KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600

K082554 · Kimberly-Clark Corp. · FRG · May 1, 2009 · General Hospital

Device Facts

• Record ID: K082554
• Device Name: KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
• Applicant: Kimberly-Clark Corp.
• Product Code: FRG · General Hospital
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

KIMGUARD* 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 or by 100% ethylene oxide (EtO) 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 EtO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500, and 600. KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.

Device Story

KIMGUARD* Sterilization Wrap consists of square or rectangular sheets used by healthcare facilities to wrap medical instruments/trays prior to sterilization. The wrap acts as a barrier, allowing sterilant penetration (steam or EtO) while maintaining sterility of contents post-process. The device is a three-layer SMS (spunbond-meltblown-spunbond) polypropylene laminate. Healthcare personnel select the appropriate model (KC100-KC600) based on the weight and type of the load (ranging from 3 lbs to 25 lbs). The wrap is manually applied to enclose the device; the package is then subjected to a validated sterilization cycle. The wrap maintains the sterile state of the enclosed items until the package is opened for clinical use. Benefits include protection of sterile instruments from contamination during storage and transport.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for Medical Sterilization Packaging Systems. Evaluations included biocompatibility (irritation and sensitization per ISO 10993), sterilant penetration, dry time, and physical integrity. Sterility maintenance was validated for up to 30 days post-sterilization using various load weights (3 lbs to 25 lbs) and configurations (towels, drapes, metal masses). All results met acceptance criteria.

Technological Characteristics

Three-layer SMS (spunbond-meltblown-spunbond) polypropylene laminate. Dimensions vary by model (KC100-KC600). Compatible with pre-vacuum steam and 100% ethylene oxide sterilization. Not compatible with gravity steam sterilization. No software or electronic components.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam (270°F/132°C, 4 min) or 100% ethylene oxide (55°C, 725-735 mg/L, 40-80% RH, 60 min). Maintains sterility of enclosed devices until opened. 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

• K881471

Submission Summary (Full Text)

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K082554

Predicate

Devices:

# 510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)

| Date Summary was Prepared: | April 14, 2009 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Thomas Kozma<br>Director, Regulatory Affairs<br>Kimberly-Clark Health Care<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>Ph: 770.587.8393<br>FAX: [phone]<br>Email: [e-mail] |
| Primary Contact for this 510(k) Submission: | Lisa Peacock, Consultant to Kimberly-Clark Health Care<br>SciMed, Inc.<br>Ph: 706.216.3413<br>FAX: [phone]<br>Email: [e-mail] |
| Device Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Product Code: | FRG |
| Intended Use: | KIMGUARD* Sterilization Wrap is intended to be used to enclose<br>another medical device that is to be sterilized by a health care provider<br>by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100%<br>ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/<br>55°C and 40% - 80% relative humidity for 60 minutes. The wrap is<br>intended to allow sterilization of the enclosed medical device(s) and<br>also to maintain sterility of the enclosed device(s) until opened. The<br>wrap was validated for aeration times for EtO sterilization of 8 hours at<br>55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for<br>pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and<br>300 and for dry times of 30 minutes for Models 400, 500, and 600.<br>KIMGUARD* Sterilization Wrap is not indicated for use for gravity<br>steam sterilization. |

See Wrap Model Recommendations on Page 3.

*MAY - 1 2009*

The KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, The KIMGUAHD Glonically are substantially equivalent to the KC400, RC300, and RO000) are oabstanding - Treations of Sterile Wraps

Page 1 of 3 - 510(k) Summary

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(K881471)

and the control control control control controllers and

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| Substantial<br>Equivalence: | The KIMGUARD* Sterilization Wrap is substantially equivalent to the<br>predicates in intended use, design, and materials. The predicate<br>devices were constructed of a three-layer laminate composed of a layer<br>of meltblown polypropylene bonded on both surfaces with a layer of<br>spunbonded polypropylene. The sheets of sterilization wrap are square<br>or rectangular fabric produced using a polypropylene three-layer SMS<br>(spunbond-meltblown-spunbond) process. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Testing: | KIMGUARD* Sterilization Wrap performance has been tested in<br>accordance with the applicable requirements recommended in<br>Premarket Notification [510(k)] Submissions for Medical Sterilization<br>Packaging Systems in Health Care Facilities; Draft Guidance for<br>Industry and FDA (March 7, 2002). Testing included biocompatibility<br>(i.e., irritation and sensitization) in compliance with the methods of ISO<br>10993, sterilant penetration, dry time, and physical integrity. The Wrap<br>has also been tested for the ability to maintain sterility of pack contents<br>after sterilization for up to 30 days under standard conditions. All<br>results of testing met acceptance criteria. |

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| | | | Table 1. Wrap Model Recommendations' |
|--|--|--|---------------------------------------|
|--|--|--|---------------------------------------|

| KIMGUARD*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|-------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example: towel<br>packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package<br>(for example:<br>standard linen packs) | 6 lbs | 2 huck towels (17"x 29")<br>2 fluid resistant U-drape (68"x109")<br>1 fluid resistant universal bar drape<br>(70" x 108") |
| KC300 | Light to Moderate<br>Weight Package (for<br>example: general use<br>medical instruments) | 9 lbs | For Pre-Vacuum Steam:<br>15 huck towels (17"x 29")<br>1 small fluid resistant drape (60"x 76")<br>5 lbs of metal mass<br>FOR EtO:<br>16 huck towels<br>2 fluid resistant large drapes (76"x100")<br>1 fluid resistant small drape (76"x60")<br>1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to Heavy<br>Weight Package (for<br>example: general use<br>medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 11 lbs of<br>metal mass |
| KC5003 | Heavyweight<br>Package (for<br>example: general use<br>medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>15 lbs of metal mass |
| KC6003 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 25 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>23 lbs of metal mass |

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The KC400, KC500, and KC500 model waps were validated for sterilianting overs with these model Intelling and RC600 model waps well validation in steriit ating in steriit atincently this oncles will these models. It is linen, and it is recommended to hot exceed 3 tos of normal resistant inemal of the mail of the mail.
recommended that the user not include fluid-resistant linens in KC400 mod fluid resistant materials has not been evaluated with these models.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kimberly-Clark Corporation C/o Ms. Lisa Peacock Scimed, Incorporated 172 Conductor Drive Dawsonville, Georgia 30534

Re: K082554

Trade/Device Name: KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 15, 2009 Received: April 17, 2009

Dear Ms. Peacock:

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.

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.

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.

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Page 2- Ms. Peacock

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runner
Susan Runner, D.D.S., M.A.

Susan Runner, D.D.S., MA Acting 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): _K082554

## Device Name: _ KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)

Indications for Use:

KIMGUARD* 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 2709E/1329C for 4 minutes or by 100% ethylene oxide (EtO) 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 EtO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 ℃. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500, and 600.

KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.

See Wrap Model Recommendations on Page 2.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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)

Shale A Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082554

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### Indications for Use

| Wrap Model Recommendations<br>KIMGUARD*<br>Sterilization Wrap<br>Models | Intended Loads | Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study | Descriptions of Loads Used in Sterility Maintenance Validation Study |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight Package (for example: towel packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package (for example: standard linen packs) | 6 lbs | 2 huck towels (17"x 29")<br>2 fluid resistant U-drape (68"x109")<br>1 fluid resistant universal bar drape (70" x 108") |
| KC300 | Light to Moderate Weight Package (for example: general use medical instruments) | 9 lbs | FOR Steam:<br>15 huck towels (17" x 29")<br>1 small fluid resistant drape (60" x 76")<br>5 lbs metal mass<br>FOR EtO:<br>16 huck towels<br>2 fluid resistant large drapes (76"x100")<br>1 fluid resistant small drape (76"x60")<br>1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to Heavy Weight Package (for example: general use medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 11 lbs of metal mass |
| KC5003 | Heavyweight Package (for example: general use medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 15 lbs of metal mass |
| KC6003 | Very Heavy Weight Package (for example: general use medical instruments) | 25 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 23 lbs of metal mass |

Individual results may differ due to factors such as variations in handling practices, wrepping techniques and holling methods individual riskuller the use of irregularly shaped contents, which may put added stress on the wap. Each healthcare Hesults may also differ do the abo of wrop model is most appropriate for each intended use.

Itality shulld delefthing for itself which wapped package contant weights indicated for each wrap model. Furthernes, it is If is recommended to not exceed the namun wapped package contact were whole were with and the mail of the Maria Maria National is recommended to not exceed the number, weight, and size of the weight of the weight the metal mass).
Sterilization Wraps (i.e.: the number and size of the fluid resistant l

Stenization Vriaps (i.e. the namber and size of the nailed for sterilant penetration with 3 lbs of non-fluid resistent linen, and it consemped that is recommented to not exceed 3 lbs of norther perfilms proles with bless model hit is recommended to recommended be is recommended to tot exceed 3 ibs of nor-libration of the model wrops, as use of such fluid resistent materials and not been evaluated with these models.