(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical mesh, with no mention of AI or ML capabilities.
No.
Explanation: The device, DynaMesh®-POSTERIOR, is a surgical mesh intended to support tissue and stabilize fascial structures for repairing hernias. It is a long-term implantable device, not a therapeutic device that actively treats a disease or condition through non-invasive means or delivers therapy.
No
Explanation: The device is described as a surgical mesh used to support tissue and stabilize fascial structures for repairing hernias. It does not perform any diagnostic functions like detecting, monitoring, or predicting a medical condition.
No
The device description clearly states it is a "textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (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 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 from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.
Product codes
FTL
Device Description
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR 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 from Solvay Solexis.
The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free.
The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF.
DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked 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
Various Laboratory Bench Tests have been conducted on DynaMesh®-POSTERIOR 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
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
October 31, 2018
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft % Neil Armstrong RA Advisor to FEG Textiltechnik MeddiOuest Regulatory Affairs Ltd Unit 73B Hebron Industrial Estate Kilkenny, R95 CRK2 Ireland
Re: K182087
Trade/Device Name: DynaMesh-POSTERIOR Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: July 11, 2018 Received: August 2, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Joseph Nielsen" in a large, bold font. To the right of the name, there is some smaller text that reads "Digitally s DN: c=US ou=FDA, S, 0.9.2342.1 Date: 201". The text appears to be part of a digital signature or certificate.
Digitally signed by Joseph Nielsen -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Joseph Nielsen -
S,
0.9.2342.19200300.100.1.1=2000367505
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
See PRA Statement below.
07/11/2018
510(k) Number (if known) K182087
Device Name DynaMesh®- POSTERIOR
Indications for Use (Describe)
DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K182087 Page 1 of 3
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: July 11, 2018
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®-POSTERIOR
4
Predicate Devices used to Demonstrate Substantial Equivalence:
The FEG Textiltechnik DynaMesh®-POSTERIOR is substantially equivalent to:
| Product Name: | DynaMesh®-VENTRAL, K161550 |
|---|---|
| Manufacturer: | FEG Textiltechnik, Aachen, Germany |
Description, including Intended Use
DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall.
DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR 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 from Solvay Solexis.
The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free.
The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF.
DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked 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®-POSTERIOR 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®-VENTRAL K161550.
The FEG Textiltechnik DynaMesh®-POSTERIOR has a slightly different structure to give more uniform properties in both horizontal and vertical directions, as a clinician
5
| Feature | FEG Textiltechnik
DynaMesh®-POSTERIOR | FEG Textiltechnik
DynaMesh®-VENTRAL |
|-----------------------|------------------------------------------|----------------------------------------|
| Clearance/Approval | Subject Device | K161550 |
| 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 |
preference option for situations where there is no clear preferred orientation.
Summary of Non-Clinical and Clinical Data
Various Laboratory Bench Tests have been conducted on DynaMesh®-POSTERIOR 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®-POSTERIOR is substantially equivalent in terms of safety, effectiveness and performance to the predicate device.