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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 pre-vacuum steam at 270°F/132°C for 4 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 dry times for pre-vacuum steam sterilization 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 sterilization of 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 Heath DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended 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. 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 DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization by pre-vacuum steam. The study aims to demonstrate that the wrap allows for sterilization of the enclosed contents and maintains sterility for an adequate period.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance tests, but it does not explicitly state numerical acceptance criteria 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 for at least 30 days." The "Summary of Testing" also notes that the data supports the conclusion that the DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate device in terms of performance and safety attributes.

Based on the provided information, the unstated acceptance criteria for each test would be that the DuraBlue™ Sterilization Wrap performs at least as well as, or equivalently to, the predicate device (KIMGUARD ONE-STEP Sterilization Wrap) and meets the general requirements for sterilization wrap.

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

The document does not explicitly state numerical sample sizes for each specific test (e.g., sterilization efficacy test, dry time test). However, it lists the "loads used in the Sterility Maintenance Validation Study" for each of the six DuraBlue™ Sterilization Wrap models (CH100 to CH600). These loads, comprising specific quantities of items (e.g., 16 huck towels, 5 lbs of metal mass), represent the test articles for that validation. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

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

This information is not provided in the document. The study appears to be focused on physical and microbiological validation of the device's performance, rather than assessment by human experts interpreting data.

4. Adjudication Method for the Test Set:

This information is not provided as the study does not involve expert adjudication of results. The results are likely determined by objective measurements and standardized test methods (e.g., sterility testing, physical property measurements).

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 type of study is not applicable and was not conducted. The DuraBlue™ Sterilization Wrap is a physical medical device (sterilization wrap), not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This concept is not applicable as the device is a physical sterilization wrap, not an algorithm. The "standalone" performance here refers to the device's inherent ability to perform its function (sterilize and maintain sterility) without human intervention in the sterilization or maintenance process beyond proper usage. The performance tests described (sterilization efficacy, dry time, sterility maintenance, physical properties) inherently represent the standalone performance of the wrap.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this device is based on scientific and technical standards for sterilization and sterility maintenance. This includes:

• Microbiological Negativity: For sterilization efficacy and sterility maintenance, the "ground truth" is typically the absence of microbial growth in culture, indicating sterility.
• Physical Property Measurements: Quantifiable measurements of material strength, porosity, and other physical characteristics.
• Time-Based Validation: For dry times and sterility maintenance duration, the ground truth is established by empirical testing under specified conditions.

8. The Sample Size for the Training Set:

This concept is not applicable as the DuraBlue™ Sterilization Wrap is a tested medical device, not a machine learning model that requires a training set.

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

This concept is not applicable as the device is not a machine learning model.

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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 STERRAD® 100S System. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. All models have been validated for sterilization of lumens 2,5 mm in diameter or larger and 250 mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is double layer sterilization wraps made from 100% polypropylene spunbond-methown-spunbond (SMS) fabric. The wrap in intended to be used to enclose another medical device that is to be sterilized by a health care provider by STERRAD® 100S System. This wrap design allows for use of the simulaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. This submission covers six different models of Cardinal Heatth DuraBlue™ Sterlization Wrap. Each model is made from material of Caranal rieantl Durante in Sulabite in Suite Lacin While Leacher technology technology.

This document describes the performance testing for the Cardinal Health DuraBlue™ Sterilization Wrap.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DuraBlue™ Sterilization Wrap are directly related to its ability to:

• Allow for sterilization of enclosed contents.
• Maintain sterility of enclosed contents for at least 30 days.

While specific numerical acceptance criteria are not explicitly stated in a table format in the provided text, the document 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 for at least 30 days." This implies that the device successfully met the performance objectives for both sterilization efficacy and sterility maintenance for the specified duration.

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

The document does not provide specific numerical sample sizes for the various tests. It generally refers to "Extensive performance testing" and "Successful completion of the sterilization performance tests."

• Sterility Maintenance Validation Study: The "loads used in the Sterility Maintenance Validation Study corresponded to the maximum wrapped package content weights in Table 2." These loads included various metal instruments packaged in different sized trays for each of the six wrap models (CH100 to CH600).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, the data would typically be generated for the purpose of demonstrating device safety and effectiveness, suggesting prospective studies.

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 type of device (sterilization wrap) does not typically involve human expert interpretation for ground truth establishment in the same way an imaging or diagnostic device would. Performance is measured through microbiological and physical property tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment of performance for a sterilization wrap does not typically involve human expert adjudication in the context of diagnostic interpretation. Results are based on physical and biological testing metrics.

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. The DuraBlue™ Sterilization Wrap is a physical medical device (sterilization wrap), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The DuraBlue™ Sterilization Wrap is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the sterilization wrap would be established through:

• Microbiological assays: To confirm that sterilization of enclosed contents is achieved (e.g., elimination of microbial burden) and that sterility is maintained over time (e.g., absence of microbial growth on sterile indicators or internal contents).
• Physical property testing: To ensure the wrap maintains its integrity, strength, and barrier properties before, during, and after the sterilization process, and during handling and storage, to prevent recontamination.
• Compatibility testing: To ensure the wrap does not adversely react with the sterilant and its chemical properties remain acceptable.

8. The Sample Size for the Training Set

Not applicable. As a physical product, there is no "training set" in the context of machine learning or AI. Performance is tested directly under specified protocols.

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

Not applicable. There is no training set for this type of device.

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