(224 days)
The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.
Fluoro-Tex Cardiovascular Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP).
Here's an analysis of the provided text regarding the Fluoro-Tex™ Cardiovascular Patch, structured according to your request:
In this case, the device is a cardiovascular patch, and the testing focuses on mechanical and biocompatibility properties rather than algorithm performance. Therefore, questions related to AI/algorithm performance (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable.
Acceptance Criteria and Device Performance for Fluoro-Tex™ Cardiovascular Patch
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but rather presents a comparison of the Fluoro-Tex™ Cardiovascular Patch to predicate devices. The implicit acceptance criterion is that the Fluoro-Tex™ patch performs comparably or better than the predicate devices across the measured mechanical properties.
| Test / Performance Metric | Predicate Device 1 (Gore-Tex® Cardiovascular Patch) | Predicate Device 2 (IMPRA® Cardiovascular Patch) | Fluoro-Tex™ Cardiovascular Patch (Reported Performance) | Implicit Acceptance Criteria (Comparative) |
|---|---|---|---|---|
| Tensile Strength (kg/cm²) | 26.7 (n=4) | 20.5 (n=4) | 20.7 (n=6) | Comparable to or exceeding predicate devices |
| Suture Strength (kg/pin) | 2.1 (n=4) | 1.8 (n=4) | 2.0 (n=6) | Comparable to or exceeding predicate devices |
| Burst Strength (psi) | Na (Not applicable/not provided) | 294 (n=5) | 284 (n=5) | Comparable to or exceeding the IMPRA® patch (as Gore-Tex® data is not available) |
2. Sample size used for the test set and the data provenance:
- Tensile Strength:
- Gore-Tex®: n=4
- IMPRA®: n=4
- Fluoro-Tex™: n=6
- Suture Strength:
- Gore-Tex®: n=4
- IMPRA®: n=4
- Fluoro-Tex™: n=6
- Burst Strength:
- IMPRA®: n=5
- Fluoro-Tex™: n=5
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be laboratory-based mechanical testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is laboratory mechanical testing data, not expert-derived ground truth.
4. Adjudication method for the test set:
Not applicable, as this is laboratory mechanical testing data.
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:
Not applicable, as this device is a physical medical patch, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device is a physical medical patch, not an algorithm.
7. The type of ground truth used:
- Mechanical Tests: The "ground truth" implicitly refers to the measured physical properties of the materials and devices under controlled laboratory conditions, using established engineering test methods.
- Biocompatibility: Demonstrated through cytotox, FTIR, and in-house cleanliness testing, relying on the known safety profile of PTFE, the material used in the device and its predicates.
8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device.
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JUL - 7 2000
Section 9
5.10 (k) Summary
| Contact Person: | Bruce Ruefer2430 N. 7th Ave., Ste. 4Bozeman, MT 59715Ph: 406-58607666, Fax 406-586-5665 |
|---|---|
| Date Prepared: | July 7, 2000 |
| Classification Name: | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE,POLYPROPYLENE |
| Common Name: | Cardiovascular Patch |
| Trade Name: | Fluoro-Tex™ Cardiovascular Patch |
| Classification Code: | DXZ |
| Device Predicates: | Gore-Tex® Cardiovascular PatchImpra® Cardiovascular Patch |
| Device Description: | Fluoro-Tex Cardiovascular Patch consists of a sheet of porousexpanded polytetrafluoroethylene (ePTFE) internally reinforcedwith fluorinated ethylene propylene (FEP). |
| Statement of Intended Use: |
The Fluoro-Tex Cardiovascular Patch is intended for the repair of the cardiovascular system.
Substantial Equivalence:
The Fluoro-Tex Cardiovascular Patch is substantially equivalent to Gore-Tex® Cardiovascular Patch and IMPRA Cardiovascular Repair Patch. The predicate devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE); The Fluoro-Tex Cardiovascular Patch and the predicate devices are intended for the repair of cardiovascular defects
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5.10 (k) Summary (page 2)
Discussion of Testing Performed:
- The Fluoro-Tex Cardiovascular Patch was mechanically tested and 1. compared to the predicate devices according to the following table:
| Gore-Tex®Cardiovascular Patch | IMPRA®CardiovascularPatch | Fluoro-Tex™CardiovascularPatch | |
|---|---|---|---|
| Tensile Strength(kg/cm2) | 26.7, n=4 | 20.5, n=4 | 20.7, n=6 |
| Suture Strength(kg/pin) | 2.1, n=4 | 1.8, n=4 | 2.0, n=6 |
| Burst Strength(psi) | Na | 294, n=5 | 284, n=5 |
- The Fluoro-Tex Cardiovascular Patch was tested and found 2. biocompatible via cytotox, FTIR, and extensive in-house cleanliness testing. Full biocompatibility testing for this device was not done as the device is constructed of PTFE, a polymer known and demonstrated to be safe, biocompatible, non-reactive, and the same polymer from which the legally marketed predicate devices are made.
CONCLUSION:
Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the Fluoro-Tex™ Cardiovascular Patch, the GORE-TEX® Cardiovascular Patch and the IMPRA® Cardiovascular Repair Patch are substantially equivalent
Bruce G. Ruefer, President
date
GORE-TEX is a Registered Trademark of W.L. Gore and Associate Fluoro-Tex is a Trademark of Bridger Biomed Inc. IMPRA is a Registered Trademark of C.R. Bard Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2000
Mr. Bruce G. Ruefer President Bridger Biomed, Inc. 2430 N.7th Street, Ste. 4 Bozeman, MT 59715
K994032 Re: Fluoro-Tex Cardiovascular Patch Regulatory Class: II (two) Product Code: DXZ Dated: April 6, 2000 Received: April 10, 2000
Dear Mr. Ruefer:
We have reviewed your Section 510(k) notification of intent to market We have reviewed your becerem or (i), (i) (in the device is a the device referenced above and no have to use stated in the s substancially equivalemarketed predicate devices marketed in enclosure) to regally markeed problems and has monthest of the interstate Commence prior of the connects that have been reclassified Medical Device Amendments) of to active Federal Food, Drug, and in accordance with the provisions or the market the device, subject to Cosmetic Act (Acc). "Ioa maj/ controls of the general controls che general concrolo provide requirements for annual registration, provisions of the nee increase solucing practice, labeling, and Frocing or a against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device IS Classilled (800 abbroval), it may be subject to such Controls) of Class III (Fremands off)
additional controls. Existing major regulations affection Repto 800 additional concrors. Enrostigations, Title 21, Parts 800 can be round in the out equivalent determination assumes compliance co oys. It babbandood Manufacturing Practice requirements, as set with the current oose natem Regulation (QS) for Medical Devices: rorth in the gaardy of CFR Part 820) and that, through periodic QS General regulation od Drug Administration (FDA) will verify such Inspections, the rood and Buy with the GMP regulation may result in assumptions. Furral of compari regarders in the Federal Register . Please notė: this concerning your acremarket notification submission does not affect any response to your pat have under sections 531 through 542 of the Act obligation you might have and one of the 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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Brim E. Harvey
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known): _K994032
Device Name: Fluoro-Tex™ Cardiovascular Patch
Indications For Use: The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tom E. Haneym
Blina Shanker
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number _
(Optional Format 3-10-98)
§ 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).