SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the date "APR 28 2014" in a bold, sans-serif font. The letters and numbers are uniformly sized and spaced. The date is likely printed or stamped onto a document or surface. Image /page/0/Picture/2 description: The image shows the logo for Adhezion Biomedical. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of curved lines that form a circular shape. The company name is written in a sans-serif font, with the word "Adhezion" in a larger font size than the word "Biomedical" which is written below it. ## 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 | (610) 241-7191 | | Fax Number | (610) 373-2081 | | Establishment<br>Registration | 3006385287 | | Name of contact<br>person | Richard Jones, Regulatory and Quality Assurance Consultant | | Date prepared | February 26, 2014 | | Name of Device(s): | | | Trade or proprietary<br>names | SURGISEAL® Topical Skin Adhesive<br>SURGISEAL Stylus™ 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, K123936, K130329)<br>SURGISEAL Stylus™ Topical Skin Adhesive (K130474)<br>Dermabond® Topical Skin Adhesive (P960052/S003)<br>Indermil™ Tissue Adhesive (P010002/S004)<br>LiquiBand® Flow Control (K122446) | | Reason for 510(k)<br>submission | Labeling Change to include Microbial Barrier description | | Device Description | SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid<br>skin adhesive containing a monomeric (2-octyl cyanoacrylate)<br>formulation and the colorant D&C Violet #2. It incorporates the<br>Teardrop applicator that consists of a thermoformed blister tray with a<br>heat sealed lid with an attached applicator sponge tip. The Stylus<br>applicator incorporates the identical adhesive formula but incorporates | | | the Stylus applicator that consists of a plastic ampoule, which houses<br>the adhesive, contained with the longer plastic sleeve within a longer<br>plastic sleeve with an attached applicator tip. When SURGISEAL is<br>applied to the skin with either Applicator, it polymerizes in minutes. | | | In vitro studies have shown that SURGISEAL acts as a physical barrier<br>to microbial penetration as long as the adhesive film remains intact.<br>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. | | Indications for use | SURGISEAL is intended for topical applications only to hold closed<br>easily approximated skin edges of wounds from surgical incisions,<br>including punctures from minimally invasive surgery, simple,<br>thoroughly cleansed, trauma induced lacerations.<br>SURGISEAL may be used in conjunction with, but not in place of, deep | | | dermal sutures. | | Technological<br>Characteristics | The technological characteristics of both SURGISEAL Topical Skin<br>Adhesive (K082993, K123936 & K130329) and SURGISEAL<br>STYLUS Skin Adhesive (K130474) are identical. SURGISEAL<br>adhesive consists of a monomeric (2-octyl cyanoacrylate) liquid<br>adhesive formulation packaged in a single-use applicator. The device is<br>a low viscosity formulation to allow for varied layered applications of<br>the adhesive to the intended area and allow for either a single consistent<br>intact film thickness, continuous layer or two thin layers of the adhesive<br>to the wound area. | | | SURGISEAL is used for topical applications only to hold closed, easily<br>approximated skin edges of wounds while maintaining wound<br>approximation. | | | In vitro studies have shown that SURGISEAL acts as a physical barrier<br>to microbial penetration as long as the adhesive film remains intact.<br>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. | | Substantial<br>Equivalence | Biocompatibility: | | | Biocompatibility testing was previously conducted on the currently<br>marketed devices, SURGISEAL Teardrop (K082993, K123936 &<br>K130329) and SURGISEAL Stylus (K130474) per the International<br>Standard ISO-10993, "Biological Evaluation of Medical Devices, Part<br>I : Evaluation and Testing". The existing testing is deemed supportive<br>of the proposed labeled devices. Based on the results from those<br>studies, both proposed labeled devices are considered to be non-toxic,<br>non-irritating, non-sensitizing and biocompatible. No additional | | biocompatibility testing was necessary as the subject devices are<br>identical those identified in K082993 and K130474. | | | <b>Performance Testing:</b> | | | Bench tests in this submission include: Microbial Barrier Tests and<br>Film Thickness determinations for each of the two applicators. | | | <b>Sterilization and Shelf-Life</b> | | | SURGISEAL® Topical Skin Adhesive is terminally sterilized by<br>electron beam irradiation as well as by gamma irradiation ; both in<br>accordance with ISO 11137-2:2006 | | | SURGISEAL Stylus™ Topical Skin Adhesive is sterilized in<br>accordance with the order of operation of the assembly. The filled<br>ampoule containing the adhesive is sterilized by gamma irradiation in<br>accordance with ISO 11137-2:2006. Then the finished bulk applicator<br>in the secondary packaging is sterilized by ethylene oxide in accordance<br>with ISO 11135-1:2008 and ISO 11135-2:2008. | | | The proposed labeling modification sterilization does not impact the 24<br>month (2 year) expiration date (shelf-life) proposed for these products<br>and will therefore remain to be labeled with a two (2) year expiration<br>date. | | {1}------------------------------------------------ {2}------------------------------------------------ The labeling change clarifies 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 devices, SURGISEAL Teardrop and SURGISEAL Stylus, have demonstrated to be safe & efficacious. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or protecting another person, or a bird-like figure. The symbol is composed of three curved lines that converge at the bottom. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOGG-G609 Silver Spring, MI) 20993-0002 April 28, 2014 Adhezion Biomedical, LLC Mr. Richard Jones Regulatory and Quality Assurance Consultant One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610 Re: K140517 Trade/Device Name: SURGISEAL™ Topical Skin Adhesive, SURGISEAL Stylus" Topical Skin Adhesive Regulation Number: 21 CFR 878,4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: February 26, 2014 Received: February 28, 2014 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 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 cither 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 {4}------------------------------------------------ Page 2 - Mr. Richard Jones device-related adverse events) (21 CFR 803); 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. 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 (800) 638-2041 or (301) 796-7100 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.lda.gov/MedicalDevices/Safety/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. for Sincercly yours, ## David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Section 7: Indications for Use 510(k) Number (if known): TBD K140517 Device Names: SURGISEAL® Topical Skin Adhesive SURGISEAL Stylus™ 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** Page 1 of Abbreviated 510(k) Submission SURGISEAL* Topical Skin Adhesive Adhezion Biomedical, LLC Page 7-1