LIQUIBAND ULTIMA, MODEL LB0004

K083531 · Medlogic Global , Ltd. · MPN · Feb 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083531
• Device Name: LIQUIBAND ULTIMA, MODEL LB0004
• Applicant: Medlogic Global , Ltd.
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Device Story

LiquiBand is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. Supplied in a single-patient-use 0.5g high-density polyethylene ampoule with a polypropylene applicator tip. Device functions by polymerizing upon contact with skin to bond approximated wound edges. Used by clinicians for topical skin closure; provides a protective barrier for simple incisions and lacerations. Benefits include efficient wound closure and potential reduction in scarring compared to traditional sutures in low-tension areas.

Clinical Evidence

Bench testing only. Comparative performance testing against Indermil Tissue Adhesive demonstrated equivalence in tensile strength (ASTM F2255-05, F2258-05, F2458-05), polymerization time, heat of polymerization, viscosity, hydrolytic degradation, applicator expression force, water vapor transmission rate, and chemical composition.

Technological Characteristics

Material: n-butyl-2-cyanoacrylate. Packaging: 0.5g high-density polyethylene ampoule with polypropylene applicator tip. Principle: Topical tissue adhesive polymerization. Standards: Tensile strength testing per ASTM F2255-05, F2258-05, F2458-05. Sterilization: Sterile.

Indications for Use

Indicated for closure of topical skin incisions (including laparoscopic) and trauma-induced lacerations in areas of low skin tension that are simple, cleansed, and have easily approximated edges. May be used with deep dermal stitches.

Regulatory Classification

Identification

A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b) *Tissue adhesive for non-topical use* —(1)*Identification.* A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.

Predicate Devices

• Indermil® Tissue Adhesive (P010002)

Submission Summary (Full Text)

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LiquiBand® Topical Skin Adhesive LB 0004 Traditional 510(k) Premarket Notification

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Page 5-1

Traditional 510(k) Premarket Notification

K083531

Page 1 of 2

5.0 TRADITIONAL 510(K) SUMMARY

Submitted by:
MedLogic Global, Ltd.
Western Wood Way
Langage Science Park
Plymouth, Devon, UK PL 5 BG

FEB 12 2009

Contact Person:
Tierney Norsted Ph.D., M.P.H.
Exec Vice President, Sr. Principal Advisor
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, Minnesota 55416
952-746-8021
[e-mail]

Date of Summary:
February 11, 2009

Device Trade Name:
LiquiBand® Topical Skin Adhesive

Product Code:
LB 0004

Common or Usual Name:
Topical Skin Adhesive

Classification Name:
Tissue Adhesive (21 CFR 878.4010)

Predicate Device(s):
Indermil® Tissue Adhesive (P010002)

Device Description:
LiquiBand Topical Skin Adhesive is a sterile, topical tissue
adhesive containing n-butyl-2-cyanoacrylate. LiquiBand Topical
Skin Adhesive is supplied in a single patient use 0.5g High
Density Polyethylene ampoule with polypropylene applicator tip.

Indication for Use:
LiquiBand Topical Skin Adhesive is indicated for the closure of
topical skin incisions including laparoscopic incisions, and
trauma-induced lacerations in areas of low skin tension that are
simple, thoroughly cleansed, and have easily approximated
edges. LiquiBand Topical Skin Adhesive may be used in
conjunction with, but not in place of, deep dermal stitches.

Substantial Equivalence:
LiquiBand Topical Skin Adhesive is substantially equivalent to
Indermil Tissue Adhesive (P010002) with regard to Indication
For Use, formulation, technology, target population, intended
application, mechanism of action and performance at achieving
their intended use.

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LiquiBand
Topical Skin Adhesive LB 0004
Traditional 510(k) Premarket Notification

### Substantial Equivalence Testing Summary:

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The following comparative testing demonstrated substantially equivalent performance between LiquiBand Topical Skin Adhesive and Indermil Tissue Adhesive:

Page 5-2

- Tensile strength (ASTM F2255-05, F2258-05, F2458-05) E
- Set (polymerization) time ■
- Heat of polymerization t
- Viscosity ■
- Hydrolytic degradation .
- Applicator expression force 트
- Water vapor transmission rate l
- GC Chemical Analysis 1

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 2 2009

MedLogic Global Ltd. % Tierney Norsted, Ph.D., M.P.H. Regulatory & Clinical Research Institute, Inc. 5353 Wayzata Blyd. Minneapolis, MN 55416

Re: K083531

Trade/Device Name: LiquiBand Tissue Adhesive Regulation Number: 21 CFR 878.4010 (a) Regulation Name: Tissue adhesive for topical approximation of skin Regulatory Class: II Product Code: MPN Dated: November 26, 2008 Received: November 28, 2008

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 either 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.

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.

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## Page 2 - Tierney Norsted, Ph.D., M.P.H.

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT 4.0

| 510(k) Number: | K083531 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | LiquiBand® Topical Skin Adhesive |
| Model Number: | LB 0004 |
| Indications For Use: | LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. |

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

Over-the-Counter Use: NO (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)

Marl A. Melleur

(Division Sign-Off) Division c.º General, Restorative, and Neurological Devices

**510(k) Number** K083531