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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the DynaMesh®-CICAT surgical mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical (bench) testing.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based only on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria with numerical targets. Instead, it states that various bench tests were conducted "to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products." This implies the acceptance criteria were based on meeting established norms for surgical meshes or demonstrating performance comparable to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Performance to an accepted norm or substantial equivalence to predicate products for:	Demonstrated performance through various laboratory bench tests. Implied that results were comparable to the predicate devices or met accepted industry standards for surgical meshes.
Burst Strength Test	Tested
Tensile Testing	Tested
Tri-Elasticity Testing	Tested
Suture Pullout Strength Test	Tested
Tear Resistance Testing	Tested
Porosity Test	Tested

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

The document does not specify the sample sizes used for each of the listed bench tests. It only states that "Various Laboratory Bench Tests have been conducted." The data provenance is from "FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH" in Germany, and the tests are described as non-clinical (bench tests), implying they were conducted in a laboratory setting. There is no indication of retrospective or prospective human data.

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 to the provided document. The "ground truth" here refers to the physical properties of the mesh determined through engineering/mechanical testing, not human-interpreted data. Therefore, there's no mention of experts or their qualifications for establishing ground truth in this context.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used when human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For mechanical bench tests, the measurements are generally objective and standardized.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or mentioned. This document describes a surgical mesh, not an AI-powered diagnostic device.

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

No such study was performed or mentioned. This information pertains to AI algorithms, which are not relevant to this medical device.

7. The type of ground truth used

The ground truth used for the device evaluation was engineering/mechanical measurement data obtained from laboratory bench tests. These tests directly measure physical properties like burst strength, tensile strength, tear resistance, suture pullout strength, tri-elasticity, and porosity.

8. The sample size for the training set

This information is not applicable as there is no machine learning or AI algorithm involved that would require a training set. The device is a physical surgical mesh.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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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:

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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.

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% PVDFMonofilament	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.

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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

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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

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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

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.