(79 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 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.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Must allow for sterilization of enclosed contents. | Demonstrated to allow for sterilization of enclosed contents. |
| Dry Time | Validated for specific dry times (20 or 30 minutes) for models. | Validated for 20 minutes for CH100 & CH200; 30 minutes for CH300-CH600. |
| Sterility Maintenance | Maintains sterility of enclosed contents for at least 30 days. | Demonstrated to maintain sterility for at least 30 days. |
| Physical Properties | Comparable to predicate device before and after sterilization. | Characterized before and after sterilization; supports substantial equivalence. |
| Biocompatibility | Complies with ISO 10993. | Complies with methods of ISO 10993. |
| Lumen Sterilization (CH400, CH500, CH600) | Validated for lumens 3mm diameter or larger and 400mm or less in length. | Validated for lumens 3mm diameter or larger and 400mm or less in length. |
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.
§ 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).