← Product Code [GAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM) · K081002 # MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE (K081002) _Sutures India Pvt., Ltd. · GAM · Jun 9, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K081002 ## Device Facts - **Applicant:** Sutures India Pvt., Ltd. - **Product Code:** [GAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM.md) - **Decision Date:** Jun 9, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4493 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use Sutures India's MONOGLYDE Absorbable Poliglecaprone suture, is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. ## Device Story MONOGLYDE is a sterile, flexible, monofilament synthetic absorbable surgical suture composed of Poliglecaprone 25 (a copolymer of glycolide and epsilon-caprolactone). The device is inert, non-collagenous, and non-antigenic. It is available in dyed (D&C Violet #2) and undyed forms. The suture is intended for use by surgeons in clinical settings for soft tissue approximation. It functions as a mechanical support for tissue during the healing process and is absorbed by the body over time. The device is supplied for single use only and is sterilized via ethylene oxide (EO) gas. It provides surgeons with a reliable material for wound closure, reducing the need for suture removal and minimizing tissue reaction. ## Clinical Evidence Bench testing only. No clinical data provided. Performance was verified through USP 29 testing protocols for suture diameter, length, knot pull tensile strength, needle attachment strength, extractable color, and sterility. Biocompatibility and toxicity were assessed according to ISO-10993 standards. ## Technological Characteristics Material: Poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone). Form: Sterile, flexible monofilament thread. Colorant: D&C Violet #2 (conforming to 21 CFR 74.3602). Sterilization: Ethylene oxide (EO) gas. Compliance: USP 29 monographs for diameter, tensile strength, needle attachment, and sterility. Biocompatibility: ISO-10993 compliant. ## Regulatory Identification An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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 - Monocryl, Absorbable (Poliglecaprone 25) sutures ([K930772](/device/K930772.md)) - Unicaprone Absorbable (Poliglecaprone 25) Suture ([K072646](/device/K072646.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ #### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE JUN - 9 2008 PAGE No: 17.0-1 SECTION No: 17.0 ### 510k SUMMARY as required by: 21CFR 807.92 A. APPLICANT INFORMATION | Name | : SUTURES INDIA PVT. LTD | |-------------------|----------------------------------------------------------------------------------------| | Address | : 472 D 13 th Cross, 4 th Phase,
Peenya Industrial Area,
Bangalore-560058. India | | PHONE NO. | : 91-80-41868000 (30 lines) | | FAX NO. | : 91-80-41171056 | | E mail | : sales@suturesin.com | | Web Address | : www.suturesin.com | | B. Contact Person | : L.G.Chandrasekhar
MANAGING DIRECTOR | | C. Date Prepared | : 1.4.2008 | | D. DEVICE NAME | : | - : MONOGLYDE Trade Name . - : Absorbable Surgical Suture, Synthetic (Poliglecaprone 25) Common name - : Absorbable (Poliglecaprone 25) suture Classification Name . #### F. PREDICATE DEVICES - A. Monocryl, Absorbable (Poliglecaprone 25) sutures, 510(k) Number K930772, Ethicon Incorporation, Somerville, NJ 088760151 B. Unicaprone Absorbable (Poliglecaprone 25) Suture, 510(k) Number K072646, United Medical Industries Co.Ltd (UNIMED), Riyadh, SA 11553 {1}------------------------------------------------ ### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE KO81002 5 PAGE No: 17.0-2 SECTION No: 17.0 #### F. DESCRIPTION OF THE DEVICE MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic. MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also. #### G. INTENDED USE OF THE DEVICE Sutures India's MONOGLYDE Absorbable Poliglecaprone suture, is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. {2}------------------------------------------------ K0 81002 page 3 of 5 #### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE SECTION No: 17.0 ### COMPARISON TABLE SUTURES INDIA'S "MONOGLYDE" ABSORBABLE POLIGLECAPRONE SUTURE TO PREDICATE DEVICES . | Comparison Parameters | Monoglyde | Monocryl | Unicaprone | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------|------------| | Absorbable (Poliglecaprone 25) suture is a synthetic Absorbable surgical suture. It is a sterile flexible monofilament thread, composed of Poliglecaprone. | Same | Same | Same | | The sutures are inert, noncollageneous and nonantigenic. | Same | Same | Same | | Absorbable (Poliglycaprone 25) suture is dyed with D&C Violet #2 and being monofilament it is coated | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is supplied for single use only. | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is sterilized by E.O. gas method | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is packaged in the same or equivalent manner, and has the same or equivalent labeling claims as that of the predicate devices including indications, warnings, cautions and precautions | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture meets the official monograph of the United States Pharmacopeia current edition U.S.P. 29 for extractable color. | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter<861> | Same | Same | Same | | Absorbable (Poliglecaprone 25)suture meets the performance requirements defined in the current edition of U.S.P. 29 for Tensile strength<881> | Same | Same | Same | | Comparison Parameters | Monoglyde | Monocryl | Unicaprone | | Absorbable (Poliglecaprone 25) suture
meets the performance requirements defined
in the ia current edition of U.S.P. 29 for
Needle attachment<871> | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture
meets the performance requirements defined
in the United States Pharmacopeia current
edition U.S.P. 29 for finished suture Length
Requirement (95% of stated label length) | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture
meets the performance requirements defined
in the United States Pharmacopeia current
edition U.S.P. 29 for sterility | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is
packed in a same or equivalent manner with
sterile single or double packing having
labeling conforming to 21CFR & U.S.P. 29 | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is
biologically compatible when tested as per
ISO-10993 | Same | Same | Same | | Absorbable (Poliglecaprone 25) suture is
tested and proved to be non toxic, when
tested as per ISO-10993 for toxicity | Same | Same | Same | {3}------------------------------------------------ K081002 page 4 of 5 : : {4}------------------------------------------------ K081002 Page 5 of 5 ### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE PAGE No: 17.0-4 SECTION No: 17.0 #### CONCLUSION Sutures India's MONOGLYDE Absorbable (Poliglecaprone 25) suture is composed of the same material, as that of the predicate 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 D&C Violet No.2 at a concentration that conforms to the requirements of Title 21 CFR § 74.3602, as are of the predicate devices. Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 29 demonstrates Sutures India's MONOGLYDE, Absorbable (Poliglecaprone 25) suture meets or exceeds In-house specifications and are equivalent in terms of the above mentioned predicate devices. ### For SUTURES INDIA PVT. LTD, 1. G. CHANDRASEKHAR L.G. ChandraselthaECTOR Managing Director {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, facing to the left. The eagle is stylized with three lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUN - 9 2008 Sutures India Private Limited % L.G. Chandrasekhar 472 D 13th Cross, 4th Phase Peenya Industrial Area Bangalore-560058 India Re: K081002 Trade/Device Name: MONOGLYDE Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: May 22, 2008 Received: May 27, 2008 Dear L.G. 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 {6}------------------------------------------------ Page 2 - L.G. Chandrasekhar 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Mullan Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number K081002 Device Name: MONOGLYDE ABSORBABLE SURGICAL SUTURE (SYNTHETIC) (MONOFILAMENT POLIGLECAPRONE 25) Indications For Use: MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES Neil R.P. O'Flynn for man (Division Sign-Off) Division of General, Restorative, and Neurological Devices 1081002 510(k) Number__ 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) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K081002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K081002) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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