Not Found
No
The description focuses on the material properties and physical structure of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to support tissue and stabilize fascial structures, which implies a therapeutic function for repairing incisional hernias.
No
This device is a surgical mesh used to support and stabilize fascial structures, indicated for repairing incisional hernias. It is an implantable device for treatment, not for diagnosing conditions.
No
The device description clearly states it is a textile structure knitted from PVDF monofilament fiber, which is a physical material, 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 incisional hernias." This is a surgical implant used directly on the patient's body.
- Device Description: The device is a "textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber." It's a physical mesh for surgical repair.
- 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, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
DynaMesh®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is indicated for repairing incisional hernias in all current extraperitoneal surgical techniques.
Product codes
79 FTL
Device Description
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is a textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber. Polyvinylidene Fluoride (PVDF) has been used for approximately 20 years for long-term implants in cardiac and vascular surgery because of its biocompatibility and durability. PVDF is a high performance polymer material with very high material purity. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a pattern of zig-zag marking stripes as visual aid to the clinician facilitating correct mesh positioning; the mesh is correctly positioned when the zig-zag stripes are in the craniocaudal direction. DynaMesh®-CICAT is supplied as a sterile, flat sheet of material without any coatings or additives. The FEG Textiltechnik's DynaMesh®-CICAT 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 DvnaMesh®-CICAT to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products:
- Burst Strength Test
- Tensile Testing
- Tri-Elasticity Testing
- Suture Pullout Strength Test
- Tear Resistance Testing
- Porosity Test
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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K131530 Page 1/3 Revised Section 5 of K131530 "510(k) Summary" September 14, 2012
Image /page/0/Picture/1 description: The image shows the logo for DynaMesh. The word "Dyna" is in bold black font, while the word "Mesh" is in a white outlined font. There is a registered trademark symbol to the right of the word "Mesh". There is a black line underneath the entire logo.
by FEG Textiltechnik mbH
www.dyna-mesh.com
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH uelicher Strasse 338a 52070 Aachen 011 49 241 1892374-0 011 49 241 1892374-59
510(k) Summary (as required by 21 CFR 807.92(c))
Owner's Name:
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH Juelicher Str. 338a 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
OCT 2 3 2013
Date this Summary was Prepared:
September 14, 2013
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®-CICAT
Predicate Devices used to Demonstrate Substantial Equivalence: The FEG Textiltechnik DynaMesh®-CICAT is substantially equivalent to:
1
K131530 Page 2/3
Revised Section 5 of K131530 "510(k) Summary" September 14, 2012
DynaMesh®-PP (Light and Standard), K073579 Product Name: 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®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is constructed for repairing incisional hernias in all current extraperitoneal surgical techniques.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is a textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber.
Polyvinylidene Fluoride (PVDF) has been used for approximately 20 years for long-term implants in cardiac and vascular surgery because of its biocompatibility and durability. PVDF is a high performance polymer material with very high material purity.
The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis.
Product information:
PVDF SOLEF® 1008/0001 Trade Name: Chemical Name: Polyvinylidene Fluoride 24937-79-9 CAS Req. No .:
The knitted mesh structure consists of uncoloured PVDF Monofilaments with a pattern of zig-zag marking stripes as visual aid to the clinician facilitating correct mesh positioning; the mesh is correctly positioned when the zig-zag stripes are in the craniocaudal direction.
DynaMesh®-CICAT is supplied as a sterile, flat sheet of material without any coatings or additives. The FEG Textiltechnik's DynaMesh®-CICAT 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®-CICAT 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 .
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K131530 Page 3/3
Revised Section 5 of K131530 "510(k) Summary" September 14, 2012
- 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 ە same subcontract facility
as the FEG Textiltechnik DynaMesh®-PP (Light and Standard) K073579.
| Clearance/Approval | Subject Device | K073579 |
|---|---|---|
| Structure | knitted mesh | same |
| Material | 100% PVDF | |
| Monofilament | Polypropylene | |
| 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 DvnaMesh®-CICAT to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products:
- Burst Strength Test .
- Tensile Testing .
- Tri-Elasticity Testing .
- o Suture Pullout Strength Test
- Tear Resistance Testing .
- . Porosity Test
Conclusion
From review of the non-clinical data FEG Textiltechnik conclude that the DynaMesh®-CICAT is substantially equivalent in terms of safety, effectiveness and performance to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
FEG Textiltechnik Forschungs- und Entwicklungsgellschaft mbH C/O Mr. Neil R. Armstrong MeddiQuest Limited Herlington House, Orton Malborne Peterborough, Cambridgeshire PE2 5XS United Kingdom
Re: K131530
Trade/Device Name: Dynamesh - CICAT Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 14, 2013 Received: September 23, 2013
October 23, 2013
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
4
Page 2 - Mr. Neil R. Armstrong
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Center for Devices and Radiological Health
5/08/2013
Indications for Use
510(k) Number (if known): K131530
Device Name: DynaMesh®-CICAT
extraperitoneal surgical techniques.
Indications for Use:
DynaMesh®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is indicated for repairing incisional hernias in all current
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) . Division of Surgical Devices 510(k) Number: K131530
Page 1 of 1
Section 4. Indications for Use Statement