(28 days)
K 965038
Not Found
No
The description focuses on the material composition and antimicrobial properties of a surgical mesh, with no mention of AI or ML.
Yes
The device is described as being used for the "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects" and is intended for "long-term implantation as reinforcing surgical meshes," which are therapeutic applications.
No
Explanation: The device is described as a surgical mesh for reconstruction and repair of hernias and soft tissue deficiencies. It is an implantable device used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of expanded polytetrafluoroethylene (ePTFE) and antimicrobial agents, which are physical materials, 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 for the "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects." This describes a surgical implant used directly in the body for structural support and repair.
- Device Description: The description details a surgical mesh made of ePTFE and antimicrobial agents, intended for "long-term implantation." This further confirms its use as an implantable medical device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
IVDs are used to perform tests on samples taken from the body, while this device is implanted into the body.
N/A
Intended Use / Indications for Use
For use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Product codes (comma separated list FDA assigned to the subject device)
ETT
Device Description
These devices are composed of expanded polytetrafluoroethylene (ePTFE) and antimicrobial agents. GORE-TEX ePTFE Medical Products have been available for more than two decades and the safety and efficacy of these devices have been confirmed by well over 5,000,000 implants. The applicant devices are intended for long-term implantation as reinforcing surgical meshes. They incorporate the antimicrobial agents silver carbonate and chlorhexidine diacetate to inhibit bacterial colonization of the device for up to ten days postimplantation. The only change which will result to the applicant devices as a result of the clearance of K 981051 is the addition of the contraindication, " Not for pre-term and neonatal populations".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 965038
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
APR 1 5 1998
Premarket Notification Summary
W. L. Gore & Associates, Inc. 1. Submitter: 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900 Phone: (520) 779-2771 FAX: (520) 779-1456
| Contact: | John W. Nicholson, Regulatory Affairs |
|---|---|
| Preparation Date: | March 30, 1998 |
2. Applicant
Trade Name: GORE-TEX® Soft Tissue Patch PLUS Biomaterial Device: GORE-TEX® MycroMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial with Holes
Common Name: Surgical Mesh
Substantially Equivalent Devices: 3.
These four devices were cleared for an indication revision (the addition of the clause, "and for the temporary bridging of fascial defects" to the existing cleared indication) under K 965038, and so these products will serve as their own predicates.
4. Device Description:
These devices are composed of expanded polytetrafluoroethylene (ePTFE) and antimicrobial agents. GORE-TEX ePTFE Medical Products have been available for more than two decades and the safety and efficacy of these devices have been confirmed by well over 5,000,000 implants. The applicant devices are intended for long-term implantation as reinforcing surgical meshes. They incorporate the antimicrobial agents silver carbonate and
1
chlorhexidine diacetate to inhibit bacterial colonization of the device for up to ten days postimplantation. The only change which will result to the applicant devices as a result of the clearance of K 981051 is the addition of the contraindication, " Not for pre-term and neonatal populations".
5. Intended Use:
The applicant devices will have the same intended uses as those of the cited predicates : For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
6. Technological Characteristics:
No new technological characteristics result from the addition of the presented contraindication. The applicant devices' design, performance and material characteristics are not being changed in any way and only the labeling is revised as a result of this submission's clearance. Therefore, no technological characteristic revisions have occurred when comparing the applicant devices with their cited, substantially equivalent predicate devices.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the public's well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Mr. John Nicholson Requlatory Affairs Associate W.L. Gore & Associates, Incorporated Medical Products Division P.O. Box 900 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900
Re: K981051 GORE-TEX® Soft Tissue Patch PLUS; Trade Name: GORE-TEX® DualMesh PLUS Biomaterrial; GORE-TEX® MycroMesh PLUS Biomaterial; and GORE-TEX® DualMesh PLUS Biomaterial with Holes Requlatory Class: II Product Code: ETT Dated: March 17, 1998 Received: March 18, 1998
Dear Mr. Nicholson:
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 aqainst 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 found 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory
3
Page 2 - Mr. Nicholson
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.
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 your 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Muk n melkem
for 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
Page_ 1 of 1
510(k) Number (if known): __K 981051
Device Name: Gore-Tex Soft Tissue Patch Plus, Gore-Tex MycroMesh Biomaterial, Gore-Tex DualMesh Biomaterial, Gore-Tex-MycroMesh Plus Biomaterial,
Gore-Tex DualMesh Plus Biomaterial with holes Indications For Use:
For use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Mark N Melkese
(Division Sign-Off)
emw Division of General Restorative Devices
510(k) Number K981051
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_U (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)