SURGISEAL TOPICAL SKIN ADHESIVE

K130329 · Adhezion Biomedical, LLC · MPN · Dec 3, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130329
• Device Name: SURGISEAL TOPICAL SKIN ADHESIVE
• Applicant: Adhezion Biomedical, LLC
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Dec 3, 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, heat-sealed lid, and attached sponge tip. The device is used by clinicians to hold closed easily approximated skin edges of surgical incisions and trauma-induced lacerations. Upon application to the skin, the monomer polymerizes within minutes to form a protective, adhesive bond. It serves as a topical closure method, potentially used alongside deep dermal sutures. The device is intended for professional use in clinical settings. The current submission supports a labeling change and the addition of a secondary terminal sterilization process (gamma irradiation) alongside the existing electron beam irradiation method.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was established through comparative bench testing against the predicate device, confirming that the modified device remains safe and efficacious.

Technological Characteristics

Monomeric 2-octyl cyanoacrylate formulation with D&C Violet #2 colorant. Low-viscosity liquid for layered application. Single-use applicator with sponge tip. Terminally sterilized via electron beam or gamma 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. May be used with deep dermal sutures. No specific age or gender restrictions noted.

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 Topical Skin Adhesive (K082993)
• Dermabond Advanced (K100423)

Submission Summary (Full Text)

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## Appendix 3: 510(k) Summary

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

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| 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<br>DEC 03 2013 |
| Name of contact person | Caridad Smith, Director of Regulatory Affairs and Quality Assurance |
| Date prepared | November 20, 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* Topical Skin Adhesive (K082993)<br>Dermabond Advanced (also known as DERMABOND NX Topical Skin<br>Adhesive - K100423) |
| Reason for 510(k) submission | Labeling Change and Sterilization method (Gamma) |
| Device Description | SURGISEAL® 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 Topical Skin Adhesive is intended for topical applications |
| | incisions, including punctures from minimally invasive surgery, simple.<br>thoroughly cleansed, trauma induced lacerations. |
| | SURGISEAL may be used in conjunction with, but not in place of, deep<br>dermal sutures. |
| 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<br>adhesive formulation packaged in a single-use applicator. The device is a<br>low viscosity formulation to allow for varied layered applications of the<br>adhesive to the intended area and allow for either a single thick, continuous<br>layer or two thin layers of the adhesive to the wound area. |
| | SURGISEAL is used for topical applications only to hold closed easily<br>approximated skin edges of wounds while maintain wound approximation. |
| Substantial<br>Equivalence | Biocompatibility: |
| | The biocompatibility testing that was previously conducted to the currently<br>marketed device, SURGISEAL (K082993) per the International Standard<br>ISO-10993, "Biological Evaluation of Medical Devices. Part 1: Evaluation<br>and Testing". The existing testing is deemed supportive of the proposed<br>labeled device, SURGISEAL. Based on the lack of changes conducted to<br>support the requirements for biological evaluation of devices for the<br>prolonged exposure. surface-contacting materials the biocompatibility test<br>method of the currently marketed product was the same. Based on the<br>results from those studies, the proposed labeled device is considered to be<br>non-toxic, non-irritating, non-sensitizing and biocompatible. |
| | Performance Testing:<br>The biocompatibility of SURGISEAL Topical Skin Adhesive modified<br>proposed label product is identical to the currently marketed product;<br>therefore the performance testing provided in the Premarket Notification<br>K082993 is the same. Additional bench testing was performed to support<br>the modification to the currently marketed product. |
| | Sterilization and Shelf-Life |
| | The modified labeled device is terminally sterilized by electron beam<br>irradiation, which is identical to the predicate device (K082993), as well as<br>by gamma irradiation; both in accordance with ISO 11137-2:2006. |

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| There is no impact on the labeling change from SURGISEAL 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 to have a two (2) year expiration date. |

...

The labeling changes attempts to clarify the performance of the device in order to characterize the ease. safety, or effective use of the product. Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be safe, efficacious per the performance studies.

The inclusion of a secondary irradiation sterilization process to terminally sterilize the SURGISEAL product is being included in order to support the labeling of the medical device as "sterile". The documentation presented in Appendices 1-5, of the important properties/specifications of the device SURGISEAL remain unaffected and therefore provides further assurance of substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2013

Adhezion Biomedical, L.L.C. Caridad Smith Senior Manager of Regulatory Affairs/Quality Assurance One Meridian Parkway, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K130329

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: October 29, 2013 Received: October 31, 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Caridad Smith

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Radiological Health

# Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

Enclosure

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#### Appendix 6: Revised Indications for Use Form

### Indications for Use

510(k) Number (if known): K130329

Device Name: SURGISEAL(R) 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 (Part 21 CFR 801 Subpart D)

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AND/OR Over-The-Counter Use

(21 CFR 807 Subpan C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130329

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