SURGISEAL Topical Skin Adhesvie

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by flowing lines that resemble a ribbon or fabric. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 17, 2015 Adhezion Biomedical, LLC Ms. Tracy Lofgren Authorized Regulatory Consultant One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610 Re: K150866 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: June 17, 2015 Received: June 18, 2015 Dear Ms. Lofgren: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. For Sincerely yours. Joshua C. Nipper -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150866 Device Name SURGISEAL® Topical Skin Adhesive ### Indications for Use (Describe) 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 | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for Adhezion Biomedical. The logo consists of a stylized blue wave-like design on the left, followed by the company name "Adhezion" in a bold, sans-serif font. Below "Adhezion" is the word "BIOMEDICAL" in a smaller, sans-serif font, also in blue. # 510(k) Summary [In accordance with 21CFR 807.92] # Adhezion Biomedical, LLC SURGISEAL® Topical Skin Adhesive #### Submitter / 510(k) Holder 1. Adhezion Biomedical LLC One Meridian Boulevard, Suite 1B02 Wyomissing, PA 19610 Tel: 970.379.4707 Fax: 610.373.2081 | Contact Person: | Tracy Lofgren<br>Authorized Regulatory Consultant<br>Adhezion Biomedical, LLC | |--------------------|-------------------------------------------------------------------------------| | Date Prepared: | July 15, 2015 | | 2. Device Name | | | Proprietary Name: | SURGISEAL® Topical Skin Adhesive | | Common/Usual Name: | Device, Tissue Adhesive for Topical Approximation | | Classification: | Class II | | Regulation: | 21 CFR 878.4010 | | Product Code: | MPN | #### 3. Predicate Device Legally Marketed device to which equivalence is claimed: | Proprietary Name: | SURGISEAL® Topical Skin Adhesive | |-------------------|----------------------------------| | 510(k) Clearance: | K130329 | #### 4. Device Description Adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. When SURGISEAL is applied to the skin with the applicator, it polymerizes in minutes. In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. {4}------------------------------------------------ #### 5. Intended Use SURGISEAL 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. #### Reason for 510(k) Submission 6. Device modification to equivalent patient contacting material due to shift of supplier #### 7. Comparison of Technological Characteristics with Predicate The technological characteristics of the proposed and predicate devices are similar. SURGISEAL adhesive consists of a monomeric (2-octyl cyanoacrylate) liquid adhesive formulation packaged in a single-use applicator. The device is a low viscosity formulation to allow for varied layered applications of the adhesive to the intended area and allow for either a single consistent intact film thickness, continuous layer or two thin layers of the adhesive to the wound area. SURGISEAL is used for topical applications only to hold closed, easily approximated skin edges of wounds while maintaining wound approximation. In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. #### Performance Testing Summary 8. # Biocompatibility: Biocompatibility testing was conducted on the new applicator material per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". The tests included cytotoxicity, acute systemic injection, guinea pig maximization sensitization and intracutaneous irritation test. With regard to the entire device, biocompatibility testing was previously conducted on the currently marketed device, SURGISEAL Teardrop (K130329). # Performance Testing: Bench tests in this submission include Film Thickness determinations for new material component; as well as an assessment of flexibility, linear and surface coverage, set-time and viscosity and in vitro wound closure strength. Shelf life bench testing was also conducted. # Sterilization and Shelf-Life SURGISEAL® Topical Skin Adhesive is sterilized by ethylene oxide and gamma irradiation; both in accordance with ISO 11137-2:2006 Stability and shelf life were verified with the same acceptance criteria as the predicate. #### 9. Conclusion Based on extensive bench performance testing, the modified device, SURGISEAL Topical Skin Adhesive is substantially equivalent to the predicate.