The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (WEGO-PDO Barbed Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning performance metrics for an AI or imaging device.

The document describes pre-market notification for a surgical suture, not an AI or imaging device. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections clearly state the types of tests performed (primarily material and sterility standards, with no clinical study included). The "SE Comparison" table compares the proposed suture device to predicate suture devices based on physical characteristics, material properties, and regulatory standards, not diagnostic performance.

To answer your prompt, you would need a document related to the clearance or approval of an AI/imaging medical device, which would detail its performance study, acceptance criteria (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, and expert involvement. This document does not provide such information.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 20, 2020

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

Re: K201139

Trade/Device Name: WEGO-PDO Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: September 15, 2020 Received: September 17, 2020

Dear Diana 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. Although this letter refers to your product as a device, please be aware 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 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201139

Device Name WEGO-PDO Barbed Suture

Indications for Use (Describe)

WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

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 is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K201139

1. Date of Preparation: 10/9/2020
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: Zhipeng Yang Position: President of Technology Tel: +86-631-5660576 Fax: +86-631-5621680 Email: Foosin-ce@163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: WEGO-PDO Barbed Suture Common Name: Absorbable Polydioxanone Surgical Suture Size: USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2

Regulatory Information Classification Name: Absorbable polydioxanone surgical suture Classification: II

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Product Code: NEW Regulation Number: CFR 878.4840 Review Panel: General & Plastic Surgery

Indications for Use:

WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Description

The proposed device is composed of suture with or without the needle.

The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2.

The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots.

The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight.

The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types.

The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

5. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K113744 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) Manufacturer: Angiotech

Predicate Device 2 510(k) Number: K120827 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone)

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Manufacturer: Angiotech

Non-Clinical Test Conclusion 6.
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 42-NF 37:2019 Absorbable Surgical Suture
USP 42-NF 37:2019 <85> Bacterial Endotoxins Limit; >
USP 42-NF 37:2019 <71> Sterility Test >
USP 42-NF 37:2019 <861> Sutures - Diameter
USP 42-NF 37:2019 <871> Sutures - Needle Attachment
USP 42-NF 37:2019 <881> Tensile Strength
ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-6:2016 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 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
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;
ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Real time Aging (three years)

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device 1	Predicate Device 2	Remark
Product Code	NEW	K113744	K120827	SE
Regulation Number	CFR 878.4840	CFR 878.4840	CFR 878.4840	SE
Class	II	II	II	SE
Indications for Use	WEGO-PDO Barbed Suture isindicated for soft tissueapproximation where use of anabsorbable suture is appropriate.	QuillTM PDO Knotless Tissue-ClosureDevice, comprised of Polydioxanone,is indicated for soft tissueapproximation where use of anabsorbable suture is appropriate.	QuillTM PDO KnotlessTissue-Closure Device, comprised ofPolydioxanone, is indicated for softtissue approximation where use of anabsorbable suture is appropriate.	SE Analysis1
Configuration	Suture and Needle	Suture and Needle	Suture and Needle	SE
Welded Loop	ManufactureMethodPurposeLength	Ultrasonicallyweldeda basic fixationloop and securethe fixation loopportion to robusttissue10mm	ManufactureMethodPurposeLength	Ultrasonicallyweldedhelp to form asecondaryvariable loop andsecure the deviceat the distal end10mm	N/A	SEAnalysis 2
Sterility	EO Sterilized	EO Sterilized	EO Sterilized	SE
SAL	$1.0×10^{-6}$	$1.0×10^{-6}$	$1.0×10^{-6}$	SE
Single Use	Yes	Yes	Yes	SE
SUTURE
Material	poly (p-dioxanone)	poly (p-dioxanone)	poly (p-dioxanone)	SE

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Color	Undyed; dyed violet with D&CViolet No.2	dyed violet with D&C Violet No.2	dyed violet with D&C Violet No.2	SEAnalysis 3
Absorbable /Non-absorbable	Absorbable	Absorbable	Absorbable	SE
Braided /Monofilament	Monofilament	Monofilament	Monofilament	SE
Type of barbs	Uni-directional,Bi-directional	Uni-directional,	Bi-directional	SEAnalysis 4
Suture Size	USP 5-0, USP 4-0, USP 3-0,USP 2-0, USP 0, USP 1, USP 2	USP 0	USP 4-0, USP 3-0, USP 2-0, USP 0,USP 1, USP 2	SEAnalysis 5
Suture Length	Models of uni-directionalbarb :15cm, 20 cm, 30 cm, 45cm, 60 cm, 70 cmModels of bidirectionalbarb :77 cm, 1010 cm, 1414cm, 1818cm, 2424 cm, 3030cm,3636 cm, 4040 cm, 45*45cm	20 cm, 30 cm, 45 cm	77 cm, 1010 cm, 1414 cm,1616cm, 2424 cm, 3030m,36*36 cm	SEAnalysis 6
Diameter of Suture	The suture diameters ofproposed device comply withthe diameter requirement listedin USP <861> Diameter.	The suture diameters ofproposed device complies with thediameter requirement listed in USP<861> Diameter.	The suture diameters ofproposed device complies with thediameter requirement listed in USP<861> Diameter.	SE
Tensile Strength	The tensile strengths ofproposed device comply withthe tensile requirement listed inUSP <881> Tensile Strength	The tensile strengths ofproposed device complies with thetensile requirement listed in USP<881> Tensile Strength	The tensile strengths ofproposed device complies with thetensile requirement listed in USP<881> Tensile Strength	SE
Needle Attachment
	The bond between suture andneedle of the applicant devicemeet the requirements definedin USP <871>.	The bond between suture andneedle of the applicant devicemeet the requirements definedin USP <871>.NEEDLE	The bond between suture andneedle of the applicant devicemeet the requirements definedin USP <871>.	SE

Cytotoxicity	No cytotoxicity.	The specific test items are unknown.However, the product should meet the	The specific test items are unknown.However, the product should meet	SE
Max Sensitization	No skin sensitization.	requirements of ISO10993 seriesstandards.	the requirements of ISO10993 seriesstandards.	Analysis 7
IntracutaneousReactivity Test	No intracutaneous reactivity.	SUTURE

Cytotoxicity	No cytotoxicity.
Max Sensitization	No skin sensitization.
IntracutaneousReactivity Test	No intracutaneous reactivity.
Acute SystemicToxicity Test	No systemic toxicity.		The specific test items are unknown.However, the product should meetthe requirements of ISO10993 seriesstandards.	SEAnalysis 8
Genotoxicity	No genotoxicity.	The specific test items are unknown.
Pyrogenicity	No potential febrile reaction.	However, the product should meet the
Muscle ImplantationStudy	No reaction to the tissue.	requirements of ISO10993 seriesstandards.
Sub chronicToxicity Study	No systemic toxicity.
Hemolysis Test(Direct Contact)	No Hemolysis
Hemolysis Test(Indirect Contact)	No Hemolysis

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SE Analysis 1 - Indications for Use

The indications for use of Predicate device 1 and Predicate device 2 includes the material (Polydioxanone) of suture. Although the indications for use of Proposed Device does not include the material of suture, the suture's material of Proposed Device is also Polydioxanone. Therefore, this item is considered to be substantially equivalent.

SE Analysis 2- Welded Loop

The manufacture method and length of proposed device's and predicate device's welded loop are same. Although the purpose of proposed device's and predicate device's welded loop is different, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.

SE Analysis 3- Color

The suture of Predicate Device 1 and Predicate Device 2 is dyed. The suture of Proposed Device is available in undyed and dye. The color of Proposed Device 1 and Predicate Device 1 and Predicate Device 2's suture is dyed with D&C Violet No. 2. The Proposed Device has more undyed suture than the Predicate Device 1 and Predicate Device 2. The test reports for the undyed suture of Proposed Device provided in this submission, including performance test, and stability demonstrates that the undyed Proposed Device complied with the requirements of USP Absorbable Surgical Suture. Therefore, this item is considered to be substantially equivalent.

SE Analysis 4- Type of barbs

The barbs of Proposed Device include uni-directional barb and bi-directional barbs. The uni-directional barb of Proposed Device is same with the barb of Predicate Device 1. The bi-directional barb of Proposed Device is same with the barb of Predicate Device 2. Therefore, this item is considered to be substantially equivalent.

SE Analysis 5- Suture Size

The suture sizes of Proposed Device and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although the range of suture size of Proposed Device is more than that of the Predicate Device 2, the suture sizes of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.

SE Analysis 6- Suture Length

The requirements for suture length of Proposed Device and Predicate Device 1 and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although we do not know the exact suture length of Predicate Device 1 and Predicate Device 2, the suture lengths of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.

SE Analysis 7- Needle Biocompatibilitv

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The needle biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 are should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, but the needle biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Sensitization and Intracutaneous Reactivity Test. These studies can demonstrate the needle biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.

SE Analysis 8- Suture Biocompatibility

The biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, the biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Genotoxicity, Pyrogenicity, Muscle Implantation Study, Sub chronic Toxicity Study, Hemolysis Test (Direct Contact) and Hemolysis Test (Indirect Contact). These studies can demonstrate the biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.

9. Substantially Equivalent (SE) Conclusion

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

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.