AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE

{0}------------------------------------------------ FEB - 6 2012 arket Notification #### Page 1 of 2 KIII 459 Histoacryl and Histoacryl Blue Image /page/0/Picture/3 description: The image shows a close-up of a document with some text. The text "510" is visible at the top of the image. The letter "B" is also visible in the image. # 510(k) SUMMARY (as required by 21 CFR 807.92) (K) SChildren - Propical Skin Adhesive Topical Skin Adhesive Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive Topical Skin Address July 7, 2011 July 7, 2011 MPANY: Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Center Valley, PA 16654 Establishment Registration Number: 2916714 CONTACT: Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) 610-731-055xy@aesculap.com Aesculap Histoacryl and Histoacryl Blue TRADE NAME: Topical Skin Adhesive COMMON NAME: CLASSIFICATION NAME: Tissue adhesive Regulation Number: 878.4010 MPN PRODUCT CODE: ### DEVICE DESCRIPTION DEVICE DESCRIPTION Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives composed of n-Histoacryl and Histoacryl Blue are sterile liquid toplaars are different in only one respect: butyl-2-cyanoacrylate monomer. The two products are different in only one respe Histoachy and History of the two products are different in only one the dye Histoacryl is provided as a ooloress liquid, and Histoacry Blue is colored with a bith a oyal as a colorless liquid, and filstoachyr black on the device during application. Histoacryl is provided as a colorless liqualization of the device during and Fistoachy is provised in athesives are supplied in 0.5 ml single patient D&C Violet #2 with intent to ease visualization of the extent of the D&C Tiber in This Market of the Supplied in ols of supplied in one of the extern of the extern of the extern of the extern of the extern of the extent of the lead History and Richard Justices remain liquid until exposed to water use plastic ampoules . Each tissue adhesives remain liquid until exposed to water ampoule can remain steries use, passes ampediation in the . Both tissue, after which it cures (polyments) ampoule can remain sterile, Both tissue, after which it cures (polymerizes) and or water-cont or water-containing substantees into ### INDICATIONS FOR USE INDICATIONS FOR USE Histoacryl and Histoacryl Blue topical skin adhesives are intended for topicalion Histoacryl and Histoacryl Blue topical skin edges of minimum-tension wounds from clean to hold closed easily approximated skin edges of minimum-induced lacerations. to hold closed easily approximated skin edges of trauma-induced lacerations. surgical incisions and simple, thoroughly cleansed, trauma-induced in place to her besting and simple, thoroughly cleansed, trauna industrial with, but not in place of, dermal sutures. 0003 {1}------------------------------------------------ ### KIII959 Histoacryl and Histoacryl Blue Page 2 of 2 ### ANTIAL EQUIVALENCE SUBSINANIA Believes that the Histoacryl and Histoacryl Blue Topical Skin Adhesive is Aliana Mather Maddiet Medictions of and Histocoryl Blue Topical Skin Adhesive, Tissue ുട്ടേയ്മ്മ, lnc. believes that the Histoacryl and Histoachyl Blue Topical Skin Adhesive, Tissue reubstantially equivalent to Histoacryl and Histoacryl Blue Topical Skin Adhe ally equivalent (0 ... The only difference is the packaging. R ## PUPPOSE FOR PREMARKET NOTIFICATION and if The purpose of this submission is to gain marketing clearance for Histoacryl and The purpose of Topical Skin Adhesive. ## TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)} The Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive is equivalent in The Aesculap Histoacryl and Filstoacryl and Histoacryl Blue Topical Skin Adhesive, performance to the predicate device Histoacryl and Histoaryl ond Histoary/ Blue performance to the predicate Gevice Pinstoury and Histoacyl and Histoacyl Blue Tissue Seal LLC (P050013). The main difference between Histoacryl Blue I Issue Seal LLO (r 0500 10). The main amore within an aluminum pouch. ### PERFORMANCE DATA Testing was performed in accordance to FDA's Class II Special Control Cuidance Testing was penomied in accordance to T brical Approximation of Skin to demonstrally Document for Tissue Adnesive for the Topical Skin Adhesive is substantially that the Aesoulap I hotodory. and inst. The following testing was performed: - Tensile strength (ASTM F2458-05) . - Set (polymerization) time . - Viscositv . - GC Chemical Analysis ● {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 FEB - 6 2012 Aesculap, Inc. % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K111959 Trade/Device Name: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: February 02, 2012 Received: February 03, 2012 Dear Ms. Racosky: 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 {3}------------------------------------------------ Page 2 - NAME 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/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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure . {4}------------------------------------------------ ### KIII959 Histoacryl and Histoacryl Blue Page 1 of 1 ### INDICATIONS FOR USE STATEMENT KIII959 510(k) Number:_ harket Notification ## Defice Name: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive Histoacryl and Histoacryl Blue topical skin adhesives are intended for topical application Histoacryi and filefoury. Dias toploskin edges of minimum-tension wounds from clean to nota olders only of thoroughly cleansed, trauma-induced lacerations. surglour including to the may be used in conjunction with, but not in place of, dermal sutures. X Prescription Use (per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Keane In Nixon (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K111959