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 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>.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the WEGO-PGCL Absorbable Surgical Monofilament Suture:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reference/Requirement	Reported Device Performance
Suture Diameter	USP 35 <861> SUTURES - DIAMETER (USP Monograph of Absorbable Surgical Suture)	The suture diameters of the proposed device comply with the diameter requirement listed in USP 35 <861> Diameter.
Needle Attachment Strength	USP 35 <871> SUTURES – NEEDLE ATTACHMENT (USP Monograph of Absorbable Surgical Suture)	The bond between suture and needle of the applicant device meets the requirements defined in USP 35 <871>.
Tensile Strength	USP 35 <881> TENSILE STRENGTH (USP Monograph of Absorbable Surgical Suture)	The tensile strengths of the proposed device comply with the tensile requirement listed in USP 35 <881> Tensile Strength.
Absorbable Surgical Suture Monograph	USP Monograph of Absorbable Surgical Suture	The performance of this absorbable sutures complies with United States Pharmacopoeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35<861>, USP 35<871> and USP35 <881>.
Residual Strength & Absorption Rate	FDA's Class II Special Controls Guidance Document: Surgical Sutures	Demonstrated and evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures. (Specific values or ranges for these are not provided in the document, only that they were demonstrated and evaluated for compliance with the guidance).
Biocompatibility (against predicate device)	ISO 10993-3, ISO 10093-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 Standard	Comply with ISO 10993-3, ISO 10093-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 Standard. (This is a comparison to the predicate, implying the predicate met these and the new device also complies).
sterility	N/A (Standard practice for surgical devices)	EO sterilized as a single-used device.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (diameter, tensile strength, needle attachment, residual strength, absorption rate, biocompatibility). It only indicates that "tests were conducted."
Data Provenance: The document does not specify the country of origin of the data. Since the manufacturer is "Foosin Medical Supplies Inc., Ltd" located in China, it's highly probable the non-clinical tests were conducted in China. The data is retrospective in the sense that these are pre-market tests performed on the device to demonstrate performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided for this type of device and study. The "ground truth" for a surgical suture's physical properties (diameter, strength, etc.) is established by comparing its performance against a universally accepted standard (e.g., United States Pharmacopoeia - USP) using validated laboratory equipment and methodologies, not by expert consensus in the typical sense for diagnostic or prognostic devices. Experts may design the tests and interpret the results, but they don't establish the ground truth through subjective assessment in this context.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation (e.g., diagnostic image reading) where there's subjectivity and potential disagreement among reviewers. For physical device testing against objective standards, the results are typically quantitative and directly measured, not subject to human adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers (e.g., radiologists) use the device to interpret cases. The WEGO-PGCL Absorbable Surgical Monofilament Suture is a physical medical device (suture) used in surgical procedures, not a diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to this device. A "standalone" performance study refers to the performance of an algorithm or AI model without human intervention, typically in diagnostic or analytical applications. This device is a physical surgical product. Its performance is evaluated through physical and material tests, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by objective, predefined standards and methodologies outlined in recognized pharmacopeias (United States Pharmacopoeia - USP) and international standards (ISO 10993 series). These standards define the acceptable range or minimum/maximum values for properties like diameter, tensile strength, and biocompatibility. The device's test results are then compared directly to these established benchmarks.

Expert Consensus: Not used for objective physical properties.
Pathology: Not used in this context.
Outcomes Data: Not used for establishing the direct physical properties in these non-clinical tests, though clinical outcomes from predicate devices would inform the safety profile.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. A "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (a surgical suture), not an AI-driven device.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no "training set" for this physical medical device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED EORM IO 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."

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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: +86-631-5621632 Fax: +86-631-5620555 Email: zsx9001@sina.com

1. Submission Correspondent
  Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. 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
1. 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 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.

1. 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

1. 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 SurgicalMonofilament Sutureis indicated for use ingeneral soft tissue approximation and/or ligation,but not for use in cardiovascular or neurologicalprocedures.	The WEGO-PGCL Absorbable SurgicalMonofilament Sutureis indicated for use ingeneral soft tissue approximation and/orligation, but not for use in cardiovascularor 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, 4-0,2-0, 0 and 1, which are the sizes identified in thecurrently recognized United StatesPharmacopoeia.	The proposed device only has 3-0 model,which is the size identified in the currentlyrecognized United States Pharmacopoeia.
Length of Suture	30cm, 45cm, 60cm, 75cm, 90cm, 100cm, 120cm,150cm, 180cm, 200cm, 250cm, 280cm, 300cm,320cm, 360cm and 390cm	SAME
Diameter of Suture	The suture diameters of proposed device complywith the diameter requirement listed in USP 35<861> Diameter.	SAME
Tensile strength	The tensile strengths of proposed device complywith the tensile requirement listed in USP 35<881> Tensile Strength	SAME
Needle Attachment	The bond between suture and needle of theapplicant device meet the requirements definedin USP 35 <871>.	SAME
Needle
Material	Stainless Steel	SAME
Needle type	Taper, Cutting, Blunt	SAME
Biocompatibility	Comply with ISO 10993-3, ISO 10093-5, ISO10993-6, 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.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
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.(b)
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.