CARDINAL HEALTH DURABLUE STERILIZATION WRAP

K120542 · Cardinal Health-Medical Products and Services · FRG · Jun 1, 2012 · General Hospital

Device Facts

• Record ID: K120542
• Device Name: CARDINAL HEALTH DURABLUE STERILIZATION WRAP
• Applicant: Cardinal Health-Medical Products and Services
• Product Code: FRG · General Hospital
• Decision Date: Jun 1, 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 be used to enclose another medical device that is to be sterilized by a health care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 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 devices for 30 days. 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 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 to wrap medical devices prior to 100% ethylene oxide (EO) sterilization. The wrap allows sterilant penetration and maintains package sterility for 30 days post-sterilization. Six models (CH100-CH600) accommodate varying load weights (3-25 lbs). The wrap supports simultaneous double-wrapping techniques and aseptic opening. Benefits include protection of sterilized instruments during storage and handling. No electronic or software components.

Clinical Evidence

Bench testing only. Performance validated per FDA guidance for sterilization packaging. Testing included sterilization efficacy, event-related maintenance of sterility, physical properties, EO residuals, and biocompatibility (ISO 10993). Validation confirmed sterilization of specified loads (up to 25 lbs) and lumen configurations (CH400-CH600).

Technological Characteristics

Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Form factor: Six models (CH100-CH600) with varying basis weights. Sterilization compatibility: 100% ethylene oxide. No electronic, software, or energy-based components.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via 100% ethylene oxide (EO) and to maintain sterility for 30 days. Models CH400, CH500, and CH600 are indicated for sterilization of two lumens (≥3mm diameter, ≤400mm length). Not indicated for gravity steam sterilization.

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 (K082177)

Submission Summary (Full Text)

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K120542

JUN - 1 2012

# CardinalHealth

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

Lavenia Ford 1430 Waukegan Road McGaw Park, IL 60085

[phone]

March 13, 2012

Sterilization Wrap

DuraBlue™ Sterilization Wrap

Class II per 21 CFR § 880.6850

Telephone Number:

Date summary Prepared:

Regulatory Affairs Contact:

Trade Name:

Classification:

Classification Name:

Predicate Device:

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

#### Description:

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterlization wraps made from 100% polypropylene spunbond-mettblown-spunbond (SMS) fabric. Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a heath care provider by 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 sterlity of the enclosed device(s) for 30 days. The wrap was validated for an aeration time for EO sterilization of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterlization of two lumens 3 mm in diameter or larger and 400 mm in length or less. The wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterlized pack to be opened aseptically.

Cardinal Health DuraBlue™ Sterilization Wrap is the subject of three Premarket Notifications cleared by the FDA-K112211, K112283 and K112918--for use with pre-vacuum steam, STERRAD 100S, and V-PRO sterilization modalities respectively. This submission is specifically for the addition for use with EO sterilization.

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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 sterlity of the enclosed contents until opened.

#### 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 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterlization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. 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 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 Recommendations'

The following loads were used in the 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 lb of metal mass.
- . CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 Ibs of metal mass.

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- CH400: 4 stacked tray liners (20 in. x 25 in.) 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.) 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.) 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 validation studies 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, 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 Cardinal Health DuraBlue™ Sterilization Wrap (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 100% ethylene oxide 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-mettblown-spunbond (SMS) trilaminate . nonwoven fabric.
- Both devices demonstrate maintenance of package sterility until opened following sterilization . by100% ethylene oxide.
- 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 100% ethylene oxide 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 100% ethylene oxide 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 Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7. 2002). Testing included sterlization efficacy, event related maintenance of package sterility, physical properties, EO residuals 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 Stenlization Wrap.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

**JUN - 2012**

Re: K120542

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: May 16, 2012 Received: May 17, 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 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.

Radiological Health

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

Enclosure

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Image /page/5/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 converge at a point, resembling a stylized bird in flight or a network of pathways.

## Indications for Use

## 510(k) Number (if known): K120542

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

### Ethylene Oxide Sterilization

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 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 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 devices for 30 days. 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 3mm diameter or larger and 400mm in length or less.

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Elizabeth T. Claire-Will

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

.510(k) Number: K120542

Page 1 of 2

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Wrap Model Recommendations1

| 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 |

The following loads were used in the 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 lb 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.) 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.) 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.) 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 validation studies corresponded to the maximum wrapped o 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 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 Cardinal Health DuraBlue™ Sterilization Wrap (i.e., the number and size of the fluid resistant linens or the weight of the metal mass).