DEMETECH NYLON NONABSORBABLE SUTURE

{0}------------------------------------------------ ## JUN 1 8 2003 510(k) Summary of Safety and Effectiveness ECH CORP for 510 (k) No. KO23028 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. | (A)(1) Submitter's name: | DemeTECH Corp | |--------------------------|--------------------------------------| | Submitter's address: | 12119 SW 131 Ave.<br>Miami, FL 33186 | Submitter's telephone number: (305) 251-2700 Contact Person: Mr. Luis Arguello, President Date Summary Prepared: September 7, 2002 - (2) Trade or proprietary device name: DemeTECH Nylon Nonabsorbable Suture Common or usual name: Nylon Nonabsorbable Surgical Suture Classification Name: Nonabsorbable Polyamide Surgical Suture Panel: General and Plastic Surgery Class: II - (3) Legally marketed predicate device: Grams Nylon Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No.: K003000) - (4) Subject device description: The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture. - (5) Subject device intended use: The DemeTECH Nylon 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 Nylon 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing right, stacked on top of each other, creating a sense of depth and unity. Public Health Service JUN 1 8 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Luis Arguello President DemeTECH Corporation 12119 SW 131 Avenue Miami, Florida 33186 Re: K023028 Trade/Device Name: DemeTECH Nylon Nonabsorbable Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: April 25, 2003 Received: May 8, 2003 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 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. Luis Arguello 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost 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}------------------------------------------------ ## DEMETECH CORP ## 510 (k) Premarket Notification DemeTECH Nylon Nonabsorbable Suture ## C. Indications for use of the Device Page 1 of 1 510(k) Number): Not known K023028 DemeTECH Nylon Nonabsorbable Suture Device Name: Indications for Use: The DemeTECH Nylon 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) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K0 23028 Prescription Use_X (Per 21 CFR 801.109) or Over-the-Counter Use 3