(12 days)
The URETEX® SUP device is indicated for the treatment of stress urinary incontinence in women.
The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment of stress urinary incontinence from urethral hyper mobility and/or intrinsic sphincter deficiency.
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.
The provided text describes the URETEX® SUP Pubourethral Sling, a medical device for treating stress urinary incontinence in women. The submission to the FDA focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical effectiveness through a standalone study with defined acceptance criteria and performance metrics typically associated with AI/ML devices.
Therefore, the requested information elements (1, 2, 3, 4, 5, 6, 7, 8, 9) related to acceptance criteria, ground truth, and specific study designs for AI/ML performance are not applicable or available in this document. This device is a traditional medical device, not an AI/ML device.
However, I can provide information based on the performance testing mentioned in the document, framed as demonstrating substantial equivalence to predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds that the URETEX® SUP device had to meet to be deemed effective or safe. Instead, the performance testing aimed to show that the URETEX® SUP device's characteristics were similar to those of its predicate devices. The "acceptance" was therefore based on demonstrating substantial equivalence, meaning the performance characteristics were not meaningfully different from existing, legally marketed devices.
| Characteristic | Acceptance Criteria (Demonstrates similarity to predicate devices) | Reported Device Performance (URETEX® SUP vs. Predicates) |
|---|---|---|
| Density | Similar to predicate devices (Ethicon Prolene®, Sofradim Parietene®) | Showed similarity to predicate devices (specific values not provided) |
| Thickness | Similar to predicate devices | Showed similarity to predicate devices |
| Elongation | Similar to predicate devices | Showed similarity to predicate devices |
| Breaking Strength | Similar to predicate devices | Showed similarity to predicate devices |
| Tear Resistance | Similar to predicate devices | Showed similarity to predicate devices |
| Burst Resistance | Similar to predicate devices | Showed similarity to predicate devices |
| Tensile Strength | Similar to predicate devices | Showed similarity to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The study referenced is "Performance Testing r." (Section 7 of the 510(k) summary).
- Study Type: Comparative physical and mechanical property testing.
- Objective: To determine that the URETEX® SUP Sling has similar performance characteristics to its predicate devices (Ethicon Prolene®, Sofradim Parietene®).
- Methodology: Testing was performed in accordance with ISO standards. Various physical and mechanical properties of the URETEX® SUP Sling were evaluated and compared against the selected predicate devices.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the document. The text mentions "All of the testing was performed using the URETEX® SUP Sling, the Ethicon Prolene®, and the Solradim Parietene® prodicate devices for comparative purposes," implying samples of each device were tested. The specific number of samples for each test (density, thickness, etc.) is not provided.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by or for Sofradim Production, likely in France (country of origin of the sponsor). This was not a clinical study; it was laboratory/bench testing of materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was physical materials testing, not a study requiring expert clinical ground truth assessment.
4. Adjudication method for the test set:
- Not applicable. Material properties (e.g., density, tensile strength) are objectively measured, not adjudicated.
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:
- Not applicable. This is a traditional medical device (surgical mesh), not an AI/ML device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a traditional medical device, not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for the performance testing was the measured physical and mechanical properties of the predicate devices, against which the URETEX® SUP's properties were compared.
8. The sample size for the training set:
- Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
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K041176
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510(k) Summary For the Sofradim Production URETEX SUP® Pubourethral Sling and Instruments
SPONSOR 1.
Sofradim Production 116 avenue du Formans 01600 Trevoux France
MAY 1 7 2004
Contact: Patrice Becker Telephone: 33 (0)4 74 08 90 00 33 (0)4 74 08 90 02 Facsimile:
DEVICE NAME 2.
URETEX SUP® Device Proprietary Name: Common/Usual Name: Surgical Mesh Classification Namc: Surgical Mesh
PREDICATE DEVICES 3.
K974098 Ethicon TVT Sofradim Parietene® Meshes K991400 Mentor Sling K980483
4. 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.
ડ. INTENDED USE
The URFTEX® SUP device is indicated for the treatment of stress urinary incontinence in women.
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K041176
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
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 as well as reinforcement of tissue during surgical repair.
The URETEX SUP, the TVT Ethicon (Prolene® mesh), the Mentor Sling and the Parietene® Polypropylenc Mesh are all made from polypropylenc sealed monofilament stitches. All of the devices arc single-use only.
PERFORMANCE TESTING r.
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 Prolenc®, and the Solradim Parietene® prodicate devices for comparative purposes. The test results showcd 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 Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
SEP 28 2012
Re: K041176 Trade/Device Name: URETEX® TO Trans-Obturator Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: May 4, 2004 Received: May 5, 2004
Dear Ms. McNamara-Cullinane:
This letter corrects our substantially equivalent letter of May 17, 2004.
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
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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,
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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K 041176
Indications for Use
510(k) Number (if known):
Device Name: URETEX® TO Trans-Obturator Urcthral Support System
Indications For Use:
The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment The Order in Creatinence from urethral hyper mobility and/or intrinsic sphincter deficiency.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Usc (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEEDF.OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.