(242 days)
No
The device description and intended use clearly define it as a physical polypropylene mesh for surgical repair, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is intended to support tissue and stabilize fascial structures, and is indicated for repairing hernias and reinforcing tissues, which are therapeutic actions.
No
The device, DynaMesh-PP, is described as a polypropylene mesh intended to support tissue and stabilize fascial structures for repairing hernias and abdominal wall repair. Its purpose is structural support, not to diagnose a condition.
No
The device description clearly states it is a polypropylene mesh, which is a physical material intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to support tissue and stabilize fascial structures of the abdominal wall" and is "indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber" that is a "sterile, flexible, flat sheet of material" intended for use "during hernia surgery." This further confirms its use as a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical implant.
The information provided clearly indicates that this is a surgical mesh used for structural support within the body, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.
Product codes
79 FTL, FTL
Device Description
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material. DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements. FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes. The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags: - the inner transparent bag contains the device only - the outer transparent bag contains the inner bag and four adhesive labels for patient records. The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991400, K031225, K061704, K930669, K002093, K070192
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
August 3, 2008 Page 128 Attachment 8
K073579
rg 194
510(k) Summary
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH Juelicher Strasse 338a D-52070 Aachen Germany 011 49 241 189 2374-0 Telephone: 011 49 241 189 2374-59 Fax:
Image /page/0/Figure/4 description: The image shows a logo with the letters "FEG" stacked vertically on the left side. To the right of the letters, the word "Textiltechnik" is written vertically. The letters and the word are in a simple, sans-serif font. The logo appears to be for a company or organization related to textile technology.
Owner's Name
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH Juelicher Str. 338a D - 52070 Aachen Germany 011 49 241 189 2374-0 Tel.: 011 49 241 189 2374-59 Fax:
Contact Person: e-mail :
Stefan Schneemelcher schneeme@feg-textiltechnik.de
Date this Summary was Prepared:
August 01, 2008
Classification:
Name: Regulation: Product Code : Regulatory Class:
Polymeric Surgical Mesh 21 CFR 878.3300 79 FTL II
Common/Usual Name:
Hernia Repair Polypropylene Mesh
Proprietary Name:
DynaMesh-PP (Standard and Light)
AUG 1 8 2008
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K073579
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August 3, 2008 Page 129
Establishment Registration Number:
| The device will be manufactured by: | |
|---|---|
| FEG Textiltechnik | |
| Forschungs- und Entwicklungsgesellschaft mbH | |
| Juelicher Strasse 338a | |
| D-52070 Aachen | |
| Germany | |
| Establishment Registration Number: "to be applied for | |
| "knitted" by | |
| Julius Boos jr. GmbH & Co. KG | |
| Liegnitzer Strasse 16 | |
| D-42277 Wuppertal |
Germany Establishment Registration Number: none and sterilized by: Rose GmbH Gottbillstrasse 25-30
Sterilized By
D-54294 Trier Germany Establishment Registration Number: none
Substantial Equivalence:
The FEG Textiltechnik DynaMesh-PP is substantially equivalent in design, use and materials to the:
Sofradim Production Pariente Polypropylene Mesh - K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard Atrium Medical Corp Meshes (various) - K930669, K002093, K070192
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is made of the same basic material as the Sofradim Production Pariente Polypropylene Mesh – K991400, polypropylene.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is manufactured by similar processes to the Sofradim Production Pariente Polypropylene Mesh – K991400.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is sterilized by a conventional sterilization cycle as is the Sofradim Production Pariente Polypropylene Mesh – K991400.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP has a reduced effective surface mesh area and weight per unit area compared to the Sofradim Production Pariente Polypropylene Mesh - K991400.
2
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August 3, 2008 Page 130
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is also THE TEG TEXRECCMIN FORSERING Construction, processing and intended use to the other predicate products:
GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 (Usher's) Marlex (various) - K792281, K922916 Davol/Bard Atrium Medical Corp Meshes (various) - K930669, K002093, K070192
Description of Product:
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material.
DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements.
FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes
The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags:
-
the inner transparent bag contains the device only
-
the outer transparent bag contains the inner bag and four adhesive labels for patient records.
The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.
Intended use:
DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall.
DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.
| Feature | Unit | Subject Device | Predicate Device | ||
|---|---|---|---|---|---|
| FEG Textiltechnik | Sofradim | ||||
| DynaMesh-PP | Parietene Mesh | ||||
| This 510(k) Submission | K991400 | ||||
| Standard | Light | Standard | Light | ||
| material | polypropylene | same | same | same | |
| mesh form | knitted | same | same | same | |
| sizes | various sizes | ||||
| supplied to be | |||||
| cut to suit | |||||
| patient | same | same | same | ||
| supplied sterile | conventional | ||||
| sterilization | |||||
| method | same | same | same | ||
| weight | g m⁻² | 72 | 36 | 76 | 36 |
| yarn diameter | μm | 165 | 140 | 150 | 115 |
| yarn length per unit | m m⁻² | 3579 | 2519 | 4388 | 3537 |
Technological Companson to Predicate Device
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August 3, 2008 Page 131
| Page 131
Feature | Unit | Subject Device
FEG Textiltechnik
DynaMesh-PP
This 510(k) Submission | | Predicate Device
Sofradim
Parietene Mesh
K991400 | |
|-----------------------------------------------|--------|------------------------------------------------------------------------------|-------|-----------------------------------------------------------|-------|
| | | Standard | Light | Standard | Light |
| area of mesh patch | | | | | |
| surface area per unit
area of mesh patch | m² m⁻² | 1.86 | 1.11 | 2.07 | 1.28 |
| tensile strength -
longitudinal | N cm⁻¹ | 52 | 28 | 42 | 23 |
| tensile strength -
transverse | N cm⁻¹ | 59 | 22 | 44 | 19 |
| suture pull-out
strength -
longitudinal | N cm⁻¹ | 47 | 30 | 43 | 31 |
| suture pull-out
strength -
transverse | N cm⁻¹ | 43 | 32 | 50 | 19 |
Conclusion
Conclusion
Based on the above information, FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH believes that DynaMesh-PP (standard and light) can be determined substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2008
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH % MeddiQuest Limited Mr. Neil R. Armstrong Business & Technology Center/Bessemer Drive Stevenage, Hertsfordshire SG2 2DX United Kingdom
Re: K073579
Trade/Device Name: DynaMesh-PP (Standard and Light) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 3, 2008 Received: August 11, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
5
Page 2 -- Mr. Neil R. Armstrong
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
March 3, 2008 Page 8
Attachment 1
Indications for Use
510(k) Number (if known): Device Name: _ DynaMesh-PP (Standard and Light)____
Indications for Use:
DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073574