GOLNIT Non-Absorbable PTFE Surgical Suture

K163049 · Antarma Dba Golnit Sutures · NBY · Jun 21, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163049
• Device Name: GOLNIT Non-Absorbable PTFE Surgical Suture
• Applicant: Antarma Dba Golnit Sutures
• Product Code: NBY · General, Plastic Surgery
• Decision Date: Jun 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5035
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

GOLNIT Non-Absorbable PTFE Surgical Suture is a sterile, single-use, non-absorbable monofilament suture manufactured from 100% virgin expanded polytetrafluoroethylene (ePTFE). The device is used by clinicians for soft tissue approximation and ligation in the oral cavity, including barrier membrane fixation. The suture is supplied in various lengths and diameters (U.S.P. 2-0 to 6-0), either loose or swaged to medical-grade stainless steel needles of various curvatures and tips. The device is intended for short-term implantation (up to 30 days). It is provided in a double-pouch sterile packaging system and sterilized via ethylene oxide. The clinician uses the suture to secure tissue or membranes; the device remains in place until removed. The material is biocompatible, non-cytotoxic, and non-pyrogenic, providing a stable, inert mechanical closure for oral surgical sites.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including USP performance requirements (tensile strength, needle attachment, diameter) and biocompatibility testing (cytotoxicity, irritation, sensitization, and pyrogenicity per ISO 10993).

Technological Characteristics

Material: 100% virgin expanded polytetrafluoroethylene (ePTFE) monofilament. Suture sizes: U.S.P. 2-0 to 6-0 (oversized diameter). Needle: Medical-grade stainless steel. Sterilization: Ethylene oxide (ISO 11135). Packaging: Double-pouch (ISO 11607-1/2, EN 868-5). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation).

Indications for Use

Indicated for approximation and ligation of soft tissue in the oral cavity, including fixation of barrier membranes. Not for use in central nervous system or central circulatory system procedures.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Osteogenics Biomedical, Inc. Cytoplast™ Sutures (K003028)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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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 Badalyan<br>Chief Executive Officer, Antarma LLC<br>1204 Avenue U, #2030<br>Brooklyn, NY 11229<br>718-219-0731<br>[e-mail] |
| Proprietary Name: | GOLNIT Non-Absorbable Surgical Suture |
| Common Names: | Non-absorbable Surgical Suture, Synthetic:<br>• 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.

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.

### 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

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.

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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 Equivalence<br>Comparison | | | |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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:<br>Class II per 21 CFR 878.5035 | Same |
| Product Code | NBY | NBY | Same |
| Intended Use | GOLNIT Non-Absorbable PTFE<br>Surgical Suture is a<br>removable, non-<br>absorbable surgical<br>suture intended for use in<br>the approximation and<br>ligation of soft tissue in<br>the oral cavity including<br>fixation of barrier<br>membranes. | The CytoplastTM Suture is<br>intended for use in the<br>approximation and ligation<br>of soft tissue in the oral<br>cavity, including fixation<br>of barrier membrane. | The new device has the<br>same Intended Use as<br>Cytoplast Suture<br>(K003028) for oral cavity<br>suturing. |
| How Supplied | PTFE: Sterile<br>monofilament, thread,<br>undyed (natural) in<br>various sizes with<br>attached needles<br>Approximate U.S.P.<br>Sizes:2-0 to 6-0 | PTFE: Sterile<br>monofilament, thread,<br>undyed (natural) in various<br>sizes with attached needles<br>U.S.P. Sizes: 2-0 to 4-0 | The How Supplied for the<br>new device is comparable<br>to the predicate device,<br>CytoplastTM Sutures, in<br>terms of USP sizes (gauge)<br>and attachment of needles. |
| Use | Single Use Only | Single Use Only | Same |
| Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence<br>Comparison | | | |
| Feature | New Device | Predicate Device | Discussion |
| Color | Natural (undyed) | Natural (undyed) | Same |
| Material<br>Composition | Polytetrafluoroethylene<br>(ePTFE) polymer (100%),<br>expanded and uncoated<br>monofilaments | Polytetrafluoroethylene<br>(PTFE) polymer,<br>monofilament, uncoated,<br>high density monofilament | The polymer format of the<br>new device is expanded<br>whereas the Cytoplast™<br>Suture polymer is extruded<br>as a high density PTFE<br>monofilament. |
| Needle Choices | Stainless steel: Needle tips:<br>Taper, Reverse Cutting,<br>Taper-Cutting,<br>Needle Curvature: $\frac{1}{2}$ , 3/8,<br>5/8, $\frac{1}{4}$ , and straight<br>Length: various | Similar: Stainless steel<br>needles with various<br>needles points and needle<br>curvature | The types of GOLNIT<br>needle tips and shapes are<br>similar to the predicate<br>devices and provides a<br>range of eyeless suture<br>needle designs for user<br>convenience or preference. |
| Suture<br>Characteristics | Non-absorbable and does<br>not undergo any changes in<br>vivo. | Not absorbed and no<br>significant changes known<br>to occur in vivo. | The new device test results<br>indicate requirements met<br>for Biocompatibility per<br>ISO 10993 per FDA<br>Special Controls Guidance<br>Class II Special Controls<br>Guidance Document:<br>Surgical Sutures; Section<br>7. The sutures are<br>biocompatible for<br>implantation of short<br>duration less than 30 days. |
| Suture<br>Diameter,<br>Suture Length | Meets U.S.P. requirements<br>except for variance in | Meets U.S.P. requirements | New device with the<br>expanded PTFE |
| Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence Comparison | | | |
| Feature | New Device | Predicate Device | Discussion |
| Needle<br>Attachment,<br>Strength, Knot<br>Pull Tensile | diameters. | | monofilament (designated<br>as ePTFE) differs from<br>USP requirements for<br>diameter. |
| Packaging | Dry packaged in tear-open<br>double, paper/PET/CPP<br>pouches | Dry packaged in<br>paper/polyester-propylene<br>tear-open pouch | New device has same or<br>equivalent design to the<br>predicate devices. |
| Safety | Biocompatible per<br>ISO10993 for<br>cytotoxicity, maximum<br>sensitization and<br>irritation. | Biologically inert, non-<br>cytotoxic | New device has same or<br>equivalent biocompatibility<br>to the predicate devices<br>tested per ISO 10993-5 for<br>cytotoxicity and 10993-10<br>for maximum sensitization<br>and irritation. |
| | Non-pyrogenic | Not determined | The new device has been<br>tested to verify non-<br>pyrogenicity characteristic<br>per USP. There is no impact<br>on the product safety. |
| | Sterilization per ISO<br>11135 | 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.