(45 days)
The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue and the reconstruction of hernias.
The FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP).
The provided text describes a 510(k) summary for the FluoroTex™ Surgical Mesh, demonstrating its substantial equivalence to a predicate device, the GORE-TEX® Soft Tissue Patch. It does not contain information about a study proving the device meets acceptance criteria in the sense of a clinical trial or performance evaluation against predefined thresholds for classification (e.g., sensitivity, specificity, accuracy) that are typical for diagnostic or AI-driven medical devices. Instead, the "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical and chemical testing.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for several categories:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FluoroTex™ Surgical Mesh were implicitly met by demonstrating that its mechanical and chemical characteristics were "substantially equivalent" to those of the predicate device, the GORE-TEX® Soft Tissue Patch. The study involved direct comparison of key material properties.
| Acceptance Criteria (based on predicate) | Reported Device Performance (FluoroTex™ Surgical Mesh) |
|---|---|
| Material Composition: 100% ePTFE | ePTFE reinforced with FEP |
| Pore Size: 10 to 30 microns | 10 to 30 microns |
| Material Strength (Kg/cm, 1mm thick): 14.8 | 13.8 |
| Suture Retention Strength (Kg/pin, 1mm thick): 4.9 | 2.2 |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: n=15 for Material Strength and Suture Retention Strength for the FluoroTex™ Surgical Mesh. An identical sample size (n=15) is reported for the predicate device's data, which was sourced from Gore literature.
- Data Provenance: The FluoroTex™ Surgical Mesh data was generated internally at Bridger Biomed, Inc. labs. The predicate device's data was reported in Gore literature. The country of origin is not specified but given the company names and FDA context, it is likely the United States. The data is retrospective in the sense that the predicate's data already existed, while the new device's data was generated specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of device comparison is based on established engineering and materials science testing standards (ASTM methods) rather than expert consensus on medical image interpretation or clinical outcomes.
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Adjudication method for the test set:
- Not applicable. Data was derived from standardized ASTM test methods, not expert adjudication of subjective assessments.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes a medical device (surgical mesh), not an AI-driven diagnostic tool, and therefore no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- Standardized engineering and materials testing (ASTM methods) for mechanical and chemical properties. The "truth" is based on the measurable physical properties of the materials as determined by these validated tests.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
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Bridger Biomed, Inc.
7 1999 JAN
2430 N. 7th Street, Ste. 4, Bozeman, MT 59715 ph: 1-406-586-7666 or fax: 1-406-586-5665
5.10 (k) Summary
November 18, 1998
Bruce Ruefer Contact Person: Classification Name: Surgical Mesh Common Name: Surgical Mesh FluoroTex™ Surgical Mesh Trade Name:
The FluoroTex Surgical Mesh is substantially equivalent to Gore-Tex® Soft Tissue Patch. GORE-TEX Soft Tissue Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE); FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP). The FluoroTex™ Surgical Mesh and the predicate device are intended for the repair of hernias and soft tissue.
| GORE-TEX SoftTissue Patch | FluoroTex SurgicalMesh | |
|---|---|---|
| Dimensions | 1 millimeter and 2-millimeter thickness ina variety of sizes. | 1 millimeter and 2millimeter thickness ina variety of sizes. |
| Porosity | pore size 10 to 30microns | pore size 10 to 30microns |
| MaterialComposition | 100% ePTFE | ePTFE reinforced,with FEP |
| Material Strength(Kg/cm, 1 millimeterthick material) | 14.8(1) | 13.8(2) |
| Suture RetentionStrength (Kg/pin 1millimeter thickmaterial) | 4.9(1) | 2.2(2) |
Summary of Technological Characteristics
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5.10 (k) Summary (page 2)
November 18, 1998
| Contact Person: | Bruce Ruefer |
|---|---|
| Classification Name: | Surgical Mesh |
| Common Name: | Surgical Mesh |
| Trade Name: | FluoroTex™ Surgical Mesh |
(1) Reported in Gore literature; n=15; Standard ASTM methods. Test Notes: (2) Tested at Bridger Biomed, Inc. labs; n=15; Standard ASTM methods.
CONCLUSION:
Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FluoroTex Surgical Mesh and the Gore-Tex Soft Tissue Patch are substantially equivalent.
Bruce G. Rueter
Bruce G. Ruefer, President
NOV 18 1998
date
GORE-TEX is a Registered Trademark of W.L. Gore and Associates FluoroTex is a Trademark of Bridger Biomed Inc.
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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 or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 JAN
Mr. Bruce G. Ruefer President Bridger Biomed, Inc. 2430 North 7th Street, Suite 4 Bozeman, Montana 59715
Re: K984197 Trade Name: FluoroTex™ Surgical Mesh Regulatory Class: II Product Code: FTL Dated: November 18, 1998 Received: November 23, 1998
Dear Mr. Ruefer:
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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) 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. Bruce G. Ruefer
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K984197 |
| Device Name: | Fluoro Tex |
| TM Surgical Mesh |
Indications For Use:
The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue
and the reconstruction of hernias.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign- | |
|---|---|
| Division of Genera. Restorative Device, | |
| 510(k) Number | K984197 |
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ---------------------- |
(Optional Formal 1-2-96)
§ 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.