MONOFIX PGCL, knotless wound closure device

K212810 · Samyang Holdings Corp., Ltd. · GAM · Aug 5, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K212810
• Device Name: MONOFIX PGCL, knotless wound closure device
• Applicant: Samyang Holdings Corp., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Aug 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

Device Story

Synthetic absorbable monofilament suture; PGA-PCL material; features uni-directional barbs and triangular stopper for tissue anchoring; eliminates need for manual knots. Available in lengths 15-60cm, sizes 1 to 3-0, with various needle shapes. Used by clinicians in surgical settings for soft tissue approximation. Device functions by anchoring tissue via barbs and stopper, providing mechanical closure. Benefits include simplified wound closure procedure without knot tying.

Clinical Evidence

Bench testing only. Compliance with USP <861> (diameter), USP <871> (needle attachment), USP <881> (tensile strength), and USP/EP monographs for absorbable sutures. Biocompatibility testing per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation, hemolysis) and ASTM F756-17. Sterilization validated per ISO 11135:2014 and ISO 10993-7. Sterile barrier integrity per ASTM F88 and accelerated aging per ASTM F1980.

Technological Characteristics

Material: Poly(glycolide-co-ε-carprolactone) (PGA-PCL). Form: Monofilament, undyed, barbed. Dimensions: 15-60cm length, USP sizes 1 to 3-0. Needle: Stainless steel. Sterilization: Ethylene oxide (EO). Standards: USP <861>, <871>, <881>; ISO 10993; ISO 11135; ASTM F88; ASTM F1980; ASTM F756-17.

Indications for Use

Indicated for soft tissue approximation in patients where absorbable suture is appropriate. Contraindicated for tissue under tension; not shown safe for hernia, laparotomy, bowel anastomosis, vascular suture lines, or vaginal cuff closure.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

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

• Quill™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design (K141778)

Reference Devices

• STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device (K182873)

Submission Summary (Full Text)

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August 5, 2022

Samyang Holdings Corp., Ltd. % Sanglok Lee Manager Wise Company Inc. #507,#508 166, Gasan digital 2-ro Geumcheon-gu, Seoul 08503 Korea, South

Re: K212810

Trade/Device Name: MONOFIX PGCL, knotless wound closure device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 30, 2021 Received: September 3, 2021

Dear Sanglok Lee:

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.

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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 and Part 809 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K212810

Device Name MONOFIX PGCL, knotless wound closure device

#### Indications for Use (Describe)

MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

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

| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------|
| <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# The assigned 510(k) Number: K212810

## 01. Date of Submission: 05.20.2022

## 02. Applicant

Company name: Samvang Holdings Corp., Ltd. Address: 55, Munpyeongseo-ro, 18beon-gil, Daedeok-gu, Daejeon, 34302, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

### 03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #507, 166, Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

## 04. Subject Device Identification

Trade Name: MONOFIX PGCL, knotless wound closure device Common Name: Absorbable PGA-PCL surgical suture with needle Classification Name: Absorbable poly(glycolide/l-lactide) surgical suture Product Code: GAM Panel: General and Plastic Surgery Devices Regulation Number: 21 CFR 878.4493 Device Class: II

### 05. Indication for use

MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

## 06. Predicate devices

Predicate device 510(k) Number: K141778 Device Name: Quill™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design Manufacturer: Surgical Specialties Corporation

Reference device 510(k) Number: K182873 Device Name: STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device Manufacturer: Ethicon

### 07. Device Description

MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along

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the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.

## 08. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:

Class II Special Controls Guidance Document: Surqical Sutures: Guidance for Industry and FDA USP <861> Suture Diameter USP <871> Suture-Needle attachment USP <881> Tensile Strength Surgical Suture USP Monographs: Absorbable Surgical Suture EP Monographs: Sutures, Sterile Synthetic Absorbable Monofilament

## Sterilization

ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development. validation and routine control of a sterilization process for medical devices ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Sterile barrier system testing ASTM F 88, Standard Test Method for Seal Strength of Flexible Barrier Materials

## Accelerated aging stability testing

- ASTM F 1980, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility)

### Biocompatibility testing

- 1) Suture Needle
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-4: Selection of tests for interactions with blood
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials

### 2) Suture

- ISO 10993-1: Selection of Tests
- ISO 10993-2: Animal Welfare
- ISO 10993-12: Sample Preparation
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-3: Tests for Genotoxicity
- ISO 10993-6: Test for Local Effects after Implantation
- ISO 10993-4: Selection of tests for interactions with blood
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
- In vivo tensile strength of Monofix PGCL was performed to evaluate the tensile strength retention rate.

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# 09. Substantially Equivalent Conclusion

# Table 1: Substantial Equivalence Comparison

| Product Name | Subject Device | Predicate Device | Reference Device | Equivalence<br>Discussion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 510(k) Number | k212810 | K141778 | K182873 | |
| Product Code | GAM | GAM | GAM | same |
| Indications for<br>use statements | MONOFIX PGCL, knotless<br>wound closure device is<br>indicated for use in soft<br>tissue approximation where<br>the use of absorbable suture<br>is appropriate. MONOFIX<br>PGCL, knotless wound<br>closure device should not be<br>used to approximate tissue<br>under tension and the use of<br>barbed suture has not been<br>shown to be safe in the<br>closure of hernias,<br>laparotomy incisions, bowel<br>anastomosis or suture lines,<br>vascular suture lines, and<br>vaginal cuff closure in<br>controlled clinical or<br>preclinical studies for<br>minimally invasive or open<br>surgery. | Quill™ MONODERM™<br>Device is indicated for use in<br>soft tissue approximation<br>where the use of absorbable<br>sutures is appropriate. | STRATAFIX™ Spiral<br>MONOCRYL™ Knotless<br>Tissue Control Device is<br>indicated for use in soft<br>tissue approximation where<br>the use of absorbable<br>sutures is appropriate. | same |
| Class | II | II | II | same |
| Sterile | Yes | Yes | Yes | same |
| Single Use | Single use | Single use | Single use | same |
| Material | Poly(glycolide-co-ε-<br>carprolactone)(PGA-PCL) | Poly(glycolide-co-ε-<br>carprolactone)(PGA-PCL) | Poly(glycolide-co-ε-<br>carprolactone)(PGA-PCL) | same |
| Color | Undyed | Undyed, Dyed(Violet) | Undyed | Same<br>Analysis 1 |
| Absorbable/<br>Non-absorbable | absorbable | absorbable | absorbable | same |
| Braided/<br>Monofilament | Monofilament | Monofilament | Monofilament | same |
| Barbed/<br>Not Barbed | Uni-directional barbs | Uni-directional barbs | Uni-directional barbs | same |
| Suture Size | USP size 1 to 3-0 | USP size 1 to 4-0 | unknown | same |
| Needle Material | Stainless steel | Stainless steel | Stainless steel | same |
| Sterilization | EO | EO | EO | same |
| USP Diameter<br>Requirements | Oversize.<br>Suture meets requirements<br>for "Absorbable Surgical<br>Suture" except diameter. | Suture meets exceeds<br>requirements for<br>"Absorbable Surgical Suture" except diameter. | Oversize.<br>Suture meets requirements<br>for "Absorbable Surgical<br>Suture" except diameter. | Same<br>Analysis 2 |
| Tensile Strength<br>requirements | Suture meets the<br>performance requirements<br>defined for "Tensile strength"<br><881> | Suture meets the<br>performance requirements<br>defined for "Tensile strength"<br><881> | Suture meets the<br>performance requirements<br>defined for "Tensile strength"<br><881> | same |
| Needle<br>Attachment<br>Requirements | Suture meets the<br>performance requirements<br>defined for "Needle<br>Attachment" <871> | Suture meets the<br>performance requirements<br>defined for "Needle<br>Attachment" <871> | Suture meets the<br>performance requirements<br>defined for "Needle<br>Attachment" <871> | same |

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# Analysis 1 - Color

The suture of predicate device is undyed and dyed. The suture is only available in undyed. K182873 added as a reference device to support the difference in undyed characteristic. This difference does not affect the safety and effectiveness of the product.

# Analysis 2 - USP Diameter Requirements

USP designations for diameter are used to describe MONOFIX PDO Device suture after barbing except for minor variation in suture diameter with a maximum average of 0.1 mm.

The actual diameter of the non-barbed section fiber is one size greater size with a maximum overage of 0.1 mm.

The USP and EU Pharmacopoeia sizes of the Proposed Device are further defined in Table 1.

### Table 1. Diameter Comparison

| USP Device size<br>Designation | EU Pharmacopoeia<br>Device size<br>(Metric / Ph. Eur.)<br>Designation | MONOFIX PGCL,<br>knotless wound closure device | | |
|--------------------------------|-----------------------------------------------------------------------|------------------------------------------------|----------------------|--------------------------|
| | | USP | Metric /<br>Ph. Eur. | Tensile strength<br>size |
| 1 | 4 | 1 | 4 | 0 |
| 0 | 3.5 | 0 | 3.5 | 2-0 |
| 2-0 | 3 | 2-0 | 3 | 3-0 |
| 3-0 | 2 | 3-0 | 2 | 4-0 |

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is oversized barbed suture. K182873 added as a reference device to support the difference in USP Diameter characteristic.

## 10. Conclusion

The subject device, MONOFIX PGCL, knotless wound closure device, is determined to be Substantially Equivalent (SE) to the predicate devices, QuilI™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design (K141778) in respect of safety and effectiveness.