DURA BLUE STERILIZATION WRAP

K112211 · Cardinal Health200, LLC · FRG · Oct 20, 2011 · General Hospital

Device Facts

• Record ID: K112211
• Device Name: DURA BLUE STERILIZATION WRAP
• Applicant: Cardinal Health200, LLC
• Product Code: FRG · General Hospital
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Cardinal Heath DuraBlue™ Sterilization Wrap is 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. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization 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 sterilization of lumens of 3mm diameter or larger and 400mm in length or less. Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

Device Story

DuraBlue™ Sterilization Wrap consists of double-layer 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. Used by healthcare providers in clinical settings to wrap medical devices prior to pre-vacuum steam sterilization. Design allows for simultaneous double-wrapping and aseptic opening. Wrap acts as a barrier to maintain sterility of enclosed contents for at least 30 days post-sterilization. Six models (CH100-CH600) provide varying basis weights to accommodate different load requirements, ranging from light towel packs to heavy instrument trays. Healthcare facilities select appropriate model based on package weight and content type. Device does not require active operation; performance relies on material integrity during sterilization cycle and storage.

Clinical Evidence

Bench testing only. Performance validated per FDA guidance for medical sterilization packaging. Testing included sterilization efficacy, dry time (20-30 mins), event-related sterility maintenance (30 days), physical properties, and biocompatibility (ISO 10993). Validation used specific load configurations (towels, drapes, metal mass) corresponding to maximum weight ratings for each model.

Technological Characteristics

Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Form factor: Six models (CH100-CH600) of varying basis weights. Sterilization: Pre-vacuum steam (270°F/132°C, 4 min). Biocompatibility: Compliant with ISO 10993.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for pre-vacuum steam sterilization (270°F/132°C for 4 minutes) and to maintain sterility for 30 days. Not indicated for gravity steam sterilization. Specific models (CH100-CH600) are indicated for varying load weights (3-25 lbs). Models CH400-CH600 are indicated for lumens ≥3mm diameter and ≤400mm length.

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 (Models KC100, KC200, KC400, KC500 and KC600) (K082177)
• KIMGUARD ONE-STEP Sterilization Wrap (Model KC300) (K091685)

Submission Summary (Full Text)

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K112211

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of the company name in a bold, sans-serif font. Above the name are three curved lines that appear to be stylized representations of a cardinal's feathers or wings.

OCT 2 0 2011

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

#### SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DuraBlue™ Sterilization Wrap

Manufacturer:

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

Regulatory Affairs Contact:

1430 Waukegan Road McGaw Park, IL 60085

Lavenia Ford

[phone]

Telephone Number:

Date summary Prepared: September 28, 2011

DuraBlue™ Sterilization Wrap Trade Name:

Classification: Class II per 21 CFR § 880.6850

Classification Name: Sterilization Wrap

Predicate Device:

K082177 - KIMGUARD ONE-STEP Sterilization Wrap (Models KC100, KC200, KC400, KC500 and KC600) K091685 - KIMGUARD ONE-STEP Sterilization Wrap (Model KC300)

Description:

Cardinal Heath 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 by pre-vacuum steam at 270°F/132°C for 4 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 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™ Sterlization Wrap. Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterlify of the enclosed contents for at least 30 days.

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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 pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CH100 and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for sterilization of lumens of 3mm diameter or larger and 400mm in length or less.

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

| DuraBlue™<br>Sterilization Wrap<br>Model | Intended Load | Maximum Recommended<br>Wrapped Package Content<br>Weights2 |
|------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------|
| CH100 | Very light weight package (for<br>example: towel packs) | 3 lbs |
| CH200 | Light weight package (for<br>example: standard linen<br>packs) | 6 lbs |
| CH300 | Light to moderate weight<br>package (for example:<br>general use medical<br>instruments) | 9 lbs |
| CH400 | Moderate to heavy weight<br>package (for example:<br>general use medical<br>instruments) | 13 lbs |
| CH500 | Heavyweight package (for<br>example: general use<br>medical instruments) | 17 lbs |
| CH600 | Very heavy weight package<br>(for example: general use<br>medical instruments) | 25 lbs |

Wrap Model Recommendations1

The following loads were used in the Sterility Maintenance Validation Study:

- 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 Ibs of metal mass.
- . CH400: 4 stacked tray liners (20 in. x 25 in.) 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.) 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.) and 18 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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

1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may

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put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

f I is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health DuraBlue™ Sterilization Wraps (i.e., the number and size of the fluid resistant linens or the weight of the metal mass).

#### Substantial Equivalence

The DuraBlue ™ Sterilization Wrap is substantially equivalent to the predicate devices.

- Both devices are double layer sterilization wraps which allow for use of the simultaneous double-. wrapping technique and for a sterilized pack to be opened aseptically.
- Both devices are intended to be used with the same pre-vacuum steam 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-meltblown-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 prevacuum steam 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 pre-vacuum steam sterilization parameters.

#### Summary of Testing

DuraBlue™ Stenlization Wrap performance has been tested in accordance with the applicable requirements recommended in the FDA's Guidance Document Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included sterilization efficacy, dry time, 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™ Sterlization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Stenlization Wrap.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 2 0 2011

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 Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K112211

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: September 2, 2011 Received: September 6, 2011

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cirthon D. Mutaar

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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### Indications for Use

## 510(k) Number (if known): K112211

# Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

## Pre-vacuum Steam Sterilization

Indications for Use:

Cardinal Heath DuraBlue ™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterlized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain steriity of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam.y Sterliization 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 sterlization of lumens of 3mm diameter or larger and 400mm in length or less.

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

| DuraBlue™<br>Sterilization Wrap<br>Model | Intended Load | Maximum Recommended<br>Wrapped Package Content<br>Weights1 |
|------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------|
| CH100 | Very light weight package (for<br>example: towel packs) | 3 lbs |
| CH200 | Light weight package (for<br>example: standard linen<br>packs) | 6 lbs |
| CH300 | Light to moderate weight<br>package (for example:<br>general use medical<br>instruments) | 9 lbs |
| CH400 | Moderate to heavy weight<br>package (for example:<br>general use medical<br>instruments) | 13 lbs |
| CH500 | Heavyweight package (for<br>example: general use<br>medical instruments) | 17 lbs |
| CH600 | Very heavy weight package<br>(for example: general use<br>medical instruments) | 25 lbs |

Wrap Model Recommendations

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The following loads were used in the Sterility Maintenance Validation Study:

- 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 Ibs of metal mass.
- CH400: 4 stacked tray liners (20 in. x 25 in.) 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.) 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.) and 18 lbs of metal mass in a ● 23 in. x 11 in. x 3.5 in. tray.
- Note: The loads used in the Sterility Maintenance Validation Study corresponded to the O maximum wrapped package content weights in the table.

1 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Heath DuraBlue™ Sterilization Wrap (i.e., the number and size of the fluid resistant linens or the weight of the metal mass).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Edhat B. Clamine - Wils
(Division Sign. Off.)

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

510(k) Number: KII2211

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)