(40 days)
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 using the following modalities:
- Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
- Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles .
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 aging testing for a duration of 180 days for each indicated modality.
Cardinal Health DuraBlue™ Sterlization 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 Standard, Flex, Express, and Duo cycles of the Johnson & Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The proposed DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days.
Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:
DuraBlue™ Sterilization Wrap Acceptance Criteria and Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Properties | Acceptance Criteria (Implied by "PASS" or "Compatible") | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Must allow for sterilization of enclosed contents | PASS |
| Microbial Barrier Properties (Aerosol Challenge) | Must maintain microbial barrier | PASS |
| Event Related Shelf Life (Sterility Maintenance) | Must maintain sterility for a specified period | PASS - 180 days |
| Material Compatibility with Indicated Sterilization Method | Must be compatible with STERRAD® 100NX and NX sterilization systems | Compatible |
| Biocompatibility | Must be biocompatible | PASS |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document specifies that "Each model is made from material of a different basis weight, though all models utilize the same material technology." There are six models (CH100, CH200, CH300, CH400, CH500, CH600). The "Sterility Maintenance Validation Study" used one of each model, with specific tray contents for each model. Therefore, the minimum sample size for the sterility maintenance test set would be 6 units (one of each model). However, performance testing also included sterilization efficacy, microbial barrier properties, material compatibility, and biocompatibility, which likely involved more samples and replicates for thorough validation. The exact total number of individual samples tested across all performance properties is not explicitly stated but would be expected to be higher than just 6.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, the testing would have been prospective to generate data for regulatory approval. The testing was conducted by Cardinal Health 200, LLC, located in McGaw Park, IL, USA, implying the studies were conducted in the USA or in facilities compliant with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the test set. For sterilization wrap, ground truth is typically empirical (e.g., microbial challenges, physical property measurements) rather than interpreted by human experts like in imaging studies. The "PASS" results would indicate that the measured performance met pre-defined, objective criteria.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. For performance testing of a sterilization wrap (e.g., sterilization efficacy, microbial barrier), results are typically determined by objective laboratory measurements and testing protocols (e.g., biological indicator kill, physical integrity assessment) rather than subjective expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiology images) and the AI's impact on their performance is being assessed. Sterilization wrap performance is determined through objective material and microbiological testing.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are standalone (algorithm only, though this is not an "algorithm" in the AI sense, but rather the device itself). The performance tests (sterilization efficacy, microbial barrier, material compatibility, biocompatibility) directly evaluate the wrap's inherent properties and its interaction with the sterilization process, without human intervention in the performance measurement itself.
7. The Type of Ground Truth Used
The ground truth used for the performance testing of the DuraBlue™ Sterilization Wrap is primarily empirical and objective measurement-based:
- Sterilization Efficacy: Likely involves biological indicator (BI) kill results, confirming the sterility of enclosed contents after sterilization.
- Microbial Barrier Properties: Measured through aerosol challenge tests, evaluating the wrap's ability to prevent microbial ingress.
- Event Related Shelf Life (Sterility Maintenance): Real-time aging studies followed by sterility testing or integrity checks.
- Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) before and after sterilization to ensure the material is not compromised.
- Biocompatibility: In vitro and/or in vivo tests to confirm the material does not elicit adverse biological responses, in compliance with ISO 10993.
8. The Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning algorithms. Since the DuraBlue™ Sterilization Wrap is a physical medical device and not an AI/ML algorithm, there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
§ 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).