FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

{0}------------------------------------------------ Image /page/0/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 31, 2016 M/S. Meril Endo Surgery Private Limited Mr. Umesh Sharma Deputy General Manager - Quality Assurance 3fl, E1-e3, Meril Park, Survey No. 135/2/b & 174/2, Muktanand Marg Chala, Vapi, Gujaret 396191 INDIA Re: K160623 Trade/Device Name: Filasilk - Natural Non-absorbable Silk Surgical Suture, Filamide -Non Absorbable Polyamide Surgical Sutures, Mericron XI - Non Absorbable Polyester Surgical Suture, Filaprop - Non Absorbable Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP, GAR, GAT, GAW Dated: March 1, 2016 Received: March 4, 2016 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 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. {1}------------------------------------------------ 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 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 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 yours. Jennifer R. Stevenson -A 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) K160623 Device Name FILAMIDE Indications for Use (Describe) FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures. Type of Use (Select one or both, as applicable) | <span> <b> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | |----------------------------------------------------------------------------------------------------------------------| | <span> <b> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> | #### 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160623 Device Name FILAPROP Indications for Use (Describe) FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------| | | <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="font-family: Arial;">☐</span> 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160623 Device Name FILASILK Indications for Use (Describe) FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures. Type of Use (Select one or both, as applicable) > 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160623 Device Name MERICRON XL Indications for Use (Describe) MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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 {6}------------------------------------------------ ## 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: Feb 26, 2016 ### II. Device | Sr. No. | Trade Proprietary Name | / Common Name | Classification | Regulatory Class | Product Code | Regulation Number | Review Panel | |---------|------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------|------------------|--------------|-------------------|---------------------------| | 1. | FILASILKTM<br>Natural Non-absorbable Silk Surgical Suture | Natural Non-absorbable Silk Surgical Suture | Suture, Non absorbable, Silk | II | GAP | 878.5030 | General & Plastic Surgery | | 2. | FILAMIDETM<br>Non Absorbable Polyamide Surgical Sutures | Non-absorbable Polyamide Surgical Suture | Suture, Non absorbable, Synthetic, Polyamide | II | GAR | 878.5020 | General & Plastic Surgery | | 3. | MERICRON XLTM Non Absorbable Polyester Surgical Suture | Non absorbable Poly (Ethylene Terephthal ate) Suture | Suture, Non absorbable, Synthetic, Poly (Ethylene Terephthalate) | II | GAT | 878.5000 | General & Plastic Surgery | | 4. | FILAPROPTM<br>Non Absorbable Polypropylene Surgical Suture | Non-absorbable Polypropyl ene Surgical Suture | Suture, Non absorbable, Synthetic, Polypropylene | II | GAW | 878.5010 | General & Plastic Surgery | {7}------------------------------------------------ ## III. Predicate Device | Sr. No. | Meril's Proprietary Name | Suture Trade / Predicate Device Name | Predicate Device 510(k) No. | |---------|---------------------------------------------------------|--------------------------------------|-----------------------------| | 1. | FILASILKTM Natural Non-absorbable Silk Surgical Suture | TRUSILK | K041514 | | 2. | FILAMIDETM Non Absorbable Polyamide Surgical Sutures | TRULON | K041510 | | 3. | MERICRON XLTM Non Absorbable Polyester Surgical Suture | TRUBOND | K041512 | | 4. | FILAPROPTM Non Absorbable Polypropylene Surgical Suture | PROLENE | K133356 | ## IV. Device Description #### a. FILASILK™ Natural Non-absorbable Silk Surgical Suture FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture. #### b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes. #### c. MERICRON XL™ Non Absorbable Polyester Surgical Suture MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes {8}------------------------------------------------ ## d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes ## V. Intended Use #### a. FILASILK™ Natural Non-absorbable Silk Surgical Suture FILASILK'" is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures. #### b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures FILAMIDE™ Non-absorbable Polyamide Surgical suture is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures. ### c. MERICRON XL™ Non Absorbable Polyester Surgical Suture MERICRON XL™ suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurological and ophthalmic procedures. ## d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture FILAPROP™ sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. #### 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 Dye / Un-dyed - 5. Suture Coating - 6. Single use - 7. Sterilisation method {9}------------------------------------------------ - 8. Packaging - 9. Label Claim - 10. Performance - a. Diameter USP <861> - b. Tensile strength USP <88l> - c. Needle attachment USP <871> - d. Suture Length - 11. Labeling 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 <88l> - 3. Needle attachment USP <871> - 4. Suture Length - 5. Biocompatibility - a. In Vitro Cytotoxicity Study - b. Skin Sensitization Study - c. Intracutaneous Reactivity Test - d. Acute Systemic Toxicity Study - e. Sub Chronic Toxicity Study - f. Intramuscular Implantation Test - Bacterial Reverse Mutation Test g. - h. Mammalian Erythrocyte Micronucleus Test - In Vitro Hemolysis Test i. - Pvrogen Test .... #### VIII. Conclusion Meril's Surgical Sutures are composed of the same materials, as are the predicate devices and has the same design, as do the predicate. The subject devices are offered with the same colorants as predicate devices i.e. Logwood extract black used in FILASILK™ & FILAMIDE™ is in accordance to 21 CFR 73.1410, D&C Green No. 6 used in MERICRON XL™ is in accordance with 21 CFR 74.3206 & Phthalocyanine blue used in FILAPROP™ is in accordance with 21 CFR 74. 3045). Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle {10}------------------------------------------------ attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes.