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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.

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.

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KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.

Here's an analysis of the provided text regarding the KimGuard Smart-Fold Sterilization Wrap, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported numerical device performance results for direct comparison. Instead, it states that "All test results met acceptance criteria." The acceptance criteria mentioned are qualitative and relate to the successful fulfillment of certain functional and safety requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify an exact numerical sample size for each test conducted. It describes the "Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study" and "Descriptions of Loads Used in Sterility Maintenance Validation Study" for each wrap model, which indicate the types and maximum weights of items tested within the wraps.
  • KC250: 6 lbs. (e.g., 2 huck towels, 2 fluid-resistant U-drapes, 1 fluid-resistant universal bar drape)
  • KC450: 13 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 11 lbs. metal mass)
  • KC550: 17 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 15 lbs. metal mass)
  • KC650: 25 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 23 lbs. metal mass)
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to testing conducted "in compliance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting it was conducted specifically for this submission, implying a prospective study design for regulatory approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described focuses on the physical and functional performance of the sterilization wrap itself, rather than diagnostic interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests described are objective measures of device performance (e.g., sterility maintenance, dry time, physical integrity) rather than subjective assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a sterile barrier system, not a diagnostic imaging or screening tool that would involve human readers interpreting cases with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm. The performance described is its standalone function in maintaining sterility and allowing sterilization.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on:

• Objective measurements of sterility: Demonstrated by the ability to prevent microbial ingress and maintain a sterile environment for a specified duration (up to 30 days).
• Physical and material property evaluations: Ensuring the wrap retains its integrity, permits sterilant penetration, and has appropriate dry/aeration times.
• Biocompatibility testing: Ensuring the materials are safe for patient contact.

These are established through standardized laboratory and performance testing methods relevant to sterilization wraps.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" is used.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or machine learning algorithm is involved for this device.

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