SURGISEAL TOPICAL SKIN ADHESIVE

K130474 · Adhezion Biomedical, LLC · MPN · May 31, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130474
• Device Name: SURGISEAL TOPICAL SKIN ADHESIVE
• Applicant: Adhezion Biomedical, LLC
• Product Code: MPN · General, Plastic Surgery
• Decision Date: May 31, 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 Stylus and Stylus Twist are sterile, single-use topical skin adhesives containing 2-octyl cyanoacrylate and D&C Violet #2 colorant. Device consists of a monomeric liquid adhesive in a plastic ampoule within an applicator sleeve. Stylus features a nylon fiber foam tip; Stylus Twist features an HDPE composition foam tip. Used by clinicians to hold closed skin edges of surgical or trauma wounds. Adhesive polymerizes in minutes upon skin contact. Modification from predicate involves applicator design (ampoule/sleeve materials) and increased volume (≥0.5 mL). Device provides wound closure support; does not replace deep dermal sutures.

Clinical Evidence

Bench testing only. No clinical data presented. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic and non-irritant status. Performance testing (flexibility, in-vitro wound closure, viscosity, set-time, purity, surface/linear coverage) demonstrated equivalence to predicate.

Technological Characteristics

Monomeric 2-octyl cyanoacrylate adhesive with D&C Violet #2. Applicator: LDPE/PP/Barex 210 ampoule, MDPE sleeve, nylon fiber (Stylus) or HDPE (Stylus Twist) foam tip. Volume ≥0.5 mL. Sterilization: Gamma irradiation (ISO 11137-2:2006) for ampoule; Ethylene oxide (ISO 11135-1:2008, ISO 11135-2:2008) for finished applicator. Shelf-life: 24 months.

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 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)
• DERMABOND NX (DERMABOND Advanced) (K100423)
• Derma+Flex QS (K101276)

Submission Summary (Full Text)

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K130474

Section 8: 510(k) Summary

MAY 3 1 2013

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<br>Registration | 3006385287 |
| Name of contact<br>person | Caridad Smith, Sr. Manager of Regulatory Affairs and Quality Assurance |
| Date prepared | May 28, 2013 |
| Name of Device(s): | |
| Trade or<br>proprietary name | SURGISEAL ® Stylus™ and Stylus Twist™ Topical Skin Adhesive |
| Common or usual<br>name | Device, Tissue Adhesive for Topical Approximation |
| Classification<br>name | Class II |
| Classification<br>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)<br>DERMABOND NX (DERMABOND Advanced ® - (K100423)<br>Derma+Flex QS (K101276) |
| Reason for 510(k)<br>submission | Modification to Currently Marketed Device |
| Device Description | SURGISEAL Stylus and Stylus Twist Topical Skin Adhesive are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip.<br><br>This Stylus applicator tray 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 only to |
| | hold closed easily approximated skin edges of wounds from surgical incisions,<br>including punctures from minimally invasive surgery, simple, thoroughly<br>cleansed, trauma induced lacerations.<br><br>SURGISEAL may be used in conjunction with, but not in place of, deep dermal<br>sutures. |
| Technological<br>Characteristics | The technological characteristics of SURGISEAL Stylus™ and Stylus Twist™<br>Topical Skin Adhesive are equivalent in performance to the predicate device<br>SURGISEAL Topical Skin Adhesive.<br><br>SURGISEAL product family consists of a monomeric (2-octyl cyanoacrylate)<br>liquid adhesive formulation packaged in a single-use applicator. The device is a<br>low viscosity formulation to allow for varied layered applications of the adhesive<br>to the intended area and allow for either a single thick, continuous layer or two<br>thin layers of the adhesive to the wound area.<br><br>SURGISEAL product family is used for topical applications only to hold closed<br>easily approximated skin edges of wounds.<br><br>The differences between the proposed devices SURGISEAL Stylus™ and Stylus<br>Twist ™ Topical Skin Adhesive; and the predicate devices are the following:<br>The currently marketed, SURGISEAL® Topical Skin Adhesive, single<br>use applicator consists of a thermal formed LDPE/PP/Polyacrylonitrile<br>(Barex 210) foil heated seal on a PET/Aluminum/Polyacrylonitrile backing<br>with attached Polyurethane foam with a PE Layer, which is supplied at a<br>volume of about 0.35 mL<br><br>The proposed devices SURGISEAL Stylus™ and Stylus Twist ™ Topical<br>Skin Adhesives, single-use applicator consists of a a thermal formed<br>LDPE/PP/Polyacrylonitrile<br>(Barex 210) adhesive<br>Ampoule with an Aluminum ampoule lid including a plastic inner layer<br>(seal). The applicator sleeve is MDPE, which are supplied at a volume of ≥<br>0.5mL.<br>The SURGISEAL Stylus has a Nylon fiber foam tip. The SURGISEAL Stylus Twist has a HDPE composition foam tip. |
| Substantial<br>Equivalence | Biocompatibility:<br><br>The biocompatibility testing of the adhesive, that was previously conducted to the<br>currently marketed device, SURGISEAL (K082993) per the International Standard<br>ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and<br>Testing" is deemed supportive of the proposed devices, SURGISEAL Stylus™<br>and Stylus Twist ™ Topical Skin Adhesive. Based on the lack of changes to the<br>formulation, there was no additional biocompatibility testing of the adhesive<br>conducted to support the requirements for biological evaluation of devices for the<br>prolonged exposure.. The following biocompatibility testing was performed on<br>the Stylus product(s): |

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| Biocompatibility Test | Test Description | Summary of<br>Results | Results |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------|---------|
| Cytotoxicity - (SURGISEALTM<br>Stylus Topical Skin Adhesive<br>Flock Tip (Lot James A)) | ISO 10993-Part<br>5 - Test for In-<br>Vitro<br>Cytotoxicity | No<br>Cytotoxic<br>Effect | PASS |
| Cytotoxicity - SURGISEALTM<br>Stylus TwistTM Topical Skin<br>Adhesive (Lot x 5923) | ISO 10993-Part<br>5 - Test for In-<br>Vitro<br>Cytotoxicity | No<br>Cytotoxic<br>Effect | PASS |
| ISO Intracutaneous Reactivity<br>Test - SecureSealTM (Lot<br>121512i) | ISO 10993-10:<br>Test for Irritation<br>and Skin<br>Sensitization | No Dermal<br>Reactions | PASS |
| Primary Skin Irritation<br>SecureSealTM - (Lot 121512i) | ISO 10993-10:<br>Test for Irritation<br>and Skin<br>Sensitization | No Dermal<br>Irritations | Pass |

Based on the results from those studies, the proposed devices are considered to be non-cytotoxic, and non-irritants.

## Performance Testing:

The following testing was performed on the proposed devices, SURGISEAL Stylus™ and Stylus Twist™ Topical Skin Adhesive is listed below:

- Flexibility �
- In-vitro wound closure .
- Viscosity
- Set-time .
- Purity
- Surface Coverage
- Linear Coverage

The performance testing identified above demonstrated that the applicator design modification to the currently marketed product does not impact the performance specification criteria identified for the SURGISEAL product family.

## Sterilization and Shelf-Life

The proposed devices, SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive are sterilized in accordance with the order of operation of the assembly. First to be sterilized is the filled ampoule containing the adhesive, by gamma irradiation in accordance with ISO 11137-2:2006. Then the finished bulk applicator in the secondary packaging is sterilized by ethylene oxide in accordance

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| with ISO 11135-1:2008 and ISO 11135-2:2008. |
|-------------------------------------------------------------------------------|
| The SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive does not |
| impact the 24 month (2 year) expiration date (shelf-life) proposed for these |
| products. Real-time and accelerated aging studies were performed using the |
| STYLUS products and they demonstrated the same performance characteristics as |
| the currently marketed, predicate device SURGISEAL Topical Skin Adhesive |
| (K082993). The proposed devices, SURGISEAL Stylus™ and Stylus Twist TM |
| Topical Skin Adhesive will be labeled with a two (2) year expiration date. |
| |

Based on extensive bench performance testing, the proposed devices SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive, in comparison to predicate device, SURGISEAL (K082993) have demonstrated to be safe and efficacious per the performance studies.

The order of operation of a two-part sterilization process of the proposed devices, SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive, is necessary in order to sterilize the product and achieve a 10 6 SAL, while supporting the labeling of the medical device as "sterile". In order to maintain the expected performance of the devices, in accordance with the currently marketed SURGISEAL device properties/specifications of the device SURGISEAL remains unaffected and therefore provides further assurance of substantial equivalence, as documented throughout the submission

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

### 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/ Quality Assurance One Meridian Parkway, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K130474

Trade/Device Name: SURGISEAL Stylus™ Topical Skin Adhesive and SURGISEAL Stylus Twist Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: May 07, 2013 Received: May 08, 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

May 31, 2013

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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 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/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours. FOR Peter D. Rumm -S

| | Mark N. Melkerson |
|--|------------------------------|
| | Acting Director |
| | Division of Surgical Devices |

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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## Section 5: Indications for Use

#### K130474 510(k) Number (if known): TBD

Device Name(s):

SURGISEAL Stylus™ Topical Skin Adhesive SURGISEAL Stylus Twist™ 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 Over-The-Counter Use

(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)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130474

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Abbreviated 510(k) Submission Adhezion Biomedical, LLC SURGISEAL® Topical Skin Adhesive Page 17 of 685