SURGISEAL TOPICAL SKIN ADHESIVE

K082993 · Adhezion Biomedical · MPN · Dec 19, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082993
• Device Name: SURGISEAL TOPICAL SKIN ADHESIVE
• Applicant: Adhezion Biomedical
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SurgiSeal 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, simple, thoroughly cleansed, trauma induced lacerations. SurgiSeal may be sued in conjunction with, but not in place of, deep dermal sutures.

Device Story

SurgiSeal is a sterile, liquid topical skin adhesive composed of 2-octyl cyanoacrylate and D&C Violet #2 colorant. Supplied in a thermoformed blister tray with an attached applicator sponge tip, the device is intended for professional use to close skin wounds. Upon application to the skin, the monomeric formulation polymerizes within minutes to form a protective bond. It serves as an alternative or adjunct to traditional wound closure methods like sutures for superficial skin approximation. The device is used in clinical settings to facilitate wound healing; the formulation's moisture vapor transmission properties are designed to support faster healing compared to predicate devices.

Clinical Evidence

Bench testing only. Performance evaluated per Class II Special Controls Guidance Document. Comparative bench tests against Dermabond showed comparable results. Moisture Vapor Transmission Rate testing indicated higher transmission of moisture and oxygen, suggesting potential for faster healing.

Technological Characteristics

Active ingredient: 2-octyl cyanoacrylate; Colorant: D&C Violet #2. Form factor: Liquid adhesive in thermoformed blister tray with sponge tip applicator. Sterilization: Sterile. Biocompatibility: ISO 10993 compliant. Adhesion: ASTM standardized testing.

Indications for Use

Indicated for topical closure of easily approximated skin edges of surgical incisions (including minimally invasive surgery punctures) and simple, cleansed, trauma-induced lacerations. May be used adjunctively with deep dermal sutures.

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

• Dermabond High Viscosity Topical Skin Adhesive

Submission Summary (Full Text)

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DEC 1 9 2008

## KO82993 Premarket Notification Summary

Submitted by: Adhezion Biomedical 506 Pine Mountain Road Hudson, NC 28638

Phone: [phone]

Contact Person: Richard G. Jones Sr. Vice President Phone: [phone] Email: [e-mail]

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Date of Summary: October 3, 2008

Device Trade Name: SurgiSeal Topical Skin Adhesive

Common or Usual Name: Topical Skin Adhesive

Classification Name: Tissue Adhesive Product Code: MPN

Predicate Device: Dermabond High Viscosity Topical Skin Adhesive

Device Description: SURGISEALTM Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.

When SURGISEAL is applied to the skin, it polymerizes in minutes.

Indications for Use: SURGISEAL is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

> SURGISEAL may be sued in conjunction with, but not in place of, deep dermal sutures.

Substantial Equivalence: SurgiSeal is substantially equivalent to Dermabond. Both use the same active ingredient, 2-Octyl Cyanoacrylate, equivalent in the ASTM Standardized Tests for Adhesion, ISO10993 Biocompatibility Tests for Safety and Animal Test for effect on healing.

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082993

Other Testing: SurgiSeal was evaluated in tests to establish a performance profile in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. The Bench Tests, with Dermabond as control, showed results comparable. One test, Moisture Vapor Transmission Rate, showed higher results which suggest greater transmission of moisture and oxygen to the wound that has the potential to provide a faster healing rate.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Adhezion Biomedical % Mr. Richard G. Jones Senior Vice President 506 Pine Mountain Road Hudson, North Carolina 28638

DEC 1 9 2008

Re: K082993

Trade/Device Name: SurgiSeal™ Topical Skin Adhesive Regulation Number: 21 CFR 878,4010 (a) Regulation Name: Tissue adhesive for topical approximation of skin Regulatory Class: II Product Code: MPN Dated: October 3, 2007 Received: October 7, 2007

Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Iisting 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 - Mr. Richard G. Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) promarket 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 vours.

Mark N. Mullens

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

510{k} Number (if known); K082993

Device Name: SurgiSeal ™Topical Skin Adhesive

Indications For Use: SurgiSeal ™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, simple, thoroughly cleansed, trauma induced lacerations.

> SurgiSeal ™Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

ਮ Prescription Lise (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)

Mark A Milkim

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(Division Sign-Off) Division of General, Restor and Neu

510(k) Number