(256 days)
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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylenevinylacetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days).
The provided text describes the acceptance criteria and the study proving the device meets these criteria for Tyvek Sterilization Pouches with Chevron Seal (K170429), when used with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to ISO 11607-1 | |
| Seal strength maintained | Met: Seal strength performance characteristics were maintained for the manufactured seal. |
| Microbial Barrier | Met: The contents of pouches were sterile when the processed pouches were subjected to the microbial aerosol challenge test. |
| Burst resistance | Met: Ability to withstand the internal pressurization was maintained. |
| Peel open characteristics maintained | Met: Peel open characteristics were maintained. |
| Material Compatibility | |
| Seal strength, microbial barrier, burst, and peel open tests pass | Met: Pass (Demonstrated material compatibility characteristics of the Tyvek Sterilization Pouches) |
| Biocompatibility | |
| Materials non-toxic, FDA compliant, meet ISO 11607-1; Biological and residual evaluations meet acceptable criteria | Met: Pass (Provides reasonable assurance for safety) |
| Shelf Life | |
| Physical properties and microbial barrier maintained for 5 years | Met: Pass (Verified at the end of shelf life of 5 years; Stability demonstrates reasonable assurance for effectiveness) |
| Performance in the Anprolene AN75 Cycle | |
| Sterilant Penetration (EO penetrates pouch, inactivates 6-Log biological indicators) | Met: Allow a Sterility Assurance Level (SAL) of 10^-6 for the sterilization cycle. |
| Maintenance of Package Sterility | Met: Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer. |
| Overall substantial equivalence to predicate device | Met: Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject device is substantially equivalent to the predicate device (Tyvek Sterilization Pouches with Chevron Seal, K152058) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test (e.g., number of pouches tested for seal strength, microbial barrier, etc.). It refers to "performance testing" and "studies" but doesn't quantify the number of units/samples used in these tests.
- Data Provenance: The context of the document (FDA 510(k) submission) implies these studies were conducted by the manufacturer, Andersen Sterilizers, Inc., likely in the United States (their address is Haw River, North Carolina). The studies appear to be prospective in nature, designed to demonstrate the safety and effectiveness of the device for the specific new indication (use with Anprolene AN75).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies described are primarily bench tests and performance testing against industry standards (ISO, ASTM) and internal validation. They do not involve expert human interpretation of data in the same way a diagnostic AI device would. "Ground truth" here is established through scientific testing methods (e.g., biological indicator inactivation for sterility, physical property measurements for package integrity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation of this device is based on objective physical and microbiological test results, not on human interpretation or consensus. Therefore, no adjudication method was used or needed.
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, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device product, not a software algorithm. The "performance" described is purely the physical and biological efficacy of the pouch itself in the sterilization process, independent of human interpretation or automated algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established through objective scientific measurements and standardized testing methodologies, including:
- Microbiological testing: Such as microbial aerosol challenge tests and biological indicator inactivation assays to demonstrate sterility assurance levels.
- Physical property testing: Measurements of seal strength, burst strength, and peel open characteristics to assess package integrity.
- Chemical/Material analysis: To confirm material compatibility and biocompatibility against established standards (e.g., ISO 11607-1).
- Time-based stability testing: To demonstrate shelf life and maintenance of sterility over time.
8. The sample size for the training set
Not applicable. This device is a physical product (sterilization pouch), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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).