(224 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a physical patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a patch intended for the repair of the cardiovascular system, which is a direct treatment for a medical condition.
No
Explanation: This device is a patch intended for repair of the cardiovascular system, which is a therapeutic function, not a diagnostic one. It does not identify diseases or conditions.
No
The device description clearly states it is a physical patch made of ePTFE and FEP, and the performance studies focus on mechanical properties and biocompatibility, indicating a hardware device.
Based on the provided information, the Fluoro-Tex™ Cardiovascular Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "repair of the cardiovascular system." This describes a surgical implant used directly within the body, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description of the device as a "sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP)" further confirms it's a physical implant material.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
The information provided clearly describes a medical device intended for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
The Fluoro-Tex Cardiovascular Patch is intended for the repair of the cardiovascular system.
The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.
Product codes
DXZ
Device Description
Fluoro-Tex Cardiovascular Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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
Mechanical testing and biocompatibility testing were performed.
Mechanical testing compared the Fluoro-Tex Cardiovascular Patch to predicate devices for Tensile Strength, Suture Strength, and Burst Strength.
Tensile Strength: Fluoro-Tex™ - 20.7, n=6; Gore-Tex® - 26.7, n=4; IMPRA® - 20.5, n=4.
Suture Strength: Fluoro-Tex™ - 2.0, n=6; Gore-Tex® - 2.1, n=4; IMPRA® - 1.8, n=4.
Burst Strength: Fluoro-Tex™ - 284, n=5; IMPRA® - 294, n=5. (Gore-Tex® Not Applicable)
Biocompatibility testing included cytotox, FTIR, and extensive in-house cleanliness testing. Full biocompatibility testing was not done as the device is constructed of PTFE, which is known to be safe, biocompatible, and non-reactive, and is the same polymer used in predicate devices.
Key Metrics
Tensile Strength (kg/cm2): 20.7, n=6
Suture Strength (kg/pin): 2.0, n=6
Burst Strength (psi): 284, n=5
Predicate Device(s)
Not Found (The text lists them but not with K/DEN numbers)
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
JUL - 7 2000
Section 9
5.10 (k) Summary
| Contact Person: | Bruce Ruefer
2430 N. 7th Ave., Ste. 4
Bozeman, MT 59715
Ph: 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 Patch
Impra® Cardiovascular Patch |
| Device Description: | Fluoro-Tex Cardiovascular Patch consists of a sheet of porous
expanded polytetrafluoroethylene (ePTFE) internally reinforced
with 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
1
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®
Cardiovascular
Patch | Fluoro-Tex™
Cardiovascular
Patch |
|------------------------------|-----------------------------------|-----------------------------------|----------------------------------------|
| 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.
2
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.
3
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
4
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)