(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and compliance with standards for surgical sutures, with no mention of AI or ML.
No.
The device is a surgical suture used for wound closure and repair, which are restorative rather than therapeutic functions.
No
The device is a surgical suture used for wound closure and tissue repair, not for diagnosing medical conditions.
No
The device description clearly states it is a monofilament, non-absorbable surgical suture composed of stainless steel, including suture and needle, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair." These are all surgical procedures performed in vivo (within the living body).
- Device Description: The device is a surgical suture, which is a material used to hold body tissues together after injury or surgery. This is a physical implant/tool used directly on the patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The information provided describes a surgical device used for physical repair within the body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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.
Product codes
GAO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, sternal, orthopaedic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 Bacterial Endotoxins Test
- USP 41-NF 36:2018 Pyrogen Test (USP Rabbit Test)
- USP 41-NF 36:2018 Sutures – Diameter
- USP 41-NF36:2018 Sutures – Needle Attachment
- USP 41-NF 36:2018 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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
-
- Date of Preparation: 26/10/2019
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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
5
-
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 Bacterial Endotoxins Test
-
USP 41-NF 36:2018 Pyrogen Test (USP Rabbit Test)
-
USP 41-NF 36:2018 Sutures – Diameter
-
USP 41-NF36:2018 Sutures – Needle Attachment
-
USP 41-NF 36:2018 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)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
Substantially Equivalent (SE) Comparison 8.
Table 1 Comparison of Technology Characteristics
| ITEM | Proposed Device
WEGO-STAINLESS STEEL | Predicate Device
Surgical Stainless Steel Suture
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
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/
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. | SE
Analysis 2 |
| Suture Length | 20cm, 23cm, 30cm, 35cm, 40cm, 45cm, 50cm, 60cm, 75cm,150cm | Unknown | SE
Analysis 3 |
| Diameter of Suture | The suture diameters of proposed device comply with the diameter requirement listed in USP Diameter. | The suture diameters of proposed device comply with the diameter requirement listed in USP Diameter. | SE |
| Tensile Strength | The tensile strengths of proposed device comply with the tensile requirement listed in USP Tensile Strength | The tensile strengths of proposed device comply with the tensile requirement listed in USP Tensile Strength | SE |
| Needle Attachment | The bond between suture and needle of the applicant device meet the requirements defined in USP . | The bond between suture and needle of the applicant device meet the requirements defined in USP . | 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 | |
7
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.
8
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.
-
- 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.
- Substantially Equivalent (SE) Conclusion