KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM

K102666 · Kimberly-Clark Corp. · KKX · Nov 9, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102666
• Device Name: KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
• Applicant: Kimberly-Clark Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. These drapes meet the Level 4 requirements of the AAMI Liquid Barrier Classifications. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Device Story

Surgical drapes function as physical barriers to isolate surgical sites from microbial and other contamination. Constructed from multi-layer polypropylene laminates (spunbond/meltblown/spunbond base sheets; spunbond/meltblown/film or spunbond/film reinforcement fabrics). Treated for water repellency and static dissipation. Provided in various sizes/shapes, potentially including fluid collection pouches or clear film panels. Used in clinical settings (OR) to cover patients. Single-use, sterile or bulk non-sterile (for subsequent EtO sterilization). Provides protection to the patient by maintaining a sterile field and preventing fluid strike-through.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, primary skin irritation, sensitization) and performance testing for Level 4 liquid barrier compliance per ANSI/AAMI PB70:2003. All results met acceptance criteria.

Technological Characteristics

Base sheet: 3-layer polypropylene spunbond/meltblown/spunbond laminate. Reinforcement: spunbond/meltblown/film (CONTROL PLUS*) or spunbond/film (SURROUND*) laminates. Materials include polypropylene, surfactant, and blue pigment. Thermally embossed. Topically treated for water repellency and static dissipation. Complies with ANSI/AAMI PB70:2003 Level 4 liquid barrier performance.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during surgical procedures.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Kimberly-Clark* KC100 Surgical Drapes and Equipment Covers (K083234)

Submission Summary (Full Text)

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K102666

# 510(k) Summary for the Kimberly-Clark* Corporation
Surgical Drapes with AAMI Liquid Barrier Level 4 claim

| Date Summary was Prepared: | November 3, 2010 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV - 9 2010 |
| 510(k) Submitter: | Marcia Johnson, RAC<br>Technical Leader, Regulatory Affairs<br>Kimberly-Clark Health Care<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>Ph: 770.587.8566<br>FAX: [phone]<br>Email: [e-mail] |
| Primary Contact<br>for this 510(k)<br>Submission: | Marcia Johnson, RAC<br>Technical Leader, Regulatory Affairs<br>Kimberly-Clark Health Care<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>Ph: 770.587.8566<br>FAX: [phone]<br>Email: [e-mail] |
| Device Trade<br>Name: | Kimberly-Clark* Surgical Drapes |
| Device Common<br>names | Sterile surgical drapes |
| Device Product<br>Codes and<br>Classification<br>Names: | KKX Class II<br>Surgical Drapes (21 CFR 878.4370) |
| Predicate Devices | The predicate device for these Kimberly-Clark* Surgical Drapes<br>with AAMI Liquid Barrier Level 4 claim are the Kimberly-Clark*<br>surgical drapes cleared in premarket notification<br>K083234 KC100 Surgical Drapes and Equipment Covers. |
| Device<br>Description: | The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier<br>Level 4 claim are constructed with various base sheet and<br>reinforcement fabric types, provided in various sizes and shapes,<br>and may contain fluid collection pouches or clear film panels as<br>components. The base sheet fabric is a three layer laminate<br>comprised of polypropylene spunbond/polypropylene<br>meltblown/polypropylene spunbond. Layers are thermally<br>embossed together producing a single layer with various basis<br>weights. Fabric is topically treated to enhance water repellency<br>and to assure static dissipation. |

## Page 1 of 2 - Section 6. 510(k) Summary

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K102666

The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are either CONTROL PLUS*, a spunbond/meltblown/film laminate or SURROUND*, a spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Intended Use: Level 4 claim are devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. These drapes meet the Level 4 requirements of the AAMI Liquid Barrier Classifications.

> The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

## Technological Characteristics and Substantial Equivalence:

The Kimberly-Clark* Surgical Drape with AAMI Liquid Barrier Level 4 claim, that is subiect of this premarket notification is substantially equivalent to the predicate KC100 Surgical Drapes and Equipment Covers (K083234) in intended use, design and biocompatibility. The performance attributes of the Kimberly-Clark* Surgical Drape with AAMI Liquid Barrier Level 4 claim are substantially equivalent to the predicate drape. The key difference is the drapes subject of this submission have been tested for compliance to Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

Summary of In addition to performance testing in accordance with industry Testing: recognized test methods, these drapes have been tested for biocompatibility using cytotoxicity, primary skin irritation tests and sensitization testing. Additionally, the Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim were tested in compliance with the requirements of :

- · Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."
All results of testing met acceptance criteria.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is in a simple, sans-serif font and is horizontally oriented. The text is likely part of a document header or title, indicating the affiliation or subject matter related to health and human services.

Public Health Service

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

Kimberly-Clark Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

NOV - 9 2.0.0

Re: K102666

Trade/Device Name: Kimberly-Clark Surgical Drapes with AAMI Liquid Barrier Level 4 claim Model Numbers List Attached Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 14, 2010 Received: September 15, 2010

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. Ed 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 (OS) 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/Offices/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,

Jans Itodo

for

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):

Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim Device Name: Model Numbers List Attached

Indications for Use:

Kimberly-Clark* Corporation intends to market the sterile Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim meet the Level 4 requirements of the AAMI Liquid Barrier classifications.

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Prescription Use (Part 21 CFR 801 Subpart D) 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 Device Evaluation (ODE)

Elysabeth S. Clavie-Wallace

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

510(k) Number: K102666

Page 1 of 2

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# Indications for Use Model Number List

| Product Name | Model Number | | Drape Materials |
|-----------------------------------------|--------------|---------|---------------------------------------|
| | nonsterile | sterile | |
| Breast Drape | 79236 | 89236 | SMS base panel with SF reinforcement |
| Laparoscopic Abdominal<br>Drape | 79233 | 89233 | SMS base panel with SF reinforcement |
| EENT Split Drape | 79351 | 89352 | SMS base panel with SF reinforcement |
| Laparotomy Drape w/ Arm<br>Board Covers | 79228 | 89228 | SMS base panel with SMF reinforcement |
| Laparotomy Drape w/<br>Troughs | 79234 | 89234 | SMS base panel with SMF reinforcement |
| Laparotomy Drape | 79210 | 89211 | SMS base panel with SMF reinforcement |
| Cardiovascular Split Drape | 79451 | 89451 | SMS base panel with SMF reinforcement |
| Hip Drape | 79341 | 89341 | SMS base panel with SMF reinforcement |
| CVARTS* CV Incise Drape | 79466 | 89466 | SMS base panel with SMF reinforcement |
| ORTHOARTS* Hip Drape | 79346 | 89346 | SMS base panel with SMF reinforcement |
| ORTHOARTS* Lower<br>Extremity Drape | 79278 | 89278 | SMS base panel with SMF reinforcement |

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