SURGISEAL TOPICAL SKIN ADHESIVE

K123936 · Adhezion Biomedical, LLC · MPN · Apr 24, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123936
• Device Name: SURGISEAL TOPICAL SKIN ADHESIVE
• Applicant: Adhezion Biomedical, LLC
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Apr 24, 2013
• 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 used in conjunction with, but not in place of, deep dermal sutures.

Device Story

SURGISEAL is a sterile, liquid topical skin adhesive composed of monomeric 2-octyl cyanoacrylate and D&C Violet #2 colorant. It is supplied in a single-use applicator consisting of a thermoformed blister tray with a heat-sealed lid and an attached sponge tip. The device is applied topically by a clinician to hold closed skin edges of surgical incisions or trauma-induced lacerations. The low-viscosity formulation allows for either a single thick, continuous layer or two thin layers. The adhesive polymerizes to form a protective film over the wound. It is used in clinical settings to assist in wound approximation, potentially reducing the need for traditional sutures in superficial applications, though it is intended to be used in conjunction with deep dermal sutures when necessary.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included wound closure strength, set-time, linear coverage, film thickness, and tissue approximation time, demonstrating equivalence to predicate devices.

Technological Characteristics

Monomeric 2-octyl cyanoacrylate liquid adhesive with D&C Violet #2 colorant. Single-use applicator with sponge tip. Terminally sterilized via electron beam irradiation per ISO 11137-2:2006. Biocompatibility per ISO 10993.

Indications for Use

Indicated for topical closure of easily approximated skin edges of surgical incisions (including minimally invasive surgery punctures) and simple, thoroughly cleansed, trauma-induced lacerations. Contraindicated for use in place of 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

• SURGISEAL (K082993)
• Sure + Close and DERMA+FLEX QS (K101276)
• Dermabond Advanced (K100423)

Submission Summary (Full Text)

{0}------------------------------------------------

## Section 8: 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 is below:

·

| Submitter Information: | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Adhezion Biomedical, LLC |
| Address | One Meridian Boulevard<br>Suite 1B02<br>Wyomissing, PA 19610 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment Registration | 3006385287 |
| Name of contact person | Caridad Smith, Sr. Manager of Regulatory Affairs and Quality Assurance |
| Date prepared | April 23, 2013 |
| Name of Device: | |
| Trade or proprietary name | SURGISEAL® Topical Skin Adhesive |
| Common or usual name | Device, Tissue Adhesive for Topical Approximation |
| Classification name | Class II |
| Classification Panel | General and Plastic Surgery Devices |
| Regulation | Class II, under 21 CFR 878.4010 |
| Product Code(s) | MPN |
| Legally Marketed device(s) to which equivalence is claimed | SURGISEAL (K082993)<br>Sure + Close and DERMA+FLEX QS ( K101276)<br>Dermabond Advanced (K100423) |
| Reason for 510(k) submission | Labeling Change |
| Device Description | SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin<br>adhesive containing a monomeric (2-ocylt cyanoacrylate) formulation and the<br>colorant D&C Violet #2. Each applicator consists of a thermoformed blister<br>tray with a heat sealed lid with an attached applicator sponge tip. This<br>applicator tray with sponge tip is contained in an outer Tyvek pouch. |
| Indications for use | SURGISEAL Topical Skin Adhesive is intended for topical applications only<br>to hold closed easily approximated skin edges of wounds from surgical<br>incisions, including punctures from minimally invasive surgery, simple,<br>thoroughly cleansed, trauma induced lacerations.<br><br>SURGISEAL may be used in conjunction with, but not in place of, deep<br>dermal sutures. |

{1}------------------------------------------------

:

| | K123936 p |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The technological characteristics of SURGISEAL Topical Skin Adhesive are<br>equivalent in performance to the predicate device SURGISEAL Topical Skin<br>Adhesive. |
| | SURGISEAL consists of a monomeric (2-octyl cyanoacrylate) liquid adhesive<br>formulation packaged in a single-use applicator. The device is a low viscosity<br>formulation to allow for varied layered applications of the adhesive to the<br>intended area and allow for either a single thick, continuous layer or two thin<br>layers of the adhesive to the wound area. |
| | The main difference between proposed labeled SURGISEAL and currently<br>marketed SURGISEAL is to allow a single layer application. The proposed<br>labeled SURGISEAL will contain similar application language to the<br>following legally marketed predicate device(s): |
| | Sure + Close and DERMA+FLEX QS ( K101276)<br>Dermabond Advanced (K100423) |
| Substantial<br>Equivalence | Biocompatibility: |
| | Biocompatibility testing was previously conducted on the currently marketed<br>device, SURGISEAL (K082993) per the International Standard ISO-10993,<br>"Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".<br>The existing testing is deemed supportive of the proposed labeled device,<br>SURGISEAL. Based on the results from those studies, the proposed labeled<br>device is considered to be non-toxic, non-irritating, non-sensitizing and<br>biocompatible. No additional biocompatibility testing was necessary as<br>the subject device is identical to K082993. |
| | Performance Testing:<br>The biocompatibility of SURGISEAL Topical Skin Adhesive modified<br>proposed label product is identical to the currently marketed product; therefore,<br>the performance testing provided in the Premarket Notification K082993 is<br>identical. Additional bench testing was performed to support the modification<br>to the currently marketed product. Bench tests included: wound closure<br>strength, set-time, linear coverage, film thickness and tissue approximation<br>time. |
| | In all cases, the modified labeled SURGISEAL Topical Skin Adhesive met<br>specifications and demonstrated equivalence to the predicate device(s). |
| | Sterilization and Shelf-Life |
| | The modified labeled device is terminally sterilized by electron beam<br>irradiation in accordance with ISO 11137-2:2006, which is identical to the<br>predicate device (K082993). |
| | There is no impact on the labeling change from two light layer applications of<br>the topical skin adhesive to a single "thick, continuous" layer application of the |
| | |
| modified labeled device on the expiration date (shelf-life) of the product. | |
| Therefore an adoption of the current shelf-life for the predicate device can be | |
| assumed. The proposed device, SURGISEAL Topical Skin Adhesive will be | |
| labeled with a two (2) year expiration date. | |
| | |

{2}------------------------------------------------

Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol. The caduceus is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Adhezion Biomedical, LLC % Ms. Caridad Smith Sr. Manager of Regulatory Affairs and Quality Assurance One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610

Letter dated: April 24, 2013

Re: K123936

Trade/Device Name: SURGISEAL® Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: March 22, 2013 Received: March 25, 2013

Dear Ms. Smith:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

{4}------------------------------------------------

Page 2 - Ms. Caridad Smith

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 (OS) 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.

## Mark Nijelkerson -S

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

Enclosure

{5}------------------------------------------------

Section 5: Indications for Use

510(k) Number (if known): K123936

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 may be used in conjunction with, but not in place of, deep dermal sutures.

Prescription Use X

AND/OR

(Part 21 CFR 801 Subpart D)

(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)

JiyoungDang -S

Page 1 of

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123936

> K123936/S001 SURGISEAL Topical Skin Adhesive Page 78 of 166