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 using the following modalities:

Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles .
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.

Device Description

Cardinal Health DuraBlue™ Sterlization 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 Standard, Flex, Express, and Duo cycles of the Johnson & Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The proposed DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:

DuraBlue™ Sterilization Wrap Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Performance Properties	Acceptance Criteria (Implied by "PASS" or "Compatible")	Reported Device Performance
Sterilization Efficacy	Must allow for sterilization of enclosed contents	PASS
Microbial Barrier Properties (Aerosol Challenge)	Must maintain microbial barrier	PASS
Event Related Shelf Life (Sterility Maintenance)	Must maintain sterility for a specified period	PASS - 180 days
Material Compatibility with Indicated Sterilization Method	Must be compatible with STERRAD® 100NX and NX sterilization systems	Compatible
Biocompatibility	Must be biocompatible	PASS

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Size: The document specifies that "Each model is made from material of a different basis weight, though all models utilize the same material technology." There are six models (CH100, CH200, CH300, CH400, CH500, CH600). The "Sterility Maintenance Validation Study" used one of each model, with specific tray contents for each model. Therefore, the minimum sample size for the sterility maintenance test set would be 6 units (one of each model). However, performance testing also included sterilization efficacy, microbial barrier properties, material compatibility, and biocompatibility, which likely involved more samples and replicates for thorough validation. The exact total number of individual samples tested across all performance properties is not explicitly stated but would be expected to be higher than just 6.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, the testing would have been prospective to generate data for regulatory approval. The testing was conducted by Cardinal Health 200, LLC, located in McGaw Park, IL, USA, implying the studies were conducted in the USA or in facilities compliant with US regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. For sterilization wrap, ground truth is typically empirical (e.g., microbial challenges, physical property measurements) rather than interpreted by human experts like in imaging studies. The "PASS" results would indicate that the measured performance met pre-defined, objective criteria.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. For performance testing of a sterilization wrap (e.g., sterilization efficacy, microbial barrier), results are typically determined by objective laboratory measurements and testing protocols (e.g., biological indicator kill, physical integrity assessment) rather than subjective expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiology images) and the AI's impact on their performance is being assessed. Sterilization wrap performance is determined through objective material and microbiological testing.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are standalone (algorithm only, though this is not an "algorithm" in the AI sense, but rather the device itself). The performance tests (sterilization efficacy, microbial barrier, material compatibility, biocompatibility) directly evaluate the wrap's inherent properties and its interaction with the sterilization process, without human intervention in the performance measurement itself.

7. The Type of Ground Truth Used

The ground truth used for the performance testing of the DuraBlue™ Sterilization Wrap is primarily empirical and objective measurement-based:

Sterilization Efficacy: Likely involves biological indicator (BI) kill results, confirming the sterility of enclosed contents after sterilization.
Microbial Barrier Properties: Measured through aerosol challenge tests, evaluating the wrap's ability to prevent microbial ingress.
Event Related Shelf Life (Sterility Maintenance): Real-time aging studies followed by sterility testing or integrity checks.
Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) before and after sterilization to ensure the material is not compromised.
Biocompatibility: In vitro and/or in vivo tests to confirm the material does not elicit adverse biological responses, in compliance with ISO 10993.

8. The Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning algorithms. Since the DuraBlue™ Sterilization Wrap is a physical medical device and not an AI/ML algorithm, there is no training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, the question of how its ground truth was established is not applicable.

Summary

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123.857

Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that intersect, resembling a bird in flight or an abstract design. The text "CardinalHealth" is written in a bold, sans-serif font.

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

JAN 2 3 2013

510(k) SUMMARY DuraBlue™ Sterilization Wrap

Manufacturer:

Cardinal Health 200, LLC 1430 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact:

Lavenia Ford 1430 Waukegan Road McGaw Park, IL 60085

DuraBlue™ Sterilization Wrap

(847) 887-3323 Telephone Number:

Date summary Prepared: December 20, 2012

Trade Name:

Class II per 21 CFR § 880.6850 Classification:

Sterilization Wrap

Classification Name: Sterilization Wrap

Common Name:

Product Code: FRG

Predicate Device:

K122507 - DuraBlue™ Sterilization Wrap - Johnson & Johnson STERRAD NX

Description:

Extensive performance testing has also been completed on Cardinal Health DuraBlue™ Sterilization Wrap in the this submission for the new indication for use with the Standard. Flex, Express, and DUO cycles of the Johnson & Johnson STERRAD® 100NX and the additional maintenance of sterility with the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed

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contents. Physical properties testing included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated modalities and storaqe because the polypropylene material is inert and very stable. Additionally, the DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days following sterilization via the indicated Johnson & Johnson STERRAD® NX and 100NX cycles.

Table 1: Performance Testing of Proposed DuraBlue Sterilization Wrap sterilized by STERRAD® 100NX or STERRAD® NX system

Performance Properties	Results
Sterilization Efficacy	PASS
Microbial BarrierProperties	Aerosol Challenge	PASS
	Event Related ShelfLife	PASS- 180 days
Material Compatibility with IndicatedSterilization Method	Compatible
Biocompatibility	PASS

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.

Indications for Use:

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 using the following modalities:

Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles .

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.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Johnson & Johnson STERRAD® 100NX and STERRAD® NX cycles in Table 1 and 2.

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Table 1 - Validated Johnson & Johnson STERRAD® 100NX Sterilization Cycles

Johnson & JohnsonSTERRAD® Systemand Cycle	MaximumRecommendedChamber Load	Intended Load
Johnson & JohnsonSTERRAD® 100NXStandard Cycle	21.4 lbs	Reusable metal and non-metal medical devices, including upto 10 lumens of the following lumen dimensions per chamberload: an inside diameter of 0.7 mm or larger and a length of500 mm or shorter of single-channel stainless steellumens (A maximum of five lumens per tray persterilization cycle)
Johnson & JohnsonSTERRAD® 100NX FlexCycle	12.2 lbs	One or two single-channel Flexible Endoscope with or withouta silicone mat and no additional load. The flexible endoscopemay contain: a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850mm or shorter (A maximum of two flexibleendoscopes, one per tray per sterilization cycle)
Johnson & JohnsonSTERRAD® 100NXExpress Cycle	10.7 lbs	Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of matedstainless steel and titanium surfaces, and rigid or semi-rigidendoscopes without lumens
Johnson & JohnsonSTERRAD® 100NX DuoCycle	13.2 lbs	One or two single-channel Flexible Endoscope with or withouta silicone mat and no additional load. The flexible endoscopemay contain: a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 875mm or shorter

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Johnson &JohnsonSTERRAD®System andCycle	Maximum RecommendedChamber Load	Intended Load
Johnson &JohnsonSTERRAD®NXStandardCycle	10.7 lbs	Reusable metal and non-metal medical devices, including upto 10 lumens of the following lumen dimensions per chamberload:an inside diameter of 1 mm or larger and a length of150 mm or shorter of single-channel stainless steellumensan inside diameter of 2 mm or larger and a length of400 mm or shorter of single-channel stainless steellumens
Johnson &JohnsonSTERRAD®NXAdvancedCycle	10.7 lbs	Reusable metal and non-metal medical devices, including upto 10 lumens of the following lumen dimensions per chamberload:an inside diameter of 1 mm or larger and a length of500 mm or shorter of single-channel stainless steellumensOROne single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscopemay contain:a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850mm or shorter

Table 2 – Validated Johnson & Johnson STERRAD® NX Sterilization Cycles

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SterilizationWrap Model	Intended Load	Maximum Recommended WrappedPackage Content Weight2
CH100	Very light weight package(for example: batteries)	10.7 lbs
CH200	Light weight package(for example: telescope with light cord)	10.7 lbs
CH300	Light to moderate weight package(for example: general use medical instruments)	10.7 lbs
CH400	Moderate to heavy weight package(for example: general use medical instruments)	10.7 lbs
CH500	Heavy weight package(for example: general use medical instruments)	10.7 lbs
CH600	Very heavy weight package(for example: general use medical instruments)	10.7 lbs

Table 3 - Wrap Model Recommendations1

The following loads were used in the Sterility Maintenance Validation Study:

· CH100: 23 in. x 11 in. x 4 in. tray containing metal instruments
· CH200: 23 in. x 11 in. x 4 in. tray containing metal instruments
· CH300: 23 in. x 11 in. x 4 in. tray containing metal instruments
· CH400: 23 in. x 11 in. x 4 in. tray containing metal instruments
· CH500: 23 in. x 11 in. x 4 in. tray containing metal instruments
· CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments

Note: The loads used in the Sterility Maintenance Validation Study corresponded to the maximum wrapped package content weights in Table 2.

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the DuraBlue™ Sterilization Wraps.

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Substantial Equivalence

The proposed DuraBlue" Sterilization Wrap is substantially equivalent to the predicate devices. Both devices:

. Have the same intended use
Have the same material composition .
Have the same physical and chemical properties .
Have the same configurations/dimensions .
Demonstrate maintenance of package sterility within the period of time for which performance . data demonstrating maintenance of sterility has been provided
Performance and safety attributes are substantially equivalent to the predicate. The physical . properties of all wrap models have been characterized both before and after exposure to Johnson & Johnson STERRAD® 100NX and STERRAD® NX sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue ™ Sterilization Wrap sterilized with the Johnson & Johnson STERRAD® 100NX Standard, Flex, Express, and Duo cycles or the Johnson & Johnson STERRAD® NX Standard or Advanced cycles is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilizedwith the Johnson & Johnson STERRAD® NX system. The data demonstrates that the DuraBlue™ Sterilization Wrap is compatible with the Standard, Flex, Express, and Duo cycles of the Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX Sterilization System.

Summary of Testing

DuraBlue™ Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in the 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) in this submission. Testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993. Data from testing demonstrates that the performance of the DuraBlue™ Sterilization Wrap intended for use with the Johnson & Johnson STERRAD® 100NX Sterilization System or the Johnson & Johnson STERRAD® NX is substantially equivalent to the DuraBlue™ Sterilization Wrap intended for use with the Johnson & Johnson STERRAD® NX Sterilization System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2013

Cardinal Health 200, Limited Liability Company C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062

Re: K123857

Trade/Device Name: DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 8, 2013 Received: January 10, 2013

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowed your corrent the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Ls m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123857

· Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

STERRAD® 100NX Sterilization System, Standard, Flex, Express, and Duo Cycles

STERRAD® NX Sterilization System, Standard and Advanced Cycles

Indications for Use:

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 using the following modalities:

Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles

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 testing for a duration of 180 days for each indicated modality.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Johnson & All models of Burabled - Otonialism - Sterman - NX cycles in Table 1 and 2.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Devices Evaluation (ODE)

Ramesh C. Panguluri -S 2013.01.23 12:25:02 -05'00'

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k)

Regulation Number and Section

§ 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).