(27 days)
Not Found
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its intended use. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.
Yes
The device is used in percutaneous transluminal angioplasty to treat obstructive lesions, which is a therapeutic procedure.
No
The device description and intended use indicate it is a therapeutic device used for angioplasty, not for diagnosis.
No
The device description clearly describes a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat obstructive lesions in blood vessels and fistulae. This is an in vivo procedure.
- Device Description: The device is a catheter with a balloon designed to be inserted into blood vessels. This is a medical device used for a therapeutic intervention in vivo.
- 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 compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for use inside the body.
N/A
Intended Use / Indications for Use
The Bard® ConquestTM PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac and renal arteries; native or synthetic arteriovenous dialysis fistulae
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)
Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter.
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.
Opti-Plast Centurion™ 5.5 Fir PTA Catheter
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
Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E. Covington, GA 30014
JAN 1 7 2002
BARD
510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION
- A.. Submitter Information:
| Submitter's Name: | C.R. Bard, Inc., Peripheral Technologies Division |
|---|---|
| Submitter's Address: | 13183 Harland Drive, Covington, GA 30014 |
| Contact Person: | Carol Vierling |
| Contact Person's Telephone Number: | (770) 385-2347 |
| Contact Person's FAX Number: | (770) 385-2340 |
| Date of Preparation: | December 14, 2001 |
-
B. Device Name:
Bard® Conquest™ PTA Balloon Dilatation Catheter -
C. Predicate Device:
Opti-Plast Centurion™ 5.5 Fir PTA Catheter -
D. Device Description: ·
The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
1
E. Intended Use:
The Bard® Conquest™ PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
-
F. Technological Characteristics Summary:
The Bard® Conquest™ PTA Balloon Dilatation Catheter is offered in 6, 7 or 8 Fr shaft diameters and shaft lengths of 50, 75 or 100cm, depending on balloon size. Various balloon diameters and lengths are available. -
G. Performance Data:
Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter.
2
Image /page/2/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 three wavy lines representing the flow of life. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Ms. Carol Vierling Director, Regulatory Affairs C.R. Bard, Inc. Bard Peripheral Technologies 13183 Harland Drive, N.E. Covington, GA 30014
Re: K014212
Trade Name: Bard® Conquest™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 14, 2001 Received: December 21, 2001
Dear Ms. Vierling:
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.
3
Page 2 - Ms. Carol Vierling
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Dallas Miller
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT 5
Indications for Use Statement
| Device
| Name | Bard® ConquestTM PTA Balloon Dilatation Catheter |
|---|---|
| Indications | |
| for Use | The Bard® ConquestTM PTA Balloon Dilatation Catheter |
| is recommended for use in Percutaneous Transluminal Angioplasty of the | |
| femoral, iliac and renal arteries and for the treatment of obstructive lesions | |
| of native or synthetic arteriovenous dialysis fistulae. This catheter is not | |
| for use in coronary arteries. |
PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
N
Division of Cardiovascular & Respiratory Devices
510(k) Number 2617212
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________