(30 days)
Not Found
Not Found
No
The summary describes a physical biomaterial with no mention of software, algorithms, or any computational processing that would indicate AI/ML.
Yes
The device is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects, which are therapeutic interventions.
No
Explanation: The device, GORE-TEX® DualMesh® Biomaterial, is indicated for "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects." This describes a therapeutic or reconstructive function, not a diagnostic one. It does not identify a disease, condition, or health status.
No
The device description clearly indicates it is a physical biomaterial made of ePTFE, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details a "Biocompatible, expanded polytetrafluoroethylene (ePTFE)" material with specific surface characteristics. This is consistent with a surgical mesh or biomaterial, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description and intended use do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the GORE-TEX® DualMesh® Biomaterial is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GORE-TEX® DualMesh® Biomaterial is indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Product codes
FTL
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with one open microstructure surface and one closed microstructure surface. The open microstructure surface is texturized with a "corduroy" pattern to aid in surface identification and proper surface orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device.
The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh.
Design control and verification testing has been performed for this device modification.
Key Metrics
Not Found
Predicate Device(s)
The previously cleared GORE-TEX® DualMesh® Biomaterial with a "hexagon" identification pattern
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
JUL 29 1999
Attachment IV Special 510 (k) Premarket Notification GORE-TEX® DualMesh® Biomaterial
Premarket Notification 510(k) Summary
W.L. Gore and Associates, Inc. A. Submitter 3750 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 86002-0900
520-779-2771
R. Larry Pratt Contact :
Date Submitted: June 28, 1999
B. Applicant Device
Trade Name: GORE-TEX® DualMesh® Biomaterial.
Classification Name: Surgical Mesh.
C. Applicant Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with one open microstructure surface and one closed microstructure surface. The open microstructure surface is texturized with a "corduroy" pattern to aid in surface identification and proper surface orientation.
D. Applicant Device Indications For Use
GORE-TEX® DualMesh® Biomaterial is indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
- E. Predicate Device
The previously cleared GORE-TEX® DualMesh® Biomaterial with a "hexagon" identification pattern is cited as the predicate device.
F. Technological Characteristics
This Premarket Notification submission is for a modification to an existing, currently marketed device. The modification is to change the texturing pattern on the tissue ingrowth surface of the predicate device.
The modified texturing pattern does not change the device's intended use or indications. Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device.
1
Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device.
The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh.
Design control and verification testing has been performed for this device modification.
G. Safety and Effectiveness Conclusions
This Premarket Notification concerns a modification to the surface identification pattern for use in proper surface orientation. The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength and material characterization values. In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device.
The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed. Both the applicant device and the predicate device perform their equivalent clinical functions by incorporating biocompatible materials to permanently or transiently bridge or support a tissue defect.
The applicant device is substantially equivalent to the previously cleared predicate device.
2
Image /page/2/Picture/1 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 body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Mr. R. Larry Pratt Regulatory Affairs W. L. Gore & Associates, Inc. Medical Products Division 3450 West Kiltie Lane Flagstaff. Arizona 86002
Re: K992189
Trade Name: GORE-TEX DualMesh Biomaterial Regulatory Class: II Product Code: FTL Dated: June 28, 1999 Received: June 29, 1999
Dear Mr. Pratt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be lound in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. R. Larry Pratt
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5 10(k) Number (if known):
Device Name: GORE-TEX DualMesh Biomaterial
Indications For Use:
GORE-TEX DualMesh Biomaterial is indicated for the reconstruction GORE-IEX Dualmest Bromaocirar is Includes and for the temporary bridging of fascial defects.
92189
(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 Devices | |
| 510(k) Number | K992183 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| (Optional Format 1-2-96) |
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