(46 days)
The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
The proposed Surgical and Prosthetic Trays are reusable perforated containers that are intended to store and organize the instruments needed before, during and after implant surgery and the prosthetic procedure as well as hold instruments during sterilization.
The Trays are containers composed of three main components: a lid, a base and an overlay, which are all made of polyphenylsulfone (Radel R5000NT). The trays have co-molded silicone tooling supports and silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the guided surgery or prosthetic procedure workflow and the position of the instruments within the tray for the different product lines.
The proposed Surgical and Prosthetic Trays are available in two tray sizes. The Surgical trays are available in medium size with outer dimensions of 7.3 x 5.5 x 2.4 inches and the Prosthetic trays are available in small size with outer dimensions of 5.4 x 3.9 x 2.4. Each tray size is offered in 2 inner tray configurations with varied instrument loads, see Table 1.
The provided text describes the acceptance criteria and the studies that prove the device meets these criteria for "Surgical and Prosthetic Trays" (K220791).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization cycle validation | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ISO 17665-2:2009 | Sterility assurance level (SAL) of ≤ 10-6 | Pass |
| Drying validation | AAMI TIR12:2020, ANSI/AAMI/ISO 17665-2:2009 | No visible moisture, ≤ 3% weight gain of packaging and absorbable materials | Pass |
| Cleaning (Manual Pre-Cleaning and automated Cleaning) | AAMI TIR 30:2011, ISO 15883-1:2014 | No visible soil. | |
| Protein and TOC content Limit |
§ 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).