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.

Device Description

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Golnit Nylon Monofilament Suture device, based on the provided FDA 510(k) summary:

This document is a 510(k) summary for a medical device (Golnit Nylon Monofilament Suture), which seeks substantial equivalence to a legally marketed predicate device. As such, it focuses on demonstrating that the new device performs as safely and effectively as the predicate, rather than establishing absolute efficacy against a disease target. Therefore, many standard clinical study elements like "number of experts," "adjudication method," "MRMC study," and "effect size" are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined by USP and FDA Guidance)	Reported Device Performance (Golnit Nylon Monofilament Suture)
Suture Diameter per USP <861> requirements	Meets requirements
Suture Needle Attachment per USP <871> requirements	Meets requirements
Tensile Strength per USP <881> requirements	Meets requirements
Sterile	Yes
Biocompatible	Yes
Shelf life stability	Supported by real-time aging stability testing

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical sample size. The testing referred to "tests in accordance with the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength." This implies an unspecified but sufficient number of samples were tested to meet USP standards for each characteristic.
Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility, as is typical for device performance testing for 510(k) submissions. No specific country of origin or retrospective/prospective classification is mentioned, as this is laboratory-based physical and chemical performance data, not patient-level data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. The "ground truth" for this device's performance is established by standardized, objective physical and chemical tests (e.g., measuring diameter, tensile strength) against published specifications from the United States Pharmacopeia (USP) and FDA Special Controls Guidance. It does not involve expert interpretation of clinical images or patient outcomes.

4. Adjudication Method for the Test Set

Not Applicable. As the "ground truth" is determined by objective physical and chemical measurements against established standards, no human adjudication of results is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was done or is applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done

Not Applicable. This device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth is established by objective, quantitative measurements against pre-defined specifications outlined in the United States Pharmacopeia (USP) monographs for non-absorbable sutures (specifically USP <861> for diameter, USP <871> for needle attachment, and USP <881> for tensile strength), and FDA Class II Special Controls Guidance: Surgical Sutures. Biocompatibility is assessed against ISO 10993-1.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI algorithm that requires a "training set." Performance is evaluated through physical and chemical testing.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set is involved.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

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. 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

{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)

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.

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}------------------------------------------------

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 704New 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 andPlastic 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 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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES

Attribute	Proposed Device - GolnitNylon Monofilament Suture	Predicate Device -REXLON	Reference Device -Golnit Non-Absorbable PTFESurgical Suture
Product Code	GAR	GAR	NBY
Regulation	21 CFR 878.5020	21 CFR 878.5020	21 CFR 878.5035
Intended use	Soft tissue approximationand/or ligation	Soft tissue approximationand/or ligation	Soft tissueapproximation and/orligation
Indications for use	The Golnit NylonMonofilament Suture isindicated for use in generalsoft tissue approximationand/or ligation, including usein ophthalmic procedures, butnot for use in cardiovascularor neurological procedures.	REXLON is indicated for usein general soft tissueapproximation and/orligation, including use inophthalmic procedures, butnot for use in cardiovascularor neural tissue.	The GOLNIT Non-Absorbable PTFESurgical Suture isindicated for use in alltypes of soft tissueapproximation and/orligation, includingdental, cardiovascularand general surgeries,as well as repair of thedura mater. The deviceis not indicated for usein ophthalmic surgery,microsurgery andperipheral neural tissue
How Supplied	Sterile monofilament threadin various colors and sizeswith or without attachedneedles	Sterile monofilament threadin various colors and sizeswith or without attachedneedles	Sterile monofilamentthread in various sizeswith or without attachedneedles
Suture Specifications
Material	Polyamide surgical suturefrom long-chain aliphaticpolymers Nylon 6 and Nylon6,6	Polyamide surgical suturefrom long-chain aliphaticpolymers Nylon 6 and Nylon6,6	Polytetrafluoroethylene(ePTFE) polymer(100%),expanded and uncoatedmonofilaments
Color (colorant)	Undyed (natural)Black (Logwood extract)	Undyed (natural)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 – GolnitNylon Monofilament Suture	Predicate Device –REXLON	Reference Device –Golnit Non-Absorbable PTFESurgical 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 1Blue: USP 8/0 to USP 2Undyed: USP 8/0 to USP 1	2-0 to 6-0
Length	10 cm to 300 cm with 5 cmintervals	15 cm, 20 cm, 30 cm, 35 cm,40 cm, 45 cm, 50 cm, 60 cm,70 cm, 75 cm, 80 cm, 100cm, 150 cm, 200 cm	10 cm to 300 cm with 5cm intervals

Needle
Material	Stainless steel	Stainless steel	Stainless steel
Needle type	Taper, Cutting, Reverse-cutting, Taper-cutting(tapercut), Spatula, Diamond,no needle	Reverse cutting, Taper point,Spatula	Taper, Reverse Cutting,Taper-Cutting

Performance Characteristics and Safety
Packaging	Dry packaged in tear-opendouble paper/PET/CPPpouches	Dry packaged in tear-openpouch	Dry packaged in tear-open doublepaper/PET/CPPpouches
Suture Diameter perUSP <861>	Meets requirements	Meets requirements	Meets requirements
Suture NeedleAttachment per USP<871>	Meets requirements	Meets requirements	Meets requirements
Tensile Strength perUSP <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.

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
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.(b)
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.