SYNTHETIC ABSORBABLE SUTURE

K130737 · Foosin Medical Supplies Inc., Ltd. · GAM · Jan 14, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K130737
• Device Name: SYNTHETIC ABSORBABLE SUTURE
• Applicant: Foosin Medical Supplies Inc., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jan 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.

Device Story

WEGO-PGCL Absorbable Surgical Monofilament Suture is a synthetic, absorbable monofilament suture composed of poly(glycolide-co-caprolactone) (PGCL). Device is provided EO sterilized for single use. Suture is available in dyed (D&C violet No. 2) or undyed forms, attached to stainless steel needles (taper, cutting, or blunt types). Used by clinicians for soft tissue approximation and ligation. Performance complies with USP monograph requirements for absorbable surgical sutures, including diameter, needle attachment, and tensile strength. Device provides mechanical support to tissue during healing before being absorbed by the body.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance verified via USP 35 standards (diameter, needle attachment, tensile strength), ASTM standards for packaging integrity (F88, F1140, F1929), and ISO 10993 series for biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity). Residual strength and absorption rate studies performed per FDA Class II Special Controls Guidance.

Technological Characteristics

Material: Poly(glycolide-co-caprolactone) (PGCL). Needle: Stainless steel. Form: Monofilament, dyed/undyed. Sterilization: Ethylene Oxide (ISO 11135-1). Standards: USP 35 <861>, <871>, <881>; ASTM F88, F1140, F1929; ISO 10993. Connectivity: None (mechanical device).

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for 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

• MoNo Q (PGCL) (K100461)

Submission Summary (Full Text)

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K130737 Page 1/5 E9 Revised 510(k) Summary

# JAN 1 4 2014

# Exhibit #9 Revised 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K130737

- 1. Date of Submission: Jan 08, 2014
2. Sponsor

> 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: Suxia Zhao Position: Deputy Chief Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

3. Submission Correspondent

> Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-199, Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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### Proposed Device Identification 4.

Proposed Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Common Device Name: PGCL Synthetic Absorbable Suture

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

### Intended Use Statement:

The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.

Predicate Device Identification 5.

> 510(k) Number: K100461 Product Name: MoNo Q (PGCL) Manufacturer: Riverpoint Medical

### Device Description 6.

The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery.

The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL): and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture.

The proposed suture size is 3-0, which is the size identified in the currently recognized United States Pharmacopoeia.

The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35<861>, USP 35<871> and USP35 <881>.

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

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## 7. 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 35 <861> SUTURES - DIAMETER

USP 35 <871> SUTURES -- NEEDLE ATTACHMENT

USP 35 <881> TENSILE STRENGTH

USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE

ASTM F88-09, Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications;

ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;

USP <85> Bacterial Endotoxin Limit

ISO 10993, Biological Evaluation of Medical Devices;

Including:

ISO 10993-3:2003 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity :

ISO 10993-5:1999, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;

ISO 10993-6:1994 Biological Evaluation of Medical Devices, Part6: Test for Local Effects after Implantation;

ISO 10993-10:2002, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;

ISO 10993-11:1993. Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity International Organization for Standardization.

Additionally, the residual strength and absorption rate studies were performed and the sutures were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures

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| | Tab. 3-1 SE Comparison | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| ITEM | Proposed Device | Predicate Device |
| Product Code | WEGO-PGCL Absorbable Surgical<br>Monofilament Suture | K100461<br>MoNo Q (PGCL) |
| Regulation No. | GAM | Same |
| Class | 21 CFR 878.4493 | Same |
| Sterile | II | Same |
| Single Use | Yes | Yes |
| Configuration | Yes | Yes |
| | PGCL Suture and Needle | Same |
| | Suture | |
| Material | glycolide-co-caprolactone (PGCL) | Same |
| Color | Dyed suture (Violet), Undyed Suture | Same |
| Absorbable/Nonabsorbable | Absorbable | Same |
| Multifilament/Monofilament | Monofilament | Same |
| Suture Size | The proposed device size is 3-0, which is the<br>sizes identified in the currently recognized<br>United States Pharmacopoeia. | Available suture sizes are<br>standard according to USP<br>requirements. |
| Length of Suture | 30cm, 45cm, 60cm, 75cm, 90cm, 100cm,<br>120cm, 150cm, 180cm, 200cm, 250cm, 280cm,<br>300cm, 320cm, 360cm and 390cm | Unknown |
| Diameter of Suture | The suture diameters of proposed device comply<br>with the diameter requirement listed in USP 35<br><861> Diameter. | Meet the requirements defined in<br>the USP |
| Tensile strength | The tensile strengths of proposed device comply<br>with the tensile requirement listed in USP 35<br><881> Tensile Strength | Meet the requirements defined in<br>the USP |
| Needle Attachment | The bond between suture and needle of the<br>applicant device meet the requirements defined<br>in USP 35 <871> | Meet the requirements defined in<br>the USP |
| | Needle | |
| Material | Stainless Steel | Same |
| Needle type | Taper, Cutting, Blunt | Same |
| Biocompatibility | Comply with ISO 10993-3, ISO 10093-5, ISO<br>10993-6, ISO 10993-10, ISO 10993-11 Standard | Same |

### 8. Substantially Equivalent Conclusion

The proposed device, WEGO-PGCL Absorbable Surgical Monofilament Suture, is determined to be E9-4

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ﺮ

.

E9 Revised 510(k) Summary

Substantially Equivalent (SE) to the predicate device, MoNo Q (PGCL) (K100461), in respect of safety and effectiveness.

E9-5

. -

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Foosin Medical Supplies Incorporated, Ltd c/o Ms. Diana Hong January 14, 2014 P.O. BOX 120-119 Shanghai, 200120 CHINA

Re: K130737

Trade/Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/1-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: December 2, 2013 Received: December 4, 2013

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Diana Hong

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerely yours,

# Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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...

## Exhibit #10 Indications for Use

510(k) Number: K130737

Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture

Indications for Use:

The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.

& PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause -S

Page 1 of 1

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130737

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