LIQUIBAND ULTIMA, LUT 003

K100284 · Medlogic Global Limited · MPN · Apr 9, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100284
• Device Name: LIQUIBAND ULTIMA, LUT 003
• Applicant: Medlogic Global Limited
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Apr 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LiquiBand Ultima 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 Ultima topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Device Story

LiquiBand Ultima is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. Supplied in a single-patient-use dual-tip configuration. Applied topically by clinicians to hold closed skin edges of surgical incisions or trauma-induced lacerations. Polymerizes upon contact with skin to form a bond, providing wound closure. Used in clinical settings; intended for use alongside deep dermal stitches where necessary. Benefits include non-invasive wound closure for low-tension areas.

Clinical Evidence

Bench testing only. Comparative performance testing demonstrated equivalence to predicate device regarding tensile strength (ASTM F2255-05, F2258-05, F2458-05), set time, heat of polymerization, viscosity, and GC chemical analysis.

Technological Characteristics

Sterile n-butyl-2-cyanoacrylate topical tissue adhesive. Single-patient-use dual-tip applicator. Bench testing performed per ASTM F2255-05, F2258-05, and F2458-05 for tensile strength. No electronic components or software.

Indications for Use

Indicated for closure of easily approximated skin edges of surgical incisions (including laparoscopic) and simple, cleansed, trauma-induced lacerations. For use in conjunction with deep dermal stitches. Prescription use only.

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® LB 0004 (K083531)

Submission Summary (Full Text)

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K100284

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LiquiBand® Ultima
Traditional 510(k) Premarket Notification

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| 5.0 | TRADITIONAL 510(K) SUMMARY<br>APR - 9 2010 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | 17th March 2010 |
| Device Trade Name: | LiquiBand® Ultima |
| Product Code: | LUT 003 |
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Predicate Device(s): | LiquiBand® LB 0004 (K083531) |
| Device Description: | LiquiBand® Ultima is a sterile, topical tissue adhesive containing<br>n-butyl-2-cyanoacrylate. LiquiBand® Ultima is supplied in a<br>single patient use dual tip configuration. |
| Indication for Use: | LiquiBand® Ultima 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® Ultima may be used in conjunction with, but not in<br>place of, deep dermal stitches. |
| Substantial Equivalence: | LiquiBand® Ultima is substantially equivalent to LiquiBand<br>Topical Skin Adhesive (K083531) 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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K100284

LiquiBand® Ultima Traditional 510(k) Premarket Notification

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## Substantial Equivalence Testing Summary:

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

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 9 2010

MedLogic Global, Ltd. % Mr. Michael Browne Quality and Regulatory Affairs Manager Western Wood Way - Langage Science Park Plymouth, Devon, PL7 5BG, United Kingdom

Re: K100284

Trade/Device Name: LiquiBand® Ultima Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: March 17, 2010 Received: March 22, 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 he 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

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Page 2 - Mr. Michael Browne

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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Mark N. Melkerson

Mark N. Melk Director Division of Surgical, Orthopedic And Restorative 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: | K100284 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | LiquiBand® Ultima |
| Model Number: | LUT 003 |
| Indications For Use: | LiquiBand Ultima 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 Ultima topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches. |

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

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)

Daniel Kiane for MKM

(Division Sign-Off) (Division Sign-city), Orthopedic, and Restorative Devices

510(k) Number K100284

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