WEGO-PGCL Absorbable Surgical Monofilament Suture

K142810 · Foosin Medical Supplies Inc., Ltd. · GAM · Nov 14, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142810
• Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture
• Applicant: Foosin Medical Supplies Inc., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Special
• 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, monofilament, absorbable suture composed of poly(glycolide-co-caprolactone) (PGCL). It is provided sterile for single-use in clinical settings for soft tissue approximation and ligation. The device is available in various sizes (6-0 to 1) and lengths, with or without stainless steel needles. It functions by providing temporary wound support during the healing process before being absorbed by the body. Healthcare providers, such as surgeons, use the suture to close incisions or ligate vessels. The device benefits patients by facilitating tissue healing while minimizing the need for suture removal due to its absorbable nature.

Clinical Evidence

Bench testing only. Compliance with USP 35 <861> (diameter), USP 35 <871> (needle attachment), and USP 35 <881> (tensile strength) was demonstrated. Biocompatibility testing was performed in accordance with ISO 10993-3, 5, 6, 10, and 11. Residual strength and absorption rates were evaluated per FDA Class II Special Controls Guidance for Surgical Sutures.

Technological Characteristics

Material: Poly(glycolide-co-caprolactone) (PGCL); Colorant: D&C violet No. 2 (CI 60725); Needle: Stainless steel; Sterilization: Ethylene Oxide (EO); Standards: USP 35 <861>, <871>, <881>; Biocompatibility: ISO 10993 series; Form factor: Monofilament suture with/without needle; Sizes: 6-0, 5-0, 4-0, 2-0, 0, 1.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular or neurological procedures. Applicable to all patient populations requiring soft tissue 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

• WEGO-PGCL Absorbable Surgical Monofilament Suture (K130737)

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

November 14, 2014

Foosin Medical Supplies Incorporated, LTD Ms. Diana Hong MID-LINK Consulting Company, LTD P.O. Box 120-119 200120 Shanghai China

Re: K142810

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: October 27, 2014 Received: October 30, 2014

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

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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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/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 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 yours,

# 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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DEPARIMENT OF HEALIH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K142810

Device Name

WEGO-PGCL Absorbable Surgical Monofilament Suture

Proposed Models: 6-0, 5-0, 4-0, 2-0, 0 and 1

Indications for Use (Describe)

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

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

2 Prescription Use (Part 21 CER 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## Section 3 510(k) Summary

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

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- 1. Date the summary was prepared: 09/01/2014
- 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: 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 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. Proposed Device Identification
Proposed Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Common Device Name: PGCL Synthetic Absorbable Suture Proposed Models: 6-0, 5-0, 4-0, 2-0, 0 and 1

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.

- న్. Predicate Device Identification
510(k) Number: K130737 Product Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Manufacturer: Foosin Medical Supplies Inc., Ltd

- 6. Device Description
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 is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes 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>.

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

- 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

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

- 8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device(s) | Predicate Device |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K130737 |
| Product Code | GAM | GAM |
| Regulation Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Class | II | II |
| Intended Use | The WEGO-PGCL Absorbable Surgical<br>Monofilament Sutureis indicated for use in<br>general soft tissue approximation and/or ligation,<br>but not for use in cardiovascular or neurological<br>procedures. | The WEGO-PGCL Absorbable Surgical<br>Monofilament Sutureis indicated for use in<br>general soft tissue approximation and/or<br>ligation, but not for use in cardiovascular<br>or neurological procedures. |
| Configuration | PGCL Suture and Needle | PGCL Suture and Needle |
| Sterile | Yes | Yes |
| Single Use | Yes | Yes |
| Suture | | |
| Material | glycolide-co-caprolactone (PGCL) | SAME |
| Color | Dyed suture (Violet), Undyed Suture | SAME |

Table 3-1 Comparison of Technology Characteristics

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Project #: M0092014

| Absorbable/Nonabsorbable | Absorbable | SAME |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Multifilament/Monofilament | Monofilament | SAME |
| Suture Size | The proposed device is available in6-0, 5-0, 4-0,<br>2-0, 0 and 1, which are the sizes identified in the<br>currently recognized United States<br>Pharmacopoeia. | The proposed device only has 3-0 model,<br>which is the size identified in the currently<br>recognized United States Pharmacopoeia. |
| Length of Suture | 30cm, 45cm, 60cm, 75cm, 90cm, 100cm, 120cm,<br>150cm, 180cm, 200cm, 250cm, 280cm, 300cm,<br>320cm, 360cm and 390cm | SAME |
| Diameter of Suture | The suture diameters of proposed device comply<br>with the diameter requirement listed in USP 35<br><861> Diameter. | SAME |
| Tensile strength | The tensile strengths of proposed device comply<br>with the tensile requirement listed in USP 35<br><881> Tensile Strength | SAME |
| Needle Attachment | The bond between suture and needle of the<br>applicant device meet the requirements defined<br>in USP 35 <871>. | SAME |
| 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 |

The proposed device, WEGO-PGCL Absorbable Surgical Monofilament Suture, is determined to be Substantially Equivalent (SE) to the predicate device, WEGO-PGCL Absorbable Surgical Monofilament Suture (K130737), in respect of safety and effectiveness.