(117 days)
The Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cycle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used.
This document describes the Andersen Sterilizers, Inc. Tyvek Sterilization Pouches with Chevron Seal (K152058).
The acceptance criteria and related study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Seal strength performance characteristics | Maintained for the manufactured seal; Meets ISO and ASTM requirements |
| Microbial Barrier | Contents of pouches sterile when subjected to microbial aerosol challenge; Meets ISO and ASTM requirements |
| Burst ability | Withstood internal pressurization; Meets ISO and ASTM requirements |
| Peel open characteristics | Maintained; Meets ISO and ASTM requirements |
| Material Compatibility | Pass (seal strength, microbial barrier, burst, and peel open tests) |
| Biocompatibility | Materials are non-toxic, FDA compliant, meet ISO 11607-1, biological evaluations meet acceptable criteria; Pass |
| Shelf Life (Physical properties, microbial barrier) | Physical properties and microbial barrier of processed pouches verified at end of 5 years; Pass |
| Sterilant Penetration (Sterility Assurance Level) | Inactivated 6-Log biological indicators under worst-case half-dose conditions; Achieved 10^-6 sterility assurance level for the sterilization cycle |
| Maintenance of Package Integrity (Sterility) | Sterility maintained for at least 3 months (90 days) after EOGas 4 processing; Pass |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each specific test mentioned (e.g., number of pouches tested for seal strength, microbial barrier, etc.).
- The data provenance is not specified beyond indicating that "Performance testing was conducted." It does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document describes performance testing against established standards (ISO, ASTM) and internal criteria, rather than relying on human expert assessment for ground truth.
4. Adjudication method for the test set:
- Not applicable. The tests are objective and based on established technical standards and measurements, not subjective human assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a sterilization pouch and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. The performance testing described is for the physical and functional characteristics of the sterilization pouch itself.
7. The type of ground truth used:
- The ground truth for the performance tests is based on established industry standards and regulatory requirements, such as ISO 11607-1, ASTM standards, FDA compliance for materials, and specific biological indicator inactivation levels (e.g., 6-Log reduction for sterility assurance).
8. The sample size for the training set:
- Not applicable. This device is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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).