NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE

{0}------------------------------------------------ JUN 2 - 2005 # SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE SECTION NO: 16 · PAGE NO: -16-1 ### 510K SUMMARY as required by: 21CFR 807.92 ### A. APPLICANT INFORMATION | Name | : SUTURES INDIA PVT. LTD | |-------------|-------------------------------------------------------------------------------------------| | Address | : Sutures India Pvt. Ltd.<br>118, 3rd Phase, Peenya Industrial Area,<br>Bangalore–560058. | | PH.NO. | : 91-80-28395150 / 28370367 / 28377850 | | FAX NO | : 91-80-28392280. | | Email | : sutures@vsnl.com | | Web address | : www.suturesin.com | B. Contact Person : L.G.Chandrasekhar : MANAGING DIRECTOR C. Date Prepared : May 15,2004 D. DEVICE NAME - Trade Name . : TRUBOND - . Common name : Nonabsorbable Surgical Suture,U.S.P. (Coated and Braided Polyester) - Classification Name : Nonabsorbable (Poly ethylene Terephthalate) Surgical Suture . # E. PREDICATE DEVICES - Polyester Nonabsorbable Surgical Suture, 510(k) Number K001172, C.P.Medical, . Portland, OR 97232. - Polyester Nonabsorbable Surgical Suture, 510(k) Number K961925. R.K.Medical . L.L.C, Danbury, CT 06810 K041512 Page 1 of 8 {1}------------------------------------------------ K041512 page 2 of 4 # SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE PAGE NO: -16-2 SEC.LION NO:16 ### F. DESCRIPTION OF THE DEVICE ·TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia **Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached. # G. INTENDED USE OF THE DEVICE Sutures India's "TRUBOND" a Nonabsorbable Surgical Suture (Polyester) is indicated for use in soft tissue approximation and / or ligation, including use in cardiovascular, ophthalmic and neurological procedures. | Comparison items | Sutures<br>India<br>Pvt.ltd | CP Medical | R.K.Medical | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------|----------------------| | Polyester Nonabsorbable Surgical Suture is a<br>multifilament nonabsorbable, sterile, flexible<br>thread prepared from fibers of high molecular<br>weight, long chain, linear polyesters having<br>recurrent aromatic rings as an integral<br>component. | Same | Same | Same | | The sutures are inert, noncollageneous and<br>nonantigenic. | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture is<br>available undyed or dyed. | D & C<br>Green<br>No. 5 or<br>Logwood | D & C<br>Green No.6 | D & C Green<br>No. 6 | | Polyester Nonabsorbable Surgical Suture is<br>offered both uncoated and treated with<br>biocompatible coatings to enhance its<br>handling properties. | Same | Same | Same | | Comparison items | Sutures<br>India Pvt.<br>Ltd | CP Medical | R.K.Medical | | Polyester Nonabsorbable Surgical Suture is<br>indicated for use in soft tissue approximation<br>and/ or ligation, including use in<br>cardiovascular, ophthalmic and neurological<br>procedures. | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture is<br>supplied for single use only. | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture is<br>sterilized by EO method | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture is<br>packaged in the same or equivalent manner,<br>and has the same or equivalent labeling<br>claims as the predicate devices including<br>indications, warnings, cautions and<br>precautions | Same | Same | Same | | Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Diameter<861> | Same | Same | Same | | Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Tensile strength<881> | Same | Same | Same | | Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Needle attachment<871> | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture<br>meets the Official Monograph of the United<br>States Pharmacopeia current edition USP26<br>for extractable color | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture<br>meets the Official Monograph of the United<br>States Pharmacopeia current edition USP26<br>for Sterility | Same | Same | Same | | Comparison items | Sutures<br>India Pvt.<br>Ltd | C.P. Medical | R.K.Medical | | Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Finish suture Length Requirement<br>(95% of stated label length) | Same | Same | Same | | Finished suture material packaged in a same<br>or equivalent manner with sterile single or<br>double packing having labeling conforming<br>to 21CFR and USP 26 | Same | Same | Same | | Polyester Nonabsorbable Surgical Suture is<br>biologically compatible when tested as per<br>ISO-10993 | Same | Same | Same | # COMPARISON TABLE SUTURES INDIA 'S "TRUBOND" POLYESTER NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES {2}------------------------------------------------ 147012 Page 394 # SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR MISSION OF TREF POLYESTER SURGICAL SUTURE SECTION NO: 16 PAGE NO: -16-3 {3}------------------------------------------------ K041512 . page 4 of 4 # SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE ### PAGE NO: -16-4 SECTION NO:16 ### CONCLUSION Sutures India's "TRUBOND" Polyester Nonabsorbable Surgical Suture is composed of the same material, as are the predicated devices and has the same design, as do the predicate devices. The suture is manufactured in a manner typical of the industry and equivalent to that used to produce predicate devices. Further the subject device is offered with the same colorant Logwood extract or D & C Green 5 at a concentration that conforms to the requirements of FDA. Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Suture India "TRUBOND" Polyester Nonabsorbable Surgical Suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices. Duff L.G.Chandrasekhar Managing Director {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 - 2005 Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area, Bangalore 560058, India Re: K041512 Trade/Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: May 3, 2005 Received: May 6, 2005 Dear Mr. Chandrasekhar: 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. {5}------------------------------------------------ # Page 2 - Mr. L.G. Chandrasekhar 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 (240) 276-0115 . 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/industry/support/index.html. Sincerely yours, Signature Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use K041512 510(k) Number (if known): Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture Indications For Use: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ortive . . . ... ... ... ... ... ....................................................................................................................................................