INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200

K052870 · Kimberly-Clark Corp. · NZP · Sep 29, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052870
• Device Name: INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
• Applicant: Kimberly-Clark Corp.
• Product Code: NZP · General, Plastic Surgery
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

INTEGUSEAL Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

Device Story

INTEGUSEAL Microbial Sealant; film-forming cyanoacrylate-based product; ready-to-use applicator. Applied to skin over standard surgical skin prep and under surgical drapes prior to incision. Polymerizes to form bond with skin; immobilizes bacteria; reduces risk of skin flora contamination during surgery. Used in clinical/surgical settings; applied by surgical staff. Compatible with standard skin preps, incise drapes, electro-surgical tools, defibrillation, and wound closure strips. Benefits patient by providing barrier against microbial migration into surgical site.

Clinical Evidence

Testing included in vitro microbial barrier testing and in vivo surgical incision microbial contamination testing. Device demonstrated compatibility with standard skin preparations, incise drapes, electro-surgical procedures, and wound closure techniques.

Technological Characteristics

Cyanoacrylate-based film-forming sealant. Ready-to-use applicator. Applied topically. Forms physical barrier upon polymerization. Compatible with standard surgical materials and incise drapes.

Indications for Use

Indicated for use following preoperative skin preparation and prior to surgical incision to reduce risk of skin flora 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

• Medical Development Concepts ACTI-Gard Antimicrobial Film (K000442)

Submission Summary (Full Text)

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K052870

## PREMARKET NOTIFICATION (510(K)) SUMMARY

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SEP 2 9 2006

| Submitted by: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 USA<br>Tel: [phone] |
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| Contact Person: | Tierney Norsted Ph.D., M.P.H.<br>Exec Vice President, Principal Advisor<br>Regulatory & Clinical Research Institute, Inc.<br>5353 Wayzata Blvd., Suite 505<br>Minneapolis, Minnesota 55416<br>952-746-8021<br>[e-mail] |
| Date of Summary: | September 14, 2006 |
| Device Trade Name: | INTEGUSEAL Microbial Sealant |
| Common or Usual Name: | Surgical Drape Accessory |
| Classification Name: | 878.4370 Surgical Drape Accessory |
| Predicate Device(s): | Medical Development Concepts ACTI-Gard Antimicrobial Film (K000442) |
| Device Description: | INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based<br>product provided in a ready-to-use applicator. The Sealant is intended to<br>be applied on the skin over commonly used surgical skin preparation<br>products with standard surgical draping prior to a surgical incision. Upon<br>polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria<br>and thereby reducing the risk of skin flora contamination throughout a<br>surgical procedure. |
| Indication for Use: | INTEGUSEAL Microbial Sealant is intended for use after typical<br>preoperative skin preparations, with standard surgical draping, and prior<br>to a surgical incision. The product is used to reduce the risk of skin flora<br>contamination throughout a surgical procedure. |
| Substantial Equivalence: | INTEGUSEAL is substantially equivalent to Medical Concepts<br>Development ACTI-Gard Antimicrobial Film. Both products are placed on<br>the skin following the application of standard surgical skin preparation<br>products and prior to surgical incision and are intended to reduce the risk<br>of skin flora contamination throughout a surgical procedure. |
| Substantial Equivalence<br>Testing Summary: | Testing demonstrating the substantial equivalence of INTEGUSEAL to<br>ACTI-Gard included in vitro microbial and other barrier testing as well as<br>in vivo surgical incision microbial contamination testing. |
| Other Testing Summary: | Significant testing was performed to demonstrate that INTEGUSEAL is<br>compatible with various surgical circumstances, including: |
| • | Is compatible with standard skin preparation products and with incise drapes |
| • | Is compatible with various surgical materials, tools and techniques, including electro-surgical and defibrillation procedures |
| • | Is compatible with various incisional closure techniques and products, including wound closure adhesion strips |

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*Registered Trademark of Kimberly-Clark Worldwide, Inc. or its affiliates. ©2005 KCWW. All rights reserved. 190061-00.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting community and connection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 9 2006

Medlogic Global, Limited C/O Dr. Tierney Norsted Executive Vice-President Regulatory & Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334

Re: K052870

Trade/Device Name: Integuseal Microbial Sealant Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: NZP Dated: August 3, 2006 Received: August 4, 2006

Dear Dr. Norsted:

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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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 – Dr. Norsted

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Clus

Chiu Lin, Ph.D. 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

K052870 510(k) Number:

Integuseal Microbial Sealant Device Name:

Integuseal Microbial Sealant is intended for use after Indications For Use: typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shila F. Murphy, MD 9/24/06

Jn-Off) on of Anesthesiology, General Hospital, ാന Control, Dental Devices

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Number: K 052870