(126 days)
The Sterisheet Sterilization Wraps are single use non woven sterilization wraps intended to enclose medical devices that are to be sterilized 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 Sterisheet Sterilization Wraps are single use, non-sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. 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 wrapped following manufacturer's instructions. After completion of the sterilization process, the Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 month.
The provided text describes the performance testing and acceptance criteria for the Sterisheet® Sterilization Wrap (K152291).
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to ISO 11607-1 | Met requirements |
| - Package Integrity: Porous material providing a microbial barrier; physical and chemical properties are maintained. | Met requirements |
| - Material Compatibility: Compatibility with respect to forming and sealing processes; suitable folding and drape ability; suitability for use in EO sterilization processes and cycle parameters. | Met requirements |
| - Biocompatibility: Materials are non-toxic and meet ISO 11607-1 requirements; biological evaluation meets acceptable criteria; bio-burden control; provides reasonable assurance for safety. | Pass |
| - Shelf Life: Physical properties and microbial barrier verified at the end of the 5-year claimed shelf life. | Pass |
| Performance in the EOGas 4 Cycle | Met requirements |
| - Sterilant Penetration: Sterilant penetrated the pouch under worst-case half-dose conditions or an extreme biological challenge scenario, and inactivated 6-Log biological indicators. | Allowed a sterility assurance level of $10^{-6}$ for the sterilization cycle |
| - Maintenance of Package Integrity: Sterility maintained for at least 3 months after processing in an EOGas 4 sterilizer. | Pass |
Study Details
The provided document describes non-clinical performance testing to demonstrate the safety and effectiveness of the Sterisheet® Sterilization Wrap. This is a technical validation rather than a clinical study involving human patients or ground truth established by medical experts for diagnostic purposes. Therefore, some of the requested information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.
The study focuses on demonstrating the physical, chemical, and biological performance of the sterilization wrap itself.
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Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "test set" as would be used for an AI/diagnostic device. The testing involves physical samples of the sterilization wrap subjected to various conditions and analyses. The provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilization wrap is established through adherence to standards (e.g., ISO 11607-1) and objective measurements of sterility, material integrity, and biological efficacy, not expert consensus on an image or clinical finding.
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Adjudication method for the test set: Not applicable. Performance is evaluated against objective standards and biological indicators, not through human adjudication of differing opinions.
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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 is not an AI/diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
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The type of ground truth used:
- Objective Standards: Compliance with ISO 11607-1 requirements for packaging of terminally sterilized medical devices.
- Biological Efficacy: Inactivation of 6-Log biological indicators to demonstrate a sterility assurance level of $10^{-6}$ (using the overkill method and half cycle or half dose validation methods under worst-case conditions).
- Physical and Chemical Properties: Bench testing to verify package integrity, material compatibility, and shelf-life stability.
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The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set" in that context.
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How the ground truth for the training set was established: Not applicable.
§ 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).