SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive

K161011 · Adhezion Biomedical, LLC · MPN · Nov 8, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161011
• Device Name: SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
• Applicant: Adhezion Biomedical, LLC
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Nov 8, 2016
• Decision: SESE
• Submission Type: Traditional
• 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 containing 2-octyl cyanoacrylate and D&C Violet #2 colorant. It is supplied in three applicator formats: Teardrop (blister tray with sponge tip), Stylus, and Twist (plastic ampoule within sleeves with applicator tip). The device is applied topically by a clinician to hold skin edges together; it polymerizes in minutes to form a flexible, intact film. The adhesive acts as a physical barrier to microbial penetration while the film remains intact. It is intended for use in clinical settings for surgical and trauma wound closure. The anhydrous nature of the adhesive prevents bacterial growth within the film. The device benefits patients by providing a non-invasive method for wound approximation, potentially reducing the need for traditional sutures or staples in appropriate cases.

Clinical Evidence

No clinical data was conducted for this submission. The device relies on previously established biocompatibility and performance data from predicate devices. In vitro studies previously demonstrated the adhesive acts as a physical barrier to microbial penetration while the film remains intact.

Technological Characteristics

Monomeric 2-octyl cyanoacrylate liquid adhesive; low viscosity. Applicators: Teardrop (blister tray/sponge), Stylus/Twist (ampoule/sleeve). Sterilization: Electron beam or gamma irradiation (ISO 11137-2:2006) for adhesive; Ethylene oxide (ISO 11135-1:2008, ISO 11135-2:2008) for Stylus/Twist assembly. 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.

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)

Reference Devices

• SURGISEAL Stylus Topical Skin Adhesive (K130474, K140517)
• SURGISEAL Twist Skin Adhesive (K130474, K133963, K141215)
• SURGISEAL Topical Skin Adhesive (K123936, K130329, K140517)

Submission Summary (Full Text)

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

November 8, 2016

Adhezion Biomedical, LLC Richard Jones Regulatroy And Quality Assurance Consultant One Meridian Boulevard, Suite 1b02 Wyomissing, Pennsylvania 19610

Re: K161011

Trade/Device Name: Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: April 7, 2016 Received: April 11, 2016

Dear Mr. Richard 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## David Krause -S

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

Enclosure

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## Section 6: Indications for Use

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
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**Indications for Use**

| 510(k) Number (if known) | K161011 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SURGISEAL® Topical Skin Adhesive<br>SURGISEAL Stylus™ Topical Skin Adhesive<br>SURGISEAL Twist™ Topical Skin Adhesive |
| Indications for Use (Describe) | SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin<br>edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly<br>cleansed, trauma induced lacerations. |
| | SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures |

Type of Use (Select one or both, as applicable)

| <span style="display:inline-block; margin-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; margin-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | |
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## Section 7: 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: | |
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| Name | Adhezion Biomedical, LLC |
| Address | One Meridian Boulevard<br>Suite 1B02<br>Wyomissing, PA 19610 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment<br>Registration | 3006385287 |
| Name of contact<br>person | Richard Jones, Regulatory and Quality Assurance Consultant |
| Date prepared | November 3, 2016 |
| Name of Device(s): | |
| Trade or proprietary<br>names | SURGISEAL® Topical Skin Adhesive<br>SURGISEAL Stylus™ Topical Skin Adhesive<br>SURGISEAL Twist™ Topical Skin Adhesive |
| Common or usual<br>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<br>device(s) to which<br>equivalence is<br>claimed | SURGISEAL® Topical Skin Adhesive - K082993 |
| Reason for 510(k)<br>submission | Labeling change |
| Device Description | SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin<br>adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and<br>the colorant D&C Violet #2. It incorporates the Teardrop applicator that<br>consists of a thermoformed blister tray with a heat sealed lid with an<br>attached applicator sponge tip. The Stylus and Twist applicators contain<br>the identical adhesive formula and incorporate a plastic ampoule, which<br>houses the adhesive, contained within the double longer plastic sleeves<br>with an attached applicator tip. When SURGISEAL is applied to the skin<br>with these applicators, it polymerizes in minutes. |
| Indications for use | SURGISEAL is intended for topical applications only to hold closed easily<br>approximated skin edges of wounds from surgical incisions, including |
| | punctures from minimally invasive surgery, simple, thoroughly cleansed,<br>trauma induced lacerations.<br>SURGISEAL may be used in conjunction with, but not in place of, deep<br>dermal sutures. |
| Technological | The technological characteristics of SURGISEAL Topical Skin Adhesive |
| Characteristics | (K082993, K123936, K130329 & K140517), SURGISEAL Stylus Topical<br>Skin Adhesive (K130474 & K140517) and SURGISEAL Twist Skin<br>Adhesive (K130474, K133963, K141215) are identical. SURGISEAL<br>adhesive consists of a monomeric (2-octyl cyanoacrylate) liquid adhesive<br>formulation packaged in a single-use applicator. The device is a low<br>viscosity formulation to allow for varied layered applications of the<br>adhesive to the intended area and allow for either a single consistent intact<br>film thickness, continuous layer or two thin layers of the adhesive to the<br>wound area. |
| | SURGISEAL is used for topical applications only to hold closed, easily<br>approximated skin edges of wounds while maintaining wound<br>approximation. |
| | Due to the anhydrous property of the SurgiSeal adhesive, gram + and<br>gram - bacteria which become incorporated within the adhesive upon<br>application, are not expected to grow within the adhesive. |
| | <i>In vitro</i> studies have shown that SURGISEAL acts as a physical barrier to<br>microbial penetration as long as the adhesive film remains intact. |
| | Clinical studies were not conducted to demonstrate microbial barrier<br>properties and a correlation between microbial barrier properties and a<br>reduction in infection have not been established. |

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| Substantial<br>Equivalence | Biocompatibility: |
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| | Biocompatibility testing was previously conducted on the currently<br>marketed devices, SURGISEAL Teardrop (K082993), SURGISEAL<br>Stylus (K130474) and SURGISEAL Twist (K130474) per the<br>International Standard ISO-10993, "Biological Evaluation of Medical<br>Devices, Part 1: Evaluation and Testing”. The existing testing is deemed<br>supportive of the proposed labeled devices. Based on the results from<br>those studies, both proposed labeled devices are considered to be non-<br>toxic, non-irritating, non-sensitizing and biocompatible. No additional<br>biocompatibility testing is necessary as the subject devices are identical<br>those identified in K082993 and K130474. |
| | Sterilization and Shelf-Life |
| | SURGISEAL® Topical Skin Adhesive is terminally sterilized by electron<br>beam irradiation as well as by gamma irradiation; both in accordance with<br>ISO 11137-2:2006 |
| | SURGISEAL Stylus™ and SURGISEAL Twist™ Topical Skin Adhesives<br>are sterilized in accordance with the order of operation of the assembly.<br>The filled ampoule containing the adhesive is sterilized by gamma<br>irradiation in accordance with ISO 11137-2:2006. Then the finished bulk<br>applicator in the secondary packaging is sterilized by ethylene oxide in<br>accordance with ISO 11135-1:2008 and ISO 11135-2:2008. |
| | SURGISEAL has a 2 year shelf life. |