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 by pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for sterilization of lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

Device Description

Cardinal Heath DuraBlue™ Sterilization 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 pre-vacuum steam at 270°F/132°C for 4 minutes. 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 DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization by pre-vacuum steam. The study aims to demonstrate that the wrap allows for sterilization of the enclosed contents and maintains sterility for an adequate period.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance tests, but it does not explicitly state numerical acceptance criteria for each test. Instead, it states that "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." The "Summary of Testing" also notes that the data supports the conclusion that the DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate device in terms of performance and safety attributes.

Based on the provided information, the unstated acceptance criteria for each test would be that the DuraBlue™ Sterilization Wrap performs at least as well as, or equivalently to, the predicate device (KIMGUARD ONE-STEP Sterilization Wrap) and meets the general requirements for sterilization wrap.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Efficacy	Must allow for sterilization of enclosed contents.	Demonstrated to allow for sterilization of enclosed contents.
Dry Time	Validated for specific dry times (20 or 30 minutes) for models.	Validated for 20 minutes for CH100 & CH200; 30 minutes for CH300-CH600.
Sterility Maintenance	Maintains sterility of enclosed contents for at least 30 days.	Demonstrated to maintain sterility for at least 30 days.
Physical Properties	Comparable to predicate device before and after sterilization.	Characterized before and after sterilization; supports substantial equivalence.
Biocompatibility	Complies with ISO 10993.	Complies with methods of ISO 10993.
Lumen Sterilization (CH400, CH500, CH600)	Validated for lumens 3mm diameter or larger and 400mm or less in length.	Validated for lumens 3mm diameter or larger and 400mm or less in length.

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

The document does not explicitly state numerical sample sizes for each specific test (e.g., sterilization efficacy test, dry time test). However, it lists the "loads used in the Sterility Maintenance Validation Study" for each of the six DuraBlue™ Sterilization Wrap models (CH100 to CH600). These loads, comprising specific quantities of items (e.g., 16 huck towels, 5 lbs of metal mass), represent the test articles for that validation. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

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

This information is not provided in the document. The study appears to be focused on physical and microbiological validation of the device's performance, rather than assessment by human experts interpreting data.

4. Adjudication Method for the Test Set:

This information is not provided as the study does not involve expert adjudication of results. The results are likely determined by objective measurements and standardized test methods (e.g., sterility testing, physical property measurements).

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:

This type of study is not applicable and was not conducted. The DuraBlue™ Sterilization Wrap is a physical medical device (sterilization wrap), not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This concept is not applicable as the device is a physical sterilization wrap, not an algorithm. The "standalone" performance here refers to the device's inherent ability to perform its function (sterilize and maintain sterility) without human intervention in the sterilization or maintenance process beyond proper usage. The performance tests described (sterilization efficacy, dry time, sterility maintenance, physical properties) inherently represent the standalone performance of the wrap.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this device is based on scientific and technical standards for sterilization and sterility maintenance. This includes:

Microbiological Negativity: For sterilization efficacy and sterility maintenance, the "ground truth" is typically the absence of microbial growth in culture, indicating sterility.
Physical Property Measurements: Quantifiable measurements of material strength, porosity, and other physical characteristics.
Time-Based Validation: For dry times and sterility maintenance duration, the ground truth is established by empirical testing under specified conditions.

8. The Sample Size for the Training Set:

This concept is not applicable as the DuraBlue™ Sterilization Wrap is a tested medical device, not a machine learning model that requires a training set.

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

This concept is not applicable as the device is not a machine learning model.

Summary

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K112211

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of the company name in a bold, sans-serif font. Above the name are three curved lines that appear to be stylized representations of a cardinal's feathers or wings.

OCT 2 0 2011

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:

1430 Waukegan Road McGaw Park, IL 60085

Lavenia Ford

(847) 887-3323

Telephone Number:

Date summary Prepared: September 28, 2011

DuraBlue™ Sterilization Wrap Trade Name:

Classification: Class II per 21 CFR § 880.6850

Classification Name: Sterilization Wrap

Predicate Device:

K082177 - KIMGUARD ONE-STEP Sterilization Wrap (Models KC100, KC200, KC400, KC500 and KC600) K091685 - KIMGUARD ONE-STEP Sterilization Wrap (Model KC300)

Description:

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

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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 by pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CH100 and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for sterilization of lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

DuraBlue™Sterilization WrapModel	Intended Load	Maximum RecommendedWrapped Package ContentWeights2
CH100	Very light weight package (forexample: towel packs)	3 lbs
CH200	Light weight package (forexample: standard linenpacks)	6 lbs
CH300	Light to moderate weightpackage (for example:general use medicalinstruments)	9 lbs
CH400	Moderate to heavy weightpackage (for example:general use medicalinstruments)	13 lbs
CH500	Heavyweight package (forexample: general usemedical instruments)	17 lbs
CH600	Very heavy weight package(for example: general usemedical instruments)	25 lbs

Wrap Model Recommendations1

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

CH100: 16 huck towels (17 in. x 29 in.). .
. CH200: 2 huck towels (17 in. x 29 in.), 3 fluid resistant drapes (108 in. x 72 in.).
. CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 Ibs of metal mass.
. CH400: 4 stacked tray liners (20 in. x 25 in.) and 8 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
. CH500: 4 stacked tray liners (20 in. x 25 in.) and 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
. CH600: 4 stacked tray liners (20 in. x 25 in.) and 18 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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

1 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

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put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

f I 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 Cardinal Health DuraBlue™ Sterilization Wraps (i.e., the number and size of the fluid resistant linens or the weight of the metal mass).

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 pre-vacuum steam 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-meltblown-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 prevacuum steam 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 pre-vacuum steam sterilization parameters.

Summary of Testing

DuraBlue™ Stenlization Wrap performance has been tested in accordance with the applicable requirements recommended in the FDA's Guidance Document Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included sterilization efficacy, dry time, 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™ Sterlization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Stenlization Wrap.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 2 0 2011

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 Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K112211

Trade/Device Name: Cardinal Health DuraBlue" Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 2, 2011 Received: September 6, 2011

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.

Cirthon D. Mutaar

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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Indications for Use

510(k) Number (if known): K112211

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

Pre-vacuum Steam Sterilization

Indications for Use:

Cardinal Heath DuraBlue ™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterlized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain steriity of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam.y Sterliization of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for sterlization of lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

DuraBlue™Sterilization WrapModel	Intended Load	Maximum RecommendedWrapped Package ContentWeights1
CH100	Very light weight package (forexample: towel packs)	3 lbs
CH200	Light weight package (forexample: standard linenpacks)	6 lbs
CH300	Light to moderate weightpackage (for example:general use medicalinstruments)	9 lbs
CH400	Moderate to heavy weightpackage (for example:general use medicalinstruments)	13 lbs
CH500	Heavyweight package (forexample: general usemedical instruments)	17 lbs
CH600	Very heavy weight package(for example: general usemedical instruments)	25 lbs

Wrap Model Recommendations

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

CH100: 16 huck towels (17 in. x 29 in.).
. CH200: 2 huck towels (17 in. x 29 in.), 3 fluid resistant drapes (108 in. x 72 in.),
CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), . 5 Ibs of metal mass.
CH400: 4 stacked tray liners (20 in. x 25 in.) and 8 lbs of metal mass in a . 23 in. x 11 in. x 3.5 in. tray.
CH500: 4 stacked tray liners (20 in. x 25 in.) and 12 lbs of metal mass in a . 23 in. x 11 in. x 3.5 in. tray.
CH600: 4 stacked tray liners (20 in. x 25 in.) and 18 lbs of metal mass in a ● 23 in. x 11 in. x 3.5 in. tray.
- Note: The loads used in the Sterility Maintenance Validation Study corresponded to the O maximum wrapped package content weights in the table.

1 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 Cardinal Heath DuraBlue™ Sterilization Wrap (i.e., the number and size of the fluid resistant linens or the weight of the metal mass).

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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Edhat B. Clamine - Wils
(Division Sign. Off.)

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

510(k) Number: KII2211

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

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).