(209 days)
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C
KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.
The provided document is a 510(k) premarket notification for the KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650). It describes the device's indications for use, comparison to predicate devices, and a summary of nonclinical tests performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it lists "Performance Requirements" and indicates "Passed" for each. The acceptance criterion implicitly seems to be "meeting the performance requirements" or demonstrating that the wrap "maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems." The specific quantitative thresholds for these "passed" results are not detailed in this summary.
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| STERRAD Sterilant Penetration | Passed |
| Material Compatibility/Biocompatibility post-sterilization using maximum hydrogen peroxide concentration (Cytotoxicity, Dermal Irritation) | Passed |
| Material Usability post-sterilization | Passed |
| Maintenance of Package Integrity (180 Days) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the nonclinical tests. For example, it doesn't state how many wraps were tested for "STERRAD Sterilant Penetration" or "Maintenance of Package Integrity."
The data provenance is not explicitly stated. The tests were performed as part of a 510(k) submission to the FDA, suggesting they were conducted by the manufacturer (Kimberly-Clark Health Care, later Halyard Health) to demonstrate device performance. It is implied to be prospective testing specifically for this submission, rather than retrospective data analysis from external sources. No information about country of origin of the data beyond the manufacturer's location (Roswell, GA) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to a device like a sterilization wrap. The "ground truth" for a sterilization wrap is typically established through objective laboratory testing according to established standards (e.g., ISO, ASTM, or specific sterilization system validation protocols) rather than expert interpretation of images or clinical assessment. Therefore, there's no mention of experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective human assessment, such as in clinical trials or image interpretation studies where multiple readers agree on a diagnosis. This is not relevant for the performance testing of a sterilization wrap, which relies on objective measurements and tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers interpreting images or data, with or without AI assistance. This device is a physical medical device (sterilization wrap) rather than a diagnostic tool, so such a study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to the device under review. The KIMGUARD* Smart-Fold* Sterilization Wrap is a physical product, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the performance tests appears to be established through:
- Objective laboratory testing and controlled experiments: For STERRAD Sterilant Penetration, this would involve measuring the presence or absence of sterilant penetration.
- Adherence to relevant ISO standards for biocompatibility: For Material Compatibility/Biocompatibility, this refers to ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Dermal Irritation).
- Functional testing: For Material Usability post-sterilization, this would likely involve evaluating the physical properties and integrity of the wrap after sterilization.
- Time-based integrity testing: For Maintenance of Package Integrity (180 Days), this involves evaluating the barrier properties and physical integrity of the package over an extended period.
The ground truth is based on the outcomes of these standardized and objective tests, rather than expert consensus, pathology, or clinical outcomes data in the way these terms are typically used for diagnostic or therapeutic devices.
8. Sample Size for the Training Set
This information is not applicable. As stated previously, this device is a physical medical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device like a sterilization wrap.
§ 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).