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.

Device Description

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are constructed with various base sheet and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene meltblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation.

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.

AI/ML Overview

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim were evaluated through performance testing to ensure compliance with the "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.'"

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003	All results of testing met acceptance criteria.
Biocompatibility (cytotoxicity, primary skin irritation, and sensitization tests)	All results of testing met acceptance criteria.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set or the country of origin for the data. The testing was described as "performance testing in accordance with industry recognized test methods" and "biocompatibility using cytotoxicity, primary skin irritation tests and sensitization testing." This suggests a prospective testing methodology performed specifically for the device's premarket notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the submitted document. The ground truth for this medical device (surgical drapes) is established through standardized performance tests and material biocompatibility tests, not through expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as those with medical imaging. For the performance of surgical drapes, the results are determined by objective laboratory tests against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device in question is a surgical drape, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical product (surgical drape), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective performance standards and material safety requirements. Specifically:

Performance: Adherence to "Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003".
Biocompatibility: Results from cytotoxicity, primary skin irritation, and sensitization tests.

8. The sample size for the training set:

This information is not applicable. Surgical drapes are not developed or evaluated using machine learning algorithms that require training sets. The "training" of such a device involves product design, material selection, and manufacturing processes, followed by validation through standardized physical and biological testing.

9. How the ground truth for the training set was established:

This information is not applicable as there is no "training set" in the context of an AI algorithm for this type of medical device. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards (like ANSI/AAMI PB70: 2003) and regulatory requirements for material biocompatibility and safety.

Summary

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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, RACTechnical Leader, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8566FAX: 920.380.6351Email: Marcia.johnson@kcc.com
Primary Contactfor this 510(k)Submission:	Marcia Johnson, RACTechnical Leader, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8566FAX: 920.380.6351Email: Marcia.johnson@kcc.com
Device TradeName:	Kimberly-Clark* Surgical Drapes
Device Commonnames	Sterile surgical drapes
Device ProductCodes andClassificationNames:	KKX Class IISurgical Drapes (21 CFR 878.4370)
Predicate Devices	The predicate device for these Kimberly-Clark* Surgical Drapeswith AAMI Liquid Barrier Level 4 claim are the Kimberly-Clark*surgical drapes cleared in premarket notificationK083234 KC100 Surgical Drapes and Equipment Covers.
DeviceDescription:	The Kimberly-Clark* Surgical Drapes with AAMI Liquid BarrierLevel 4 claim are constructed with various base sheet andreinforcement fabric types, provided in various sizes and shapes,and may contain fluid collection pouches or clear film panels ascomponents. The base sheet fabric is a three layer laminatecomprised of polypropylene spunbond/polypropylenemeltblown/polypropylene spunbond. Layers are thermallyembossed together producing a single layer with various basisweights. Fabric is topically treated to enhance water repellencyand to assure static dissipation.

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

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K102666

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 (800) 638-2041 or (301) 796-7100 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:

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 AbdominalDrape	79233	89233	SMS base panel with SF reinforcement
EENT Split Drape	79351	89352	SMS base panel with SF reinforcement
Laparotomy Drape w/ ArmBoard Covers	79228	89228	SMS base panel with SMF reinforcement
Laparotomy Drape w/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* LowerExtremity Drape	79278	89278	SMS base panel with SMF reinforcement

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
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.(b)
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.