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 modalities:

Pre-vacuum steam at 270°F/132°C for 4 minutes
STERRAD® 100S system. .
Lumen, Non 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). Maintenance of package sterility was validated with real-time testing for the following durations:

180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes. .

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

For pre-vacuum steam sterilization, the wrap has been validated for dry times 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 pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO™ cycles. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the preprogrammed 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 by pre-vacuum steam at 270°F/132°C for 4 minutes, STERRAD® 100S System and the Lumen, Non Lumen, or Flexible Cycles in 270 17102 0 for 4 mililates, STERM 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems. 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 Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization and to maintain sterility for specified durations. The acceptance criteria and supporting studies are detailed below, primarily focusing on the sterility maintenance aspect, as this is the key modification highlighted in the submission, and sterilization efficacy as a fundamental performance requirement.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study that Proves the Device Meets Acceptance Criteria
Sterility Maintenance Duration:
STERRAD 100S and Amsco V-PRO (Lumen, Non Lumen, and Flexible Cycles)	180 days	Event-Related Shelf Life testing
Pre-vacuum steam at 270°F/132°C for 4 minutes	30 days	Event-Related Shelf Life testing
Sterilization Efficacy:
Allow sterilization of enclosed medical devices	Demonstrated successful completion of sterilization performance tests	Extensive performance testing on Cardinal Health DuraBlue™ Sterilization Wrap in predicate Premarket Notifications (K112211, K112283, K112918)
Physical Properties Integrity after Sterilization and Storage:
Not compromised	Integrity of wrap properties is not compromised, as the polypropylene material is inert and very stable. Data included in predicate Premarket Notifications.	Physical Properties testing included in predicate Premarket Notifications (K112211, K112283, K112918)
Dry Times for Pre-vacuum Steam Sterilization:
Models CH100/CH200: 20 minutes	Validated for 20 minutes	Validation study (not detailed here, but referenced in the Indications for Use)
Models CH300, CH400, CH500, CH600: 30 minutes	Validated for 30 minutes	Validation study (not detailed here, but referenced in the Indications for Use)
Lumen Sterilization Capacity (Pre-vacuum Steam):
Models CH400, CH500, CH600: lumens 3mm diameter or larger and 400mm length or less	Validated for these lumens	Validation study (not detailed here, but referenced in the Indications for Use)
Lumen Sterilization Capacity (STERRAD 100S):
All models: lumens 2.5mm diameter or larger and 250mm length or less	Validated for these lumens	Validation study (not detailed here, but referenced in the Indications for Use)
Amsco V-PRO Cycles Validation:	Demonstrated effective aeration	Validation study (not detailed here, but referenced in the Indications for Use)

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

The provided document does not explicitly state the sample size for the "Event-Related Shelf Life testing" (which would be the primary test set for the sterility maintenance claim) or the "Extensive performance testing" for sterilization efficacy.

Data Provenance: The studies are described as "real-time testing" for sterility maintenance and "extensive performance testing" for sterilization efficacy. The data is internally generated by Cardinal Health 200, LLC, a US-based company, suggesting the studies were conducted domestically. They are retrospective in the sense that the data is being presented post-collection as part of a 510(k) submission.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth. For sterility and sterilization efficacy testing, ground truth is typically established through microbiological methods (e.g., sterility testing, biological indicators) and physical/chemical tests, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests described (sterility testing, physical properties testing) involve objective measurements rather than subjective assessments requiring adjudication or consensus.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a sterilization wrap, not an imaging or diagnostic device that typically involves human readers interpreting results.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Event-Related Shelf Life testing" and "Extensive performance testing" demonstrate the performance of the wrap itself (the "algorithm only without human-in-the-loop performance" equivalent for this type of device) in achieving and maintaining sterility. The efficacy of the wrap is evaluated independently of human interpretation of a diagnostic output.

7. Type of Ground Truth Used

The ground truth used for these studies would be based on:

Sterility: Absence of microbial growth in sterility tests (microbiological cultures).
Sterilization Efficacy: Inactivation of biological indicators (spore tests) and successful passage of physical/chemical indicators for sterilization.
Physical Properties: Objective measurements of material integrity (e.g., tensile strength, tear resistance, barrier properties) before and after sterilization/storage.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilization wrap) undergoing performance testing, not an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this type of device.

Summary

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JUN 1 3 2012

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like design above the company name. The company name is written in a bold, sans-serif font.

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

K120658 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

Telephone Number:

Date summary Prepared:

Regulatory Affairs Contact:

Trade Name:

Classification:

Classification Name:

Predicate Devices:

(847) 887-3323 May 31, 2012

DuraBlue™ Sterilization Wrap

Class Il per 21 CFR § 880.6850

Sterilization Wrap

K112211 - DuraBlue™ Sterilization Wrap - Pre-Vacuum Steam (4 min/270°) K112283 - DuraBlue™ Sterilization Wrap - STERRAD 100S K112918 - DuraBlue™ Sterilization Wrap - Amsco® V-PRO™ 1 & 1

Plus (Lumen & Non Lumen Cycles) and Amsco® V-PRO™ maX (Flexible Cycle)

Description:

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The only modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indication for Use portion of the Instructions for Use labeling:

Predicate Statement:
"The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for 30 days."
Proposed Statement:
"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:
180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non . Lumen, and Fiexible Cycles).
30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes." . .

This modification is based on Event-Related Shelf Life testing that demonstrates that the DuraBlue™ wrap maintains sterility of the enclosed contents for the 180 day test period following sterilization by STERRAD 100S or Amsco® V-PRO™ (Lumen, Non Lumen, and Flexible Cycles).

Extensive performance testing has also been completed on Cardinal Health DuraBlue™ Sterilization Wrap in the predicate Premarket Notifications. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed contents. Physical Properties testing included in the predicate Premarket Notifications also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated modalities and storage because the polypropylene material is inert and very stable. The data is included in each of the cleared Premarket Notifications, K112211, K112283, and K112918.

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 the following modalities:

Pre-vacuum steam at 270°F/132°C for 4 minutes .
STERRAD® 100S system. .
Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems

180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes.

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

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For pre-vacuum steam sterilization, the wrap has been validated for dry times 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 pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD® 100S sterlization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

Amsco® V-PRO® Cycle	MaximumRecommendedChamber Load	Intended Load
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
Non LumenCycle	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

Validated Amsco® V-PRO™ cycles

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Wrap Model Recommendations for Pre-Vacuum Steam Sterilization

and the comments of the comments of the comments of

and the comments of the country

SterilizationWrap Model	Intended Load	MaximumRecommendedWrapped PackageContent Weights
CH100	Very light weight package(for example: towel packs).	3 lbs(1,36 kg)
CH200	Light weight package(for example: standard linen packs).	6 lbs(2,7 kg)
CH300	Light to moderate weight package(for example: general use medical instruments).	9 lbs(4 kg)
CH400	Moderate to heavy weight package(for example: general use medical instruments).	13 lbs(5,9 kg)
CH500	Heavy weight package(for example: general use medical instruments).	17 lbs(7,7 kg)
CH600	Very heavy weight package(for example: general use medical instruments).	25 lbs(11,3 kg)

The state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the state of the st

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Wrap Model Recommendations for STERRAD® 100S Sterilization and V-PRO™ Sterilization

Sterilization	Intended Load	Maximum Recommended Wrapped PackageContent Weights -
Wrap Model		STERRAD® 100S	V-PRO™
CH100	Very light weight package(for example: batteries).	3 Ibs(1.36 kg)	3 Ibs
CH200	Light weight package(for example: telescope withlight cord).	6 Ibs(2.7 kg)	6.5 Ibs
CH300	Light to moderate weightpackage(for example: general usemedical instruments).	10 Ibs(4.4 kg)	g libs
CH400	Moderate to heavy weightpackage(for example: general usemedical instruments).	10 lbs(4.4 kg)	9.1 lbs
CH200	Heavy weight package(for example: general usemedical instruments).	10 lbs(4.4 kg)	9.1 lbs
CHEOD	Very heavy weight package(for example: general usemedical instruments).	10 lbs(4.4 kg)	9.1 lbs

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 ●
Are indicated for the same sterilization parameters ●
Are indicated for the same Maximum Wrapped Package Content Weights .

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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 le March 7, 2002) in the predicate Premarket Notifications. Risk analysis showed that the modification to the information provided in the labeling does not present an increase or change in risk of illness or injury associated with the use of the device.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and the USA. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

JUN 1 3 2012

Ms. Lavenia Ford Manager, Regulatory Affairs Cardinal Health 200, LLC 1430 Waukegan Road McGaw Park, Illinois 60085

Re: K120658
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: June 1.2012 Received: June 4, 2012

Dear Ms. Ford:

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- Ms. Ford

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/ ucm 1 1 5809.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

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

Indications for Use Form

510(k) Number (if known): K120658

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

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 modalities:

Pre-vacuum steam at 270°F/132°C for 4 minutes
STERRAD® 100S system. .
Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems

180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes. .

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 OF NEEDED)

Concurrence of CDRH, Office of Devices Evaluation (ODE)

Elizabeth F. Clamino Williams

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

510(k) K120658

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

Page 1 of 4

510(k) Number:

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Amsco® V-PRO® Cycle	MaximumRecommendedChamber Load	Intended Load
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
Non LumenCycle	19.65 lbs.	Non-lumened reusable metal and non-metal medical devices
Flexible Cycle	24 lbs	Single or dual lumen surgical flexible endoscopes andbronchoscopes in either of two load configurations:Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load 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 devices The 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

Validated Amsco® V-PRO™ cycles

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Wrap Model Recommendations for Pre-Vacuum Steam Sterilization

Company of Children

・

SterilizationWrap Model	Intended Load	MaximumRecommendedWrapped PackageContent Weights2
CH100	Very light weight package(for example: towel packs).	3 lbs(1,36 kg)
CH200	Light weight package(for example: standard linenpacks).	6 lbs(2,7 kg)
CH300	Light to moderate weightpackage(for example: general usemedical instruments).	9 lbs(4 kg)
CH400	Moderate to heavy weightpackage(for example: general usemedical instruments).	13 lbs(5,9 kg)
CH500	Heavy weight package(for example: general usemedical instruments).	17 lbs(7,7 kg)
CH600	Very heavy weight package(for example: general usemedical instruments).	25 lbs(11,3 kg)

. .

. . . .

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Wrap Model Recommendations for STERRAD® 100S Sterilization and V-PRO™ Sterilization

SterilizationWrap Model	Intended Load	Maximum Recommended Wrapped PackageContent Weights2
		STERRAD® 100S	V-PRO™
CH100	Very light weight package(for example: batteries).	3 lbs(1.36 kg)	3 lbs
CH200	Light weight package(for example: telescope withlight cord).	6 lbs(2.7 kg)	6.5 lbs
CH300	Light to moderate weightpackage(for example: general usemedical instruments).	10 lbs(4.4 kg)	9 lbs
CH400	Moderate to heavy weightpackage(for example: general usemedical instruments).	10 lbs(4.4 kg)	9.1 lbs
CH500	Heavy weight package(for example: general use.medical instruments).	10 lbs(4.4 kg)	9.1 lbs
CH600	Very heavy weight package(for example: general usemedical instruments).	10 lbs(4.4 kg)	9.1 lbs

. . . . .

. .

Page 4 of 4

. . . . . . .

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).