(85 days)
No
The description focuses on the material composition and physical properties of a surgical mesh, with no mention of AI or ML.
Yes
The device 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," which describes a therapeutic purpose.
No
The device is a surgical mesh used for tissue reinforcement and stabilization, not for diagnosing conditions.
No
The device description clearly states it is a surgical mesh made from physical materials (polypropylene and collagen-based hydrogel) and is used in surgical procedures. It is a physical implant, not software.
Based on the provided information, the UGYTEX Mesh is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "surgical mesh used during open or laparoscopic procedures," made from materials like polypropylene and collagen. This further confirms its use as a surgical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The UGYTEX Mesh does not perform any such function. It is a physical implant.
Therefore, the UGYTEX Mesh is a surgical device, specifically a surgical mesh, and not an IVD.
N/A
Intended Use / Indications for Use
The UGYTEX 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.
Product codes
FTL
Device Description
The UGYTEX Mesh is a surgical mesh used during open or laparoscopic procedures. The UGYTEX Mesh is made from polypropylene and a collagen based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the mesh but serves to temporary separate the mesh from adjacent organs to minimize visceral attachment to the mesh, which may occur during the healing process. The UGYTEX Mesh is offered in several sizes and shapes to accommodate the type and approach of the operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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)
Biocompatibility testing demonstrates that the materials used in the Sofradim UGYTEX Mesh are biocompatible and safe for its intended use.
Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were all evaluated. The test results showed that the Sofradim UGYTEX Mesh has similar performance characteristics as previously cleared surgical meshes.
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
§ 878.3300 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
JAN 1 5 2004
K033376
Pilz
510(k) Summary for UGYTEX® Mesh
1. SPONSOR
Sofradim Production 116 Avenue du formans 01600 Trevoux France
Contact: Christophe Cosson 33 (0)4 74 08 90 00 Telephone: Facsimile: 33 (0)4 74 08 90 02
2. DEVICE NAME
UGYTEX® Mesh Proprietary Name: Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh
PREDICATE DEVICES 3.
Sofradim Parictex® Composite Mesh K002699 Sofradim Parietene® Mesh K991400 Ethicon Gynemesh Prolene Soft K013718
4. DEVICE DESCRIPTION
The UGYTEX Mesh is a surgical mesh used during open or laparoscopic procedures. The UGYTEX Mesh is made from polypropylene and a collagen based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the mesh but serves to temporary separate the mesh from adjacent organs to minimize visceral attachment to the mesh, which may occur during the healing process. The UGYTEX Mesh is offered in several sizes and shapes to accommodate the type and approach of the operation.
1
33326
p2/2
INTENDED USE 5.
The UGYTEX 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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Sofradim UGYTEX Mesh is composed of two biocompatible components: polypropylene mesh and a hydrophilic collagen film. The polypropylene material used in the UGYTEX Mesh is identical to the polypropylene used in Sofradim's Parietene polypropylene mesh, which received FDA marketing clearance under K991400. The UGYTEX Mesh is constructed of reduced diameter monofilament fibers, knitted into a design identical to the Parietene polypropylene mesh. This mesh with large pores allows fast tissue ingrowth and exhibits more flexibility than standard Parietene mesh. The collagen component of the Sofradim UGYTEX Mesh is derived from a Porcine source and meets all the requirements in the FDA collagen guidance documents. In addition, the Sofradim mesh and predicate devices are available in various sizes and shapes to accommodate different surgical procedures and/or surgeon's choice.
PERFORMANCE TESTING 7.
Biocompatibility testing demonstrates that the materials used in the Sofradim UGYTEX Mesh are biocompatible and safe for its intended use.
Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were all evaluated. The test results showed that the Sofradim UGYTEX Mesh has similar performance characteristics as previously cleared surgical meshes.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the eagle.
JAN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sofradim Production c/o Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K033376
Trade/Device Name: UGYTEX® Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 21, 2003 Received: October 23, 2003
Dear Ms. McNamara-Cullinane:
We have reviewed your Scction 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 cnactment date of the Medical Device Amendments, or 10 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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); 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.
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Page 2 - . Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko33376
510(k) Number (if known): K033376
Device Name: UGYTEX® Mesh
Indications for Use:
The UGYTEX 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 , (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Muriam' C. Provost
ivision Sign-Off) Vision of General, Restorative and Neurological Devices
Number K039376