WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Device Description

WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).

WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.

WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.

WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).

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

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "WEGO-PGLA RAPID" sutures. The submission aims to demonstrate substantial equivalence to a predicate device, VICRYL Rapide Suture (K944110), through non-clinical testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with established standards (USP and ISO). The reported device performance indicates that the WEGO-PGLA RAPID sutures met these standards.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Result)
USP 40-NF 35:2017 <861> Sutures – Diameter	Complies with USP <861> (for device before aging)
USP 40-NF 35:2017 <881> Tensile Strength	Complies with USP <881> (for device before and after real-time-aging)
USP 40-NF 35:2017 <871> Sutures - Needle Attachment	Complies with USP <871> (for device before and after real-time-aging)
ISO 10993-3:2014 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity	Complies (implied by inclusion in test list)
ISO 10993-5:2009 Tests for in vitro cytotoxicity	Complies (implied by inclusion in test list)
ISO 10993-6:2007 Tests for local effects after implantation	Complies (implied by inclusion in test list)
ISO 10993-10: 2010 Tests for irritation and skin sensitization	Complies (implied by inclusion in test list)
ISO 10993-11:2006 Tests for systemic toxicity	Complies (implied by inclusion in test list)
USP 40-NF 35:2017 <85> Bacterial Endotoxins Test	Complies (implied by inclusion in test list)
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials	Complies (implied by inclusion in test list)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration	Complies (implied by inclusion in test list)
ISO 10993-7:2008 Ethylene oxide sterilization residuals	Complies (implied by inclusion in test list)
USP 40-NF35:2017 <151> Pyrogen Test	Complies (implied by inclusion in test list)
ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials	Complies (implied by inclusion in test list)
Absorption Time	42-56 days (Proposed Device) vs. 42 days (Predicate Device) - deemed "similar"

Note: For the ISO and ASTM standards listed, the document states "The test results demonstrated that the proposed device complies with the following standards," implying that compliance with these standards serves as the acceptance criteria. Specific numerical performance data for these biological and packaging tests are not provided in this summary.

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

Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., number of sutures tested for tensile strength). It refers to "testing on samples" for physical performance and stability.
Data Provenance: The studies were non-clinical tests conducted by the manufacturer, Foosin Medical Supplies Inc., Ltd, based in Weihai, Shandong, China. The data would be prospective as it's generated specifically for this submission.

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

Not applicable. This submission is for a surgical suture and relies on objective, standard-based non-clinical testing rather than expert-based ground truth for the device's technical specifications. The "ground truth" here is compliance with the specified international and national standards.

4. Adjudication method for the test set

Not applicable. The testing involves objective measurements against predefined criteria in standards, not subjective assessments requiring adjudication by multiple experts.

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 is a submission for a surgical suture, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This is for a surgical suture, not an algorithm or AI device.

7. The type of ground truth used

The ground truth used is the standards and specifications outlined in the referenced USP and ISO documents. The device's performance is compared against the requirements within these standards (e.g., specific diameter ranges, tensile strength thresholds, biocompatibility criteria).

8. The sample size for the training set

Not applicable. There is no AI component in this device; thus, no training set is relevant.

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

Not applicable. As there is no AI component, there is no training set or ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

January 28, 2019

Foosin Medical Supplies Inc., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CN

Re: K183001

Trade/Device Name: WEGO-PGLA Rapid Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 28, 2018 Received: October 30, 2018

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Cynthia Chang -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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Indications for Use

510(k) Number (if known) K183001

Device Name WEGO-PGLA RAPID

Indications for Use (Describe)

WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not in ligation, ophthalmic, cardiovascular or neurological procedures.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

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

The assigned 510(k) Number: K183001

1. Date of Preparation: 01/24/2019
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: Lei Tang Position: Quality Manager Tel: +86-631-5661968 Fax: +86-631-5621680 Email: tang-lei@live.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: WEGO-PGLA RAPID

Common Name: Absorbable Synthetic Suture with or without Needle Size: USP 6-0, USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1 and USP 2

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

Indications for Use:

Device Description

WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.

WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.

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

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1. Identification of Predicate Device
  510(k) Number: K944110 Product Name: VICRYL Rapide Suture Manufacturer: ETHICON, INC
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 40-NF 35:2017 <861> Sutures – Diameter;
USP 40-NF 35:2017 <871> Sutures - Needle Attachment;
USP 40-NF 35:2017 <881> Tensile Strength;
A ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
A ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization :
ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
USP 40-NF 35:2017 <85> Bacterial Endotoxins Test;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;
USP 40-NF35:2017 <151> Pyrogen Test
ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials

The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging, to support the substantial equivalence between proposed device and the predicate, details are shown as follow:

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Performance	Test Sample	Test Item	Result
PhysicalPerformance	Device beforeaging	Diameter	Complies with USP <861>
		Tensile Strength	Complies with USP <881>
		Needle Attachment	Complies with USP <871>
Stability	Device afterreal-time-aging	Tensile Strength	Complies with USP <881>
		Needle Attachment	Complies with USP <871>

1. Clinical Test Conclusion
  No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate DeviceK944110
Product Code	GAM	GAM
RegulationNumber	21 CFR 878.4493	21 CFR 878.4493
Class	II	II
Intended Use	WEGO-PGLA RAPID sutures areintended for use in superficial softtissue approximation of skin andmucosa where only short-termwound support is required.WEGO-PGLA RAPID is notintended for use in ligation,ophthalmic, cardiovascular orneurological procedures.	The Vicryl Rapide Suture is indicated onlyfor use in superficial soft tissueapproximation of skin and mucosa whereonly short-term wound support (7-10 days)is required. Vicryl Rapide Suture is notintended for use in ligation, ophthalmic,cardiovascular or neurological procedures.
Configuration	Suture and Needle	Suture and Needle
Sterility	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Based Material	90% glycolide and 10%L-lactide.(PGLA)	90% glycolide and 10% L-lactide (PGLA)
CoatingMaterial	poly(glycolide-co-lactide) (30/70)and calcium stearate .	Polycaprolactone and calcium stearate
Color	Dyed and undyed	Dyed and undyed
Color AdditiveMaterial	D&C Violet No.2	D&C violet No. 2

Table 1 Comparison of Proposed Device and Predicated Device

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Absorbable /Non-absorbable	Absorbable	Absorbable
Braided /Monofilament	Braided	Braided
Suture Size	USP 6-0, USP 5-0, USP 4-0, USP3-0, USP 2-0, USP 0, USP 1 and USP2	Unknown
Length ofSuture	25cm, 30cm, 45cm, 50cm, 60cm,70cm, 75cm and 90cm	Unknown
AbsorptionTime	42~56days	42 days

The based material of proposed device is PGLA, which is similar with that of predicate device. And the performance and biocompatibility of proposed device has been demonstrated by various tests. The specifications of predicate devices are not known, however, the proposed device has been demonstrated to comply the requirements listed in USP Monograph of Absorbable Surgical Suture. The absorption time of proposed device is similar with predicate devices. The comparison and absorption tests have been conducted to confirm the absorption time of the proposed device.

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.

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.