MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

{0}------------------------------------------------ Image /page/0/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" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping faces representing the department's focus on health and human well-being. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 28, 2017 Meril Endo Surgery Private Limited % Mr. Umesh Sharma Deputy General Manager - Quality Assurance Third Floor, E1-E3, Meril Park Survey No. 135/2/B & 174/2 Muktanand Marg, Chala, Vapi, India, Valsad Gujarat, 396191, IN Re: K172659 Trade/Device Name: MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST -Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW Dated: August 28, 2017 Received: September 5, 2017 Dear Mr. Sharma: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be {1}------------------------------------------------ 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K172659 Device Name MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON Indications for Use (Describe) MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures. MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures. FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. Type of Use (Select one or both, as applicable) | 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------|---------------------------------------------| |------------------------------------------------|---------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K172659 Page 1 of 7 ### 510(k) Summary #### l. Submitter M/s. Meril Endo Surgery Private Limited Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com E-mail: umesh.sharma@merillife.com Contact Person: Umesh Sharma Date Prepared: August 26, 2017 ### II. Device | Sr.<br>No. | Trade / Proprietary<br>Name | Common<br>Name | Regulator<br>y Class | Product<br>Code | Regulation Number | Review<br>Panel | |------------|----------------------------------------------------------------------------------|-----------------------------------------------|----------------------|-----------------|-------------------|---------------------------------| | 1. | MEGASORBTM<br>absorbable Polyglycolic<br>Acid Surgical Suture | Braided coated<br>Polyglycolic<br>Acid Suture | II | GAM | 878.4493 | General &<br>Plastic<br>Surgery | | 2. | MITSUTM Absorbable<br>poly(glycolide/l-lactide)<br>Surgical Sutures | Braided coated<br>Polyglactin<br>Suture | II | GAM | 878.4493 | General &<br>Plastic<br>Surgery | | 3. | MITSU FSTTM<br>Absorbable poly<br>(glycolide / l-lactide) Surgical Sutures | Braided coated<br>Polyglactin<br>Suture | II | GAM | 878.4493 | General &<br>Plastic<br>Surgery | | 4. | FILAXYNTM Absorbable<br>poly (p-dioxanone)<br>Surgical Suture | Monofilament<br>Polydioxanone<br>Suture | II | NEW | 878.4840 | General &<br>Plastic<br>Surgery | | 5. | FILAPRONTM<br>Absorbable poly<br>(glycolide -co caprolactone) Surgical<br>Suture | Monofilament<br>Polyglecaprone<br>Suture | II | GAM | 878.4493 | General &<br>Plastic<br>Surgery | {4}------------------------------------------------ ### III. Predicate Device | Sr. No. | Meril's Suture<br>Proprietary Name | Suture Trade /<br>Predicate Device Name | Predicate Device<br>510(k) No. | |---------|------------------------------------------------------------------|-----------------------------------------|--------------------------------| | 1. | MEGASORBTM<br>Polyglycolic Acid Surgical Suture | absorbable<br>MEGASORBTM | K150717 | | 2. | MITSUTM<br>poly(glycolide/l-lactide) Surgical<br>Sutures | Absorbable<br>MITSUTM | K150717 | | 3. | MITSU FSTTM<br>poly(glycolide/l-lactide) Surgical<br>Sutures | Absorbable<br>MITSU FSTTM | K150717 | | 4. | FILAXYNTM Absorbable poly (p-<br>dioxanone) Surgical Suture | FILAPRONTM | K150717 | | 5. | FILAPRONTM<br>poly(glycolide-co-caprolactone)<br>Surgical Suture | Absorbable<br>FILAXYNTM | K150717 | ### IV. Device Description ## A. MEGASORB™ absorbable Polyglycolic Acid Surgical Suture MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate. Poly Glycolic Acid coated with polycaprolactone and calcium stearate has been found to be non-pyrogenic and eliciting only slight tissue reaction during absorption. The empirical formula of the Polyglycolic Acid, polycaprolactone and calcium stearate is (C2H2O2)n, (C6H10O2)n and C36H70Q4Ca respectively.MEGASORB™ sutures are available either undyed or dyed (D and C Violet No. 2, Colour Index number: 60725) form. MEGASORB™ is available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes. {5}------------------------------------------------ MEGASORB™ suture is available in U.S.P. size range 8-0 to 2, undyed/dyed form in pack size of 6/12/24/36. ### B. MITSUT™ Absorbable poly(glycolide/l-lactide) Surgical Sutures MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate. The empirical formula of the copolymer is (C2H2O2)m (C3HzO2)n and calcium stearate is C36H704Ca. Poly(glycolide/l-lactide) copolymer and poly(glycolide/l-lactide) with calcium stearate exhibit non-pyrogenic properties. MITSU™ sutures are available in undyed and dyed (D and C violet No. 2, Colour Index No. 60725) form. Available in a broad range of suture sizes and lengths, MITSU™ comes with standard stainless steel needles of varying types and sizes. MITSUTM suture is available in size range 8-0 to 2, undyed/dyed form, and pack size of 6/12/24/36. ### C. MITSU FST™ Absorbable poly(glycolide/l-lactide) Surgical Sutures MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The empirical formula of the copolymer is (C2H2O2)m (C3H4O2)n and calcium stearate is C36H704Ca. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture. Poly(glycolide/l-lactide) copolymer and poly(glycolide/l-lactide) with calcium stearate exhibit non-pyrogenic properties and elicit only slight tissue reaction during absorption. MITSU FST™ sutures are available in undyed form. Available in a broad range of suture sizes and lengths, MITSU FST™ comes with standard stainless steel needles of varying types and sizes. {6}------------------------------------------------ MITSU FST™ suture is available in U.S.P. size range 6-0 to 1, undyed form in pack size of 6/12/24/36. ### D. FILAXYN™ Absorbable poly (p-dioxanone) Surgical Suture FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3), Poly (p-dioxanone) polymer has non-pyrogenic properties. FILAXYN™ sutures are available in undyed or dyed (D and C Violet No.2, Color Index number: 60725) form. FILAXYN™ is available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes. FILAXYN™ suture is available in size range 7-0 to 2, undyed/dyed form in pack size of 6/12/24/36. ## E. FILAPRON™ Absorbable poly(glycolide-co-caprolactone) Surgical Suture FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone). The empirical molecular formula of the polymer is (C2H2O2)m (C6H10O2)n poly(glycolide-cocaprolactone) has non-pyrogenic properties. FILAPRON™ sutures are available either in undyed or dyed (D and C violet No. 2, Colour Index No. 60725) form. FILAPRON™ is available in a range of gauge sizes and lengths and attached to standard stainless steel needles of varying types and sizes. FILAPRON™ suture is available in size range 6-0 to 2, undyed/dyed form in pack size of 6/12/24/36. {7}------------------------------------------------ ### V. Intended Use - 1. MEGASORBTM Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures. - 2. MITSUTM suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. - 3. MITSU FST™ suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST™ suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures. - 4. FILAXYN™ sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. - 5. FILAPRON™ dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. {8}------------------------------------------------ ### VI. Substantial Equivalence The device design, material of construction, performance, packaging and intended uses are similar to the predicate device. Substantial equivalence is conducted based on the following parameters: - 1. Product description - 2. Intended use - 3. Suture Size - 4. Colorant Used - 5. Suture Coating - 6. Single use - 7. Sterilisation method - 8. Packaging - 9. Label Claim - 10. Performance - a. Diameter USP <861> - b. Tensile strength USP <88|> - Needle attachment USP <871> ﻥ ﻧ - d. Resorption profile - e. Suture Length 11. Labelling and Instructions for use (IFU) ### VII. Performance Data The Surgical Suture was subjected to the performance testing as per USP requirements. The safety and effectiveness of the Surgical Suture has been evaluated for the following performance and safety requirements. - 1. Diameter USP <861> - 2. Tensile strength USP <881> - 3. Needle attachment USP <871> - 4. Resorption Profile - 5. Suture Length - 6. Biocompatibility - a. In Vitro Cytotoxicity Study {9}------------------------------------------------ - b. Skin Sensitization Study - c. Intracutaneous Reactivity Test - d. Acute Systemic Toxicity Study - e. Sub Chronic Toxicity Study - Intramuscular Implantation Test f. - Bacterial Reverse Mutation Test g. - h. Mammalian Erythrocyte Micronucleus Test - In Vitro Hemolysis Test İ. - j. Pyrogen Test #### Conclusion VIII. Meril's Absorbable surgical Sutures are composed of the same materials, as are the predicate devices and has the same design, as do the predicate.