(91 days)
Not Found
Not Found
No
The summary describes a physical implant material and its equivalence to a predicate device based on material properties and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an implant material used for repair or replacement of anatomical structures, which falls under surgical implantation rather than therapeutic intervention designed to treat a disease or condition.
No
Explanation: The Fluoro-Tex154 Surgical Membrane is described as an implant material used for the repair or replacement of anatomical structures, not for diagnosing conditions.
No
The device is described as an "implant material" and a "sheet of porous expanded polytetrafluoroethylene (ePTFE)," which are physical components, 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 "repair or replacement of the peritoneum and pericardium." This describes a surgical implant used in vivo (within the body) for structural repair.
- Device Description: The device is described as an "implant material" consisting of a "sheet of porous expanded polytetrafluoroethylene (ePTFE)." This is a physical material intended to be placed inside the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to perform tests in vitro (outside the body) to diagnose conditions.
The description clearly points to a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
Fluoro-Tex™ Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.
Product codes
DXZ
Device Description
The Bridger Biomed Fluoro-Tex™ Surgical Membrane is substantially equivalent to Gore-Tex® Surgical Membrane. Both devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE), approximately 0.1 millimeters thick. The Fluoro-Tex™ Surgical Membrane and the predicate device are intended for the repair or replacement of the peritoneum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum and pericardium
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
Non-clinical mechanical and chemical tests, including material strength and suture retention strength, and chemical identification of the materials demonstrate that the Fluoro-Tex™ Surgical Membrane and the Gore-Tex® Surgical Membrane are substantially equivalent, and that Fluoro-Tex™ Surgical Membrane is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Gore-Tex® Surgical Membrane
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
2430 N. 7th Street, Ste. 4, Bozeman, MT 59715
973178
NOV 2 4 1997
5.10(k) Summary
20 August, 1997
| Contact Person: | Bruce Ruefer |
|---|---|
| Classification Name: | Surgical Membrane |
| Common Name: | Surgical Membrane |
| Trade Name: | Fluoro-Tex™ Surgical Membrane |
The Bridger Biomed Fluoro-Tex™ Surgical Membrane is substantially equivalent to Gore-Tex® Surgical Membrane. Both devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE), approximately 0.1 millimeters thick. The Fluoro-TexTM Surgical Membrane and the predicate device are intended for the repair or replacement of the peritoneum.
Summary of Technological Characteristics
| | Gore-Tex® Surgical
Membrane | Fluoro-Tex™ Surgical
Membrane |
|-------------------------|------------------------------------------------|------------------------------------------------|
| Dimensions | nominal 0.1 millimeter sheet | nominal 0.1 millimeter sheet |
| Porosity | pore size less than 3.0 microns | pore size less than 3.0 microns |
| Material
Composition | expanded
polytetrafluoroethylene
(ePTFE) | expanded
polytetrafluoroethylene
(ePTFE) |
Non-clinical mechanical and chemical tests, including material strength and suture retention strength, and chemical identification of the materials demonstrate that the Fluoro-TexTM Surgical Membrane and the Gore-Tex® Surgical Membrane are substantially equivalent, and that Fluoro-Tex™ Surgical Membrane is safe and effective for its intended use.
ph: 1-406-586-7666 or fall1-406-586-5665
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Mr. Bruce G. Ruefer *President/CEO Bridger Biomed, Inc. 2430 N. 7th Street, Suite 4 Bozeman, Montana 59715
Re: K973178
Trade Name: Fluoro-Tex™ Surgical Membrane Regulatory Class: II .............................. Product Code: DXZ Dated: August 20, 1997 Received: August 25, 1997
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 requirements , 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.
2
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,
Mark M. Melleon
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
3
Statement of Indications for Use .. . . . . . . . .
Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.
Mark N. Milless
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973178
Prescription Use
(Per 21 CFR 801.109)
• •
Over-the-Counter Use.