DEMETECH SILK NONABSORBABLE SUTURE

{0}------------------------------------------------ ## DEMETECH CORP 510(k) Summary of Safety and Effectiveness for 510 (k) No. KO23029 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. DemeTECH Corp (A)(1) Submitter's name: Submitter's address: 12119 SW 131 Ave. Miami, FL 33186 Submitter's telephone number: Mr. Luis Arguello, President Contact Person: Date Summary Prepared: September 7, 2002 - (2) Trade or proprietary device name: DemeTECH Silk Nonabsorbable Suture Common or usual name: Silk Nonabsorbable Surgical Suture Classification Name: Natural Nonabsorbable Silk Surgical Suture Panel: General and Plastic Surgery Class: II - (3) Legally marketed predicate device: Grams Silk Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No .: K003001) - (4) Subject device description: The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles. - (5) Subject device intended use: The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures. - (6) Performance data: The DemeTECH Silk Nonabsorbable Suture has been demonstrated as both equivalent to the predicate device and meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "HUMAN SERVICES - USA" are arranged in a circular pattern above the caduceus, and the word "DEPARTMENT" is arranged in a circular pattern below the caduceus. NOV 2 5 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DemeTECH Corporation Luis Arguello President 12119 SW 131 Avenue Miami, Florida 33186 Re: K023029 Trade/Device Name: DemeTech™ Silk Nonabsorbable Suture Regulation Number: 878.5030 Regulation Name: Natural nonabsorable silk surgical suture Regulatory Class: Class II Product Code: GAP Dated: September 7, 2002 Received: September 11, 2002 Dear Mr. Arguello: 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 {2}------------------------------------------------ Page 2 -- Mr. Luis Arguello 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. 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Parrott (c) Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health **Enclosure** {3}------------------------------------------------ ## DEMETECH CORP 510 (k) Premarket Notification DemeTECH Silk Nonabsorbable Suture ## C. Indications for use of the Device 510(k) Number): Not known K023029 Device Name: DemeTECH Silk Nonabsorbable Suture Indications for Use: The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures. (Please do not write below this line-continue on another page if needed) --- Concurrence of CDRH, Office of Device Evaluation (ODE) Muriaine C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K023029 Prescription Use X er-the-Counter Use (Per 21 CFR 801.109) Page 1 of 1 K023029