(202 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technologies.
Yes.
The device is indicated for repairing hernias and supports tissue and stabilizes fascial structures, which are therapeutic actions.
No
The device, DynaMesh®-VENTRAL, is described as a textile structure used to support and stabilize fascial structures of the abdominal wall for repairing hernias. Its description focuses on its material composition and physical properties, and it is explicitly stated that it serves to "support the tissue and stabilize the fascial structures." There is no mention of it being used to identify or analyze diseases or conditions, which are characteristics of a diagnostic device.
No
The device description clearly states it is a textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber, indicating it is a physical implantable mesh, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support the tissue and stabilize the fascial structures of the abdominal wall" and is indicated for "repairing hernias." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber." This is a physical mesh designed for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc.
- Performance Studies: The performance studies listed are "Laboratory Bench Tests" evaluating physical properties like burst strength, tensile strength, and porosity. These are tests of the device's structural integrity and material properties, not diagnostic performance.
Therefore, the DynaMesh®-VENTRAL is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical techniques.
Product codes
FTL
Device Description
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the zig-zag-stripes are in the craniocaudal direction. The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF. DynaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Various Laboratory Bench Tests have been conducted on DynaMesh®-VENTRAL to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products:
- Burst Strength Test
- Tensile Strength
- Maximum elongation
- Suture Pullout Strength Test
- Tear Resistance Testing
- Porosity Test
- Mesh stiffness
From review of the non-clinical and clinical data, FEG Textiltechnik conclude that the DynaMesh®-VENTRAL is substantially equivalent in terms of safety, effectiveness and performance to the predicate device.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Feg Textiltechnik Forschungs-und Entwicklungsgesellschaft % Mr. Neil Armstrong RA Advisor To Feg Textiltechnik Meddiquest Limited Herlington House Orton Malborne Peterborough, PE2 5XS GB
Re: K161550
Trade/Device Name: DynaMesh®-VENTRAL Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: November 18, 2016 Received: November 23, 2016
Dear Mr. Armstrong:
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 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 adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161550
Device Name DynaMesh®-VENTRAL
Indications for Use (Describe)
DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical thecniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DynaMesh. The word "Dyna" is in dark gray, and the word "Mesh" is in yellow. There is a yellow line underneath the words, and the words "by FEG Textiltechnik mbH" are below the line.
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH Prager Ring 70 D-52070 Aachen Germany Phone: 011 49 241 1892374-0 011 49 241 1892374-59 Fax:
510(k) Summary
(as required by 21 CFR 807.92(c))
Owner's Name:
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH Prager Ring 70 D - 52070 Aachen Germany Tel: +49 241 189 23 74 - 0 +49 241 189 23 74 - 59 Fax: Stefan Schneemelcher Contact Person: e-mail: schneeme@feg-textiltechnik.de
Date this Summary was Prepared:
December 20, 2016
Classification:
Name: Regulation: Product Code: Regulatory Class: Mesh, Surgical, Polymeric 21 CFR 878.3300 79 FTL II
Common/Usual Name:
Mesh Implant used in Hernia Surgery
Proprietary Name:
DynaMesh®-VENTRAL
4
Predicate Devices used to Demonstrate Substantial Equivalence:
The FEG Textiltechnik DynaMesh®-VENTRAL is substantially equivalent to:
| Product Name: | DynaMesh®-CICAT, K131530 |
|---|---|
| Manufacturer: | FEG Textiltechnik, Aachen, Germany |
Description, including Intended Use
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is intended for hernia surgery for reinforcing connective tissue structures. DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical techniques.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber.
The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis.
The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the ziqzag-stripes are in the craniocaudal direction.
The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF.
DvnaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
Technological Characteristics Compared to Predicate Devices
The FEG Textiltechnik DynaMesh®-VENTRAL is:
- for the same intended use,
- knitted with the same equipment by the same personnel in the same facilities, .
- . packaged in same materials by same processes in the same facilities
- labeled with the same label format by the same processes in the same facilities .
- contract sterilized in the same chamber with the same cycle at the same . subcontract facility
as the FEG Textiltechnik DynaMesh®-CICAT K131530.
5
| Feature | FEG Textiltechnik
DynaMesh®-VENTRAL | FEG Textiltechnik
DynaMesh®-CICAT |
|-----------------------|----------------------------------------|--------------------------------------|
| Clearance/Approval | Subject Device | K131530 |
| Structure | knitted mesh | same |
| Material | 100% PVDF Monofilament | same |
| Manufacturing Process | Knitted by FEG | same |
| Packaging Materials | poly, paper, cardboard | same |
| Packaging Process | Packed by FEG | same |
| Sterilization Process | Sterilized by Rose GmbH | same |
Summary of Non-Clinical and Clinical Data
Various Laboratory Bench Tests have been conducted on DynaMesh®-VENTRAL to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products:
- . Burst Strength Test
- Tensile Strength ●
- Maximum elongation
- Suture Pullout Strength Test .
- Tear Resistance Testing ●
- . Porosity Test
- . Mesh stiffness
Conclusion
From review of the non-clinical and clinical data, FEG Textiltechnik conclude that the DynaMesh®-VENTRAL is substantially equivalent in terms of safety, effectiveness and performance to the predicate device.