(226 days)
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:
| Product name | Article
Number | Max Load (g) | Vent to Volume
Ratio (in-1) |
|--------------------------|-------------------|--------------|--------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.
The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.
The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.
| Table 5.1- Surgical Tray configurations | ||||
|---|---|---|---|---|
| Product name | Model number | Max no of instruments | Max load (g) | Vent to volume ratio (in-1) |
| OmniTaper Surgical Tray | 68015282 | 51 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 45 | 513.7 | 0.033 |
This document describes the premarket notification (510(k)) for Dentsply Sirona Inc.'s "Surgical Trays" (K212281). The acceptance criteria and the study proving the device meets these criteria are detailed in section 5.7 "Non-Clinical Performance Data" and related subsections.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization cycle validation | Sterility assurance level (SAL) of |
§ 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).