(72 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 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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Allow sterilization of enclosed contents by STERRAD® 100S System. | Successfully demonstrated in sterilization performance tests. |
| Maintain sterility of enclosed contents for at least 30 days. | Successfully demonstrated in sterility maintenance validation study. |
| Compatible with STERRAD® 100S System. | Data supports conclusion of compatibility. |
| Physical properties (pre and post-sterilization) comparable to predicate device. | Resulting data supports substantial equivalence in physical properties. |
| Biocompatibility in compliance with ISO 1099. | Tested and found compliant. |
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.
§ 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).