WEGO-PGLA RAPID

K183001 · Foosin Medical Supplies Inc., Ltd. · GAM · Jan 28, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183001
• Device Name: WEGO-PGLA RAPID
• Applicant: Foosin Medical Supplies Inc., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jan 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Device Story

WEGO-PGLA RAPID is a synthetic, absorbable, braided surgical suture composed of 90% glycolide and 10% L-lactide copolymer. Designed for superficial soft tissue approximation of skin and mucosa requiring short-term wound support; not for ligation, ophthalmic, cardiovascular, or neurological use. Suture is coated with poly(glycolide-co-lactide) (30/70) and calcium stearate; available in various USP gauge sizes and lengths, with or without stainless steel needles. Device is EO sterilized and intended for single use. Clinicians use the suture to close wounds; the material provides temporary support before being absorbed by the body (42-56 days). Performance is verified through tensile strength, diameter, and needle attachment testing per USP standards.

Clinical Evidence

No clinical study is included in this submission. Evidence is based on bench testing, including physical performance (diameter, tensile strength, needle attachment), stability (real-time aging), and biocompatibility (genotoxicity, cytotoxicity, local effects, irritation, sensitization, systemic toxicity, pyrogenicity, and hemolysis).

Technological Characteristics

Synthetic, braided, absorbable suture; 90% glycolide/10% L-lactide copolymer. Coated with poly(glycolide-co-lactide) (30/70) and calcium stearate. EO sterilized. Complies with USP <861> (diameter), <871> (needle attachment), <881> (tensile strength), and European Pharmacopoeia standards. Biocompatibility per ISO 10993 series. Available in USP sizes 6-0 to 2.

Indications for Use

Indicated for superficial soft tissue approximation of skin and mucosa requiring short-term wound support. Contraindicated for ligation, ophthalmic, cardiovascular, or neurological procedures.

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

• VICRYL Rapide Suture (K944110)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

January 28, 2019

Foosin Medical Supplies Inc., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CN

Re: K183001

Trade/Device Name: WEGO-PGLA Rapid Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 28, 2018 Received: October 30, 2018

Dear Ms. Hong:

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 mav, 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 avare 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Cynthia Chang -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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K183001

Device Name WEGO-PGLA RAPID

Indications for Use (Describe)

WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not in ligation, ophthalmic, cardiovascular or neurological procedures.

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

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## 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}------------------------------------------------

# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K183001

- 1. Date of Preparation: 01/24/2019
- Sponsor Identification 2.

Foosin Medical Supplies Inc., Ltd No.20, Xingshan Road, Weihai Torch Hi-tech Science Park, Weihai, Shandong, 264210, China

Establishment Registration Number: 3006562124

Contact Person: Lei Tang Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

# Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

{4}------------------------------------------------

#### 4. Identification of Proposed Device

Trade Name: WEGO-PGLA RAPID

Common Name: Absorbable Synthetic Suture with or without Needle Size: USP 6-0, USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1 and USP 2

#### Regulatory Information

Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Classification: II Product Code: GAM Regulation Number: 21 CFR 878.4493 Review Panel: General & Plastic Surgery

#### Indications for Use:

WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

### Device Description

WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).

WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.

WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.

WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).

The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

{5}------------------------------------------------

- 5. Identification of Predicate Device
510(k) Number: K944110 Product Name: VICRYL Rapide Suture Manufacturer: ETHICON, INC

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > USP 40-NF 35:2017 <861> Sutures – Diameter;
- > USP 40-NF 35:2017 <871> Sutures - Needle Attachment;
- > USP 40-NF 35:2017 <881> Tensile Strength;
- A ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
- A ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
- > ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
- > ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization :
- > ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
- > USP 40-NF 35:2017 <85> Bacterial Endotoxins Test;
- > ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
- > ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;
- > USP 40-NF35:2017 <151> Pyrogen Test
- > ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials

The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging, to support the substantial equivalence between proposed device and the predicate, details are shown as follow:

{6}------------------------------------------------

| Performance | Test Sample | Test Item | Result |
|-------------------------|---------------------------------|-------------------|-------------------------|
| Physical<br>Performance | Device before<br>aging | Diameter | Complies with USP <861> |
| | | Tensile Strength | Complies with USP <881> |
| | | Needle Attachment | Complies with USP <871> |
| Stability | Device after<br>real-time-aging | Tensile Strength | Complies with USP <881> |
| | | Needle Attachment | Complies with USP <871> |

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device | Predicate Device<br>K944110 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GAM | GAM |
| Regulation<br>Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Class | II | II |
| Intended Use | WEGO-PGLA RAPID sutures are<br>intended for use in superficial soft<br>tissue approximation of skin and<br>mucosa where only short-term<br>wound support is required.<br>WEGO-PGLA RAPID is not<br>intended for use in ligation,<br>ophthalmic, cardiovascular or<br>neurological procedures. | The Vicryl Rapide Suture is indicated only<br>for use in superficial soft tissue<br>approximation of skin and mucosa where<br>only short-term wound support (7-10 days)<br>is required. Vicryl Rapide Suture is not<br>intended for use in ligation, ophthalmic,<br>cardiovascular or neurological procedures. |
| Configuration | Suture and Needle | Suture and Needle |
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Based Material | 90% glycolide and 10%<br>L-lactide.(PGLA) | 90% glycolide and 10% L-lactide (PGLA) |
| Coating<br>Material | poly(glycolide-co-lactide) (30/70)<br>and calcium stearate . | Polycaprolactone and calcium stearate |
| Color | Dyed and undyed | Dyed and undyed |
| Color Additive<br>Material | D&C Violet No.2 | D&C violet No. 2 |

## Table 1 Comparison of Proposed Device and Predicated Device

{7}------------------------------------------------

| Absorbable /<br>Non-absorbable | Absorbable | Absorbable |
|--------------------------------|---------------------------------------------------------------------------|------------|
| Braided /<br>Monofilament | Braided | Braided |
| Suture Size | USP 6-0, USP 5-0, USP 4-0, USP<br>3-0, USP 2-0, USP 0, USP 1 and USP<br>2 | Unknown |
| Length of<br>Suture | 25cm, 30cm, 45cm, 50cm, 60cm,<br>70cm, 75cm and 90cm | Unknown |
| Absorption<br>Time | 42~56days | 42 days |

The based material of proposed device is PGLA, which is similar with that of predicate device. And the performance and biocompatibility of proposed device has been demonstrated by various tests. The specifications of predicate devices are not known, however, the proposed device has been demonstrated to comply the requirements listed in USP Monograph of Absorbable Surgical Suture. The absorption time of proposed device is similar with predicate devices. The comparison and absorption tests have been conducted to confirm the absorption time of the proposed device.

#### Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.