← Product Code [MPN](/submissions/SU/subpart-e%E2%80%94surgical-devices/MPN) · K152096 # DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive (K152096) _ETHICON, Inc. · MPN · Oct 22, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MPN/K152096 ## Device Facts - **Applicant:** ETHICON, Inc. - **Product Code:** [MPN](/submissions/SU/subpart-e%E2%80%94surgical-devices/MPN.md) - **Decision Date:** Oct 22, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4010 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use DERMABOND ADVANCED™ Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. High viscosity DERMABOND® Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High viscosity DERMABOND® Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. ## Device Story Sterile, liquid topical skin adhesive; monomeric 2-octyl cyanoacrylate formulation with D & C Violet No. 2 colorant. Provided in single-use pen-style or vial-based applicators containing a crushable ampoule. Applied topically by clinician to wound edges; syrup-like viscosity prevents migration; polymerizes within minutes to form a protective film. Acts as a microbial barrier while adhesive remains intact. Used in surgical or clinical settings for wound approximation. Benefits include secure closure of skin edges and microbial barrier protection. No software or electronic components. ## Clinical Evidence No clinical data presented. Substantial equivalence based on identical technological characteristics to predicate devices. Microbial barrier properties supported by in vitro studies. ## Technological Characteristics Monomeric 2-octyl cyanoacrylate adhesive with D & C Violet No. 2. Syrup-like viscosity. Single-use applicator with crushable glass ampoule in plastic housing. Sterile. No electronic or software components. ## Regulatory 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 - DERMABOND ADVANCED™ Topical Skin Adhesive ([K100423](/device/K100423.md)) - High Viscosity DERMABOND® Mini Topical Skin Adhesive ([P960052](/device/P960052.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 22, 2015 Ethicon Incorporated Ms. Donna Marshall Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876 Re: K152096 Trade/Device Name: DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: July 27, 2015 Received: July 28, 2015 Dear Ms. Marshall: 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 {1}------------------------------------------------ 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 (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/Resourcesfor You/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, # David Krause -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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K152096 Device Name DERMABOND Advanced™ Topical Skin Adhesive #### Indications for Use (Describe) DERMABOND ADVANCED™ Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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." # Page 15 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) #### K152096 Device Name High Viscosity DERMABOND® Mini Topical Skin Adhesive #### Indications for Use (Describe) High viscosity DERMABOND® Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High viscosity DERMABOND® Adhesive may be used in conjunction with. but not in place of, deep dermal stitches. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ 510(k) Change Being Effected DERMABOND Advanced Topical Skin Ad And DERMABOND Mini Topical Skin Adhesive Ethicon. Inc. K152096 Page 1 of 3 PART OF THE JOHNSON&JOHNSON FAMILY OF COMPANIES # 510(k) Summary ## Submitter: Ethicon, Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151 USA Contact Person: Donna Marshall Manager, Regulatory Affairs Ethicon, Inc. a Johnson & Johnson company Ph: (908) 541-3990 Fax: (908) 218-2595 e-mail: dmarsha2@its.jnj.com Date Prepared: July 27, 2015 DERMABOND ADVANCED™ Topical Skin Adhesive and Device Trade Name: High Viscosity DERMABOND® Mini Topical Skin Adhesive Device Common Name: Topical Skin Adhesive Class: II Tissue Adhesive for the Topical Approximation of Skin (21 CFR 878.4010) Product Code: Classification Name: MPN | Predicate Device | 510(k) Number | |------------------------------------------------------|---------------| | DERMABOND ADVANCED™ Topical Skin Adhesive | K100423 | | High Viscosity DERMABOND® Mini Topical Skin Adhesive | P960052 | {5}------------------------------------------------ # Device Description DERMABOND ADVANCED™: DERMABOND ADVANCED™ Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided as a single-use applicator in a blister package. The pen style applicator is composed of a crushable ampoule contained within a plastic applicator. As it is applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Studies have shown that following application, DERMABOND ADVANCED™ Adhesive acts as a barrier to prevent microbial penetration as long as the adhesive remains. # Device Description High Viscosity DERMABOND® Mini Topical Skin Adhesive: High viscosity DERMABOND® Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single-use applicator packaged in a blister pouch. The applicator is composed of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. In vitro studies have shown that high viscosity DERMABOND® Adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties. High viscosity DERMABOND® Adhesive is different from the regular, or low viscosity DERMABOND® Adhesive due to the increased viscosity of the liquid adhesive formulation. Low viscosity DERMABOND® Adhesive has a viscosity slightly greater than water, while high viscosity DERMABOND® Adhesive has a syrup-like viscosity. The increased viscosity of high viscosity DERMABOND® Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. # Indications for Use DERMABOND ADVANCED: DERMABOND ADVANCED™ Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. # Indications for Use High Viscosity DERMABOND® Mini Topical Skin Adhesive: High viscosity DERMABOND® Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High viscosity DERMABOND® Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. {6}------------------------------------------------ # Summary of Technological Characteristics: DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (Instructions for Use) that have been revised to add a contraindication, as well as other clarifications to ensure safer, more effective use of the device. # Substantial Equivalence: DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (Instructions for Use) that have been revised to add a contraindication, as well as other clarifications to ensure safer, more effective use of the device. #### Conclusion: DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are considered to be substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MPN/K152096](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MPN/K152096) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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