GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0.

The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple.

GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible.

GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.

AI/ML Overview

The provided document describes the GOLNIT Non-absorbable PTFE Surgical Suture, a surgical device, and includes information relevant to its acceptance criteria and the study that proves it meets those criteria.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in a typical quantitative format. Instead, it refers to fulfilling requirements of the United States Pharmacopeia (U.S.P.) and ISO standards. The performance is generally described as meeting these standards.

Based on the text, here's a reconstructed table:

Acceptance Criteria (Standard / Test)	Reported Device Performance
U.S.P. Requirements for Non-Absorbable Sutures:
- Tensile strength	Meets U.S.P. requirements.
- Needle attachment strength	Meets U.S.P. requirements.
- Suture Diameter (U.S.P. < 861>)	Meets U.S.P. requirements except for variance in diameters (the suture is "oversized in diameter" and "differs from USP requirements for diameter"). This is noted as a difference from the standard U.S.P. nomenclature. The document states "Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Non-Absorbable Surgical Sutures except for the variance in suture diameter."
- Non-Pyrogenicity (USP)	Verified non-pyrogenic per USP.
Biocompatibility (ISO 10993-1, -5, -10):
- Cytotoxicity (ISO 10993-5)	Non-cytotoxic.
- Irritation (ISO 10993-10)	Non-irritant.
- Sensitization (ISO 10993-10)	Non-sensitizer.
Sterilization (ISO 11135)	Sterilized by Ethylene Oxide, conforming to ISO 11135.
Packaging (ISO 11607-1:2006, ISO 11607-2:2006, EN 868-5:2009)	Conforms to these international product standards and norms. (Packaged in labelled two-pouch packaging system consisting of medical grade heat-sealable pouches).
Shelf-life	Stability testing performed to support the proposed shelf life. (Specific shelf life not stated, but implied to be supported).

The general conclusion states that all testing demonstrated the GOLNIT PTFE suture is "as safe and effective as the predicate, meets current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and the sutures are substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set for performance testing. It mentions "Testing is performed on each lot of product to verify that these USP requirements have been met," suggesting ongoing quality control, but not a specific sample size for a single substantial equivalence study.

Data provenance (country of origin, retrospective/prospective) is not explicitly stated. The context implies it's internal testing conducted by Antarma dba GOLNIT Sutures for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the type of device and study described. Surgical sutures are physical devices, and their performance is evaluated through objective, standardized physical and biological testing (tensile strength, biocompatibility, etc.), not by expert interpretation of images or clinical outcomes that require "ground truth" established by human experts in the traditional sense of AI/diagnostic device studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept (adjudication for ground truth) is relevant for studies involving human interpretation or clinical endpoints, not for the physical and biological testing of a surgical suture.

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

Not applicable. This is a physical medical device (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) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established by adherence to recognized national and international standards for medical devices and surgical sutures. Specifically:

Physical performance: United States Pharmacopeia (U.S.P.) standards for non-absorbable surgical sutures (e.g., tensile strength, needle attachment, diameter).
Biocompatibility: ISO 10993 series (e.g., ISO 10993-1, -5, -10).
Sterilization: ISO 11135.
Packaging: ISO 11607 series, EN 868-5.

These standards serve as the "ground truth" or benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical product, not an AI model requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 21, 2017

Antarma dba GOLNIT Sutures Ms. Armine Badalyan Chief Executive Officer 1204 Avenue U, #2030 Brooklyn, New York 11229

Re: K163049

Trade/Device Name: GOLNIT Non-absorbable PTFE Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluoroethylene surgical suture Regulatory Class: Class II Product Code: NBY Dated: May 24, 2017 Received: May 31, 2017

Dear Ms. 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. 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 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.

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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,

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

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Indications for Use

510(k) Number (if known) K163049

Device Name

GOLNIT Non-Absorbable PTFE Surgical Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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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Image /page/3/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized letter G on the left. To the right of the G is the word "GOLNIT" in large, bold letters, with the word "SUTURES" in smaller letters underneath.

5.1. 510(k) Summary

In accordance with 21 CFR 807.92, the following summary of information is provided.

Date:	June 16, 2017
Device Owner:	Antarma dba GOLNIT Sutures
Company Contact:	Armine BadalyanChief Executive Officer, Antarma LLC1204 Avenue U, #2030Brooklyn, NY 11229718-219-0731armine@golnit.com
Proprietary Name:	GOLNIT Non-Absorbable Surgical Suture
Common Names:	Non-absorbable Surgical Suture, Synthetic:• Non-absorbable, Expanded, Polytetrafluoroethylene (PTFE) Suture
Classification Names:	Suture, Surgical, Non-absorbable, Polytetrafluoroethylene
Regulation Numbers:	21 CFR 878.5035
Regulatory Class:	Class II
Product Codes:	NBY
Review Panel:	General & Plastic Surgery

510 (k) Predicate Devices:	New Device
Osteogenics Biomedical, Inc.	GOLNIT Non-Absorbable PTFE
Cytoplast™ Sutures	Surgical Suture:
K003028	• Non-absorbable, Expanded,
	Polytetrafluoroethylene (PTFE)
	Surgical Suture

5.2 Device Description

GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for

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Image /page/4/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo consists of a stylized letter "G" on the left, followed by the word "GOLNIT" in large, bold, pink letters. Below "GOLNIT" is the word "SUTURES" in smaller, pink letters.

diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0.

The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple.

5.3 Device Format

The GOLNIT Non-absorbable PTFE Surgical Suture is packaged into labelled two-pouch packaging system consisting of medical grade heat-sealable pouches for single use only. The pouches conform to the international product standards and norms: ISO 11607-1:2006. ISO 11607-2:2006, EN 868-5:2009.

The suture final configuration consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles coiled in double pouches, sterilized by ethylene oxide, cartoned in labeled white board boxes and shipping containers.

5.4 Special Controls

FDA Guidance "'Class II. Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA was followed during the preparation of this submission.

5.5 Intended Use

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Image /page/5/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo consists of a stylized letter "G" in a square on the left, followed by the word "GOLNIT" in large, bold letters. Below "GOLNIT" is the word "SUTURES" in smaller letters. The entire logo is in a pink color.

5.6 Technological Characteristics

GOLNIT Non-absorbable Surgical PTFE Sutures have been designed to meet the requirements for tensile strength, and needle attachment strength as specified in current USP for non-absorbable sutures. Testing is performed on each lot of product to verify that these USP requirements have been met.

Sizing designations for GOLNIT Non-absorbable Surgical PTFE Suture does not follow the standard United States Pharmacopeia (USP) nomenclature used for many commercially available nonabsorbable sutures, differing in the diameter-strength relationship. The sutures in the current submission are oversized in diameter.

5.7. Subject Device vs. Predicate Device

The determination of substantial equivalence for the suture device compared to the predicate devices was based on a detailed device description, including intended use, color and materials composition, and sterilization. In addition, performance testing and conformance with voluntary performance standards, e.g. ANSVAAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP 29 - Non-Absorbable Surgical Sutures, and the FDA "Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA, December 19,2002 demonstrates compliance to U.S.P. Requirements.

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Image /page/6/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized "G" on the left side, enclosed in a square. To the right of the "G" is the word "GOLNIT" in large, bold letters, with the word "SUTURES" underneath in smaller letters.

GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification

Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial EquivalenceComparison
Feature	New Device	Predicate Device	Discussion
Device Name	GOLNIT Non-absorbable PTFE Surgical Suture	Osteogenics Biomedical, Inc. CytoplastTM Sutures	New device vs Predicate device
FDA Device Premarket Notification	New device	K003028	New device vs Predicate device
FDA Device Classification	Class II per 21 CFR 878.5035	Same:Class II per 21 CFR 878.5035	Same
Product Code	NBY	NBY	Same
Intended Use	GOLNIT Non-Absorbable PTFESurgical Suture is aremovable, non-absorbable surgicalsuture intended for use inthe approximation andligation of soft tissue inthe oral cavity includingfixation of barriermembranes.	The CytoplastTM Suture isintended for use in theapproximation and ligationof soft tissue in the oralcavity, including fixationof barrier membrane.	The new device has thesame Intended Use asCytoplast Suture(K003028) for oral cavitysuturing.
How Supplied	PTFE: Sterilemonofilament, thread,undyed (natural) invarious sizes withattached needlesApproximate U.S.P.Sizes:2-0 to 6-0	PTFE: Sterilemonofilament, thread,undyed (natural) in varioussizes with attached needlesU.S.P. Sizes: 2-0 to 4-0	The How Supplied for thenew device is comparableto the predicate device,CytoplastTM Sutures, interms of USP sizes (gauge)and attachment of needles.
Use	Single Use Only	Single Use Only	Same
Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial EquivalenceComparison
Feature	New Device	Predicate Device	Discussion
Color	Natural (undyed)	Natural (undyed)	Same
MaterialComposition	Polytetrafluoroethylene(ePTFE) polymer (100%),expanded and uncoatedmonofilaments	Polytetrafluoroethylene(PTFE) polymer,monofilament, uncoated,high density monofilament	The polymer format of thenew device is expandedwhereas the Cytoplast™Suture polymer is extrudedas a high density PTFEmonofilament.
Needle Choices	Stainless steel: Needle tips:Taper, Reverse Cutting,Taper-Cutting,Needle Curvature: $\frac{1}{2}$ , 3/8,5/8, $\frac{1}{4}$ , and straightLength: various	Similar: Stainless steelneedles with variousneedles points and needlecurvature	The types of GOLNITneedle tips and shapes aresimilar to the predicatedevices and provides arange of eyeless sutureneedle designs for userconvenience or preference.
SutureCharacteristics	Non-absorbable and doesnot undergo any changes invivo.	Not absorbed and nosignificant changes knownto occur in vivo.	The new device test resultsindicate requirements metfor Biocompatibility perISO 10993 per FDASpecial Controls GuidanceClass II Special ControlsGuidance Document:Surgical Sutures; Section7. The sutures arebiocompatible forimplantation of shortduration less than 30 days.
SutureDiameter,Suture Length	Meets U.S.P. requirementsexcept for variance in	Meets U.S.P. requirements	New device with theexpanded PTFE
Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence Comparison
Feature	New Device	Predicate Device	Discussion
NeedleAttachment,Strength, KnotPull Tensile	diameters.		monofilament (designatedas ePTFE) differs fromUSP requirements fordiameter.
Packaging	Dry packaged in tear-opendouble, paper/PET/CPPpouches	Dry packaged inpaper/polyester-propylenetear-open pouch	New device has same orequivalent design to thepredicate devices.
Safety	Biocompatible perISO10993 forcytotoxicity, maximumsensitization andirritation.	Biologically inert, non-cytotoxic	New device has same orequivalent biocompatibilityto the predicate devicestested per ISO 10993-5 forcytotoxicity and 10993-10for maximum sensitizationand irritation.
	Non-pyrogenic	Not determined	The new device has beentested to verify non-pyrogenicity characteristicper USP. There is no impacton the product safety.
	Sterilization per ISO11135	Sterilized by Ethylene Oxide	Same

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Image /page/7/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized "G" on the left side of a square. To the right of the square, the word "GOLNIT" is written in large, bold letters. Below "GOLNIT", the word "SUTURES" is written in smaller letters.

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Image /page/8/Picture/0 description: The image is a logo for Golnit Sutures. The logo is pink and features a stylized letter G on the left side of the logo. To the right of the G is the word "GOLNIT" in large, bold letters, and below that is the word "SUTURES" in smaller letters.

GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification

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Image /page/9/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo features a stylized letter "G" on the left, enclosed in a square. To the right of the "G" is the word "GOLNIT" in a bold, sans-serif font, with the word "SUTURES" underneath in a smaller font. The entire logo is in a pink color.

GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification

5.8. Performance Data:

Per FDA's Special Control Guidance Document Surgical Sutures, performance testing including testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence to the predicate devices. Biocompatibility testing performed on each suture material type for implantable material included Cytotoxicity, Irritation and Sensitiation, and Pyrogenicity.

All testing performed has demonstrated that the GOLNIT PTFE suture is as safe and effective as the predicate, meets current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and the sutures are substantially equivalent to the predicate devices.

Design verification testing (U.S.P. <871> - Sutures - Needle Attachment; U.S.P. <881> -Tensile Strength; U.S.P. < 861> -Sutures -Diameter) was conducted to demonstrate the performance of the subject devices to prove conformance to the requirements of U.S.P. standards except for suture diameter. Stability testing was performed to support the proposed shelf life.

The materials selected were based on known biocompatibility (per ISO 10993) and are substantially equivalent to the materials used in the predicate devices listed. Biocompatibility testing performed on each suture material type for implantable material. Testing included: Cytotoxicity, Irritation, Sensitization and Pyrogenicity. The PTFE sutures were non-cytotoxic, non-irritant and non-sensitizer material.

6. Conclusion

Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Non-Absorbable Surgical Sutures except for the variance in suture diameter. There are no new questions concerning the safety and effectiveness of the device. These results support the safety and effectiveness of the devices for their intended use.

Based on the similarities to the predicate devices identified in this submission as well as the outcome of design verification, and that the new device has the same intended use, the same fundamental technology, and the same principle of operation, we conclude that the new device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.