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 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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for WEGO-PGCL Absorbable Surgical Monofilament Suture

The WEGO-PGCL Absorbable Surgical Monofilament Suture was evaluated for substantial equivalence to a predicate device (MoNo Q (PGCL), K100461) by demonstrating compliance with established performance standards for absorbable surgical sutures.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standard/Guideline)	Reported Device Performance (WEGO-PGCL)
Suture Physical Properties	USP 35 <861> SUTURES - DIAMETER: Diameter within specified limits for suture size.	Complied with the diameter requirement listed in USP 35 <861> Diameter.
	USP 35 <881> TENSILE STRENGTH: Tensile strength meets specified minimums for suture size.	Complied with the tensile requirement listed in USP 35 <881> Tensile Strength.
	USP 35 <871> SUTURES -- NEEDLE ATTACHMENT: Bond between suture and needle meets specified strength.	Met the requirements defined in USP 35 <871>.
	USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE: Overall compliance with the monograph for absorbable sutures.	Complied with the USP monograph requirements for Absorbable Surgical Suture.
	Residual Strength and Absorption Rate (FDA Class II Special Controls Guidance Document: Surgical Sutures): Demonstrated appropriate biodegradability and strength retention.	Studies performed in accordance with FDA guidance, results indicated compliance.
Packaging Integrity	ASTM F88-09 (Seal Strength of Flexible Barrier Materials): Packaging seal strength.	Test results demonstrated compliance.
	ASTM F 1140-07 (Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications): Packaging resistance to internal pressure.	Test results demonstrated compliance.
	ASTM F1929-98(2004) (Detecting Seal Leaks in Porous Medical Package by Dye Penetration): Packaging seal integrity.	Test results demonstrated compliance.
Sterilization	ISO 11135-1:2007 (Sterilization of health care products- Ethylene oxide): Requirements for EO sterilization.	Test results demonstrated compliance.
Biocompatibility	USP <85> Bacterial Endotoxin Limit: Endotoxin levels within acceptable limits.	Test results demonstrated compliance.
	ISO 10993-3:2003 (Genotoxicity, Carcinogenicity and Reproductive Toxicity): Evaluation for potential genotoxic, carcinogenic, or reproductive effects.	Complied with ISO 10993-3.
	ISO 10993-5:1999 (In vitro cytotoxicity): Evaluation for cytotoxic potential.	Complied with ISO 10993-5.
	ISO 10993-6:1994 (Local Effects after Implantation): Evaluation of local tissue reactions after implantation.	Complied with ISO 10993-6.
	ISO 10993-10:2002 (Irritation and delayed-type hypersensitivity): Evaluation for irritation and sensitization.	Complied with ISO 10993-10.
	ISO 10993-11:1993 (Systemic toxicity): Evaluation for systemic toxic effects.	Complied with ISO 10993-11.

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

The document does not explicitly state specific sample sizes for "test sets" in the context of individual tests. Instead, it refers to the performance of "non clinical tests" conducted to verify compliance with various established standards (USP, ASTM, ISO). The nature of these tests (e.g., tensile strength, diameter measurement, biocompatibility) implies that a sufficient number of samples were tested to meet the statistical requirements outlined in the respective standards.

Data Provenance: The document does not explicitly state the country of origin for the data generated from the non-clinical tests. However, the sponsor is Foosin Medical Supplies Inc., Ltd, located in Weihai, Shandong, China. The studies were non-clinical, meaning they were laboratory-based tests of the device's physical, chemical, and biological properties, not human subject data. Therefore, the data would be retrospective in the sense that it reflects the performance of manufactured batches, and its origin would be related to the manufacturing and testing facilities in China.

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

This section is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by objective, standardized measurements and criteria defined in recognized international and national standards (USP, ASTM, ISO). These tests do not involve human expert interpretation or adjudication to establish a "ground truth" in the way that, for example, medical image analysis requires expert reads. The standards themselves dictate the acceptable ranges and methodologies.

4. Adjudication Method for the Test Set

This section is not applicable as the tests are objective, standardized measurements against predefined criteria. There is no mention of subjective interpretation of results requiring an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm in diagnostic tasks, often with a focus on clinical endpoints or diagnostic accuracy. The current submission is for a medical device (surgical suture) and involves physical and biological property testing, not diagnostic imaging or clinical interpretation by multiple readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This section is not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report. The "device performance" refers to its inherent physical, chemical, and biological attributes as measured in laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests conducted is defined by the objective, quantitative criteria and methodologies specified in globally recognized standards and monographs. These include:

USP (United States Pharmacopeia) Monographs: Specifically USP 35 <861> (Diameter), USP 35 <871> (Needle Attachment), USP 35 <881> (Tensile Strength), and the general Monograph of Absorbable Surgical Suture. These documents define the precise methods and acceptable ranges for these physical properties.
ASTM (American Society for Testing and Materials) Standards: Such as ASTM F88-09, ASTM F1140-07, and ASTM F1929-98(2004) for packaging integrity. These standards provide exact testing procedures and pass/fail criteria.
ISO (International Organization for Standardization) Standards: Specifically SO 11135-1:2007 for sterilization and various parts of ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility. These standards specify how tests should be performed and what constitutes an acceptable biological response.
FDA Class II Special Controls Guidance Document: Surgical Sutures: This document provides guidance on residual strength and absorption rate studies, outlining the expectations for acceptable performance.

Essentially, the ground truth is compliance with established, quantitative, and scientifically validated testing standards.

8. The Sample Size for the Training Set

This section is not applicable. This submission is for a medical device (surgical suture), not a machine learning model or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The testing conducted is to demonstrate product quality and compliance with established standards.

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

This section is not applicable for the same reasons as point 8; there is no training set for this device.

Summary

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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

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

Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-199, Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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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 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 SurgicalMonofilament Suture	K100461MoNo 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 thesizes identified in the currently recognizedUnited States Pharmacopoeia.	Available suture sizes arestandard according to USPrequirements.
Length of Suture	30cm, 45cm, 60cm, 75cm, 90cm, 100cm,120cm, 150cm, 180cm, 200cm, 250cm, 280cm,300cm, 320cm, 360cm and 390cm	Unknown
Diameter of Suture	The suture diameters of proposed device complywith the diameter requirement listed in USP 35<861> Diameter.	Meet the requirements defined inthe USP
Tensile strength	The tensile strengths of proposed device complywith the tensile requirement listed in USP 35<881> Tensile Strength	Meet the requirements defined inthe USP
Needle Attachment	The bond between suture and needle of theapplicant device meet the requirements definedin USP 35 <871>	Meet the requirements defined inthe USP
	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

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

E10-1

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.