(30 days)
Not Found
No
The device description and performance studies focus on the material properties and handling characteristics of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is indicated for the reconstruction of hernias and soft tissue deficiencies, and the temporary bridging of facial defects, which are therapeutic applications.
No
The device is a biomaterial used for reconstruction and temporary bridging of defects, not for diagnosing medical conditions.
No
The device description clearly details a physical biomaterial composed of ePTFE and silicone components, indicating it is a hardware medical device, 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 facial defects. This is a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details a biomaterial composed of ePTFE and silicone, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The GORE-TEX DualMesh EMERGE PLUS Biomaterial consists of an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive. The silicone component is designed to provide a stiffening effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component.
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)
W.L. Gore & Associates, Inc. performed device integrity testing to support that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to the predicate devices. All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements.
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.
K022782, K000185, K981051, K965038, K946106
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
Special 510(k) Premarket Notification K032168
AUG 15 2003
GORE-TEX DualMesh EMERGE PLUS Biomaterial
(p.1 of 2)
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | GORE-TEX DualMesh EMERGE PLUS Biomaterial |
|---|---|
| Common Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
| Device Classification: | Class II |
| Product Classification and Code: | 878.3300, FTL |
| Classification Panel: | General and Plastic Surgery Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Brandon Hansen |
| Regulatory Affairs | |
| Medical Products Division | |
| W.L. Gore & Associates, Inc. | |
| 3450 West Kiltie Lane | |
| Flagstaff, AZ 86001 | |
| Telephone: (928) 864-3784 | |
| Facsimile: (928) 864-4144 | |
| E-mail: bhansen@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
Device Description
The GORE-TEX DualMesh EMERGE PLUS Biomaterial consists of an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive. The silicone component is designed to provide a stiffening
1
Special 510(k) Premarket Notification K432168 (4.2 a 2) K032168
GORE-TEX DualMesh EMERGE PLUS Biomaterial
effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component.
Indication for Use
GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.
Substantially Equivalent Devices
In W.L. Gore & Associates' opinion, the GORE-TEX DualMesh EMERGE PLUS Biomaterial is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.
- GORE-TEX DualMesh EMERGE and EMERGE PLUS Biomaterial (W.L. Gore & � Associates, Inc., Flagstaff, AZ) -- K022782
- GORE-TEX DualMesh PLUS Biomaterial (W.L. Gore & Associates, Inc., Flagstaff, AZ) -. K000185, K981051, K965038, K946106
Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from that of the predicate devices listed above.
Summary of Studies
W.L. Gore & Associates, Inc. performed device integrity testing to support that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to the predicate devices. All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements.
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the W. L. Gore & Associates, Inc. GORE-TEX DualMesh EMERGE PLUS Biomaterial through this Special 510(k) Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2003
Mr. Brandon Hansen Regulatory Affairs W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86001
Re: K032168
Trade/Device Name: GORE-TEX DualMesh EMERGE PLUS Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 15, 2003 Received: July 17, 2003
Dear Mr. Hansen:
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 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.
3
Page 2 - Mr. Brandon Hansen
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Alan Webb
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification K032168
GORE-TEX DualMesh EMERGE PLUS Biomaterial
INDICATION FOR USE
510(k) Number (if known):
432168
Device Name:
GORE-TEX DualMesh EMERGE PLUS Biomaterial
Intended Use / Indication For Use:
GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number [032