WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Device Description

The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE 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-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

AI/ML Overview

This document describes the premarket notification for the WEGO-PTFE surgical suture, asserting its substantial equivalence to a predicate device. It includes information on non-clinical testing performed to establish this equivalence, but no clinical study was conducted. Therefore, the device does not have acceptance criteria based on clinical performance.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a premarket notification for a surgical suture claiming substantial equivalence to a predicate device, the "acceptance criteria" are based on compliance with recognized standards and biocompatibility, rather than clinical performance metrics. The "reported device performance" refers to the results of non-clinical tests demonstrating this compliance.

Acceptance Criteria (Compliance with Standard)	Reported Device Performance (WEGO-PTFE Test Results)
USP 39-NF 34:2016 Nonabsorbable Surgical Suture	Complies with the requirements
USP 39-NF 34:2016 <861> Sutures Diameter	Complies with the requirements
USP 39-NF 34:2016 <871> Sutures Needle Attachment	Complies with the requirements
USP 39-NF 34:2016 <881> Tensile Strength	Complies with the requirements
ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity	Conforms to the requirements
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity	Conforms to the requirements
ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation	Conforms to the requirements
ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	Conforms to the requirements
ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	Conforms to the requirements
USP <85> Bacterial Endotoxins Limit	Complies with the requirements
ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials	Complies with the requirements
ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages	Complies with the requirements
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration	Complies with the requirements
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals	Conforms to the requirements
ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process	Complies with the requirements
Shelf life stability (Product performance and Package integrity)	Supported by test reports for three years, two years, one year, and six months

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the non-clinical tests. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly stated in terms of country of origin, but the submitting company is "Foosin Medical Supplies Inc., Ltd." located in Weihai, Shandong, China. The studies are non-clinical, likely laboratory-based, and therefore not categorized as retrospective or prospective in the human study sense.

3. 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)

This information is not applicable. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., USP, ISO, ASTM), not by expert consensus on clinical cases. The tests themselves are designed to measure against predefined physical and biological parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical study or expert-based evaluation of a test set for performance was conducted. The tests are laboratory procedures with defined pass/fail criteria based on standards.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a surgical suture, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

This information is not applicable as the device is a surgical suture, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced standards (e.g., USP for tensile strength and diameter, ISO for biocompatibility categories). These standards provide quantifiable criteria that the device must meet.

8. The sample size for the training set

This information is not applicable. There is no training set mentioned or implied as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 31, 2017

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

Re: K170842

Trade/Device Name: WEGO-PTFE Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: June 15, 2017 Received: June 20, 2017

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.

Sincerely,

David Krause -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) K170842

Device Name WEGO-PTFE

Indications for Use (Describe)

WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not in ophthalmic surgery, microsurgery and peripheral neural tissue

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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Tab #7 510(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: K170842

1. Date of Preparation: 7/23/2017
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. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: WEGO-PTFE Common Name: Non-Absorbable Surgical Suture Size: USP 6-0, USP 5-0, USP 4-0, USP 3-0 and USP 2-0

Regulatory Information Classification Name: Nonabsorbable Expanded Polytetraflouroethylene Surgical Suture Classification: II Product Code: NBY Regulation Number: CFR 878.5035 Review Panel: General & Plastic Surgery

Indications for Use:

Device Description

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-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

ર : Identification of Predicate Device
510(k) Number: K072076 Product Name: Cytoplast PTFE Suture Manufacturer: Osteogenics Biomedical, Inc.

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6. 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 39-NF 34:2016 Nonabsorbable Surgical Suture; >
USP 39-NF 34:2016 <861> Sutures Diameter; >
USP 39-NF 34:2016 <871> Sutures Needle Attachment; >
USP 39-NF 34:2016 <881> Tensile Strength;
ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
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;
A 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;
A USP <85> Bacterial Endotoxins Limit;
♪ ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1140/F1140M-13. Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages;
A ASTM F1929-12 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;
♪ ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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

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7. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

Item	Proposed DeviceWEGO-PTFE	Predicate DeviceCytoplast PTFE SutureK072076
Product Code	NBY	NBY
Regulation Number	CFR 878.5035	CFR 878.5035
Class	II	II
Intended Use	WEGO-PTFE is indicated for use in	The Cytoplast PTFE suture is indicated
	all types of soft tissue approximation	for use in all types of soft tissue
	and/or ligation, including	approximation and/or ligation, including
	cardiovascular, dental and general	cardiovascular, dental and general
	surgeries. The device is not indicated	surgeries, as well as repair of the dura
	for use in ophthalmic surgery,	mater. The device is not indicated for use
	microsurgery and peripheral neural	in ophthalmic surgery, microsurgery and
	tissue.	peripheral neural tissue.
Material	Polytetrafluoroethylene	Polytetrafluoroethylene
Color	Undyed	Undyed
Absorbable /Non-absorbable	Non-absorbable	Non-absorbable
Braided /Monofilament	Monofilament	Monofilament
Sterility	EO Sterilized	EO Sterilized
Suture Size	USP 6-0, USP 5-0, USP 4-0, USP 3-0,USP 2-0	USP 4-0, USP 3-0, USP 2-0
Single Use	Yes	Yes
Performance	Comply with:	Comply with:
	USP 39 <861>	USP 30 <861>
	USP 39 <871>	USP 30 <871>
	USP 39 <881>	USP 30 <881>
Biocompatibility	Conforms to the requirements of ISO	Conforms to the requirements of ISO
	10993 series Standards	10993 series Standards

Table 1 Comparison of Proposed Device and Predicated Device (K072076)

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Ref.:M0232015

9. Substantially Equivalent (SE) Conclusion

Based on the comparison, the intended use, characteristic, materials, sterility of proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

In addition, the results of performance tests performed on the proposed device can also demonstrate the proposed device is complied with FDA recognized standards, which the predicate device was also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in proposed device are biocompatible.

Based on the comparison above, the proposed device, WEGO-PTFE, is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.