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.

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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the DynaMesh®-VENTRAL surgical mesh, which is a medical device for repairing hernias. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed study information typically found in an FDA PMA (Premarket Approval) application or a clinical trial report.

Here's a breakdown of the requested information based on the provided text, with explanations for what is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical thresholds against which the DynaMesh®-VENTRAL was evaluated. Instead, it lists "Laboratory Bench Tests" that were conducted to "demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products." The performance details for each test (e.g., specific burst strength values, tensile strength values) are not reported in this summary.

Test Type	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not detailed in document)
Burst Strength Test	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Tensile Strength	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Maximum elongation	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Suture Pullout Strength Test	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Tear Resistance Testing	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Porosity Test	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)
Mesh stiffness	To meet accepted norms and/or be substantially equivalent to predicate	Performance demonstrated (details not provided)

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

The document mentions "various Laboratory Bench Tests" but does not specify the sample sizes used for these tests. Data provenance (country of origin of the data, retrospective or prospective) is also not mentioned for these bench tests. Given they are bench tests on the device materials, "country of origin of the data" would likely refer to the testing facility, which is not specified.

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

This information is not applicable or not provided in this type of submission. Bench tests typically involve laboratory technicians or engineers performing standardized tests, not medical experts establishing ground truth in a clinical context.

4. Adjudication method for the test set

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcomes, not for material property bench tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done or mentioned. This document describes a 510(k) submission based on substantial equivalence to a predicate device, primarily supported by bench testing of material properties, not clinical comparative effectiveness studies involving human readers.

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

Not applicable. The DynaMesh®-VENTRAL is a physical surgical mesh, not a software algorithm or AI device.

7. The type of ground truth used

For the bench tests, the "ground truth" would be the physical properties and performance of the device as measured by standardized laboratory methods. This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense. These tests aim to objectively measure the material characteristics of the mesh. The comparison is made against "accepted norms" and the performance of the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As mentioned above, this is not an AI/ML algorithm.

Summary

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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

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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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.

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Feature	FEG TextiltechnikDynaMesh®-VENTRAL	FEG TextiltechnikDynaMesh®-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.

Regulation Number and Section

§ 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.