(448 days)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.
The H2O2 Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.
| Performance Metric | Acceptance Criteria (Standard Reference and/or Implied Criterion) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Meet the requirement of SAL 10-6 (ANSI/AAMI/ISO 14937:2009) | The test met the requirement of SAL 10-6 |
| Package Integrity (Physical Properties) | (Tested before and after Gas Plasma Sterilization) | |
| Thickness Variations (mm) | (ASTM F 2251-03) No specific numerical acceptance criteria provided, but "Small" values for both new and predicate are similar. | Small: 0.145 (before/after); Large: 0.146 (before/after) |
| Tear Resistance (g) | (ASTM D1922) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 259 (before), 258 (after); MD: 282 (before), 280 (after) |
| Tensile strength of plastic film (kgf/mm2) | (ASTM D882) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 575 (before), 531 (after); MD: 577 (before), 531 (after) |
| Tensile strength of Tyvek® (N/2.54cm) | (ASTM D 5035) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 174 (before), 170 (after); MD: 163 (before), 162 (after) |
| Burst Strength (kPa) | (ASTM F1140-07) No specific numerical acceptance criteria provided, but similar to predicate. | Small: 21.4 (before), 17.95 (after); Large: 4.49 (before), 2.03 (after) |
| Seal Peel Test (g/15mm) | Pass (ASTM F88/F88M-09; ISO 11607-1) - The predicate also reports "Pass". | Upper: 340.3 (before), 493.6 (after); Down: 506.7 (before), 709.9 (after); Left: 345.7 (before), 436.0 (after); Right: 316.5 (before), 518.5 (after). Result: Pass |
| Dye penetration Test | No Channels identified on package (ASTM F 1929-12; ISO 11607-1) | No Channels identified on package |
| Microbial Barrier Test |
§ 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).