DURABLUE STERILIZATION (AMSCO V-PRO) WRAP

K112918 · Cardinal Health200, LLC · FRG · Jan 20, 2012 · General Hospital

Device Facts

• Record ID: K112918
• Device Name: DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
• Applicant: Cardinal Health200, LLC
• Product Code: FRG · General Hospital
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider in the 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) for 30 days. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO® sterilization cycles.

Device Story

DuraBlue™ Sterilization Wrap consists of double-layer 100% polypropylene SMS (spunbond-meltblown-spunbond) fabric; used by healthcare providers to enclose medical devices prior to sterilization in Amsco® V-PRO® 1, 1 Plus, and maX low-temperature systems. Wrap design facilitates simultaneous double-wrapping technique and aseptic opening. Device maintains sterility of enclosed contents for at least 30 days post-sterilization. Healthcare facilities select appropriate wrap model (CH100-CH600) based on package weight and content geometry. Benefits include protection of sterilized instruments during storage and transport, ensuring sterility until point of use.

Clinical Evidence

Bench testing only. Performance validated per FDA guidance for sterilization packaging. Testing included sterilization efficacy, event-related maintenance of package sterility, physical property testing (pre/post-sterilization), and biocompatibility (ISO 10993). No clinical data presented.

Technological Characteristics

Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Form factor: Six models (CH100-CH600) with varying basis weights. Sterilization compatibility: Amsco® V-PRO® 1, 1 Plus, and maX low-temperature systems. Biocompatibility: Compliant with ISO 10993.

Indications for Use

Indicated for healthcare providers to enclose reusable metal and non-metal medical devices, including flexible endoscopes and bronchoscopes, for sterilization in Amsco® V-PRO® low-temperature systems. Supports specific lumen dimensions and load configurations.

Regulatory Classification

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.

Predicate Devices

• KIMGUARD ONE-STEP Sterilization Wrap (K092167)

Submission Summary (Full Text)

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K112918

JAN 2 0 2012

CardinalHealt

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

## SMDA REQUIREMENTS

| | <b>510(k) SUMMARY OF SAFETY AND EFFECTIVENESS</b><br>DuraBlue™ Sterilization Wrap<br>Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Cardinal Health 200, LLC<br>1430 Waukegan Road<br>McGaw Park, IL 60085 |
| Regulatory Affairs Contact: | Lavenia Ford<br>1430 Waukegan Road<br>McGaw Park, IL 60085 |
| Telephone Number: | [phone] |
| Date summary Prepared: | December 21, 2011 |
| Trade Name: | DuraBlue™ Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Predicate Device: | K092167 - KIMGUARD ONE-STEP Sterilization Wrap |
| 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 in the the Lumen, or
Flexible Cycles in the Amsco V-PRO® 1, Amsco V-PRO® 1 Plus and Amsco "V-PRO" ma Temperature Sterilization Systems. This wrap design allows for use of the simultaneous doublewrapping 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.

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 sterility of the enclosed contents for at least 30 days.

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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 in the 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) for 30 days. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO® sterilization cycles.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO® cycles:

| Amsco® V-PRO®<br>Cycle | Maximum<br>Recommended<br>Chamber Load | Intended Load | Maximum Recommended<br>Wrapped Package<br>Content Weight by Wrap<br>Model¹ |
|------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical<br>devices, including up to 20 lumens of the<br>following dimensions per chamber load:<br>an inside diameter of 1 mm or larger<br>and a length of 125 mm or shorter an inside diameter of 2 mm or larger<br>and a length of 250 mm or shorter an inside diameter of 3 mm or larger<br>and a length of 400 mm or shorter | Wrap Model    Max.<br>Package Weight<br>CH100    3 lbs<br>CH200    6.5 lbs<br>CH300    9 lbs<br>CH400    9.1 lbs<br>CH500    9.1 lbs<br>CH600    9.1 lbs |
| Non Lumen Cycle | 19.65 lbs | Non-lumened reusable metal and non-metal<br>medical devices | |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible<br>endoscopes and bronchoscopes in either of<br>two load configurations:<br>1. Two trays, each containing a flexible<br>endoscope with a light cord (if not<br>integral to endoscope) and mat with no<br>additional load<br>2. One tray containing a flexible<br>endoscope with a light cord (if not<br>integral to endoscope) and mat and an<br>additional tray containing non-lumened<br>medical devices<br><br>The flexible endoscope(s) may contain<br>either:<br>a single lumen with an inside<br>diameter of 1 mm or larger and<br>a length of 1050 mm or shorter two lumens, with one lumen<br>having an inside diameter of 1<br>mm or larger and a length of<br>998 mm or shorter and the<br>other lumen having an inside<br>diameter of 1 mm or larger and<br>a length of 850 mm or shorter | |

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.

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## 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 V-PRO® 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-me!tblown-spunbond (SMS) trilaminate nonwoven fabric.
- Both devices demonstrate maintenance of package sterility for at least 30 days following sterilization by pre-vacuum steam.
- Performance and safety attributes are substantially equivalent to the predicate. The physical properties of all wrap models have been characterized both before and after exposure to V-PRO®
- 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 V-PRO® system sterilization parameters.

#### 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). Testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993. Data from testing demonstrates that the performance of the DuraBlue™ Sterilization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wrap.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Cardinal Health 200, LLC C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JAN 2 0 2012

Re: K112918

Trade/Device Name: Cardinal Health DuraBlue™ Sterilization Wrap Amsco® V-PRO® 1, Amsco®V-PRO®1 Plus and Amsco® V-PRO® maX Regulation Number: 21 CFR 880.6850

Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 3, 2012 Received: January 6, 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 Eederal 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 I ou inal of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Austin James

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

## Indication for Use

## 510(k) Number (if known): K112918

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® max

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 in the 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) for 30 days. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO® sterilization cycles.

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 Device Evaluation (ODE)

Elizabe H. F. Clarence-Wills

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

510(k) Number: K112918

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All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco "V-PRO® cycles:

| Amsco® V-PRO® Cycle | Maximum Recommended Chamber Load | Intended Load | Maximum Recommended Wrapped Package Content Weight by Wrap Model¹ | | | | | | | | | | | | | | |
|---------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of 125 mm or shorter<br>• an inside diameter of 2 mm or larger and a length of 250 mm or shorter<br>• an inside diameter of 3 mm or larger and a length of 400 mm or shorter | Wrap Model Max. Package Weight CH100 3 lbs CH200 6.5 lbs CH300 9 lbs CH400 9.1 lbs CH500 9.1 lbs CH600 9.1 lbs | | | | | | | | | | | | | | |
| Non Lumen Cycle | 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:<br><br>1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load<br><br>2. 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<br><br>The flexible endoscope(s) may contain either:<br>• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter<br>• 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 | | | | | | | | | | | | | | | |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, marriadal rocelle hay 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.