(132 days)
Not Found
No
The device is a surgical suture and needle, and the description focuses on its material composition and physical properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is a surgical suture used for approximation and ligation of tissues, which is a supportive function during surgery, not a direct therapeutic treatment for a disease or condition.
No
This device is a surgical suture used for soft tissue approximation and/or ligation, not for diagnosing conditions.
No
The device description explicitly states that the proposed device is composed of suture and needle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "soft tissue approximation and/or ligation" during surgical procedures. This is a direct intervention on the body.
- Device Description: The description details a surgical suture and needle, which are physical tools used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of WEGO-PTFE does not involve any such testing or analysis of biological samples.
- Performance Studies: The performance studies focus on the physical and biological properties of the suture and its packaging, not on the accuracy or reliability of diagnostic test results.
Therefore, WEGO-PTFE is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
NBY
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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:
- USP 39-NF 34:2016 Nonabsorbable Surgical Suture; >
- USP 39-NF 34:2016 Sutures Diameter; >
- USP 39-NF 34:2016 Sutures Needle Attachment; >
-
USP 39-NF 34:2016 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 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)
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
§ 878.5035 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.
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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
-
- Date of Preparation: 7/23/2017
-
- 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. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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:
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.
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.
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.
5
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 Sutures Diameter; >
- USP 39-NF 34:2016 Sutures Needle Attachment; >
-
USP 39-NF 34:2016 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 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)
6
7. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device
WEGO-PTFE | Predicate Device
Cytoplast PTFE Suture
K072076 |
|--------------------------------|------------------------------------------------|------------------------------------------------------|
| 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 | USP 30 |
| | USP 39 | USP 30 |
| | USP 39 | USP 30 |
| 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)
7
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.