The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Device Description

The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

AI/ML Overview

The provided document is a 510(k) summary for the "WEGO-STAINLESS STEEL" surgical suture, in which the manufacturer asserts substantial equivalence to a predicate device (Surgical Stainless Steel Suture K170767). The document describes non-clinical tests conducted to support this claim, but it does not describe an AI/ML powered device, nor does it detail acceptance criteria related to AI/ML performance, or comparative effectiveness studies of AI vs. human readers.

Therefore, the requested information regarding AI/ML acceptance criteria, study details, expert involvement, and MRMC studies cannot be extracted from this document, as it is outside the scope of a traditional medical device (surgical suture) 510(k) submission.

However, I can provide the available information regarding the non-clinical tests performed to demonstrate substantial equivalence for the surgical suture:

Acceptance Criteria and Device Performance (for Non-Clinical Tests of Surgical Suture)

The acceptance criteria for the "WEGO-STAINLESS STEEL" surgical suture were based on compliance with established international and pharmacopeial standards. The reported device performance indicates that the proposed device met these standards.

Acceptance Criteria (Standard / Requirement)	Reported Device Performance / Compliance
Biocompatibility (based on ISO 10993 series):
Cytotoxicity (ISO 10993-5)	No cytotoxicity. (Complies with ISO 10993)
Skin Sensitization (ISO 10993-10)	No skin sensitization. (Complies with ISO 10993)
Intracutaneous Reactivity Test (ISO 10993-10 implied)	No intracutaneous reactivity. (Complies with ISO 10993)
Acute Systemic Toxicity Test (ISO 10993-11)	No systemic toxicity. (Complies with ISO 10993)
Genotoxicity (ISO 10993-3)	No genotoxicity. (Complies with ISO 10993)
Pyrogenicity (USP <151>)	No potential febrile reaction. (Complies with ISO 10993)
Muscle Implantation Study (ISO 10993-6)	No reaction to the tissue. (Complies with ISO 10993)
Subchronic Toxicity Study (ISO 10993-11 implied)	No systemic toxicity. (Complies with ISO 10993)
Hemolysis Test (Direct Contact) (ASTM F756-17)	No Hemolysis. (Complies with ISO 10993)
Hemolysis Test (Indirect Contact) (ASTM F756-17)	No Hemolysis. (Complies with ISO 10993)
Physical and Performance Characteristics (based on USP standards):
Suture Diameter (USP <861>)	Complies with the diameter requirement listed in USP <861>.
Tensile Strength (USP <881>)	Complies with the tensile requirement listed in USP <881>.
Needle Attachment (USP <871>)	Meets the requirements defined in USP <871>.
Sterilization & Packaging:
Sterility Assurance Level (SAL)	$1.0\times10^{-6}$ (Met standard)
Sterilization Process Validation (ISO 11137-1, ISO 11137-2)	Verified (Radiation sterilization selected as equivalent to predicate's radiation option)
Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15)	Tested over 1-5 years shelf life. (Compliance implied by "Product performance test reports" and "Package integrity test reports")
Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-15)	Tested over 1-5 years shelf life. (Compliance implied by "Product performance test reports" and "Package integrity test reports")
Other:
Standards for Nonabsorbable Surgical Suture (USP 41-NF 36:2018)	Proposed device complies with USP requirements.
Bacterial Endotoxins Test (USP <85>)	Tested. (Compliance implied by "Product performance test reports" and being listed as a non-clinical test)
Shelf Life (Product performance and Package integrity)	Product performance test reports (one years, two years, four years and five years) and Package integrity test reports (one year, two years, three years, four years and five years) were performed. (Compliance supports proposed shelf life)

The subsequent questions are related to AI/ML device studies and are not applicable to this document, as it concerns a conventional surgical suture.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical tests on a physical device, not an AI/ML 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 applicable. Ground truth for AI/ML is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No clinical study was included, and this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

February 19, 2020

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

Re: K193209

Trade/Device Name: Wego-Stainless Steel Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAO Dated: October 26, 2019 Received: November 21, 2019

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. 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

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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 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 (QS) 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 medical devices and radiation-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.

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193209

Device Name WEGO-STAINLESS STEEL

Indications for Use (Describe)

The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

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

Designated Use (Part 373.401 Criteria)	☒
Sole or Primary Use of the Site	□

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #6 510(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: K193209

1. Date of Preparation: 26/10/2019
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

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4. Identification of Proposed Device

Trade Name: WEGO-STAINLESS STEEL

Common Name: Non-absorbable Surgical Suture with or without needle Size: USP 7-0, USP 6-0, USP 5-0, USP 4-0, USP 3-0, USP 7, USP 6, USP 5, USP 4, USP 3, USP 2, USP 1 and USP 0.

Regulatory Information

Classification Name: Stainless Steel Suture Classification: II Product Code: GAQ Regulation Number: 21 CFR 878.4495 Review Panel: General & Plastic Surgery

Indications for Use:

The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Device Description

న్. Identification of Predicate Device
510(k) Number: K170767 Product Name: Surgical Stainless Steel Suture
Non-Clinical Test Conclusion Q.
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:
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

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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
ISO11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO11137-2:2013 Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose
ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F756-17:Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F1929-15:Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
USP 41-NF 36:2018 Nonabsorbable Surgical Suture
USP 41-NF 36:2018 <85> Bacterial Endotoxins Test
USP 41-NF 36:2018 <151> Pyrogen Test (USP Rabbit Test)
USP 41-NF 36:2018 <861> Sutures – Diameter
USP 41-NF36:2018 <871> Sutures – Needle Attachment
USP 41-NF 36:2018 <881> Tensile Strength

The following stability testing was performed to support the proposed shelf life: Product performance test reports (one years, two years, four years and five years) Package integrity test reports (one year, two years, three years, four years and five years)

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

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Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison of Technology Characteristics

ITEM	Proposed DeviceWEGO-STAINLESS STEEL	Predicate DeviceSurgical Stainless Steel SutureK 170767	Remark
Product Code	GAQ	GAQ	SE
Regulation Number	21 CFR 878.4495	21 CFR 878.4495	SE
Class	II	II	SE
Intended Use	The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.	Surgical Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.	SE
Configuration	Suture and Needle	Suture and Needle	SE
Sterilization	Radiation sterilization	Radiation OR Ethylene Oxide	SEAnalysis 1
SAL	$1.0\times10^{-6}$	$1.0\times10^{-6}$	SE
Single Use	Yes	Yes	SE
SUTURE
Material	Stainless Steel	Stainless Steel	SE
Color	Undyed	Undyed	SE
Absorbable/Non-absorbable	Non-absorbable	Non-absorbable	SE
Braided/Monofilament	Monofilament	Monofilament	SE
Suture Size	WEGO-STAINLESS STEEL are available in sizes 7-0 through 7(metric sizes 0.5 -9.0) in a variety of lengths.	Surgical Stainless steel sutures are available in sizes 10-0 through 7(metric sizes 0.2 -9.0) in a variety of lengths.	SEAnalysis 2
Suture Length	20cm, 23cm, 30cm, 35cm, 40cm, 45cm, 50cm, 60cm, 75cm,150cm	Unknown	SEAnalysis 3
Diameter of Suture	The suture diameters of proposed device comply with the diameter requirement listed in USP <861> Diameter.	The suture diameters of proposed device comply with the diameter requirement listed in USP <861> Diameter.	SE
Tensile Strength	The tensile strengths of proposed device comply with the tensile requirement listed in USP <881> Tensile Strength	The tensile strengths of proposed device comply with the tensile requirement listed in USP <881> Tensile Strength	SE
Needle Attachment	The bond between suture and needle of the applicant device meet the requirements defined in USP <871>.	The bond between suture and needle of the applicant device meet the requirements defined in USP <871>.	SE
NEEDLE
Biocompatibility	Comply with ISO 10993	Comply with ISO 10993	SE
Biocompatibility
Cytotoxicity	No cytotoxicity.	comply with ISO 10993
Skin Sensitization	No skin sensitization.	comply with ISO 10993
Intracutaneous Reactivity Test	No intracutaneous reacitivty.	comply with ISO 10993
Acute Systemic Toxicity Test	No systemic toxicity.	comply with ISO 10993
Genotoxicity	No genotoxicity.	comply with ISO 10993	SE
	No genotoxicity.	Unknown
Pyrogenicity	No potential febrile reaction.	comply with ISO 10993
Muscle Implantation Study	No reaction to the tissue.	comply with ISO 10993
Subchronic Toxicity Study	No systemic toxicity.	comply with ISO 10993
Hemolysis Test(Direct Contact)	No Hemolysis	comply with ISO 10993
Hemolysis Test(Indirect Contact)	No Hemolysis	comply with ISO 10993

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SE Analysis 1 – Sterilization

The sterilization method of proposed device is radiation. The sterilization method of predicate device is radiation or Ethylene Oxide. The sterilization methods of predicate device include the radiation. Therefore, this item is considered to be substantially equivalent.

SE Analysis 2- Suture Size

The suture sizes of proposed device and predicate device are both identified in the currently recognized United States Pharmacopoeia; although the range of suture size of proposed device is smaller than that of the predicate device, the suture sizes of proposed device comply with the requirements listed in USP Nonabsorbable 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.

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SE Analysis 3- Suture Length

The requirements for suture length of proposed device and predicate device are both identified in the currently recognized United States Pharmacopoeia; although we do not know the exact suture length of predicate device, the suture lengths of proposed device comply with the requirements listed in USP Nonabsorbable 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.

1. 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

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.