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Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by 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, Standard, Flex, Express, and DUO cycles

• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed devices until it is used.

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. This product is a single-use device and for over-the-counter use only.

This document describes the validation of Cardinal Health™ Sterilization Wrap, specifically to demonstrate its substantial equivalence to a predicate device and support its use with gravity steam sterilization.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The study is referred to as "extensive performance testing" and "sterility validation studies" completed on Cardinal Health™ Sterilization Wrap. This included:

• Sterilization Performance Tests: Demonstrated that the wrap allows for sterilization of enclosed contents and maintains sterility.
• Physical Properties Testing: Supported that the integrity of the wrap properties is not compromised after sterilization by the indicated processes and storage.
• Biocompatibility Testing: Conducted in compliance with ISO 10993 methods.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document lists specific "loads" used for each sterilization method and for each wrap model (CH100-CH600) during "Sterility Validation Studies" (pages 5-6 and 13-14). These loads represent the test sets for demonstrating sterilization efficacy, microbial barrier, and maintenance of sterility.

• Gravity Steam Sterility Validation Studies:
  • CH100: 1 tray liner, 1 lb metal mass.
  • CH200: 1 tray liner, 3 lbs metal mass.
  • CH300: 1 tray liner, 6 lbs metal mass.
  • CH400: 1 tray liner, 10 lbs metal mass.
  • CH500: 1 tray liner, 12 lbs metal mass.
  • CH600: 1 tray liner, 20 lbs metal mass.
• Pre-vacuum Steam Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 3 fluid-resistant drapes.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs metal mass.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs metal mass.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs metal mass.
• EO Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs metal mass.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs metal mass.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs metal mass.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs metal mass.
• Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
  • CH100: Metal instruments.
  • CH200-CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
• Advanced Sterilization Products (ASP) STERRAD® NX® and STERRAD® 100NX® Sterility Validation Studies:
  • CH100-CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
• STERIS V-PRO® Sterility Validation Studies:
  • CH100: Metal instruments.
  • CH200-CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

The data provenance is not specified beyond the fact that Cardinal Health is a US-based company, suggesting the studies likely occurred in the USA. The nature of these validation studies (evaluating specific loads under controlled sterilization conditions) implicitly indicates they were prospective studies for the purpose of demonstrating device performance and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This document pertains to the physical and biological performance of a sterilization wrap. The "ground truth" for such devices is established through laboratory testing following recognized standards for sterilization efficacy (e.g., sterility testing, microbial barrier testing) and physical/biocompatibility characteristics. It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would. Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications like radiologists is not applicable here. The ground truth is determined by the results of validated scientific and engineering tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As explained above, the "test set" involves physical samples subjected to defined sterilization processes and subsequent lab analyses, not human interpretation of data requiring adjudication.

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. This device is a sterilization wrap, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device is based on objective laboratory measurements and tests designed to assess:

• Sterilization Efficacy: Absence of microbial growth after sterilization.
• Microbial Barrier Properties: Resistance to microbial penetration.
• Maintenance of Sterility: Absence of microbial contamination after storage period.
• Physical Properties: Integrity and strength of the wrap material after sterilization.
• Material Compatibility: No adverse interaction with sterilization agents or enclosed devices.
• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO standards.

This ground truth is established through adherence to recognized industrial and medical device standards (e.g., AAMI ST79, ISO 10993) and scientific testing methodologies.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software product that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI model development.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

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