(129 days)
Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using the following modalities:
- Pre-vacuum steam at 270°F/132°C for 4 minutes
- 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 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.
For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.
For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55℃. Models CH400, CH500, and CH600 have been validated for sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
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 pre-vacuum steam at 270°F/132°C for 4 minutes, or 100% ethylene oxide (EO) with a concentration of 725-735 mgL at 131°F/55°C and 40%-80% relative humidity for 60 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 Heatth DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.
The provided text describes the DuraBlue™ Sterilization Wrap and its performance. Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Properties | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Pass | PASS |
| Microbial Barrier Properties (Aerosol Challenge) | Pass | PASS |
| Event Related Shelf Life | 180 days | PASS - 180 days |
| Material Compatibility with Indicated Sterilization Method | Compatible | Compatible |
| Biocompatibility | Pass | PASS |
| Maintenance of Sterility (Pre-vacuum Steam) | 180 days | 180 days |
| Maintenance of Sterility (Ethylene Oxide) | 180 days | 180 days |
| Dry times for pre-vacuum steam (CH100, CH200) | 20 minutes | Validated for 20 minutes |
| Dry times for pre-vacuum steam (CH300 - CH600) | 30 minutes | Validated for 30 minutes |
| Aeration time for EO sterilization | 8 hours at 55°C | Validated for 8 hours at 55°C |
| Lumen sterilization (CH400, CH500, CH600) | 2 lumens, 3mm diameter or larger, 400mm length or less | Validated for 2 lumens, 3mm diameter or larger, 400mm length or less |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for the "test set." Instead, it describes loads used for Sterility Validation Studies for each of the six DuraBlue™ Sterilization Wrap models (CH100-CH600) for both pre-vacuum steam and EO sterilization. These loads consist of specific quantities of huck towels, fluid-resistant drapes, fluid-resistant table covers, stacked tray liners, lumens, and metal mass. The "Note" clarifies that these loads corresponded to the maximum recommended wrapped package content weights.
- Data Provenance: The document does not specify the country of origin of the data. It states that the device is manufactured by Cardinal Health 200, LLC in McGaw Park, IL, USA. The studies are described as "Event-Related Shelf Life testing" and "Sterility Validation Studies." The study refers to "FDA's Guidance Document Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting these are prospective validation studies conducted to meet regulatory requirements. Thus, the data appears to be prospective.
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 studies are described as "Sterilization Efficacy" and "Microbial Barrier Properties" testing, implying laboratory-based validation rather than expert-driven ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document. The nature of the testing (sterilization efficacy, microbial barrier) does not typically involve adjudication by human experts in the same way imaging or clinical diagnostic studies might.
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. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is also not applicable. The device is a physical product (sterilization wrap) and does not involve an algorithm or AI. Its performance is evaluated through physical and microbiological testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance claims (e.g., sterilization efficacy, microbial barrier, sterility maintenance) is established through laboratory-based scientific testing and validation methodologies, often involving microbiology (e.g., spore kill, microbial challenge) and physical testing (e.g., material compatibility, aging). This is akin to a "gold standard" of direct physical and biological measurement, rather than expert consensus or pathology in a medical imaging context.
8. The sample size for the training set:
This is not applicable. As a physical product, the DuraBlue™ Sterilization Wrap does not have a "training set" in the context of machine learning or AI. Its design and material properties are based on engineering principles and prior knowledge, not iterative training on a data set.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons mentioned in point 8.
§ 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).