(275 days)
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 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Sterisheet Sterilization Wraps are single use, non-sterilyzation 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 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.
AN85 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.
The information provided describes the acceptance criteria and a summary of non-clinical testing for the Sterisheet Sterilization Wrap (K200335), which is intended for use in a 6-hour ethylene oxide (EO) gas sterilization cycle.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Compliance to ISO 11607-1 | |||
| Physical and Chemical Properties | To evaluate the package integrity after EO sterilization | Various standards for various properties (e.g., ISO 536 for Substance, ISO 5636-3 for Permeability, EN 868-2 for Fluorescence and Water repellency) | There was no effect on the physical and chemical properties after EO sterilization. |
| Bacterial Filtration Efficiency and Germ Proofness dry and wet challenge test | To demonstrate that Sterisheet provide a microbial barrier property | Bacterial Filtration Efficiency (ASTM F2101); Germ Proofness dry and wet challenge test (DIN 58953-6) | Sterisheet passed all tests and were effective for sterility assurance pre- and post-EO sterilization. |
| Material Compatibility | To demonstrate Sterisheet is suitable for use in EO sterilization processes and the associated cycle parameters | The physical, chemical, and microbial barrier properties of Sterisheet are compatible for intended use in EO sterilization per ISO 10993 and USP | The ability of the wraps to act as a microbial barrier was unaffected, and the contents of the packs remained sterile after EO sterilization. |
| Biocompatibility | To demonstrate that Sterisheet provides reasonable assurance for safety | Biological evaluation (MEM Elution, Sensitization and Irritation Test) per ISO 10993 and USP | Not direct patient-contacting devices; Biological evaluation Showed that Sterisheet met all accepted performance criteria for non-toxicity. No pigment leaches out of Sterisheet during 6-hour EO exposures. With an additional 6-hour aeration, the residual EO detected in Sterisheet met ISO 10993-7 requirements. |
| Shelf Life | To evaluate the physical, chemical, and microbial barrier of the processed Sterisheet at the end of the claimed shelf life | Stability demonstrates reasonable assurance for effectiveness | The physical, chemical, and microbial barrier properties of the wraps were verified at the end of 5 years and met specifications. |
| Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer | |||
| Sterilant Penetration | To demonstrate Sterisheet allow sterilization of the wrapped devices in half dose, full dose, simulated-use and in-use testing | Inactivation of 6-Log biological indicators at the worst-case location in the endoscope load wrapped in the Sterisheet for all the testing performed | Data demonstrate that Sterisheet Sterilization Wraps allow penetration of EO and sterilization of the enclosed devices. |
| Maintenance of Package Sterility | To demonstrate Sterisheet maintain sterility of the enclosed medical device | The sterilized devices wrapped in Sterisheet remain sterile | Sterility was maintained for 6 months after processing in Sterisheet wrapped endoscopes. |
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 lists "Performance Testing" and "Summary of bench tests" but does not provide details on specific sample sizes for these tests. It indicates that the tests conform to ISO 11607-1, ASTM F2101, DIN 58953-6, ISO 10993, and USP standards. These are bench-level tests (non-clinical) and do not involve human subjects or geographical data provenance in the typical sense. The testing was conducted to prove the performance of the wrap itself.
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 applicable as the study described is a non-clinical performance evaluation of a sterilization wrap, not a diagnostic device relying on expert interpretation for ground truth. The "ground truth" here is the outcome of standardized physical, chemical, and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests are objective laboratory tests rather than subjective assessments 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
This information is not applicable as MRMC studies are relevant for diagnostic tools, particularly those involving human interpretation of medical images or data, often with AI assistance. The Sterisheet Sterilization Wrap is a medical device for sterilization, not a diagnostic or AI-powered interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable for the same reasons as above. The device is not an algorithm. The "standalone" performance here refers to the wrap's inherent ability to function as a microbial barrier and allow sterilant penetration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical tests is established through objective laboratory measurements and validated biological indicators. For example:
- Physical and Chemical Properties: Measured values against established standards (e.g., ISO for substance, permeability).
- Bacterial Filtration Efficiency and Germ Proofness: Efficacy in preventing microbial passage according to ASTM and DIN standards.
- Material Compatibility: Physical, chemical, and microbial barrier properties remaining acceptable after EO exposure.
- Biocompatibility: Absence of toxicity per ISO 10993 and USP (MEM Elution, Sensitization, Irritation).
- Sterilant Penetration: Inactivation of 6-Log biological indicators.
- Maintenance of Package Sterility: Absence of microorganism growth after storage.
8. The sample size for the training set
This information is not applicable. The Sterisheet Sterilization Wrap is not an AI/ML device that requires a "training set." The tests are empirical demonstrations of its physical, chemical, and biological performance.
9. How the ground truth for the training set was established
This information is 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).