GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER

{0}------------------------------------------------ KΨ3ϕ574 ## G 2 1 2003 510(k) SUMMA The Summary of Safety and Effectiveness on the GluSeal™ reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth. | Applicant: | Don Blacklock<br>GluStitch, Inc.<br>7188 Progress Way, #307<br>Delta, BC., V4G 1M6 | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Telephone: | (800) 667-2130 | | Facsimile: | (877) 450-4000 | | Date: | June 10, 2003 | | Name: | GluSeal™ | | Classification: | Liquid Adhesive Bandage, 21 CFR 880.5090 | | Predicate: | CLOSURE Medical Corporation's LIQUIDERM™ Liquid Adhesive<br>Bandage, K002338 – market clearance date, January 29, 2001. | | Description: | GluSeal™ is monomeric 2 octyl cyanoacrylate. This compound, which<br>exists in monomeric form in the plastic containers, polymerizes extremely<br>rapidly in the presence of anions, especially of hydroxyl ions (in the<br>presence of water).<br><br>GluSeal™ will be packaged in three different ways ranging from a<br>multiuse bottle containing 5 ml cyanoacrylate; a multiuse vial containing 1<br>ml cyanoacrylate, and a kit containing 12 x 0.2 ml disposable applicators.<br>Each of the multiuse kits will contain application pipettes and<br>administration dishes or administration trays. | | Intended Use: | GluSeal™ liquid adhesive bandage is intended to cover minor cuts,<br>scrapes, burns, and minor irritations of the skin and help protect them from<br>infection. | | Warnings: | • Do not apply GluSeal™ adhesive to the eye(s). If contact with the<br>eye(s) occurs, keep the eye(s) closed and covered, and immediately<br>contact an ophthalmologist. No attempt should be made to open the<br>eye(s). The adhesive will lose its adhesion over time, between one and<br>three days, and the eye(s) will open spontaneously with no damage.<br>• Do not use on infected areas, or wounds that are draining. | | Cautions: | • Do not use on mucosal surfaces (e.g., oral cavity, lips).<br>• Do not use if hypersensitive to cyanoacrylate. | | Intended Use and<br>Chemical<br>Characteristic: | The intended use and chemical structure of the GluStitch, Inc.'s GluSeal™<br>and CLOSURE Medical Corporation's LIQUIDDERM™ are equivalent. | {1}------------------------------------------------ Image /page/1/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 an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. AUG 2 1 2003 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Don Blacklock President GluStitch, Inc. 7188 Progress Way, #307 Delta, British Columbia V4G 1M6 Canada Re: K030574 Trade/Device Name: GluSeal™ Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: June 10, 2003 Received: June 11, 2003 Dear Mr. Blacklock: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {2}------------------------------------------------ Page 2 - Mr. Don Blacklock This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. to Mark N. Melberon Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | 510(k) Number (if known): | K434574 | |---------------------------|----------| | Device Name: | GluSeal™ | Indications For Use: GluSeal™ liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | for | |---------------|-----------------------------------------------------------| | | (Division Sign-Off) | | | Division of General. Restorative and Neurological Devices | | 510(k) Number | K030574 | | Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter-Use | |------------------------------------------|-------------------------| |------------------------------------------|-------------------------| (Optional Format 1-2-96) (Optional Format 1-2-96) 1 / 008A