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

Pre-vacuum steam at 270°F/132°C for 4 minutes
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 sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55℃. Models CH400, CH500, and CH600 have been validated for sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.

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 pre-vacuum steam at 270°F/132°C for 4 minutes, or 100% ethylene oxide (EO) with a concentration of 725-735 mgL at 131°F/55°C and 40%-80% relative humidity for 60 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 Heatth 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 text describes the DuraBlue™ Sterilization Wrap and its performance. Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance:

Performance Properties	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Efficacy	Pass	PASS
Microbial Barrier Properties (Aerosol Challenge)	Pass	PASS
Event Related Shelf Life	180 days	PASS - 180 days
Material Compatibility with Indicated Sterilization Method	Compatible	Compatible
Biocompatibility	Pass	PASS
Maintenance of Sterility (Pre-vacuum Steam)	180 days	180 days
Maintenance of Sterility (Ethylene Oxide)	180 days	180 days
Dry times for pre-vacuum steam (CH100, CH200)	20 minutes	Validated for 20 minutes
Dry times for pre-vacuum steam (CH300 - CH600)	30 minutes	Validated for 30 minutes
Aeration time for EO sterilization	8 hours at 55°C	Validated for 8 hours at 55°C
Lumen sterilization (CH400, CH500, CH600)	2 lumens, 3mm diameter or larger, 400mm length or less	Validated for 2 lumens, 3mm diameter or larger, 400mm length or less

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the numerical sample size for the "test set." Instead, it describes loads used for Sterility Validation Studies for each of the six DuraBlue™ Sterilization Wrap models (CH100-CH600) for both pre-vacuum steam and EO sterilization. These loads consist of specific quantities of huck towels, fluid-resistant drapes, fluid-resistant table covers, stacked tray liners, lumens, and metal mass. The "Note" clarifies that these loads corresponded to the maximum recommended wrapped package content weights.
Data Provenance: The document does not specify the country of origin of the data. It states that the device is manufactured by Cardinal Health 200, LLC in McGaw Park, IL, USA. The studies are described as "Event-Related Shelf Life testing" and "Sterility Validation Studies." The study refers to "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)," suggesting these are prospective validation studies conducted to meet regulatory requirements. Thus, the data appears to be prospective.

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 studies are described as "Sterilization Efficacy" and "Microbial Barrier Properties" testing, implying laboratory-based validation rather than expert-driven ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document. The nature of the testing (sterilization efficacy, microbial barrier) does not typically involve adjudication by human experts in the same way imaging or clinical diagnostic studies might.

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. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is also not applicable. The device is a physical product (sterilization wrap) and does not involve an algorithm or AI. Its performance is evaluated through physical and microbiological testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance claims (e.g., sterilization efficacy, microbial barrier, sterility maintenance) is established through laboratory-based scientific testing and validation methodologies, often involving microbiology (e.g., spore kill, microbial challenge) and physical testing (e.g., material compatibility, aging). This is akin to a "gold standard" of direct physical and biological measurement, rather than expert consensus or pathology in a medical imaging context.

8. The sample size for the training set:

This is not applicable. As a physical product, the DuraBlue™ Sterilization Wrap does not have a "training set" in the context of machine learning or AI. Its design and material properties are based on engineering principles and prior knowledge, not iterative training on a data set.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons mentioned in point 8.

Summary

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1-123289

Image /page/0/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic of three curved lines above the text "CardinalHealth". The text is in a bold, sans-serif font, with "Cardinal" in a darker shade than "Health".

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

510(k) SUMMARYDuraBlue™ Sterilization Wrap
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:	February 12, 2013
Trade Name:	DuraBlue™ Sterilization Wrap
Classification:	Class II per 21 CFR § 880.6850
Classification Name:	Sterilization Wrap
Common Name:	Sterilization Wrap
Product Code:	FRG
Predicate Device:	K112211 - DuraBlue™ Sterilization Wrap - Pre-vacuum Steam (4min/270°C)
	K120542 - DuraBlue™ Sterilization Wrap - Ethylene Oxide(EO) (725-735 mg/L at 55°C/40%-80%RH/60 min)

Description:

The only modification to the predicate devices involving the clarification of the sterlity maintenance information provided in the Indication for Use portion of the Instructions for Use Labeling.

FEB 2 8 2013

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. Predicate Statement:
- "The wrap is intended to allow sterilization of the enclosed medical device(s) and o maintain sterility of the enclosed device(s) for 30 days."
. Proposed Statement:
- o "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 aging testing for a duration of 180 days for each indicated modality."

This modification is based on Event-Related Shelf Life testing that demonstrates that the DuraBlue™ Sterilization Wrap maintains sterility of the enclosed contents for 180 days following sterilization by prevacuum steam or EO.

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Element of	PROPOSED	PREDICATE	PREDICATE
Comparison	Cardinal Health DuraBlue™	Cardinal Health DuraBlue™	Cardinal Health DuraBlue™
	Sterilization Wrap - Pre-vacuum	Sterilization Wrap - Pre-	Sterilization Wrap - Ethylene
	Steam or EO	vacuum Steam(K112211)	Oxide (EO)(K120542)
Key Claims	180 day Maintenance of Sterility	• Indications for use withpre-vacuum sterilization	• Indications for use withEthylene Oxidesterilization
	Testing for all modalities
Product	100% polypropylene spunbond-meltblown-spunbond (SMS) fabric	Same	Same
Properties
Intended	Cardinal Health DuraBlue™	Cardinal Health DuraBlue™	Cardinal Health DuraBlue™
Use	Sterilization Wrap is intended to	Sterilization Wrap is intended	Sterilization Wrap is intended
	enclose another medical device that is	to be used to enclose another	to be used to enclose another
	to be sterilized by a health care	medical device that is to be	medical device that is to be
	provider using the following modalities:	sterilized by a health care	sterilized by a health care
	• pre-vacuum steam at 270°F/132°C	provider by pre-vacuum steamat 270°F/132°C for 4 minutes.The wrap is not indicated for	provider by 100% ethyleneoxide (EO) with a
	for 4 minutes	use with gravity steam	concentration of 725-735 mg/L
	• 100% ethylene oxide (EO) with a	sterilization.	at 131°F/55°C and 40%-80%
	concentration of 725-735 mg/L at		relative humidity for 60
	131°F/55°C and 40%-80% relative		minutes.
	humidity for 60 minutes	The wrap is intended to allow
	The wrap is intended to allow	sterilization of the enclosed	The wrap is intended to allow
	sterilization of the enclosed medical	medical device(s) and to	sterilization of the enclosed
	device(s) and to maintain sterility of the	maintain sterility of theenclosed devices for 30 days.	medical device(s) and to
	enclosed device(s). Maintenance ofpackage sterility was validated with		maintain sterility of theenclosed devices for 30 days.
	real-time aging testing for a duration of	The wrap has been validated	The wrap has been validated
	180 days following each indicated	for dry times for pre-vacuum	for an aeration time of 8 hours
	modality.	steam sterilization of 20	at 55°C.
		minutes for Models CH100
	For pre-vacuum steam sterilization,	and CH200, and for 30	Models CH400, CH500, and
	the wrap has been validated for dry	minutes for Models CH300,	CH600 have been validated
	times of 20 minutes for Models CH100	CH400, CH500 and CH600.	for sterilization of two lumens
	and CH200 and 30 minutes for Models		of 3 mm diameter or larger and
	CH300, CH400, CH500, and CH600,		400 mm in length or less forEO sterilization.

	For EO sterilization, the wrap hasbeen validated for an aeration time of
	8 hours at 55°C.
Length of	Pre-vacuum steam: 180 days	Pre-vacuum steam: 30 days	Ethylene oxide: 30 days
Maintenance
of Sterility	Ethylene oxide: 180 days
Testing
LumenClaims	Pre-vacuum steam: Models CH400,CH500 and CH600 have been	Pre-vacuum Steam: Models	Ethylene Oxide (EO): Models
	validated for sterilization of two lumens	CH400, CH500 and CH600have been validated for	CH400, CH500, and CH600
	of 3mm diameter or larger and 400mm	sterilization of lumens of 3mm	have been validated forsterilization of two lumens of
	in length or less.	diameter or larger and 400mm	3mm diameter or larger and
		in length or less.	400mm in length or less.
	Ethylene Oxide (EO): Same as
	K120542

Table 1: Overall Comparison to Predicate Devices

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Indications for Use:

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

Pre-vacuum steam at 270°F/132°C for 4 minutes ●
. 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

SterilizationWrap Model	Intended Load	Maximum RecommendedWrapped Package ContentWeight
		Pre-Vacuum Steam and EO
CH100	Very light weight package(for example: batteries)	3 lbs
CH200	Light weight package(for example: telescope with light cord)	6 lbs
CH300	Light to moderate weight package(for example: general use medical instruments)	9 lbs
CH400	Moderate to heavy weight package(for example: general use medical instruments)	13 lbs
CH500	Heavy weight package(for example: general use medical instruments)	17 lbs
CH600	Very heavy weight package(for example: general use medical instruments)	25 lbs

Table 2 - Wrap Model Recommendations

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The following loads were used in the pre-vacuum steam Sterility Validation Studies:

· 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 lbs of metal mass.

· CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm 1. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.

The following loads were used in the EO Sterility 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 lbs 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.), 2 lumens (3 mm I. D x 400 mm), 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.), 2 lumens (3 mm 1. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.

Note: The loads used in the Sterlify Validation Study corresponded to the maximum wrapped package content weights in Table 2.

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 .

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) in the predicate Premarket Notifications. Testing included sterlization efficacy, physical properties, event related maintenance of package sterlity, and biocompatibility in compliance with the methods of ISO 10993 for pre-vacuum steam and EO. Data from testing demonstrates that the DuraBlue™ Sterilization Wrap maintains sterlity of the enclosed contents for 180 days following sterilization by pre-vacuum steam and EO.

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Table 3: Performance Testing of Proposed DuraBlue Sterilization Wrap sterilized by Pre-vacuum steam or EO

Performance Properties		Results
Sterilization Efficacy		PASS
Microbial BarrierProperties	Aerosol Challenge	PASS
	Event Related ShelfLife	PASS- 180 days
Material Compatibility with IndicatedSterilization Method		Compatible
Biocompatibility		PASS

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 28, 2013

Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062

Re: K123289

Trade/Device Name: Cardinal Health DuraBlue 114 Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 15, 2013 Received: February 19, 2013

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.

{7}------------------------------------------------

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 devicerelated 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/ReportalProblem/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,

Kwame O. Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/8/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 resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

Indications for Use

510(k) Number (if known): K123289

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 using the following modalities:

Pre-vacuum steam at 270°F/132°C for 4 minutes .
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

For pre-vacuum steam sterilization, the wrap has been validated for dry times for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, 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 3 mm diameter or larger and 400 mm in length or less for EO 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) Shani J. Smith =============================================================================================================================================================== 2013.02.28 15:52:20=05'00'

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

510(k)

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Table 1 - Wrap Model Recommendations

SterilizationWrap Model	Intended Load	Maximum RecommendedWrapped Package ContentWeight
		Pre-Vacuum Steam and EO
CH100	Very light weight package(for example: batteries)	3 lbs
CH200	Light weight package(for example: telescope with light cord)	6 lbs
CH300	Light to moderate weight package(for example: general use medical instruments)	9 lbs
CH400	Moderate to heavy weight package(for example: general use medical instruments)	13 lbs
CH500	Heavy weight package(for example: general use medical instruments)	17 lbs
CH600	Very heavy weight package(for example: general use medical instruments)	25 lbs

The following loads were used in the pre-vacuum steam Sterility Validation Studies:

· 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 lbs of metal mass.

· CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ¶. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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The following loads were used in the EO Sterility 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 lbs 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.), 2 lumens (3 mm I. D x 400 mm), 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.), 2 lumens (3 mm I. D x 400 mm), and 11.5 Ibs 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.), 2 lumens (3 mm 1. D x 400 mm), 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 Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 1.

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).