(223 days)
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
· Gravity steam at 250°F/121°C for 30 minutes.
· 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.
- · Advanced Sterilization Products (ASP) STERRAD® 100S system.
· Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 200 System.
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.
· TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.
The Cardinal Health™ Sterilization Wrap is intended to enclose medical devices for sterilization and maintain their sterility until use. The device has been tested against various sterilization methods and loads.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Maintenance of Package Sterility | Negative for growth (Microbial Aerosol Challenge) | Negative for growth (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Event Related Shelf Life | No growth (for specified durations depending on sterilization method) | 365 days for Pre-vacuum steam, Gravity steam, EO, STERRAD® 100S, STERRAD® NX, STERRAD® 100NX, VPRO 1, VPRO 1 Plus, VPRO maX, VPRO 60, VP4; 30 days for STERRAD® 200 (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Biocompatibility - Irritation | Negligible irritant | Negligible irritant (tested per ISO 10993-10) |
| Biocompatibility - Leachability | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) |
| Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) | |
| Biocompatibility - Residuals | None detected | None detected (tested per ISO 10993-7) |
| Sterilization Efficacy | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Material Compatibility (Physical Properties) | Compatible (i.e., integrity of wrap properties not compromised after sterilization and storage) | Compatible (tested for Basis weight, Air permeability, Material burst strength, Grab Tensile strength, Trapezoidal Tear strength, Hydrostatic Pressure per ASTM standards) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes various validation studies performed for different sterilization methods and wrap models. The studies involved a range of loads, including medical instruments with different geometries, lumens, flexible endoscopes, towels, drapes, and metal mass. The specific sample sizes for each test set (e.g., number of wrapped packages, number of sterilization cycles) are not explicitly stated as numerical values in the provided text.
The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given that it is a 510(k) submission for a medical device and describes "Performance testing," it is implied to be prospective testing conducted in a controlled environment to validate the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. The nature of the device (sterilization wrap) and the tests performed (microbial growth, physical properties, biocompatibility) suggest that the "ground truth" would be established through laboratory analyses and adherence to standardized testing protocols (e.g., ANSI/AAMI, ISO, ASTM), rather than expert consensus on subjective observations.
4. Adjudication Method for the Test Set:
An adjudication method is not mentioned, as it is not typically applicable to the type of objective, quantitative testing (e.g., microbial growth, physical property measurements) described for this device.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for a sterilization wrap, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study was not done. This term is applicable to AI algorithms, not physical medical devices like sterilization wraps. The performance evaluation focuses on the physical and microbiological properties of the wrap itself.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Microbial Growth/Sterility: Absence of microbial growth, determined by standard microbiological culture techniques after sterilization and shelf-life challenges.
- Physical Properties: Quantitative measurements of material characteristics (e.g., weight, air permeability, tensile strength, tear strength, burst strength, hydrostatic pressure) compared against defined specifications before and after sterilization.
- Biocompatibility: Absence of detectable residuals, clear and pH-neutral extracts, and negligible irritant response as determined by standardized ISO tests.
8. The Sample Size for the Training Set:
A training set is not applicable to this device. This concept relates to machine learning models, whereas the Cardinal Health™ Sterilization Wrap is a physical product evaluated through traditional laboratory and material science testing.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this 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).