(261 days)
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:
Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.
This document describes the validation of the ST-Z5 surgical trays for sterilization.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Automated Cleaning Validation (FDA Guidance: Reprocess Medical Devices in Healthcare Settings: Validation Methods and Labeling) | Validate cleaning instructions, ensure sterilization cycle effectiveness. | Protein assay: |
§ 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).