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
. Advanced Sterilization Products (ASP) STERRAD® 100S system.
. Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and . DUO Cycles
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) until used.

Device Description

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 using various sterilization methods (Pre-vacuum steam, 100% ethylene oxide (EO), Advanced Sterilization Products (ASP) STERRAD® systems, and STERIS Amsco® V-PRO™ systems). This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The submission covers six different models of DuraBlue™ Sterilization Wrap, each made from material of a different basis weight but utilizing the same material technology.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information provided for the DuraBlue™ Sterilization Wrap, structured as requested:

Acceptance Criteria and Device Performance for DuraBlue™ Sterilization Wrap

This submission (K130927) is a 510(k) summary for a modification to an already cleared device, DuraBlue™ Sterilization Wrap. The stated modification is a clarification to sterility maintenance information in the Instructions for Use labeling. Therefore, the acceptance criteria and performance data referenced are primarily from the underlying predicate device submissions (K123857, K123289, K120658) which established the original substantial equivalence based on performance testing.

The document does not explicitly state specific pass/fail acceptance criteria (e.g., "sterility assurance level of X" or "no positive microbial cultures") for each test. Instead, it refers to "validated" performance for various sterilization methods and loads. The reported device performance is that the wrap "has been validated" for these uses, meaning it met the implicit or explicit criteria of the validation studies conducted for the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter/Sterilization Method	Acceptance Criteria (Implicit from "Validated")	Reported Device Performance
Sterility Maintenance (General)	Ability to maintain sterility of an enclosed medical device until used.	The wrap is intended to allow for sterilization and maintenance of sterility until used. This is achieved through the material properties and validated sterile barrier system.
Double-Wrapping Technique	Compatibility with simultaneous double-wrapping.	Wrap design allows for simultaneous double-wrapping.
Aseptic Opening	Ability for a sterilized pack to be opened aseptically.	Wrap design allows for aseptic opening of a sterilized pack.
Pre-vacuum Steam Sterilization	Effective sterilization with dry times appropriate for wrap models.	Models CH100 & CH200: Validated for 20 minutes dry time. Models CH300, CH400, CH500, CH600: Validated for 30 minutes dry time. Models CH400, CH500, CH600: Validated for two lumens ≥ 3 mm diameter & ≤ 400 mm length.
100% Ethylene Oxide (EO) Sterilization	Effective sterilization with appropriate aeration time for wrap models.	Validated for 8 hours aeration at 55°C. Models CH400, CH500, CH600: Validated for two lumens ≥ 3 mm diameter & ≤ 400 mm length.
ASP STERRAD® 100S Sterilization	Effective sterilization for specified lumen dimensions across all models.	All models: Validated for lumens ≥ 2.5 mm diameter & ≤ 250 mm length.
ASP STERRAD® NX Sterilization	Effective sterilization for specified chamber load and lumen configurations.	All models: Validated for use with STERRAD® NX Standard and Advanced Cycles. Specific lumen dimensions and maximum loads are detailed in "Table 1".
ASP STERRAD® 100NX Sterilization	Effective sterilization for specified chamber load and lumen configurations.	All models: Validated for use with STERRAD® 100NX Standard, Flex, Express, and DUO cycles. Specific lumen dimensions and maximum loads are detailed in "Table 1".
STERIS Amsco® V-PRO™ Sterilization	Effective sterilization and aeration for all V-PRO™ cycles.	All models: Validated for use with Lumen, Non Lumen, and Flexible Cycles by Amsco® V-PRO™ 1, V-PRO™ 1 Plus, and V-PRO™ MAX. The wraps were validated to be effectively aerated during these cycles. Specific lumen dimensions and maximum loads are detailed in "Table 2".
Maximum Wrapped Package Content Weight	Ability to maintain integrity and sterility for specified weights.	CH100: Validated for 3 lbs (Pre-Vacuum Steam/EO), 3 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 3 lbs (V-PRO™). CH200: Validated for 6 lbs (Pre-Vacuum Steam/EO), 6 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 6.5 lbs (V-PRO™). CH300: Validated for 9 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9 lbs (V-PRO™). CH400: Validated for 13 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™). CH500: Validated for 17 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™). CH600: Validated for 25 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™).

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

The document does not explicitly state the specific numerical sample sizes (n) for each test conducted for the predicate device submissions. Instead, it details the types of loads used to validate each model of sterilization wrap for different sterilization methods. These loads represent the "test set" and are described as follows:

Pre-Vacuum Steam Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 3 fluid-resistant drapes.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass in a tray.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass in a tray.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass in a tray.
EO Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass in a tray.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass in a tray.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass in a tray.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
- CH100: Metal Instruments.
- CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
- CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
STERIS Amsco® V-PRO™ Sterility Validation Studies:
- CH100: Metal Instruments.
- CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

Data Provenance: The studies were done as "Sterility Validation Studies" to support predicate device submissions, likely conducted in a controlled laboratory or testing facility setting, which implies a prospective design for testing the new device. The country of origin of the data is not specified, but since Cardinal Health 200, LLC is based in Waukegan, IL, USA, and the submission is to the FDA, it is highly likely the data was generated in the US or under US regulatory guidelines.

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

The document does not provide details on the number or qualifications of experts specifically establishing "ground truth" for these sterilization validation studies. For medical devices like sterilization wraps, ground truth for sterility is typically established through microbiology (e.g., spore log reduction, sterility tests) in conjunction with physical parameters (e.g., temperature, pressure readings) and chemical indicators, rather than human expert opinion on images or clinical cases. The validation would follow established standards (e.g., AAMI, ISO) for sterilization efficacy.

4. Adjudication Method for the Test Set

Not applicable. As this is a physical device subject to sterility validation, there is no "adjudication method" in the context of expert review for qualitative assessments (like in image analysis studies). Sterility is determined by direct measurement (e.g., microbial culture results) rather than consensus among human reviewers.

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

Not applicable. This device is a sterilization wrap, not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted.

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

Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software requiring standalone performance testing in this context. The "standalone performance" refers to the wrap's ability to maintain sterility under various conditions when exposed to sterilization processes, independent of human interaction during the sterilization cycle itself. This is what the validation studies assessed.

7. The Type of Ground Truth Used

The ground truth used for these "Sterility Validation Studies" would be based on microbiological testing, adhering to industry standards for demonstrating sterility. This typically involves:

Biological Indicators (BIs): Spore-laden strips or vials placed within the test loads. A successful validation demonstrates a specified log reduction of microbial spores (often a Sterility Assurance Level - SAL of 10^-6), meaning no growth of test organisms after exposure to the sterilization cycle.
Physical Parameters: Monitoring and recording of physical parameters such as temperature, pressure, time, and sterilant concentration (for EO and vaporized hydrogen peroxide systems) to ensure they meet the defined cycle specifications.
Chemical Indicators (CIs): Internal and external indicators showing exposure to sterilant, but not necessarily sterility.
Package Integrity Testing: Post-sterilization testing to ensure the wrap maintains its sterile barrier integrity (e.g., burst strength, seal strength, microbial barrier testing).

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set." The performance data is derived from validation studies of the device itself.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set. The "ground truth" for the device's efficacy revolves around successful sterility validation as described in point 7.

Summary

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K130927

Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic appears to be three curved lines that converge at a point, resembling a bird in flight or a stylized leaf. The text "CardinalHealth" is written in a simple, sans-serif font.

1430 Waukegan Road Waukegan, IL 60085

www.cardinalhealth.com

510(k) SUMMARY DuraBlue™ Sterilization Wrap

Manufacturer:

Cardinal Health 200, LLC 1430 Waukegan Road Waukegan, IL 60085

1430 Waukegan Road Waukegan, IL 60085

Requlatory Affairs Contact:

Telephone Number:

Fax Number:

Date summary Prepared:

Trade Name:

Classification:

Classification Name:

Common Name:

Product Code:

Predicate Device:

(847) 887-3323

(847) 887-2461

Lavenia Ford

June 14, 2013

DuraBlue™ Sterilization Wrap

Class II per 21 CFR § 880.6850

Sterilization Wrap

FRG

K123857 – DuraBlue™ Sterilization Wrap – Johnson & Johnson STERRAD® NX and STERRAD® 100NX

K123289 - DuraBlue™ Sterilization Wrap - Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO)

K120658 – DuraBlue™ Sterilization Wrap – STERRAD® 100S and Arreoooo - Barablao - StormEx. Pro TM 1 Plus, and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems

JUN 1 8 2013

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Description:

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
Advanced Sterilization Products (ASP) STERRAD® 100S System .
Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced ● Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cycles
2 @ Cyrist
Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® VPRO™ 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.

The proposed device is identical to the device cleared in the predicate submissions. The only modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling. This change is being made in order to comply with 21CFR880.6850 which states "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."

This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

Indications for Use

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

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
Advanced Sterilization Products (ASP) STERRAD® 100S System .
Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced . Cvcles
Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cvcles
Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® VPRO™ 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) until used.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Y Models CH100 and CH200 and 30 minutes for Models CH300, CH500, and CH600. Models

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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.

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.

All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterlization 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 Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX in Table 1.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO™ cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO™ sterilization cycles.

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Table 1 – Validated Advanced Sterilization Products STERRAD® NX and STERRAD® 100NX Sterilization Cycles

AdvancedSterilizationProducts(ASP)STERRAD®System andCycle	MaximumRecommendedChamber Load	Intended Load
ASPSTERRAD® NXStandard Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150mm or shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400mm or shorter of single-channel stainless steel lumens
ASPSTERRAD® NXAdvanced Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumensOROne single-channel Flexible Endoscope with or without a siliconemat and no additional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 850 mm orshorter
ASPSTERRAD® 100NXStandard Cycle	21.4 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 0.7 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens (Amaximum of five lumens per tray per sterilization cycle)
ASPSTERRAD® 100NXFlex Cycle	12.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 850 mm orshorter (A maximum of two flexible endoscopes, one pertray per sterilization cycle)
ASPSTERRAD® 100NXExpress Cycle	10.7 lbs	Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of mated stainless steeland titanium surfaces, and rigid or semi-rigid endoscopes withoutlumens
ASPSTERRAD® 100NXDuo Cycle	13.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 875 mm orshorter

1000 Children

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Table 2 – Validated STERIS Amsco® V-PRO™ cycles
Amsco® V-PRO® Cycle	MaximumRecommendedChamber Load	Intended Load
Lumen Cycle	19.65 lbs	Reusable metal and non-metal medical devices, including up to 20lumens 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 ineither of two load configurations:1. Two trays, each containing a flexible endoscope with a light cord (ifnot integral to endoscope) and mat with no additional load2. One tray containing a flexible endoscope with a light cord (if notintegral to endoscope) and mat and an additional tray containingnon-lumened medical devicesThe flexible endoscope(s) may contain either:a single lumen with an inside diameter of 1 mm or largerand a length of 1050 mm or shorter two lumens, with one lumen having an inside diameter of 1mm or larger and a length of 998 mm or shorter and theother lumen having an inside diameter of 1 mm or largerand a length of 850 mm or shorter

and the control control control control controlled

100 - 100 - 100 - 100 -

Table 2 – Validated STERIS Amsco® V-PRO™ cycles

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Table 3 - Wrap Model Recommendations1

		Maximum Recommended Wrapped Package ContentWeight2
SterilizationWrap Model	Intended Load	Pre-VacuumSteam and EO	AdvancedSterilizationProducts (ASP)STERRAD®100S	AdvancedSterilizationProducts(ASP)STERRAD®NX and 100NX	STERISAmsco®V-PRO™
CH100	Very light weight package(for example: towel packs orbatteries).	3 lbs	3 lbs	10.7 lbs	3 lbs
CH200	Light weight package(for example: telescope with lightcord).	6 lbs	6 lbs	10.7 lbs	6.5 lbs
CH300	Light to moderate weight package(for example: general use medicalinstruments)	9 lbs	9.7 lbs	10.7 lbs	9 lbs
CH400	Moderate to heavy weight package(for example: general use medicalinstruments)	13 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH500	Heavy weight package(for example: general use medicalinstruments)	17 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH600	Very heavy weight package(for example: general use medicalinstruments)	25 lbs	9.7 lbs	10.7 lbs	9.1 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 I. D x 400 mm), and 8 Ibs 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 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 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 Ibs 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 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.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:

· CH100: Metal Instruments

· CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:

· CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.

The following loads were used in the STERIS Amsco® V-PRO™ sterility Validation Study:

· CH100: Metal Instruments
· CH200 CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments

Note: The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.

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.

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 DuraBlue™ Sterilization Wraps.

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
Demonstrate maintenance of package sterility
Are indicated for the same sterilization parameters
Are indicated for the same Maximum Wrapped Package Content Weight

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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 (March 7, 2002) in the predicate Premarket Notifications. Risk analysis showed that the modification to the information provided in the labeling does not present and increase or change in risk of illness or injury associated with the use of this device. The only modification to the labeling is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use ' labeling.

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The caduceus is depicted as a staff with a snake winding around it, and it is accompanied by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol.

Public Health Service

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

June 18, 2013

Cardinal Health Ms. Lavenia Ford Manager, Regulatory Affairs 1430 Waukegan Road WAUKEGAN, IL 60085

Re: K130927

Trade/Device Name: DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 16, 2013 Received: May 20, 2013

Dear Ms. Ford:

We have reviewed vour 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours,

Susan Runner DDS, MA Mary S. Runner--S

Kwame Ulmer M.S. Acting Division 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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Appendix 2 – Indications for Use

. . . . . .

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Image /page/11/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a bold, sans-serif font.

Indications for Use

510(k) Number (if known):

Device Name: DuraBlue™ Sterilization Wrap

Indications for Use

DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

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
. Advanced Sterilization Products (ASP) STERRAD® 100S system.
. Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and . DUO Cycles
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) until used.

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)

Susan Runner DOS,MA Mary S.
Runner -S

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

K130927 510(k)

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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 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 EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) 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 Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.

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Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Cycles

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AdvancedSterilizationProducts(ASP)STERRAD®System andCycle	MaximumRecommendedChamber Load	Intended Load
ASPSTERRAD® NXStandard Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to10 lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150mm or shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400mm or shorter of single-channel stainless steel lumens
ASPSTERRAD® NXAdvanced Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to10 lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumensOROne single-channel Flexible Endoscope with or without a siliconemat and no additional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter
ASPSTERRAD®100NXStandard Cycle	21.4 lbs	Reusable metal and non-metal medical devices, including up to10 lumens of the following lumen dimensions per chamber load:• an inside diameter of 0.7 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens (Amaximum of five lumens per tray per sterilization cycle)
ASPSTERRAD®100NX FlexCycle	12.2 lbs	One or two single-channe! Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter (A maximum of two flexible endoscopes, oneper tray per sterilization cycle)
ASPSTERRAD®100NX ExpressCycle	10.7 lbs	Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of mated stainlesssteel and titanium surfaces, and rigid or semi-rigid endoscopeswithout lumens
ASPSTERRAD®100NX Duo Cycle	13.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 875 mmor shorter

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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 ID x 400 mm) and 7.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.

· CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID 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 ID x 400 mm) and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:

· CH100: Metal instruments.

· CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:

· CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.

The following loads were used in the STERIS Amsco® V-PRO® Sterility Validation Studies: · CH100: Metal instruments.

· CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.

'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 irreqularly 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 DuraBlue™ Sterilization Wraps.

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).