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Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modalities:

• Pre-vacuum steam at 270°F/132°C for 4 minutes
• STERRAD® 100S system. .
• Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for the following durations:

• 180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
• 30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes. .

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO™ cycles. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the preprogrammed Amsco® V-PRO® sterilization cycles.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes, STERRAD® 100S System and the Lumen, Non Lumen, or Flexible Cycles in 270 17102 0 for 4 mililates, STERM 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization and to maintain sterility for specified durations. The acceptance criteria and supporting studies are detailed below, primarily focusing on the sterility maintenance aspect, as this is the key modification highlighted in the submission, and sterilization efficacy as a fundamental performance requirement.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size for the "Event-Related Shelf Life testing" (which would be the primary test set for the sterility maintenance claim) or the "Extensive performance testing" for sterilization efficacy.

• Data Provenance: The studies are described as "real-time testing" for sterility maintenance and "extensive performance testing" for sterilization efficacy. The data is internally generated by Cardinal Health 200, LLC, a US-based company, suggesting the studies were conducted domestically. They are retrospective in the sense that the data is being presented post-collection as part of a 510(k) submission.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth. For sterility and sterilization efficacy testing, ground truth is typically established through microbiological methods (e.g., sterility testing, biological indicators) and physical/chemical tests, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests described (sterility testing, physical properties testing) involve objective measurements rather than subjective assessments requiring adjudication or consensus.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a sterilization wrap, not an imaging or diagnostic device that typically involves human readers interpreting results.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Event-Related Shelf Life testing" and "Extensive performance testing" demonstrate the performance of the wrap itself (the "algorithm only without human-in-the-loop performance" equivalent for this type of device) in achieving and maintaining sterility. The efficacy of the wrap is evaluated independently of human interpretation of a diagnostic output.

7. Type of Ground Truth Used

The ground truth used for these studies would be based on:

• Sterility: Absence of microbial growth in sterility tests (microbiological cultures).
• Sterilization Efficacy: Inactivation of biological indicators (spore tests) and successful passage of physical/chemical indicators for sterilization.
• Physical Properties: Objective measurements of material integrity (e.g., tensile strength, tear resistance, barrier properties) before and after sterilization/storage.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilization wrap) undergoing performance testing, not an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this type of device.

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterlization wraps made from 100% polypropylene spunbond-mettblown-spunbond (SMS) fabric. Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a heath care provider 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 to maintain sterlity of the enclosed device(s) for 30 days. The wrap was validated for an aeration time for EO sterilization of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterlization of two lumens 3 mm in diameter or larger and 400 mm in length or less. The wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterlized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each test. Instead, it states that "Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents until opened." The reported performance is that the wrap did successfully pass these tests, demonstrating substantial equivalence to the predicate device.

• Maintains sterility of enclosed devices for 30 days.
• Compatible with EO parameters: 725-735 mg/L concentration, 131°F/55°C, 40%-80% relative humidity, 60 minutes exposure.
• Validated for 8 hours aeration time at 55°C.
• For CH400, CH500, CH600: Validated for sterilization of two lumens 3mm diameter or larger and 400mm length or less.
• Substantial equivalence to predicate (K082177 - KIMGUARD ONE-STEP Sterilization Wrap) in performance and safety attributes.
• Meets physical property requirements before and after EO exposure.
• Complies with applicable requirements of FDA's "Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities" draft guidance.
• Demonstrates acceptable EO residuals and biocompatibility per ISO 10993. | - "Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents until opened."
• "Performance and safety attributes are substantially equivalent to the predicate."
• "The physical properties of all wrap models have been characterized both before and after exposure to 100% ethylene oxide sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate, and the DuraBlue™ Sterilization Wraps are compatible with the identified 100% ethylene oxide sterilization parameters."
• "Data from testing demonstrates that the performance of the DuraBlue™ Sterilization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wrap." |

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

• Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many wraps were tested for sterility maintenance, how many cycles for sterilization efficacy). It mentions that "Extensive performance testing has been completed" and details the specific "loads used in the validation studies" for each of the six models (CH100 to CH600). These loads represent the tested configurations for evaluating sterilization efficacy and pack integrity.
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 2 fluid resistant drapes, 2.5 lbs metal mass
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass
  • CH400: 4 stacked tray liners, 7.5 lbs metal mass in a tray
  • CH500: 4 stacked tray liners, 11.5 lbs metal mass in a tray
  • CH600: 4 stacked tray liners, 19.5 lbs metal mass in a tray
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes laboratory-based performance testing conducted to support the 510(k) submission.

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 is primarily laboratory-based performance testing of the physical properties and sterilization efficacy of the wrap itself, rather than studies requiring human expert interpretation of results (like medical imaging).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device and testing described. Adjudication methods (like 2+1 or 3+1) are typically used for studies where human experts are making judgments (e.g., diagnosing conditions from images) and their agreement needs to be resolved. The tests here involve measurable physical properties, sterility, and chemical residuals.

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 is not applicable to this device. An MRMC study is relevant for diagnostic devices that are interpreted by human readers, often with or without AI assistance. The DuraBlue™ Sterilization Wrap is a medical packaging device, not a diagnostic tool, and involves no human "readers" in its performance evaluation in this context.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical sterilization wrap, not an algorithm or software. The performance tests are inherently "standalone" in that they evaluate the material itself and its interaction with the sterilization process, without human intervention during the actual sterilization or sterility maintenance phase.

7. The Type of Ground Truth Used:

The ground truth for the performance tests would be based on:

• Sterility Assessment: Typically involves biological indicator (BI) testing (e.g., showing inactivation of spores) and microbial challenge testing to confirm the sterilization process efficacy and the wrap's ability to maintain a sterile barrier. This is a scientific, objective measure.
• Physical Property Standards: Measurements of tear resistance, burst strength, porosity, etc., against predefined engineering specifications and industry standards.
• Chemical Analysis: Measurement of EO residuals in accordance with regulatory limits.
• Visual Inspection: For pack integrity, tears, or compromise.

Essentially, the ground truth is established through objective, standardized laboratory testing methods to demonstrate the physical, chemical, and biological performance of the wrap.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device. The DuraBlue™ Sterilization Wrap is a manufactured medical product that undergoes performance validation, not an artificial intelligence algorithm that requires a dataset for training.

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.

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