(437 days)
The Vis-U-All Low Temperature Tyvek Sterilization Pouch for ethylene oxide has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-All Low Temperature Tyvek Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider using ethylene oxide (ETO). The proposed pouch is available as a self seal pouch, a heat seal pouch, or heat seal tubing. The material composition of the proposed and predicate device is identical with the exception of the addition of an ISO 11140 Class 1 compliant, ethylene oxide chemical indicator on the proposed device.
The provided text describes performance testing for the Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, but it does not describe an AI/algorithm-based device. Therefore, many of the requested fields (sample size for test/training set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth for training) are not applicable to this submission.
Here's the available information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Testing | Acceptance Criteria (Implied by PASS) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Effective penetration of ETO | PASS (ETO effectively penetrates pouches) |
| Event Related Sterility Maintenance | Maintained performance (strength, microbial resistance) after aging and handling | PASS (All packs maintained performance) |
| Microbial Barrier Properties | No microbial growth | PASS (No microbial growth on test articles/negative controls) |
| Tensile / Tear / Puncture Resistance / Seal Peel Strength | No statistically significant difference in tensile properties, clean peels, acceptable burst strength, no compromise to sealing | PASS (No statistically significant differences, clean peels, acceptable burst strength) |
| Cytotoxicity | Not cytotoxic | PASS (Not cytotoxic) |
| Sterilant Residues | Not retaining harmful levels of ETO or byproducts per ISO 10993-7:1995 | PASS (Pouch materials confirmed not to retain harmful levels) |
| Chemical Indicator Class 1 Compliance | Compliant with ANSI/AAMI/ISO 11140-1:2005 requirements | PASS (Validated against requirements) |
| Chemical Indicator Toxicity | Not cytotoxic per ANSI/AAMI/ISO10993-5:1999 methodology and limits | PASS (Not cytotoxic) |
| Chemical Indicator Post-Processed Color Stability | Stable after ETO exposure for at least one year | PASS (Color is stable for at least one year) |
| Simulated Use | ETO can penetrate pouch to sterilize loads | PASS (All criteria met, ETO can penetrate) |
| Process Indicator End Point Stability - Aged Vis-U-All Tyvek pouches | Meet performance criteria after storage | PASS (Meet performance criteria) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified, but generally, such product testing for regulatory submission would be conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA) or a contracted lab. This is product validation, not clinical data, so terms like "retrospective" or "prospective" are not directly applicable in the same way they would be for patient data.
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)
Not applicable. This is a product validation study involving physical, chemical, and microbiological performance, not expert-adjudicated diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a product validation study, not expert adjudication of diagnostic findings.
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 is not an AI/algorithm-based device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be established through various standardized testing methods and international standards (e.g., ISO 10993, ANSI/AAMI/ISO 11140-1). For example:
- Sterilant Penetration: Measured by biological indicator inactivation or gas concentration measurements within the pouch.
- Microbial Barrier: Measured by bacterial challenge tests.
- Material Properties (Tensile/Tear/Puncture/Seal Peel): Measured using standardized mechanical testing equipment and methods.
- Cytotoxicity/Residues: Measured using in-vitro cell culture assays and analytical chemistry techniques following relevant standards.
- Chemical Indicator Compliance: Assessed against the specified requirements of ANSI/AAMI/ISO 11140-1.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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).