Who is the manufacturer of TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

Sutures India Private Limited filed the 510(k) submission for TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE (K041510).

What is the FDA product code for TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

GAR. It is classified under 21 CFR 878.5020 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

Nylon Nonabsorbable Surgical Suture (K001173); Nylon Nonabsorbable Surgical Suture (K960327).

Who can help prepare an FDA 510(k) submission like TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE

K041510 · Sutures India Private Limited · GAR · Jun 2, 2005 · General, Plastic Surgery

Device Facts

Record ID	K041510
Device Name	TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
Applicant	Sutures India Private Limited
Product Code	GAR · General, Plastic Surgery
Decision Date	Jun 2, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5020
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

TRULON is a sterile, nonabsorbable, flexible monofilament surgical suture composed of long-chain aliphatic polymers (Nylon 6 and Nylon 6.6). It is provided with or without an attached needle. The device is used by surgeons in clinical settings for soft tissue approximation and ligation. It functions as a mechanical fastener to hold tissue together during healing. The suture is inert, noncollageneous, and nonantigenic. It is supplied for single use only and sterilized via ethylene oxide (EO).

Clinical Evidence

Bench testing only. Testing performed per USP 26 standards including suture diameter, length, knot pull tensile strength, extractable color, needle attachment strength, and sterility. Biocompatibility testing conducted per ISO-10993.

Technological Characteristics

Material: Nylon 6 and Nylon 6.6 monofilament. Standards: USP 26 (diameter, tensile strength, needle attachment, length, sterility), ISO-10993 (biocompatibility), 21 CFR 73.1410 (logwood extract colorant). Sterilization: Ethylene Oxide (EO). Form factor: Monofilament thread with optional needle.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures. For prescription use.

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

Nylon Nonabsorbable Surgical Suture (K001173)
Nylon Nonabsorbable Surgical Suture (K960327)

Related Devices

K041511 — TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE · Sutures India Private Limited · Jun 3, 2005
K030177 — ORLON NONABSORABLE SURGICAL SUTURE USP · Sri Orion Pharmaceuticals & Sutures · Jul 21, 2003
K060528 — AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE · Aesculap, Inc. · Mar 28, 2006
K041512 — NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE · Sutures India Private Limited · Jun 2, 2005
K152795 — RiverLon (Nylon) Suture · Riverpoint Medical · Oct 28, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ KO41510 ## JUN 2 - 2005 Page 1 of 4 ## SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE PAGE NO: -16-1 SECTION NO: 16 ## 510K SUMMARY as required by: 21CFR 807.92 ## A. APPLICANT INFORMATION Name : SUTURES INDIA PVT. LTD : Sutures India Pvt. Ltd. 118, 3rd Phase, Peenya Industrial Address Arca, Bangalore-560058. India : 91-80-28395150 / 28370367 / 28377856 PH.NO. :91-80-28392280. FAX NO | E mail | : sutures@vsnl.com | |-------------------|---------------------| | Web address | : www.suturesin.com | | B. Contact Person | : L.G.Chandrasekhar | | | : MANAGING DIRECTOR | : May 07,2004 C. Date Prepared ### D. DEVICE TRADE NAME | Trade Name | : TRULON | |------------|----------| |------------|----------| : Nonabsorbable Surgical Suture,U.S.P. Common name (Monofilament Polyamide) - Classification Name : Nonabsorbable Polyamide Surgical Suture . #### E. PREDICATE DEVICES . - Nylon Nonabsorbable Surgical Suture, 510(k) Number K001173, C.P.Medical, . Portland, OR 97232. - Nylon Nonabsorbable Surgical Suture, 510(k) Number K960327. R.K.Medical . L.L.C, Danbury, CT 06810 {1}------------------------------------------------ ## SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE - KO41510 page 2 | SECTION NO:16 | PAGE NO: -16-2 | |---------------|----------------| |---------------|----------------| ### F. DESCRIPTION OF THE DEVICE TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible TKOLON Tronaosoroable Feed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. Monomathen Intead Composed Suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture . Nonabsorbable (0.5.1 ) monograph requee may be dyed Logwood Extract, C.175290 conforming to I oryannae Surgieur Strare may 2017 CFR 73.1410 . The suture may be provided with or without a standard needle attached. ### G. INTENDED USE OF THE DEVICE Suture India TRULON Nonabsorbable Ployamide Surgical suture, is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures. # COMPARISON TABLE SUTURES INDIA'S "TRULON" POLYAMIDE NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES | Comparison items | Sutures India Pvt. Ltd | C.P.Medical | R.K.Medical | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|-----------------------| | Nonabsorbable Polyamide surgical suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. | Same | Same | Same | | The sutures are inert, noncollageneous and nonantigenic. | Same | Same | Same | | Nonabsorbable Polyamide surgical suture is available dyed with logwood extract | Same | Similar | Similar | | Nonabsorbable Polyamide surgical suture is offered uncoated | Same | Coated or uncoated | Coated or uncoated | | Nonabsorbable Polyamide suture is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures. | Same | Same | Same | | Comparison items | Sutures India Pvt. 1.td | C.P.Medical | R.K.Medical | | Nnonabsorbable sterile Polyamide suture is supplied for single use only. | Same | Same | Same | | Nnonabsorbable sterile Polyamide suture is sterilized by EO method | Same | Same | Same | | Nnonabsorbable sterile Polyamide suture is packaged in the same or equivalent manner, and has the same or equivalent labeling claims as the predicate devices including indications, warnings, cautions and precautions | Same | Same | Same | | Nnonabsorbable sterile Polyamide suture meets the Official Monograph of the United States Pharmacopeia current edition USP26 for extractable color. | Same | Same | Same | | Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition USP26 for Diameter<861> | Same | Same | Same | | Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition USP26 for Tensile strength<881> | Same | Same | Same | | Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition USP26 for Needle attachment<871> | Same | Same | Same | | Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition USP26 for Sterility | Same | Same | Same | | Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition USP26 for Finish suture Length Requirement (95% of stated label length) | Same | Same | Same | | Comparison items | Sutures India Pvt. Ltd | C.P.Medical | R.K.Medical | | Finished suture material packaged in a same or equivalent manner with sterile single or double packing having labeling conforming to 21CFR and USP 26 | Same | Same | Same | | Nonabsorbable Polyamide Surgical suture is biologically compatible when tested as per ISO-10993 | Same | Same | Same | {2}------------------------------------------------ ## SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE K041510 Posse 3 of 4 #### PAGE NO: -16-3 SECTION NO:16 {3}------------------------------------------------ K041570 page 4 of 6 ### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE #### SECTION NO:16 PAGE NO: -16-4 #### CONCLUSION Suture India TRULON Nonabsorbable Polyamide 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 at a concentration that conforms to the requirements of Title 21 CFR & 73.1410 or similar FDA approved color, as are of the predicate devices. Testing of suture diameter, suture length, knot pull tensite strength, extractable color and needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices. Datz L.G.Chandrasekhar Managing Director {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circle around the eagle. JUN 2 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area. Bangalore 560058, India Re: K041510 Trade/Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR 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/cdrl/industry/support/index.html. Sincerely yours. 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 510(k) Number (if known): K041510 Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture Indications For Use: TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Prescription Use _ _ _ _ x_ 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) --------- Elen tive rological Devices ko41510 Page 1 of 1