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.

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.

AI/ML Overview

This document describes the 510(k) submission for the Sofradim Production URETEX SUP® Pubourethral Sling and Instruments (K012949), which is intended for the treatment of stress urinary incontinence in women. The study proving the device meets acceptance criteria is primarily a performance testing study to demonstrate substantial equivalence to predicate devices, rather than a clinical trial with specific acceptance criteria in terms of clinical outcomes or a standalone algorithm-only study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Predicate Device Performance Standard (Implied)	Reported URETEX SUP® Performance
Material Properties	Density	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Thickness	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Elongation	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Breaking Strength	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Tear Resistance	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Burst Resistance	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
	Tensile Strength	Similar to predicate devices	"Similar in performance characteristics" to predicate devices
Intended Use	Treatment of stress urinary incontinence in women	Same as predicate devices	Same as predicate devices
Material Composition	Polypropylene sealed monofilament stitches (tape)	Same as predicate devices	Polypropylene sealed monofilament stitches (tape)
Usage	Single-use only	Same as predicate devices	Single-use only

Note: The acceptance criteria are implicit in the comparison to predicate devices, meaning the URETEX SUP® device must perform similarly to the legally marketed predicates in the specified tests to be considered substantially equivalent. The document does not provide specific numerical acceptance thresholds but rather states that the "test results showed that the Sofradim and predicate devices were similar in performance characteristics."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of a clinical study with patients. Instead, the "test set" for this type of submission refers to the samples of the URETEX® SUP Sling, Ethicon Prolene®, and Sofradim Parietene® predicate devices that were subjected to mechanical and material property testing.

Sample Size: Not explicitly stated as a number of units or material swatches. The testing was performed on "the URETEX® SUP Sling, the Ethicon Prolene®, and the Sofradim Parietene® predicate devices." This implies that a sufficient number of each device type were tested to obtain reliable measurements for the physical properties.
Data Provenance: The testing was "performed in accordance with ISO standards" by Sofradim Production (based in Trevoux, France). This is likely retrospective in the sense that the devices already existed and were tested for this submission, rather than a prospective clinical trial. The location of the testing would be France.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The ground truth for this submission is based on objective physical and mechanical property measurements performed in a laboratory setting, not on expert clinical assessment or interpretation.

4. Adjudication Method for the Test Set

This is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert assessments or clinical outcomes, which is not the nature of the performance testing described here.

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

This is not applicable. This submission is for a medical device (surgical mesh), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI-related comparative effectiveness was performed or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This document describes a physical medical device, not an algorithm, so a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

The ground truth used for this submission is objective, measurable physical and mechanical properties of the materials, measured against established engineering and material science standards (ISO standards). It is not based on expert consensus, pathology, or outcomes data in a clinical sense for determining device performance in this specific submission section. The "ground truth" for substantial equivalence is the performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission, as it's not a machine learning or AI-driven device. Device development and testing for this product would follow engineering and manufacturing processes, not a machine learning pipeline.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

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OCT - 4 2001

K012949

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.

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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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

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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. 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:

(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 _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.