LIQUIBAND DUAL, MODEL LBD 001

K102076 · Medlogic Global Limited · MPN · Feb 18, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102076
• Device Name: LIQUIBAND DUAL, MODEL LBD 001
• Applicant: Medlogic Global Limited
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LiquiBand Dual topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Device Story

LiquiBand Dual is a sterile, topical tissue adhesive for wound closure. It utilizes a dual-applicator configuration containing n-butyl-2-cyanoacrylate for initial closure and a blend of 30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for subsequent over-layers. The device is applied topically by a clinician to hold skin edges together. It functions as a liquid adhesive that polymerizes to form a bond, providing a protective barrier for wound healing. It is intended for use in clinical settings for surgical incisions and trauma-induced lacerations.

Clinical Evidence

Bench testing only. Comparative testing against the predicate device included tensile strength (ASTM F2255-05, F2258-05, F2458-05), set (polymerization) time, heat of polymerization, viscosity, and GC chemical analysis.

Technological Characteristics

Topical tissue adhesive containing n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate. Supplied in a single-patient-use dual applicator. Testing performed per ASTM F2255-05, F2258-05, and F2458-05 for tensile strength.

Indications for Use

Indicated for closure of topical skin incisions (including laparoscopic) and simple, thoroughly cleansed, trauma-induced lacerations in areas of low skin tension with 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

• LiquiBand® Ultima (K100284)

Submission Summary (Full Text)

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| | K102076 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.0 | TRADITIONAL 510(K) SUMMARY<br>FEB 18 2011 |
| Submitted by: | MedLogic Global, Ltd.<br>Western Wood Way<br>Langage Science Park<br>Plymouth, Devon, UK PL 5 BG |
| Contact Person: | Michael Browne<br>Quality and Regulatory Affairs Manager<br>MedLogic Global, Ltd |
| Date of Summary: | 21st July 2010 |
| Device Trade Name: | LiquiBand® Dual |
| Product Code: | LBD 001 |
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Predicate Device(s): | LiquiBand® Ultima (K100284) |
| Device Description: | LiquiBand® Dual is a sterile, topical tissue adhesive containing<br>n-butyl-2-cyanoacrylate for initial wound closure and a blend of<br>30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for<br>subsequent over layers . LiquiBand® Dual is supplied in a single<br>patient use dual applicator configuration. |
| Indication for Use: | LiquiBand® Dual is indicated for the closure of topical skin<br>incisions including laparoscopic incisions, and trauma-induced<br>lacerations in areas of low skin tension that are simple,<br>thoroughly cleansed, and have easily approximated edges.<br>LiquiBand® Dual may be used in conjunction with, but not in<br>place of, deep dermal stitches. |
| Substantial Equivalence: | LiquiBand® Dual is substantially equivalent to LiquiBand Ultima<br>Topical Skin Adhesive (K100284) with regard to Indication For<br>Use, formulation, technology, target population, intended<br>application, mechanism of action and performance at achieving<br>their intended use. |

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K102076

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## Substantial Equivalence Testing Summary:

The following comparative testing demonstrated substantially equivalent performance between LiquiBand Dual and LiquiBand Ultima :

- Tensile strength (ASTM F2255-05, F2258-05, F2458-05) ..
- . Set (polymerization) time
- . Heat of polymerization
- . Viscosity
- GC Chemical Analysis .
- . Clinical Study

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the left. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MedLogic Global Limited % Mr. Michael Browne Quality and Regulatory Affairs Manager Western Wood Way Langage Science Park Plymouth, Devon, UK PL 5 BG

Re: K102076

FEB 18 201

Trade/Device Name: LiquiBand® Dual Regulation Number: 21 CFR 878.4010(a) Regulation Name: Tissue adhesive Regulatory Class: II Product Code: MPN Dated: December 21, 2010 Received: December 28, 2010

Dear Mr. Browne:

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.

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

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Page 2 - Mr. Michael Browne

or any Federal statutes and regulations administered by other l'ederal 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 tolloffre number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A. B. Ph
fr

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

Enclosure

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## KID2076 INDICATIONS FOR USE STATEMENT 4.0

510(k) Number:

- LiquiBand® Dual Device Name:
Model Number: LBD 001

Indications For Use: LiquiBand Dual topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiguiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Prescription Use: YES AND/OR Over-the-Counter Use: NO (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krasnobaev MXM

(Division Sion Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102076