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 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 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 an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two 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 Health DuraBlue™ Sterilization Wraps are double layer sterlization wraps made from 100% polypropylene spunbond-mettblown-spunbond (SMS) fabric. Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a heath care provider by 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. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed device(s) for 30 days. The wrap was validated for an aeration time for EO sterilization of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterlization of two lumens 3 mm in diameter or larger and 400 mm in length or less. The wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterlized 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

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format 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 until opened." The reported performance is that the wrap did successfully pass these tests, demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
- Allows 100% ethylene oxide (EO) sterilization of enclosed medical devices. - Maintains sterility of enclosed devices for 30 days. - Compatible with EO parameters: 725-735 mg/L concentration, 131°F/55°C, 40%-80% relative humidity, 60 minutes exposure. - Validated for 8 hours aeration time at 55°C. - For CH400, CH500, CH600: Validated for sterilization of two lumens 3mm diameter or larger and 400mm length or less. - Substantial equivalence to predicate (K082177 - KIMGUARD ONE-STEP Sterilization Wrap) in performance and safety attributes. - Meets physical property requirements before and after EO exposure. - Complies with applicable requirements of FDA's "Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities" draft guidance. - Demonstrates acceptable EO residuals and biocompatibility per ISO 10993.	- "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 until opened." - "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 100% ethylene oxide 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 100% ethylene oxide sterilization parameters." - "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."

Acceptance Criteria (Implied)

Reported Device Performance

- Allows 100% ethylene oxide (EO) sterilization of enclosed medical devices. - Maintains sterility of enclosed devices for 30 days. - Compatible with EO parameters: 725-735 mg/L concentration, 131°F/55°C, 40%-80% relative humidity, 60 minutes exposure. - Validated for 8 hours aeration time at 55°C. - For CH400, CH500, CH600: Validated for sterilization of two lumens 3mm diameter or larger and 400mm length or less. - Substantial equivalence to predicate (K082177 - KIMGUARD ONE-STEP Sterilization Wrap) in performance and safety attributes. - Meets physical property requirements before and after EO exposure. - Complies with applicable requirements of FDA's "Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities" draft guidance. - Demonstrates acceptable EO residuals and biocompatibility per ISO 10993.

- "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 until opened." - "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 100% ethylene oxide 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 100% ethylene oxide sterilization parameters." - "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."

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

Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many wraps were tested for sterility maintenance, how many cycles for sterilization efficacy). It mentions that "Extensive performance testing has been completed" and details the specific "loads used in the validation studies" for each of the six models (CH100 to CH600). These loads represent the tested configurations for evaluating sterilization efficacy and pack integrity.
- 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, 7.5 lbs metal mass in a tray
- CH500: 4 stacked tray liners, 11.5 lbs metal mass in a tray
- CH600: 4 stacked tray liners, 19.5 lbs metal mass in a tray
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes laboratory-based performance testing conducted to support the 510(k) submission.

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

This information is not provided in the document. The testing described is primarily laboratory-based performance testing of the physical properties and sterilization efficacy of the wrap itself, rather than studies requiring human expert interpretation of results (like medical imaging).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device and testing described. Adjudication methods (like 2+1 or 3+1) are typically used for studies where human experts are making judgments (e.g., diagnosing conditions from images) and their agreement needs to be resolved. The tests here involve measurable physical properties, sterility, and chemical residuals.

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 is not applicable to this device. An MRMC study is relevant for diagnostic devices that are interpreted by human readers, often with or without AI assistance. The DuraBlue™ Sterilization Wrap is a medical packaging device, not a diagnostic tool, and involves no human "readers" in its performance evaluation in this context.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm or software. The performance tests are inherently "standalone" in that they evaluate the material itself and its interaction with the sterilization process, without human intervention during the actual sterilization or sterility maintenance phase.

7. The Type of Ground Truth Used:

The ground truth for the performance tests would be based on:

Sterility Assessment: Typically involves biological indicator (BI) testing (e.g., showing inactivation of spores) and microbial challenge testing to confirm the sterilization process efficacy and the wrap's ability to maintain a sterile barrier. This is a scientific, objective measure.
Physical Property Standards: Measurements of tear resistance, burst strength, porosity, etc., against predefined engineering specifications and industry standards.
Chemical Analysis: Measurement of EO residuals in accordance with regulatory limits.
Visual Inspection: For pack integrity, tears, or compromise.

Essentially, the ground truth is established through objective, standardized laboratory testing methods to demonstrate the physical, chemical, and biological performance of the wrap.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device. The DuraBlue™ Sterilization Wrap is a manufactured medical product that undergoes performance validation, not an artificial intelligence algorithm that requires a dataset for training.

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

This information is not applicable as there is no training set for this device.

Summary

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K120542

JUN - 1 2012

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

Lavenia Ford 1430 Waukegan Road McGaw Park, IL 60085

(847) 887-3323

March 13, 2012

Sterilization Wrap

DuraBlue™ Sterilization Wrap

Class II per 21 CFR § 880.6850

Telephone Number:

Date summary Prepared:

Regulatory Affairs Contact:

Trade Name:

Classification:

Classification Name:

Predicate Device:

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

Description:

Cardinal Health DuraBlue™ Sterilization Wrap is the subject of three Premarket Notifications cleared by the FDA-K112211, K112283 and K112918--for use with pre-vacuum steam, STERRAD 100S, and V-PRO sterilization modalities respectively. This submission is specifically for the addition for use with EO sterilization.

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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 sterlity of the enclosed contents until opened.

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 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterlization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two 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 Recommendations'

The following loads were used in the validation studies:

CH100: 16 huck towels (17 in. x 29 in.). .
. CH200: 2 huck towels (17 in. x 29 in.), 2 fluid resistant drapes (108 in. x 88 in.), 2.5 lb of metal mass.
. CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 Ibs of metal mass.

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CH400: 4 stacked tray liners (20 in. x 25 in.) and 7.5 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 11.5 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 19.5 lbs of metal mass in a . 23 in. x 11 in. x 3.5 in. tray.

Note: The loads used in the validation studies 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, 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 Cardinal Health DuraBlue™ Sterilization Wrap (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 100% ethylene oxide 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-mettblown-spunbond (SMS) trilaminate . nonwoven fabric.
Both devices demonstrate maintenance of package sterility until opened following sterilization . by100% ethylene oxide.
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 100% ethylene oxide 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 100% ethylene oxide 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 Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7. 2002). Testing included sterlization efficacy, event related maintenance of package sterility, physical properties, EO residuals 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 Stenlization Wrap.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

JUN - 2012

Re: K120542

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: May 16, 2012 Received: May 17, 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.

Radiological Health

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

Enclosure

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Image /page/5/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 stylized bird in flight or a network of pathways.

Indications for Use

510(k) Number (if known): K120542

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

Ethylene Oxide Sterilization

Indications for Use:

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

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)

Elizabeth T. Claire-Will

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

.510(k) Number: K120542

Page 1 of 2

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Wrap Model Recommendations1

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

The following loads were used in the validation studies:

CH100: 16 huck towels (17 in. x 29 in.). ●
CH200: 2 huck towels (17 in. x 29 in.), 2 fluid resistant drapes (108 in. x 88 in.), 2.5 lb of metal ● mass.
CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), . ● 5 lbs of metal mass.
CH400: 4 stacked tray liners (20 in. x 25 in.) and 7.5 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 11.5 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 19.5 lbs of metal mass in a . 23 in. x 11 in. x 3.5 in. tray.
- Note: The loads used in the validation studies corresponded to the maximum wrapped o 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 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).