(44 days)
Not Found
No
The device description and intended use clearly define a physical mesh product for surgical repair, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the reconstruction of hernias and soft tissue deficiencies, which involves treating a medical condition and restoring function, thus classifying it as a therapeutic device.
No
The device is a mesh used for surgical repair and reinforcement of hernias and soft tissue deficiencies, not for diagnosing conditions.
No
The device description clearly states it is a knitted polypropylene monofilament mesh, which is a physical implantable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The GORE POLYPROPYLENE Hernia Mesh is a surgical implant used inside the body to reinforce tissue during hernia repair and other soft tissue procedures. It is a physical mesh material, not a diagnostic test.
- Intended Use: The intended use is for the surgical reconstruction of hernias and soft tissue deficiencies, which is a therapeutic procedure, not a diagnostic one.
The provided information clearly describes a surgical implant used for structural support within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® SOLYPROPYLENE HERNIA MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular). Muscle flap reinforcement
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The GORE POLYPROPYLENE HERNIA MESH is used as reinforcement during surgical repairs of hernias and other soft tissue deficiencies. GORE POLYPROP YLENE HERNIA MESH is comprised of non-absorbable, knitted 100% polypropylene monofilaments. The GORE POLYPROPYLENE HERNIA MESH is provided STERILE for single use only and offered in several sizes and shapes to accommodate the type and approach of the operation. The GORE POLYPROPYLENE HERNIA MESH will be supplied in sheets ranging from a rectangular configuration that is 2.5 x 10 cm to a rectangular configuration that is 25 x 35.5 cm. Also available is a pre-shaped oval configuration that is 6.5 x 13 CIII. The GORE POLYPROPYLENE HERNIA MESH can be trimmed to the desired size and shape using sharp surgical scissors. The mesh should be sutured or tacked to host tissue avoiding excessive tension.
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. I. Gore & Associates, Inc. performed device integrity testing to support that the GORE POLYPROPYLENF: HERNIA MESH is equivalent to the predicate devices. All device integrity test results for the GORE POLYPROPYLENE HERNIA MESH 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.
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
K043081 1/5
GORE POLYPROPYLENE HERNIA MESH
DEC 22 2004
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | GORE POLYPROPYLENE HERNIA MESH |
|---|---|
| Common Name: | Polypropylene Mesh |
| Classification Name: | Mesh, surgical, polymeric |
| Device Classification: | Class II |
| Product Classification and Code: | 878.3300, FTL |
| Classification Panel: | General and Plastic Surgery Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Michael Ivey |
| Regulatory Affairs | |
| Medical Products Division | |
| W. L. Gore & Associates, Inc. | |
| 3450 West Kiltie Lane | |
| Flagstaff, AZ 86002-0500 | |
| Telephone: (928) 864-3790 | |
| Facsimile: (928) 779-3480 | |
| E-mail: mivey@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
Image /page/0/Picture/8 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a right-pointing arrow above the word. Below the word "GORE" is the text "Creative Technologies Worldwide" in a smaller font. The word "Confidential" is in a simple sans-serif font and is positioned to the right of the Gore logo. The image is simple and contains only these two elements.
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Device Description
The GORE POLYPROPYLENE HERNIA MESH is used as reinforcement during surgical repairs of hernias and other soft tissue deficiencies.
GORE POLYPROP YLENE HERNIA MESH is comprised of non-absorbable, knitted 100% polypropylene monofilaments. The GORE POLYPROPYLENE HERNIA MESH is provided STERILE for single use only and offered in several sizes and shapes to accommodate the type and approach of the operation.
The GORE POLYPROPYLENE HERNIA MESH will be supplied in sheets ranging from a rectangular configuration that is 2.5 x 10 cm to a rectangular configuration that is 25 x 35.5 cm. Also available is a pre-shaped oval configuration that is 6.5 x 13 CIII.
The GORE POLYPROPYLENE HERNIA MESH can be trimmed to the desired size and shape using sharp surgical scissors. The mesh should be sutured or tacked to host tissue avoiding excessive tension.
Indications for Use
The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE POLYPROPYLENE HERNIA MESH may be used include, but are not limited to:
Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).
Muscle flap reinforcement
Substantially Equivalent Devices
In W. L. Gore & Associates, Inc.'s opinion, the GORE POLYPROPYLENE HERNIA MESH 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.
- Bard® Mesh (Davol, Inc. Cranston, RI) Pre-amendment Device .
- Prolene TM Soft Polypropylene Mesh (Ethicon Inc, Somerville, NJ) -. K001122
- Atrium Lite "11 Mesh (Atrium Medical Corp, Hudson, New Hampshire) ● - K002093
Image /page/1/Picture/17 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold, stylized letters, with a right-pointing arrow above it. Below the word "GORE" are smaller words, "Creative Technologies Worldwide". The word "Confidential" is written in a simple, sans-serif font.
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GORE POLYPROPYLENE HERNIA MESH
Summary of Studies
W. I. Gore & Associates, Inc. performed device integrity testing to support that the GORE POLYPROPYLENF: HERNIA MESH is equivalent to the predicate devices. All device integrity test results for the GORE POLYPROPYLENE HERNIA MESH 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. GORE POLYPROPYLENE HERNIA MESH through this 510(k) Premarket Notification.
Image /page/2/Picture/7 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the word "GORE" are smaller words that are difficult to read. The word "Confidential" is written in a simple, sans-serif font.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized stripes representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2004
Mr. Michael Ivey Regulatory Affairs Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, Arizona 86003
Re: K043081
K045081
Trade/Device Name: Gore Polypropylene Hernia Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 5, 2004 Received: November 8, 2004
Dear Mr. Ivey:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave determined the acresed predicate devices marketed in interstate for use stated in the encrosule) to regary manical povice Amendments, or to commerce prior to May 28, 1776, the enactified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The You may, inerelore, market the device, basjoct of the more of registration, listing of general controls provisions of the field is a prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major filly be subject to such additional controlial "Life 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casial Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuated of a statevice complies with other requirements of the Act that IDA has made a decerminations administered by other Federal agencies. You must or any Federal statutes and regulations and instituting, but not limited to: registration and listing (21 Comply with an the Act 810 cm . 11 CFR Part 801); good manufacturing practice requirements as set CFN Fart 607), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Michael Ivey
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you're begin finding of substantial equivalence of your device to a legally promatice notification. The 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 If you dosire specific at not any at (240) 276-0115. 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 other general micrination and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
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
5
Indications for Use
510(k) Number (if known): K043081
GORE POLYPROPYLENE HERNIA MESH
Indications for Use:
Device Name:
The GORE POL YPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted Pholypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® SOLYPROPYLENE HERNIA MESH may be used include, but are not limited to:
Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).
Muscle flap reinforcement
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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510(k) Number K04308/