NYLON SUTURE

{0}------------------------------------------------ Page 3 of 23 Phone : +91 - 452 - 535573 or 537580 : +91 - 452 - 535274 or 530984 Fax E-mail : aurolab@aurolab.com # 510(K) Summary K\$\phi\$24049\$\,\phi\$ (1 of 2) This summary of 510 (k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. The assigned 510 (k) number is: ### Applicant: FEB 2 8 2003 Aurolab. Aravind Eye Hospital, LAICO Building, 72 KK Salai, Gandhi Nagar, Madurai – 625020, India. Tel: 91 - 452 - 535573 Fax: 91 - 452 - 535274 Email: aurolab@aurolab.com bala@aurolab.com ### Contact Person: | In India | In United States | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Dr.P.Balakrishnan,<br>Managing Director,<br>Aurolab,<br>Aravind Eye Hospital<br>LAICO Building<br>72 KK Salai,<br>Gandhi Nagar,<br>Madurai - 625020,<br>India. | U.S.Representative:<br><br>Michael G. Price<br>President,<br>Visionary Medical Supplies, Inc.<br>6441 Enterprise Lane, Suite 214<br>Madison, WI 53719 | | Tel: 91 - 452 - 535573 | Phone: 608-270-3880 | | Fax: 91 - 452 - 535274 | Fax: 608-270-3882 | | Email: aurolab@aurolab.com<br>bala@aurolab.com | Email: visionarymedical@earthlink.net | # Date of 510 (k) summary preparation: November 11, 2002 Factory : Aravind Eye Hospital, LAICO Building, 72 KK Salai, Gandhi Nagar, Madurai 625 020. India Image /page/0/Picture/14 description: The image shows a logo with the letters "UL" inside a circle, with the words "REGISTERED FIRM" surrounding the top half of the circle. Below the logo, the word "aurolab" is printed in a smaller font size. Underneath "aurolab", the text "ISO 9002" is printed in bold. Finally, the text "File No. A6187" is printed at the bottom of the image. For Intraocular Lens and Suture Needle Divisions only For Intraocu **CE** 0543 "A not-for-profit organisation dedicated to {1}------------------------------------------------ Trade name: ------ K\$\phi\$2 4\$\psi\$q\$\phi\$ (P. 2 of 2) Common name: Suture, nonabsorbable, synthetic polyamide #### Predicate devices: Nonabsorbable synthetic polyamide sutures manufactured by Aurolab are equivalent to Ethicon nonabsorbable synthetic polyamide sutures. #### Device description: This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it. #### Intended use: Nonabsorbable synthetic polvamide suture manufactured by Aurolab is indicated for use in general soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures. #### Performance tests to demonstrate substanital equivalency: To establish the technical equivalency of Non absorbable sutures manufactured by Aurolab with the predicate devices, tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture- needle attachment. The test results show that Aurolab devices tested meet USP standards and are technically equivalent to the predicate devices tested. Balein Dr.P.Balakrishnan, M.D., Aurolab Date :November 11, 2002 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or other winged creature, with three distinct head profiles visible, suggesting a sense of community or collaboration. FEB 2 8 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Aurolab c/o Visionary Medical Supplies Michael G. Price President 6441 Enterprise Lane, Suite 214 Madison, Wisconsin 53719 Re: K024090 Trade/Device Name: Nylon Suture Regulation Number: 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR Dated: December 6, 2002 Received: December 11, 2002 Dear Mr.Price: 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. {3}------------------------------------------------ Page 2 – Mr. Michael G. Price 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). 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 {4}------------------------------------------------ ### Statement of Indications for Use Page 1 of 1 510(k) Number (if known): K924494 Device Name: Suture, nonabsorbable, synthetic polyamide ------------------Nylon Suture: Suture, nonabsorbable, synthetic polyamide Common name: Instructions for Use: Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaluation (ODE) . · uriam C. Provost Division Sign-Of (Division of General. Restorative Division Neurological vices (Optional Format 3-10-98) 510(k) Number Kc24090