
The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.
The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents
The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 17665-1 (Sterilization of health care products – moist heat) | To verify the ability of the sterilization process to adequately sterilize the load at 132°C and 135°C | 6 log reduction at half cycle | The ability for successful sterilization at 132°C and 135°C was confirmed. |
| ISO 17664 / AAMI TIR 12 / AAMI TIR 30 (Cleaning effectiveness) | To verify the effectiveness of the recommended cleaning process. | Protein |
§ 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).