Wego-Stainless Steel

K193209 · Foosin Medical Supplies Inc., Ltd. · GAQ · Feb 19, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193209
• Device Name: Wego-Stainless Steel
• Applicant: Foosin Medical Supplies Inc., Ltd.
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Feb 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

WEGO-STAINLESS STEEL is a monofilament, non-absorbable surgical suture composed of stainless steel; supplied with or without stainless steel needles. Used by surgeons for abdominal wound closure, hernia repair, sternal closure, and orthopaedic procedures (cerclage, tendon repair). Device provides mechanical tissue approximation. Suture sizes range from USP 7-0 to USP 7. Device is sterile, single-use, and complies with USP requirements for non-absorbable surgical sutures.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ISO 10993 (biocompatibility, genotoxicity, cytotoxicity, systemic toxicity, irritation, sensitization) and USP 41-NF 36 standards (tensile strength, diameter, needle attachment, sterility, pyrogenicity).

Technological Characteristics

Material: Stainless steel. Form: Monofilament, non-absorbable. Sizes: USP 7-0 to 7. Sterilization: Radiation (SAL 10^-6). Compliance: USP 41-NF 36 (tensile strength, diameter, needle attachment), ISO 10993 (biocompatibility), ASTM F88/F88M-15 (seal strength), ASTM F1929-15 (package integrity).

Indications for Use

Indicated for abdominal wound closure, hernia repair, sternal closure, and orthopaedic procedures (cerclage and tendon repair) in patients requiring non-absorbable surgical sutures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Stainless Steel Suture (K170767)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | <span style="text-decoration: overline;">☒</span> |
|----------------------------------------|---------------------------------------------------|
| 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone] Fax: [phone] Email: [e-mail]

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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

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.

- 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)

- 7. 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 Device<br>WEGO-STAINLESS STEEL | Predicate Device<br>Surgical Stainless Steel Suture<br>K 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 | SE<br>Analysis 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/<br>Non-absorbable | Non-absorbable | Non-absorbable | SE |
| Braided/<br>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. | SE<br>Analysis 2 |
| Suture Length | 20cm, 23cm, 30cm, 35cm, 40cm, 45cm, 50cm, 60cm, 75cm,150cm | Unknown | SE<br>Analysis 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.

- 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.