(100 days)
Not Found
No
The summary describes a mechanical balloon catheter and does not mention any AI or ML components or functionalities.
Yes
The device is described as assisting in the "dilatation of self expanding endoprostheses in large diameter vessels," which is a therapeutic intervention.
No
The device is described as assisting in the dilatation of endoprostheses, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical balloon catheter, which is a hardware component, not software.
Based on the provided information, the GORE Tri-Lobe Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the dilatation of self expanding endoprostheses in large diameter vessels." This describes a procedure performed within the body (in vivo) to modify a medical device already implanted in a patient.
- Device Description: The description focuses on the physical design and function of a catheter used for a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples to gain information about a person's health. The GORE Tri-Lobe Balloon Catheter is clearly a device used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The GORE Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The next generation GORE Tri-Lobe Balloon Catheter is designed to be used in conjunction with the implantation of an endoprosthesis. The triangular arrangement of balloons allows for continuous blood flow through the implanted device during inflation of the balloon. The next generation GORE Tri-Lobe Balloon Catheter is available in two balloon sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large diameter vessels
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparison of the next generation balloon catheter and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices. In vitro bench testing performance evaluations demonstrated that the next generation GORE Tri-Lobe Balloon Catheter met the acceptance criteria and that its performance was comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing, and, therefore, the GORE Tri-Lobe Balloon Catheter may be considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033670, K050038, K032869, K021721
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(k) Submission
510(k) SUMMARY
A. Device Name
W. L. GORE & Associates, Inc.
GORE Tri-Lobe Balloon Catheter Section 5: 510(k) SUMMARY
GORE Tri-Lobe Balloon Catheter
Proprietary Name: Common Name: Classification Name: Product Code: 21 CFR: Device Class:
GORE Tri-Lobe Balloon Catheter Balloon Catheter Catheter, Percutaneous DQY 870.1250 Class II
B. Intended Use
The GORE Tri-Lobe Balloon Catheter is intended to assist in the dilatation of selfexpanding endoprostheses in large diameter vessels.
C. Device Description
The next generation GORE Tri-Lobe Balloon Catheter is designed to be used in conjunction with the implantation of an endoprosthesis. The triangular arrangement of balloons allows for continuous blood flow through the implanted device during inflation of the balloon. The next generation GORE Tri-Lobe Balloon Catheter is available in two balloon sizes.
D. Principle of Operation and Technology
The three individual balloons apply pressure to the implanted endoprostheses and facilitate improved proximal and distal wall apposition of the implanted endoprostheses.
E. Materials
The GORE Tri-Lobe Balloon Catheter is composed of a Pebax catheter with a polycarbonate hub, polyurethane balloons, platinum iridium marker bands, and a distal tip with barium sulphate.
F. Performance
A comparison of the next generation balloon catheter and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices. In vitro bench testing performance evaluations demonstrated that the next generation GORE Tri-Lobe Balloon Catheter met the acceptance criteria and that its performance was comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing,
1
and, therefore, the GORE Tri-Lobe Balloon Catheter may be considered substantially equivalent to the predicate devices.
G. Substantial Equivalence
The next generation GORE Tri-Lobe Balloon Catheter is substantially equivalent to the following predicate devices:
- . GORE Tri-Lobe Balloon Catheter (W. L. GORE & Associates, Flagstaff, AZ) -K033670
- Reliant Stent Graft Balloon Catheter (Medtronic Endovascular Innovations, CA) . - K050038
- . Cook CODA Balloon Catheter (Cook, Inc., Bloomington, IN) - K032869
- Equalizer™ Balloon Catheter (Boston Scientific Corporation, Natick, MA) -● K021721
Differences between the devices do not raise any significant issues of safety or effectiveness.
W. L. GORE & Associates, Inc. statement of substantial equivalence is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
Date Prepared: June 24, 2008
- Prepared By: Kanu H. Vadodaria, M.S., RAC Regulatory Affairs Associate W. L. GORE & Associates, Inc. Medical Products Division 3450 West Kiltie Lane Flagstaff, Arizona 86001 Phone: 928-864-4259 Fax: 928-864-4304 E-mail: kvadodar@wlGORE.com
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 - 2008
W. L. Gore & Associates, Inc. c/o Mr. Kanu Vadodaria 3450 West Kiltie Lane Flagstaff, AZ 86001
Re: K081799
Trade/Device Name: Gore Tri-Lobe Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 15, 2008 Received: September 17, 2008
Dear Mr. Vadodaria:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
3
Page 2 -- Mr. Kanu Vadodaria
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Device Name: GORE Tri-Lobe Balloon Catheter
Indications For Use:
The GORE Tri-Lobc Balloon Catheter is intended to assist in the dilatation of self expanding endoprostheses in large diameter vessels.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardigvascular_Devices 510(k) Num