KIMGUARD SMART-FOLD* STERILIZATION WRAP

K112300 · Kimberly-Clark Corp. · FRG · Jan 19, 2012 · General Hospital

Device Facts

• Record ID: K112300
• Device Name: KIMGUARD SMART-FOLD* STERILIZATION WRAP
• Applicant: Kimberly-Clark Corp.
• Product Code: FRG · General Hospital
• Decision Date: Jan 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

Device Story

Sterilization wrap system designed to enclose medical instruments for sterilization and maintain sterility until use. Composed of multi-layer nonwoven spunbond-meltblown-spunbond (SMS) polypropylene fabric with titanium dioxide and phthalocyanine blue pigments. Features include reinforcement strips with reference lines for tray placement, adhesive tape strips for securing layers, and integrated handles/pull tabs for aseptic opening. Used in healthcare facilities by clinical staff. Protects sterilized contents from contamination; facilitates aseptic presentation of instruments in clinical settings.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance for medical sterilization packaging systems. Evaluated biocompatibility (irritation/sensitization per ISO 10993), sterilant penetration, dry times, and physical integrity. Sterility maintenance validated for up to 30 days post-sterilization.

Technological Characteristics

Nonwoven SMS (spunbond-meltblown-spunbond) polypropylene fabric; contains titanium dioxide and phthalocyanine blue pigments. Multi-layer construction with adhesive reinforcement strips. Passive barrier system; no energy source or connectivity. Sterilization via prevacuum steam or 100% ethylene oxide.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via prevacuum steam or 100% ethylene oxide. Supports various load weights: KC250 (up to 6 lbs), KC450 (up to 13 lbs), KC550 (up to 17 lbs), and KC650 (up to 25 lbs).

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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K112300

JAN 1 9 2012

## 510(k) Summary for the Kimberly-Clark* Corporation KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550 and KC650)

| Device type: | Sterilization Wrap | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date of<br>Summary: | July 28, 2011 | |
| 510(k) Submitter: | Brenda Shelkey<br>Associate Director, Quality Assurance & Regulatory<br>Affairs<br>KIMBERLY-CLARK CORPORATION<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>678-654-8021<br>[e-mail]<br>Establishment Registration Number 1033422 | |
| Primary Contact<br>for this 510(k)<br>Submission: | Same as above | |
| Classification<br>Regulation: | 21 CFR 880.6850 | |
| Device Class: | Class II | |
| Panel: | General Hospital | |
| Product Code: | FRG | |

:

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#### Intended Use:

KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

### Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization'

| KIMGUARD<br>SMART-<br>FOLD*<br>Sterilization<br>Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| KC250 | Light Weight<br>Package (for<br>example: standard<br>linen packs) | 6 lbs. | 2 huck towels (17 in. x 29 in.)<br>2 fluid-resistant U-drapes (68 in. x 109 in.)<br>1 fluid-resistant universal bar drape (70 in.<br>x 108in.) |
| KC450 | Moderate to Heavy<br>Weight Package<br>(for example:<br>general use medical<br>instruments) | 13 lbs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing 11<br>lbs. of metal mass |
| KC550 | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 17 lbs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing<br>15 lbs. of metal mass |
| KC650 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 25 Ibs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing 23<br>lbs. of metal mass |

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Device Description: KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.

Predicate Device: The KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650) is substantially equivalent to the predicate KimGuard One-Step* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) (K082177).

Substantial Equivalence: The modified design of KimGuard Smart-Fold* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KimGuard* One-Step* Sterilization Wrap (K082177) in intended use, design, and materials.

Summary of Testing: KimGuard Smart-Fold* Sterilization Wrap has been tested in compliance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included irritation and sensitization biocompatibility methods of ISO 10993 sterilant penetration, dry time, and physical integrity. The wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. All test results met acceptance criteria.

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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 and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Ms. Brenda Shelkey Associate Director, Quality Assurance & Regulatory Affairs Kimbery- Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

JAN 1 9 2012

Re: K112300

Trade/Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, AND KC650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 4, 2012 Received: January 5, 2012

Dear Ms. Shelkey:

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 - Ms. Shelkey

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,

Anthony D. Mester

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 : K112300

# Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650)

Indications for Use:

KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO aterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

See Wrap Model Recommendations on Page 2.

Prescription Use __ (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth S. Clamie-Williams
(Printed Name)

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

510(k) Number:

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## Indications for Use

# Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization1

| KIMGUARD<br>SMART-<br>FOLD*<br>Sterilization<br>Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| KC250 | Light Weight<br>Package (for<br>example: standard<br>linen packs) | 6 lbs. | 2 huck towels (17 in. x 29 in.)<br>2 fluid-resistant U-drapes (68 in. x 109 in.)<br>1 fluid-resistant universal bar drape (70 in.<br>x 108in.) |
| KC450 | Moderate to Heavy<br>Weight Package<br>(for example:<br>general use medical<br>instruments) | 13 lbs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing 11<br>lbs. of metal mass |
| KC550 | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 17 lbs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing<br>15 lbs. of metal mass |
| KC650 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 25 lbs. | 4 tray liners (20 in. x 25 in.) stacked<br>10 in. x 10 in. x 3 ½ in. tray containing 23<br>lbs. of metal mass |

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