Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider in the Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX Low Temperature Sterilization Systems. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) for 30 days. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO® 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 in the Lumen, or Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX Low Temperature Sterilization Systems. This wrap design allows for use of the simultaneous doublewrapping 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, a medical device intended to enclose other medical devices for sterilization. The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that their device is "substantially equivalent" to an already legally marketed device (the predicate device) and therefore does not require a new Premarket Approval (PMA) application.

It's important to understand that a 510(k) notification primarily focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as the predicate device. The information provided about acceptance criteria and studies reflects this context.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets for each performance metric, which is common in a rigorous clinical validation study for novel devices. Instead, it describes general compliance with regulatory guidance and substantial equivalence to a predicate device. The performance is reported in terms of demonstrating efficacy and equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Efficacy	Wrap must allow for effective sterilization of enclosed contents when used with specified V-PRO® cycles.	Successful completion of sterilization performance tests demonstrated that the wrap "allows for sterilization of the enclosed contents." DuraBlue™ Sterilization Wrap was "validated to be effectively aerated during the pre-programmed Amsco® V-PRO® sterilization cycles."
Maintenance of Sterility	Wrap must maintain sterility of enclosed contents for a specified post-sterilization period.	Demonstrated to "maintain sterility of the enclosed contents for at least 30 days."
Physical Properties (Pre/Post-Sterilization)	Physical properties of the wrap should demonstrate compatibility and integrity after exposure to V-PRO® sterilization.	"The physical properties of all wrap models have been characterized both before and after exposure to V-PRO® sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate..."
Biocompatibility	Compliance with biocompatibility standards.	Biocompatibility testing was conducted "in compliance with the methods of ISO 10993."
Substantial Equivalence	Equivalent to the predicate device (K092167 - KIMGUARD ONE-STEP Sterilization Wrap) in design, intended use, sterilization parameters, material, dimensional specifications, and performance.	Stated that "DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate devices." Detailed comparisons are made regarding double-layer design, V-PRO® compatibility, model comparability, dimensional specs, material, and post-sterilization sterility maintenance.

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

The document does not specify a "test set" in the context of a dataset with a specific sample size of cases for an AI/algorithm-based device. For this type of physical device (sterilization wrap), the "testing" involves laboratory and functional performance tests.

Sample Size: Not explicitly stated as a number of "cases" as would be in AI/imaging studies. The testing involved "all models of DuraBlue™ Sterilization Wrap" across various Amsco® V-PRO® cycles and load configurations. The phrase "extensive performance testing" is used.
Data Provenance: The studies are "performance testing" of the product itself, likely conducted in a laboratory setting by Cardinal Health or a contracted testing facility. There is no mention of country of origin of data or whether it was retrospective or prospective in the same way an AI study would report. It's inherent to device testing that it's prospective testing of the device's performance.

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

This section is not applicable to this type of device. The "ground truth" for a sterilization wrap is established by standardized testing protocols (e.g., microbial challenge tests, physical property evaluations) and adherence to regulatory guidance, not by expert consensus on "cases" as in diagnostic AI.

4. Adjudication Method for the Test Set

This section is not applicable to this type of device. Adjudication methods like "2+1, 3+1" are characteristic of clinical studies involving human observers interpreting data (e.g., radiology reads) where discrepancies need to be resolved. For a sterilization wrap, performance is typically measured against objective physical or biological criteria.

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 assesses improvements in human reader performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a physical sterilization wrap. The "comparison" is to a predicate device's performance through substantial equivalence testing, not against human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is not an algorithm or AI system. It is a physical product (sterilization wrap).

7. The Type of Ground Truth Used

For this device, the "ground truth" is established through:

Standardized Sterilization Efficacy Testing: This involves challenging the wrap with known biological indicators (spores) and verifying their inactivation after sterilization. "Successful completion of the sterilization performance tests" indicated direct measurement of sterilization effectiveness.
Physical Property Measurements: Objective measurements of material strength, porosity, barrier properties, etc., before and after sterilization.
Biocompatibility Testing: Adherence to standards like ISO 10993, which involves specific chemical and biological assays.
Event-Related Sterility Maintenance: Demonstrating the ability to maintain a sterile barrier over time, often through microbial challenge and package integrity testing.

8. The Sample Size for the Training Set

Not Applicable. This device does not use machine learning or AI, and therefore does not have "training data" in that sense. The "training set" for manufacturing and quality control would involve internal testing of material batches and finished products, but not as part of an AI model's development.

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

Not Applicable. As there is no AI training set, there is no ground truth established for it. The performance of the device itself (its "ground truth") is established through the comprehensive testing described in point 7.

Summary

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K112918

JAN 2 0 2012

CardinalHealt

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

SMDA REQUIREMENTS

	510(k) SUMMARY OF SAFETY AND EFFECTIVENESSDuraBlue™ Sterilization WrapAmsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX
Manufacturer:	Cardinal Health 200, LLC1430 Waukegan RoadMcGaw Park, IL 60085
Regulatory Affairs Contact:	Lavenia Ford1430 Waukegan RoadMcGaw Park, IL 60085
Telephone Number:	(847) 887-3323
Date summary Prepared:	December 21, 2011
Trade Name:	DuraBlue™ Sterilization Wrap
Classification:	Class II per 21 CFR § 880.6850
Classification Name:	Sterilization Wrap
Predicate Device:	K092167 - KIMGUARD ONE-STEP Sterilization Wrap
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 in the the Lumen, or
Flexible Cycles in the Amsco V-PRO® 1, Amsco V-PRO® 1 Plus and Amsco "V-PRO" ma Temperature Sterilization Systems. This wrap design allows for use of the simultaneous doublewrapping technique and also allows for a sterilized pack to be opened aseptically.

Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents for at least 30 days.

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Indications for Use:

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO® cycles:

Amsco® V-PRO®Cycle	MaximumRecommendedChamber Load	Intended Load	Maximum RecommendedWrapped PackageContent Weight by WrapModel¹
Lumen Cycle	19.65 lbs	Reusable metal and non-metal medicaldevices, including up to 20 lumens of thefollowing dimensions per chamber load:an inside diameter of 1 mm or largerand a length of 125 mm or shorter an inside diameter of 2 mm or largerand a length of 250 mm or shorter an inside diameter of 3 mm or largerand a length of 400 mm or shorter	Wrap Model Max.Package WeightCH100 3 lbsCH200 6.5 lbsCH300 9 lbsCH400 9.1 lbsCH500 9.1 lbsCH600 9.1 lbs
Non Lumen Cycle	19.65 lbs	Non-lumened reusable metal and non-metalmedical devices
Flexible Cycle	24 lbs	Single or dual lumen surgical flexibleendoscopes and bronchoscopes in either oftwo load configurations:1. Two trays, each containing a flexibleendoscope with a light cord (if notintegral to endoscope) and mat with noadditional load2. One tray containing a flexibleendoscope with a light cord (if notintegral to endoscope) and mat and anadditional tray containing non-lumenedmedical devicesThe flexible endoscope(s) may containeither:a single lumen with an insidediameter of 1 mm or larger anda length of 1050 mm or shorter two lumens, with one lumenhaving an inside diameter of 1mm or larger and a length of998 mm or shorter and theother lumen having an insidediameter of 1 mm or larger anda length of 850 mm or shorter

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.

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Substantial Equivalence

The DuraBlue ™ Sterilization Wrap is substantially equivalent to the predicate devices.

Both devices are double layer sterilization wraps which allow for use of the simultaneous double-� wrapping technique and for a sterilized pack to be opened aseptically.
Both devices are intended to be used with the same V-PRO® sterilization parameters.
Both devices are available in six comparable models of varying basis weights, which are recommended for use with the same maximum content weights.
Both devices have the same dimensional specifications.
Both devices are100% polypropylene spunbond-me!tblown-spunbond (SMS) trilaminate nonwoven fabric.
Both devices demonstrate maintenance of package sterility for at least 30 days following sterilization by pre-vacuum steam.
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 V-PRO®
sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate, and the DuraBlue™ Sterilization Wraps are compatible with the identified V-PRO® system sterilization parameters.

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 is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wrap.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Cardinal Health 200, LLC C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JAN 2 0 2012

Re: K112918

Trade/Device Name: Cardinal Health DuraBlue™ Sterilization Wrap Amsco® V-PRO® 1, Amsco®V-PRO®1 Plus and Amsco® V-PRO® maX Regulation Number: 21 CFR 880.6850

Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 3, 2012 Received: January 6, 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 Eederal 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 I ou inal 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Austin James

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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CardinalHealth

Indication for Use

510(k) Number (if known): K112918

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® max

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabe H. F. Clarence-Wills

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

510(k) Number: K112918

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All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco "V-PRO® cycles:

Amsco® V-PRO® Cycle	Maximum Recommended Chamber Load	Intended Load	Maximum Recommended Wrapped Package Content Weight by Wrap Model¹
Lumen Cycle	19.65 lbs	Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 125 mm or shorter• an inside diameter of 2 mm or larger and a length of 250 mm or shorter• an inside diameter of 3 mm or larger and a length of 400 mm or shorter	Wrap Model Max. Package Weight CH100 3 lbs CH200 6.5 lbs CH300 9 lbs CH400 9.1 lbs CH500 9.1 lbs CH600 9.1 lbs
Non Lumen Cycle	19.65 lbs	Non-lumened reusable metal and non-metal medical devices
Flexible Cycle	24 lbs	Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devicesThe flexible endoscope(s) may contain either:• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter• two lumens, with one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, marriadal rocelle hay 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.

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).