Golnit Nylon Monofilament Suture

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March 31, 2022 Antarma LLC dba Golnit Sutures Armine Badalyan CEO 276 5th Ave., Suite 704 New York, New York 10001 Re: K212888 Trade/Device Name: Golnit Nylon Monofilament Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: September 9, 2021 Received: September 10, 2021 Dear Armine Badalyan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212888 Device Name Golnit Nylon Monofilament Suture #### Indications for Use (Describe) The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized "G" inside a square on the left. To the right of the square is the word "GOLNIT" in large, bold letters, and below that is the word "SUTURES" in smaller letters. # 510(k) Summary In accordance with 21 CFR 807.92, the following summary of information is provided. ## I. SUBMITTER | Name: | Antarma LLC dba Golnit Sutures | |------------------------|-------------------------------------------------| | Address: | 276 5th Avenue, Suite 704<br>New York, NY 10001 | | Phone: | 718-219-0731 | | Contact Person: | Armine Badalyan, Chief Executive Officer | | Date Summary Prepared: | February 25, 2022 | ## II. DEVICE | Proprietary Name: | Golnit Nylon Monofilament Suture | |----------------------|----------------------------------------------------------------------------------------------------------| | Common Name: | Nonabsorbable polyamide surgical suture | | Classification Name: | Suture, Nonabsorbable, Synthetic, Polyamide | | Regulation: | 21 CFR 878.5020 | | Regulatory Class: | II | | Product Code: | GAR | | Panel: | Surgical and Infection Control Devices (OHT4) / Infection Control and<br>Plastic Surgery Devices (DHT4B) | ## III. PREDICATE DEVICE The Golnit Nylon Monofilament Suture is being compared to the predicate device, REXLON, which was cleared under K161633 and manufactured by SM ENG CO., Ltd. One reference device, the Golnit Non-Absorbable PTFE Surgical Suture, was used to support equivalence of the needle component and to support adoption into the product family for sterilization validation. The reference device was cleared under K163049. Neither the predicate device nor the reference device has been the subject to a design-related recall. ## IV. DEVICE DESCRIPTIONS The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm {4}------------------------------------------------ to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only. # V. INTENDED USE / INDICATIONS FOR USE The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES | Attribute | Proposed Device - Golnit<br>Nylon Monofilament Suture | Predicate Device -<br>REXLON | Reference Device -<br>Golnit Non-<br>Absorbable PTFE<br>Surgical Suture | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | GAR | GAR | NBY | | Regulation | 21 CFR 878.5020 | 21 CFR 878.5020 | 21 CFR 878.5035 | | Intended use | Soft tissue approximation<br>and/or ligation | Soft tissue approximation<br>and/or ligation | Soft tissue<br>approximation and/or<br>ligation | | Indications for use | The Golnit Nylon<br>Monofilament Suture is<br>indicated for use in general<br>soft tissue approximation<br>and/or ligation, including use<br>in ophthalmic procedures, but<br>not for use in cardiovascular<br>or neurological procedures. | REXLON is indicated for use<br>in general soft tissue<br>approximation and/or<br>ligation, including use in<br>ophthalmic procedures, but<br>not for use in cardiovascular<br>or neural tissue. | The GOLNIT Non-<br>Absorbable PTFE<br>Surgical Suture is<br>indicated for use in all<br>types of soft tissue<br>approximation and/or<br>ligation, including<br>dental, cardiovascular<br>and general surgeries,<br>as well as repair of the<br>dura mater. The device<br>is not indicated for use<br>in ophthalmic surgery,<br>microsurgery and<br>peripheral neural tissue | | How Supplied | Sterile monofilament thread<br>in various colors and sizes<br>with or without attached<br>needles | Sterile monofilament thread<br>in various colors and sizes<br>with or without attached<br>needles | Sterile monofilament<br>thread in various sizes<br>with or without attached<br>needles | | Suture Specifications | | | | | Material | Polyamide surgical suture<br>from long-chain aliphatic<br>polymers Nylon 6 and Nylon<br>6,6 | Polyamide surgical suture<br>from long-chain aliphatic<br>polymers Nylon 6 and Nylon<br>6,6 | Polytetrafluoroethylene<br>(ePTFE) polymer<br>(100%),<br>expanded and uncoated<br>monofilaments | | Color (colorant) | Undyed (natural)<br>Black (Logwood extract) | Undyed (natural)<br>Black (Logwood extract) | Natural (undyed) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized "G" in a square on the left. To the right of the "G" is the word "GOLNIT" in large, bold letters. Below "GOLNIT" is the word "SUTURES" in smaller letters. | Attribute | Proposed Device – Golnit<br>Nylon Monofilament Suture | Predicate Device –<br>REXLON | Reference Device –<br>Golnit Non-<br>Absorbable PTFE<br>Surgical Suture | |----------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Coating | Blue (FD&C Blue No. 2) | Blue (FD&C Blue No. 2) | None | | | None | None | None | | Nonabsorbable | Yes | Yes | Yes | | Monofilament | Yes | Yes | Yes | | Sizes | USP 10/0 to 2 | Black: USP 11/0 to 1<br>Blue: USP 8/0 to USP 2<br>Undyed: USP 8/0 to USP 1 | 2-0 to 6-0 | | Length | 10 cm to 300 cm with 5 cm<br>intervals | 15 cm, 20 cm, 30 cm, 35 cm,<br>40 cm, 45 cm, 50 cm, 60 cm,<br>70 cm, 75 cm, 80 cm, 100<br>cm, 150 cm, 200 cm | 10 cm to 300 cm with 5<br>cm intervals | | | | | | | Needle | | | | | Material | Stainless steel | Stainless steel | Stainless steel | | Needle type | Taper, Cutting, Reverse-<br>cutting, Taper-cutting<br>(tapercut), Spatula, Diamond,<br>no needle | Reverse cutting, Taper point,<br>Spatula | Taper, Reverse Cutting,<br>Taper-Cutting | | | | | | | Performance Characteristics and Safety | | | | | Packaging | Dry packaged in tear-open<br>double paper/PET/CPP<br>pouches | Dry packaged in tear-open<br>pouch | Dry packaged in tear-<br>open double<br>paper/PET/CPP<br>pouches | | Suture Diameter per<br>USP <861> | Meets requirements | Meets requirements | Meets requirements | | Suture Needle<br>Attachment per USP<br><871> | Meets requirements | Meets requirements | Meets requirements | | Tensile Strength per<br>USP <881> | Meets requirements | Meets requirements | Meets requirements | | Sterile | Yes | Yes | Yes | | Method of Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Biocompatible | Yes | Yes | Yes | The Golnit Non-Absorbable PTFE Surgical Suture was used as a reference device to support equivalence of the needle component and to support adoption into the product family for sterilization. Both the reference device and proposed device use the same stainless-steel needle from the same supplier and have the same sterilization parameters. The proposed device may be supplied with additional needle tip shapes. ## VII. PERFORMANCE DATA No clinical or animal testing was conducted. Testing that was performed demonstrate that the suture meets the requirements outlined in Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003. Testing in accordance with to the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength, was performed. This performance testing demonstrated that the Golnit Monofilament Suture meets the USP requirements for suture diameter, suture needle attachment, and tensile strength. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized letter "G" on the left side. The word "GOLNIT" is written in large, bold letters above the word "SUTURES", which is written in smaller letters. Real-time aging stability testing was performed to support shelf life of the Golnit Nylon Monofilament Suture, and this testing supported the shelf life of the device. Biocompatibility testing was also performed per Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. This testing demonstrated that the device is biocompatible. All testing demonstrated that the Golnit Nylon Monofilament Suture is as safe and effective as the predicate device. ## VIII.CONCLUSIONS Based on the performance data and comparison to the predicate device, the Golnit Nylon Monofilament Suture has been shown to be substantially equivalent to the legally marketed predicate device.