Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System .
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 the following durations:
30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

Device Description

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 by Standard and Advanced cycles of the 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.
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.

AI/ML Overview

The provided document describes the Cardinal Health DuraBlue™ Sterilization Wrap, its intended use, and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices. However, it does not contain the level of detail typically found in a clinical study report for an AI/ML medical device, which would include specific acceptance criteria with numerical targets and the reported device performance against those targets.

Instead, the document focuses on regulatory approval for the sterilization wrap itself, demonstrating its ability to facilitate sterilization and maintain sterility. The "acceptance criteria" here are implied by the successful completion of various performance tests in accordance with FDA guidance for sterilization packaging systems.

Here's an attempt to structure the information based on your request, with noted limitations due to the nature of the source document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a sterilization wrap, the "acceptance criteria" are not reported as numerical metrics like sensitivity or specificity (as would be for an AI diagnostic device). Instead, they are functional requirements for a sterilization packaging system. The performance is reported as successful completion of these requirements.

Acceptance Criteria (Implied from FDA Guidance)	Reported Device Performance
Sterilization Efficacy: The wrap must allow for effective sterilization of enclosed contents.	"Successful completion of the sterilization performance tests demonstrated that the wrap both allows for sterilization of the enclosed contents..." The DuraBlue™ Sterilization Wrap was validated for use with Standard and Advanced cycles of the STERRAD® NX Sterilization System for specific load types (e.g., up to 10 lumens of specified dimensions, or a flexible endoscope).
Maintenance of Package Sterility: The wrap must maintain sterility of enclosed devices for a specified duration.	"...and also maintains sterility of the enclosed devices until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided." Maintenance of package sterility was validated with real-time testing for 30 days following sterilization by STERRAD® NX (Standard and Advanced cycles).
Physical Properties: The wrap must retain its physical integrity and properties after sterilization.	"The physical properties of all wrap models have been characterized both before and after exposure to STERRAD® NX sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® NX Standard or Advanced cycles is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® 100S system. The data demonstrates that the DuraBlue™ Sterilization Wrap is compatible with the Standard and Advanced cycles of the STERRAD® NX Sterilization System."
Biocompatibility: The materials must be biocompatible.	"Biocompatibility in compliance with the methods of ISO 10993." (No specific results provided, but stated as completed).
Substantial Equivalence: Demonstrated equivalence to predicate devices.	The device was found substantially equivalent to predicate devices (K112283 and K120658), having the same intended use, material composition, physical and chemical properties, configurations/dimensions, and demonstating maintenance of package sterility. This was confirmed by the FDA's 510(k) clearance (K122507).

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

Sample Size: The document mentions "Extensive performance testing" and "Sterility Maintenance Validation Study" and "performance tests." However, it does not specify a numerical sample size (e.g., number of wraps, number of test cycles, or number of individual tests) for these studies. It lists various load configurations for the six different wrap models (CH100-CH600) used in the Sterility Maintenance Validation Study, each with a 23 in. x 11 in. x 4 in. tray containing metal instruments.
Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer (Cardinal Health, located in McGraw Park, IL, USA) and the FDA 510(k) submission, it is highly likely that the studies were conducted in the USA. The studies appear to be prospective in nature, as they involve testing the device under specific conditions set up to validate its performance for sterilization and sterility maintenance.

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

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a sterile barrier system, not a diagnostic or AI device that requires expert ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is established through microbiological testing (sterilization efficacy and sterility maintenance) and physical material testing, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI/ML devices where differences in expert opinions need to be reconciled to establish a robust ground truth. For this device, the outcomes are objective (e.g., presence/absence of microbial growth, material tear strength, seal integrity).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and therefore not provided in the document. MRMC studies are designed to evaluate the performance of diagnostic tools when used by multiple readers across multiple cases, often comparing AI-assisted performance to unassisted human performance. The DuraBlue™ Sterilization Wrap is a medical device used for packaging, not for diagnostic interpretation, so such a study would not be relevant.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product, not an algorithm or software. Its performance is inherent to its physical and material properties and how it interacts with the sterilization process, not an independent algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance of the DuraBlue™ Sterilization Wrap is established through objective laboratory testing:

Microbiological assays: To confirm sterilization efficacy (e.g., kill rate of biological indicators) and maintenance of sterility (e.g., absence of microbial ingress after a specified period).
Physical and chemical property testing: To assess material integrity, strength, porosity, and compatibility with the sterilization process (e.g., tensile strength, burst strength, visual inspection for damage, chemical compatibility with hydrogen peroxide plasma).

8. Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product and does not use machine learning algorithms that require a "training set" of data.

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

This information is not applicable and therefore not provided in the document, as there is no "training set" for this type of medical device.

Summary

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K122S07

CardinalHealth

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 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

(847) 887-3323

August 09, 2012

Sterilization Wrap

Telephone Number:

Date summary Prepared:

DuraBlue™ Sterilization Wrap

Class II per 21 CFR § 880.6850

Classification Name:

Predicate Device:

Trade Name:

Classification:

K112283 - DuraBlue™ Sterilization Wrap - STERRAD 100S K120658 - DuraBlue™ Sterilization Wrap - STERRAD 100S

Description:

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.

Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap both allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided.

SEP 2 6 2012

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Indications for Use:

Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System. .
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 the following durations:

30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

STERRAD®System andCycle	Maximum RecommendedChamber Load	Intended Load
STERRAD®NXStandardCycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150mm or shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400mm or shorter of single-channel stainless steel lumens
STERRAD®NXAdvancedCycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumensOROne single-channel Flexible Endoscope with or without a siliconemat and no additional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 850 mm orshorter

- Validated STERRAD® NX Sterilization Cycle

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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 2 - 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.

1Individual 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 STERRAD® NX sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® NX Standard or Advanced cycles is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® 100S system. The data demonstrates that the DuraBlue™ Sterilization Wrap is compatible with the Standard and Advanced cycles of the 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). 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 STERRAD® NX Sterilization System is substantially equivalent to the DuraBlue™ Sterilization Wrap intended for use with the STERRAD® 100S Sterilization System.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The caduceus is represented by a triple-stranded helix.

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

SEP 2 6 2012

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

Re: K122507

Trade/Device Name: Cardinal Health DuraBlue™ Sterilization Wrap Sterrad® NX Sterilization System, Standard and Advanced Cycles Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 11, 2012 Received: September 12, 2012

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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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Page 2- Mr. Devine

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,

For

Q. Sheth

Sittin. D.

Anthony D. Watson. B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows 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 converge at a point, resembling a bird in flight or a stylized leaf. The text "CardinalHealth" is written in a bold, sans-serif font.

Indications for Use

510(k) Number (if known): K122507

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

STERRAD® NX Sterilization System, Standard and Advanced Cycles

Indications for Use:

Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System .
The wrap is intended to allow steritization 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 the following durations:
30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

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)

Elijah F. (Lawrie-Willen)

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

K122507 510(k)

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STERRAD®System andCycle	Maximum RecommendedChamber Load	Intended Load
STERRAD®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
STERRAD®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 1 - Validated STERRAD® NX Sterilization Cycles

・

. ·

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Table 2 - Wrap Model Recommendations 1

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

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. trav 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.

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.

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).