(270 days)
The Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.
The proposed Washtrays are used to store and organize dental implant surgical instruments needed during implant surgery, as well as hold instruments during cleaning and sterilization. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or sterilization container.
The proposed Washtrays consist of a stainless-steel perforated tray equipped with baskets and a lid with a handle. The large basket comprises instrument holders inserted in an anodized aluminum alloy Overlay printed with visual symbols for correct positioning of the designated instruments such as drills and taps.
The designated instruments are placed in the Overlay in the Instrument holders which are made with PEEK and have a stainless steel spring to hold the instruments in place. The Overlay guides the user through the surgical protocol for implant placement. The small basket with its own small lid and silicone mat inside is used to store the instruments which can be disassembled prior to cleaning. The metal grid base has silicone feet to prevent the Washtrays from slipping/sliding when placed on a surface.
The outer dimensions for all Washtrays is the same, 10.83 x 2.32 inches. The inner arrangement of the baskets varies between the Washtrays.
The device being described is a set of "Washtrays" intended for organizing, cleaning, sterilizing, and storing surgical instruments.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Cycle Validation | Sterility assurance level (SAL) of ≤ 10⁻⁶ | Pass |
| Drying Validation | No visible moisture; ≤ 3% weight gain of packaging and absorbable materials | Pass |
| Cleaning (Manual Pre-Cleaning and Automated Cleaning) | No visible soil; 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).