(30 days)
Not Found
No
The summary describes a physical surgical implant and its insertion tools, with performance testing focused on material properties and mechanical strength. There is no mention of software, data analysis, or any computational capabilities that would suggest the use of AI or ML.
Yes.
The device is intended for the treatment of stress urinary incontinence in women, which is a medical condition.
No
Explanation: The device is a surgical implant (pubourethral sling) used for treating stress urinary incontinence. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a physical pubourethral sling made from polypropylene and includes an insertion instrument, connector, and sheath, indicating it is a hardware medical device.
Based on the provided information, the URETEX® SUP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "pubourethral sling for the treatment of stress urinary incontinence in women." This describes a surgical implant used to physically support the urethra, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a physical implant made of polypropylene tape and insertion instruments. This is consistent with a surgical device, not an IVD which typically involves reagents, analyzers, or test kits for analyzing samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the URETEX® SUP device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The URETEX® SUP device is indicated for the treatment of stress urinary incontinence in women.
The URETEX® SUP device is intended to be used as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
OTN
Device Description
The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatment of stress incontinence. The URETEX® SUP device is made from polypropylene sealed monofilament stitches (tape). It is composed of an insertion instrument, connector, sheath, and the pubourethral implant. The insertion instrument consists of a stainless steel needle with PVC tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies
Testing was performed in accordance with ISO standards. The density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were evaluated to determine the performance characteristics of the Pubourethral Sling. All of the testing was performed using the URETEX® SUP Sling, the Ethicon Prolene®, and the Sofradim Parietene® predicate devices for comparative purposes. The test results showed that the Sofradim and predicate devices were similar in performance characteristics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
OCT - 4 2001
510(k) Summary For the Sofradim Production URETEX SUP® Pubourethral Sling and Instruments
SPONSOR 1.
Sofradim Production 116 avenue du Formans 01600 Trevoux France
Contact: Patrice Becker Telephone: 33 (0)4 74 08 90 00 Facsimile: 33 (0)4 74 08 90 02
2. DEVICE NAME
| Proprietary Name: | URETEX SUP® Device |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
3. PREDICATE DEVICES
| Ethicon TVT | K974098 |
|---|---|
| Sofradim Parietene® Meshes | K991400 |
| Mentor Sling | K980483 |
DEVICE DESCRIPTION 4.
The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatment of stress incontinence. The URETEX® SUP device is made from polypropylene sealed monofilament stitches (tape). It is composed of an insertion instrument, connector, sheath, and the pubourethral implant. The insertion instrument consists of a stainless steel needle with PVC tubing.
INTENDED USE 5.
The URETEX® SUP device is indicated for the treatment of stress urinary incontinence in women.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર.
The URETEX® SUP Polypropylene Mesh is substantially equivalent to the T.V.T. Ethicon Prolene Pubourethral Tape, the Sofradim Parietene® Mesh, and the Mentor Sling Device.
The URETEX® SUP Polypropylene Mesh and the TVT device have the same intended use in that they are all used for treatment of stress urinary incontinence.
The URETEX SUP, the TVT Ethicon (Prolene® mesh), the Mentor Sling and the Parietene® Polypropylene Mesh are all made from polypropylene sealed monofilament stitches. All of the devices are single-use only.
PERFORMANCE TESTING 7.
Testing was performed in accordance with ISO standards. The density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were evaluated to determine the performance characteristics of the Pubourethral Sling. All of the testing was performed using the URETEX® SUP Sling, the Ethicon Prolene®, and the Sofradim Parietene® predicate devices for comparative purposes. The test results showed that the Sofradim and predicate devices were similar in performance characteristics.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Sofradim Production % Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTELBORO MA 02760
Re: K012949
Trade/Device Name: Sofradim URETEX®SUP Pubourethral Sling and Instruments Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 29, 2001 Received: September 4, 2001
Dear Ms. McNamara-Cullinane:
This letter corrects our substantially equivalent letter of October 4, 2001.
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 (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.
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
3
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 (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012949
Device Name: Sofradim URETEX® sur Pubourethral Sling and Instruments
Indications For Use:
The URETEX® SUP device is intended to be used as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature of Off
(Division Sign-Off) (Division of General, Restorative Division ological Devices
KO12949 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________