The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Device Description

The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. It is composed of PGLA suture and needle. The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture 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, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

AI/ML Overview

The acceptance criteria for the WEGO-PGLA Absorbable Surgical Suture are defined by its compliance with various United States Pharmacopoeia (U.S.P.) monograph requirements and several international standards for medical devices. The study conducted to prove the device meets these criteria involved a series of bench tests.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard/Requirement)	Reported Device Performance
USP 35 <861> SUTURES - DIAMETER	Complies
USP 35 <871> SUTURES – NEEDLE ATTACHMENT	Complies
USP 35 <881> TENSILE STRENGTH	Complies
USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE	Complies
ASTM F88-09 (Seal Strength)	Met design specifications
ASTM F1140-07 (Internal Pressurization Failure Resistance)	Met design specifications
ASTM F1929-98(2004) (Seal Leaks)	Met design specifications
ISO 11135-1:2007 (Sterilization)	Complies
USP <85> Bacterial Endotoxin Limit	Complies
ISO 10993-3:2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity)	Complies
ISO 10993-5:1999 (In vitro cytotoxicity)	Complies
ISO 10993-6:1994 (Local Effects after Implantation)	Complies
ISO 10993-10:2002 (Irritation and delayed-type hypersensitivity)	Complies
ISO 10993-11:1993 (Systemic toxicity)	Complies
FDA's Class II Special Controls Guidance Document: Surgical Sutures (Residual Strength and Absorption Rate)	Evaluated in accordance with requirements

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test. It generally states that "Bench tests were conducted to verify that the proposed device met all design specifications."

Data Provenance: Not explicitly stated, however, the manufacturer is Foosin Medical Supplies Inc., Ltd in Weihai, Shandong, China. The testing was conducted to U.S. and International standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The "ground truth" for surgical sutures is established by compliance with published, objective, and quantitative technical standards (like USP and ISO standards) and not by expert consensus on subjective observations. The performance metrics are physical and biological measurements.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against predefined thresholds within the standards, not on subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical product (surgical suture), not an algorithm or software. Its performance is evaluated through physical and biological bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on objective, quantitative measurements and adherence to established technical standards (e.g., USP monographs for diameter, tensile strength, needle attachment, and biological evaluation standards like ISO 10993).

8. The sample size for the training set

Not applicable. This study does not involve machine learning or AI, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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JAN 1 4 2014

Exhibit# 8 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: K130735

1. Date of Submission: Jan 07, 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

3. Submission Correspondent

.. ...

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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4. Proposed Device Identification

Proposed Device Name: WEGO-PGLA Absorbable Surgical Suture Common Device Name: PGLA 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:

1. Predicate Device Identification
  510(k) Number: K122734 Product Name: Aesculap® Novosyn Absorbable Suture Manufacturer: Aesculap® Inc.
1. Device Description
  The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue

It is composed of PGLA suture and needle.

The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture 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, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.

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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 use device.

7. Non-Clinical Test Conclusion

Bench 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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: · · ·

8. Substantially Equivalent Conclusion

ITEM	Proposed Device	Predicate Device
	WEGO-PGLA Absorbable Surgical Suture	K122734
		Aesculap® Novosyn Absorbable Suture
Product Code	GAM	Same
Regulation No.	21 CFR 878.4493	Same
Class	II	Same
Sterile	Yes	Yes
Single Use	Yes	Yes
Configuration	PGLA Suture and Needle	Same
Suture
Material	90% glycolide and 10% L-lactide (PGLA)	Same
Color	Dyed suture (Violet) and Undyed suture	Same
Absorbable/Nonabsorbable	Absorbable	Same
Braided/Monofilament	Braided	Same
Suture Size	The proposed device is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.	Available suture sizes are standard according to USP requirements.
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 comply with the diameter requirement listed in USP 35 <861> Diameter.	Meet the requirements defined in the USP
Tensile strength	The tensile strengths of proposed device comply with the tensile requirement listed in USP 35 <881> Tensile Strength	Meet the requirements defined in the USP
Needle Attachment	The bond between suture and needle of the applicant device meet the requirements defined in USP 35 <871>.	Meet the requirements defined in the USP
Needle
Material	Stainless Steel	Same
Needle type	Taper, Spatula, Cutting, Blunt	Similar

Tab. 1 SE Comparison

The proposed device, WEGO-PGLA Absorbable Surgical Suture, is determined to be Substantially Equivalent (SE) to the predicate device, Aesculap® Novosyn Absorbable Suture (K122734), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Foosin Medical Supplies Incorporated, Ltd % Ms. Diana Hong PO Box 120-119 Shanghai, 200120 CHINA

January 14, 2014

Re: K130735

Trade/Device Name: WEGO-PGLA Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-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/ResourcesforYou/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 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: K130735 Device Name: WEGO-PGLA Absorbable Surgical Suture

Indications for Use:

OPRESCRIPTION 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)

Page 1 of 1

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130735

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.