(91 days)
Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.
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.
This document is a 510(k) premarket notification for a medical device, the Fluoro-Tex™ Surgical Membrane. The primary focus of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to establish new acceptance criteria or conduct extensive studies demonstrating de novo performance.
Therefore, the requested information focuses on aspects that are not typically the subject of a traditional 510(k) submission for a device like a surgical membrane. Many of the fields you've requested (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are relevant to the evaluation of AI/ML-driven devices or diagnostic tools, which is not what this document describes.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Fluoro-Tex™ Surgical Membrane) | Comparison to Predicate (Gore-Tex® Surgical Membrane) |
|---|---|---|
| Dimensions: nominal 0.1 millimeter sheet | nominal 0.1 millimeter sheet | Substantially equivalent |
| Porosity: pore size less than 3.0 microns | pore size less than 3.0 microns | Substantially equivalent |
| Material Composition: expanded polytetrafluoroethylene (ePTFE) | expanded polytetrafluoroethylene (ePTFE) | Substantially equivalent |
| Mechanical Properties: (e.g., material strength, suture retention strength) | Non-clinical tests demonstrated substantial equivalence | Substantially equivalent |
| Chemical Identification: | Non-clinical tests demonstrated substantial equivalence | Substantially equivalent |
| Intended Use: repair or replacement of the peritoneum (and pericardium - 510(k) indicates this) | Repair or replacement of the peritoneum (and pericardium) | Substantially equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes non-clinical mechanical and chemical tests, not a clinical study with a "test set" in the context of, for example, diagnostic imaging.
- Therefore, specific sample sizes for a patient-derived test set are not applicable and not reported.
- Data provenance (country, retrospective/prospective) is not applicable as there were no patient data sets for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for this type of device (a surgical membrane). The "ground truth" here would be the physical and chemical properties of the materials themselves, evaluated through standard engineering and materials science methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to resolve disagreements among human readers/experts, which is not relevant for the non-clinical testing described.
5. 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:
- No. This is not an AI/ML-driven device or a diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance was established through non-clinical mechanical and chemical tests, comparing its inherent material properties and performance characteristics (e.g., strength, porosity, material identification) directly against those of the predicate device.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of AI/ML or statistical modeling.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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® SurgicalMembrane | Fluoro-Tex™ SurgicalMembrane | |
|---|---|---|
| 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 |
| MaterialComposition | expandedpolytetrafluoroethylene(ePTFE) | expandedpolytetrafluoroethylene(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
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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.
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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,
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
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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.
§ 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).