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

Device Description

WEGO-PGA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of Polyglycolic Acid (PGA). The formula of the polymer is (CH2O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGA suture. WEGO-PGA RAPID sutures are available undyed violet with D&C Violet No.2 (Colour Index number 60725). WEGO-PGA RAPID sutures are coated with polycaprolactone and calcium stearate.

The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40<861>, USP 40<871> and USP 40 <881>.

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

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (WEGO-PGA RAPID sutures) and includes information about non-clinical tests conducted to demonstrate its performance and substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets acceptance criteria in the context of AI/ML performance, nor does it present acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.

Therefore, I cannot fulfill the request as it pertains to AI/ML device acceptance criteria and a study proving those criteria are met. The document focuses on regulatory compliance for a traditional medical device (surgical sutures) through non-clinical testing against established standards and comparison to a predicate device.

Here's an analysis of the provided text in relation to your specific questions, highlighting what is not present for an AI/ML device:

A table of acceptance criteria and the reported device performance:
- Not present for an AI/ML device. The document lists standards the device complies with (e.g., USP monographs for suture properties, ISO standards for biocompatibility) and states that "The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging." It does not provide specific acceptance criteria values (e.g., "Accuracy > 90%") or reported performance metrics (e.g., "Accuracy achieved 92%") as would be expected for an AI/ML device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present for an AI/ML device. The non-clinical tests described involve physical and biological testing of suture samples (e.g., diameter, tensile strength, sterility, biocompatibility). The document does not specify sample sizes for these tests in an AI/ML context, nor does it refer to "data provenance" as it would for a dataset used to evaluate an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present for an AI/ML device. Ground truth establishment by experts is not relevant to the non-clinical testing of surgical sutures described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present for an AI/ML device. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, not for physical and biological testing of sutures.
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 present. This type of study is specifically for evaluating the impact of AI assistance on human performance. The document explicitly states: "No clinical study is included in this submission."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not present. There is no algorithm or AI component described for this device. The testing pertains to the physical and biological properties of the suture itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not present for an AI/ML device. The "ground truth" for the non-clinical tests consists of established scientific and regulatory standards (e.g., USP monographs for tensile strength, biocompatibility test results).
The sample size for the training set:
- Not applicable. There is no AI model, and therefore no training set, for this device.
How the ground truth for the training set was established:
- Not applicable. There is no AI model, and therefore no training set or ground truth establishment process for it.

In summary: The provided document is a 510(k) clearance letter and summary for a traditional medical device (surgical sutures) and details compliance with physical, chemical, and biological standards, along with a comparison to an existing predicate device. It does not provide any information relevant to the acceptance criteria or study design for an AI/ML-powered medical device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

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: K183004

Trade/Device Name: WEGO-PGA 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 26, 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) K183004

Device Name WEGO-PGA RAPID

Indications for Use (Describe)

WEGO-PGA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGA 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: K183004

Date of Preparation: 01/24/2019 1.
1. Sponsor Identification

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

1. Identification of Proposed Device
  Trade Name: WEGO-PGA RAPID Common Name: Absorbable Synthetic Suture with or without Needle

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K183004

Page 2/5

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

The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40<861>, USP 40<871> and USP 40 <881>.

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

ર. Identification of Predicate Device
Predicate Device 510(k) Number: K944110 Product Name: VICRYL Rapide Suture Manufacturer: ETHICON, INC
1. Non-Clinical Test Conclusion

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Page 3/5

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:

10 USP 40-NF 35:2017 <861> Sutures - Diameter;
USP 40-NF 35:2017 <871> Sutures Needle Attachment; 10
10 USP 40-NF 35:2017 <881> Tensile Strength;
10 ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
10 ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity:
10 ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
10 ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
10 ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity; USP 40-NF 35:2017 <85> Bacterial Endotoxins Test;
10 ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
10 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
0 ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;
10 USP 39-NF33:2016 <151> Pyrogen Test
10 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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Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate DeviceK944110
Product Code	GAM	GAM
RegulationNumber	21 CFR 878.4493	21 CFR 878.4493
Class	II	II
Intended Use	WEGO-PGA RAPID sutures areintended for use in superficial soft tissueapproximation of skin and mucosawhere only short-term wound support isrequired. WEGO-PGA RAPID is notintended for use in ligation, ophthalmic,cardiovascular or neurologicalprocedures.	The Vicryl Rapide Suture is indicatedonly for use in superficial soft tissueapproximation of skin and mucosawhere only short-term wound support(7-10 days) is required. Vicryl RapideSuture is not intended for use inligation, ophthalmic, cardiovascular orneurological procedures.
Configuration	Suture and Needle	Suture and Needle
Sterility	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Based Material	Polyglycolic Acid (PGA)	90% glycolide and 10% L-lactide(PGLA)
Coating Material	Polycaprolactone 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
Absorbable /Non-absorbable	Absorbable	Absorbable

Table 1 Comparison of Proposed Device and Predicated Device

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Braided /Monofilament	Braided	Braided
Suture Size	USP 6-0, USP 5-0, USP 4-0, USP 3-0,USP 2-0, USP 0, USP 1 and USP 2	Unknown
Length of Suture	25cm, 30cm, 45cm, 50cm, 60cm, 70cm,	Unknown
	75cm and 90cm
Absorption Time	42 days	42 days

The based material of proposed device is PGA, which is different from that of predicate device. However, the performance and biocompatibility of proposed device has been demonstrated by various tests. The specifications of predicate devices are not known, but the proposed device has been demonstrate to comply the requirements listed in USP Monograph of Absorbable Surgical Suture.

6. Substantially Equivalent (SE) Conclusion

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.