The UGYTEX® Dual Knit Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Device Description

The Sofradim UGYTEX® Dual Knit Mesh is a monofilament, polypropylene mesh coated in the central portion with an absorbable hydrophilic film of porcine collagen. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. The hydrophilic film minimizes visceral attachment to the mesh which may occur during the healing process. The UGYTEX Dual Knit Mesh will be offered in various configurations which may include a rectangular sheet, anterior repair system and posterior repair system.

AI/ML Overview

The provided document is a 510(k) summary for the UGYTEX® Dual Knit Mesh, a surgical mesh. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy against specific acceptance criteria in the way a pharmaceutical trial or a software algorithm study would.

Therefore, many of the requested categories are not applicable to this document. The "study" mentioned here refers to performance testing to demonstrate substantial equivalence, not a clinical trial or an AI algorithm validation study.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in a quantitative, measurable way that would typically be used for complex device performance (e.g., sensitivity, specificity, accuracy). Instead, it states that the device is "substantially equivalent" to a predicate device based on "performance testing."

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence in material, function, performance, and design to the predicate device (UGYTEX® Mesh K033376).	"The test results showed that the Sofradim UGYTEX® Dual Knit Mesh is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document only references "appropriate testing."
Data Provenance: Not specified, but likely refers to in-vitro or bench testing of the mesh material and design, rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was not a study requiring expert-established ground truth for a test set. The assessment was likely based on engineering and material science evaluations.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of varied interpretations.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" implicitly used was likely engineering specifications and performance characteristics of the predicate device (UGYTEX® Mesh K033376) and established material science standards for surgical mesh.

8. The sample size for the training set

Not applicable. This type of submission does not involve training sets in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K051503

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AUG 5 - 2005 510(k) Summary for UGYTEX® Dual Knit Mesh

ﻟﺴ ﺳ

I. SPONSOR

Sofradim Production 116 Avenue du formans 01600 Trevoux France

Contact: Christophe Cosson Telephone: 33 (0)4 74 08 90 00 Facsimile: 33 (0)4 74 08 90 02

2. DEVICE NAME

UGYTEX® Dual Knit Mesh Proprietary Name: Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh

3. PREDICATE DEVICES

Sofradim UGYTEX® Mesh K033376

4. DEVICE DESCRIPTION

The UGYTEX Dual Knit Mesh will be offered in various configurations which may include a rectangular sheet, anterior repair system and posterior repair system.

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KOrI503
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INDICATIONS FOR USE ડ.

The UGYTEX® Dual Knit Mesh is indicated for tissue reinforcement and longlasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The UGYTEX® Dual Knit Mesh is substantially equivalent in material, function, performance and design to the predicate UGYTEX® Mesh.

PERFORMANCE TESTING 7.

The appropriate testing was performed to determine the performance characteristics of the mesh. The test results showed that the Sofradim UGYTEX® Dual Knit Mesh is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an image of an eagle with its wings spread, with three lines representing the eagle's body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 8 2012

Sofradim Production % Pamela Papineau. RAC Consultant to Sofradim Production Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K051503 Trade/Device Name: UGYTEX® Dual Knit Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, OTO, PAJ Dated: June 6, 2005 Received: June 7, 2005

Dear Ms. Papineau:

This letter corrects our substantially equivalent letter of August 5, 2005.

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/Resourcesfor You/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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Image /page/4/Picture/2 description: The image contains a sequence of handwritten digits, specifically '1051503'. The digits are written in a cursive style, with some connections between the numbers. The handwriting appears to be on a white background, and the digits are in black ink.

510(k) Number (if known):

Device Name: UGYTEX® Dual Knit Mesh

Indications For Use: _ . . . . .

The UGYTEX Dual Knit Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt Ruodu

Division of General, Restorative, and Neurological Devices

KOSJ503 510(k) Number_

Sofradim Production 510(k) Sofradim UGYTEX® Dual Knit Mesh June 6, 2005

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Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.