(246 days)
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes.
b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar
c) Aeration time: 12 hours
d) Aeration temperature: 55℃
e) Aeration pressure : 841 mBar to 864 mBar
Sterilization Wrap is single use, non-sterile provide. It is divided into single and double layers, with double layer edges closed by ultrasonic suture. The sterilization Wrap is made from 100% polypropylene spunbond- meltblown - spunbond (SMS), not made with natural rubber latex.
The provided text describes the regulatory clearance of a "Sterilization Wrap" device (K222151) and its comparison to a predicate device (K181174). The information focuses on the physical, chemical, and sterilization properties of the wrap. The document does not contain information related to a study involving an AI-powered medical device or human readers for image interpretation. Therefore, I cannot provide details on the sample size for a test set, expert qualifications, or MRMC studies, as these concepts are not applicable to the provided document.
However, I can extract the acceptance criteria and performance data for the Sterilization Wrap based on the provided text, as it relates to the device's functional and safety aspects.
Here's the analysis based on the provided text:
Analysis of Sterilization Wrap Acceptance Criteria and Performance
The "Sterilization Wrap" device (K222151) has undergone non-clinical testing to demonstrate its performance and establish substantial equivalence to a predicate device (K181174). The acceptance criteria and reported device performance are generally based on meeting recognized industry standards for medical device sterilization wraps.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Proposed Device Performance | Predicate Device (K181174) Performance | Remark (from document) |
|---|---|---|---|---|
| Sterilant Penetration and Sterilization Efficacy | Achieving a 10⁻⁶ sterility assurance level (e.g., negative for growth) | Negative for growth | Negative for growth | SAME |
| Maintenance of package sterility | Maintain sterility for up to 365 Days | Negative for growth (tested for 365 days) | Negative for growth (tested for 365 days) | SAME |
| Residuals (Ethylene Oxide) | Meet ISO 10993-7 | Meet ISO 10993-7 (None detected) | Meet ISO 10993-7 | SAME |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Biocompatibility (Irritation) | Non-irritant (ISO 10993-10) | Non-irritant | Non-irritant | Pass |
| Biocompatibility (Sensitization) | Non-sensitizer (ISO 10993-10) | Non-sensitizer | Non-sensitizer | Pass |
| Material Compatibility (EO sterilization process) | Compatible to EO sterilization process | Compatible | Compatible | SAME |
| Tensile Strength | Complies with selected physical properties (ASTM D 5034 -09) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Bursting Strength | Complies with selected physical properties (ASTM D3786/D3786M-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Water Resistance Hydrostatic Pressure Test | Complies with selected physical properties (AATC127-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Air Permeability | Complies with selected physical properties (ASTM D737-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Mass per Unit Area | Complies with selected physical properties (ASTMD37776/D3776M-20) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Tearing Strength | Complies with selected physical properties (ASTM D5587-15) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Dimension | Meet ISO 11607:2019 | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Lint Generation Testing | Coefficient of linting log₁₀ ≤ 4.0 (EN 13795-1:2019) | ≤4.0 (before and after EO sterilization) | (Not explicitly stated) | Pass |
| Microbial Barrier Test | Product has good anti-bacterial permeability of the packaging material | Negative for growth | (Not explicitly stated but implied by "Maintenance of package sterility") | Pass |
| Shelf Life | Shelf Life 1 year | After 1 year accelerated aging, meets requirements and no significant change from 0 year's test results. | Not obtained (for predicate) | Passed |
2. Sample size used for the test set and the data provenance
The document refers to various standard tests (e.g., ASTM, ISO standards) for physical properties, sterilization validation, and biocompatibility. The specific sample sizes for each of these non-clinical tests are not provided in the document.
The data provenance is from non-clinical tests conducted by the manufacturer of the proposed device, Kenpax International Limited. The country of origin of the data is not explicitly stated beyond the manufacturer's address in Hong Kong and the contact person's address in Beijing, China. The studies are prospective in nature, as they involve testing the device to verify its performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this device is established through quantitative measurements and adherence to international testing standards (e.g., sterility assurance level, physical property thresholds) rather than expert consensus on interpretation, as might be the case for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for non-clinical, objective performance testing of a physical product like a sterilization wrap.
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 question is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic tool, and therefore, an MRMC study with human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on pre-defined, quantitative performance metrics and established international standards. For example:
- Sterility: Achieved a 10⁻⁶ sterility assurance level (objective microbial growth testing).
- Physical Properties: Meeting specific tensile strength, bursting strength, water resistance, air permeability, mass per unit area, tearing strength, and dimension parameters (objective physical measurements).
- Biocompatibility: Absence of cytotoxicity, irritation, and sensitization (objective biological tests against ISO standards).
- Residuals: Levels of ethylene oxide residuals below specified thresholds (objective chemical analysis).
8. The sample size for the training set
This question is not applicable. The device is a physical product, and there is no "training set" in the context of machine learning or AI models. Its design and manufacturing process would involve internal validation and quality control, but not a "training set" for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
§ 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).