(32 days)
Not Found
Not Found
No
The summary describes a standard balloon dilatation catheter and does not mention any AI/ML components or capabilities.
Yes
The device is used for percutaneous transluminal angioplasty (PTA) to treat lesions in peripheral arteries and obstructive lesions in arteriovenous fistulae, which is a therapeutic intervention.
No
This device is a balloon dilatation catheter used for percutaneous transluminal angioplasty (PTA), which is a treatment procedure to open narrowed arteries, not diagnose conditions.
No
The device description clearly describes a physical catheter with specific dimensions and materials, intended for a physical medical procedure (PTA). It also details performance studies related to the physical properties of the device (tensile strength, balloon inflation, etc.). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (percutaneous transluminal angioplasty) to treat lesions in blood vessels. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is a balloon catheter designed to be inserted into blood vessels for mechanical dilation. This is a therapeutic device used for intervention, not a diagnostic tool that analyzes samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is a rapid exchange catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device with 4.0 French nylon tubing compatible with a 0.014-inch guidewire. It will be supplied sterile, intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, 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
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter was subjected to the following The Auvance reliable design and performance under the specified testing parameters. These tests go were comprised of:
-
- Tensile test
- Balloon inflation/deflation test 2.
- Balloon burst test 3.
-
- Balloon compliance test
-
- Balloon fatigue test
- Bond strength test 6.
- Animal test 7.
-
- Shelf life test
- Sterility test 9.
- Biocompatibility test 10.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon 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.
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance 14Rx Rapid Exchange PTA Balloon Dilatation 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
-43-
Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009
510(k) Summary
Submitted By:
APR 2 7 2009
Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
Device:
Trade Name:
Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter
Proposed Classification:
Catheter, Percutaneous (74 DQY)
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Devices:
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is similar in terms of intended use. materials of construction and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous angioplasty of vessel lumens which are narrowed or obstructed.
Device Description:
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is a rapid exchange catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device with 4.0 French nylon tubing compatible with a 0.014-inch guidewire. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance 14Rx Rapid Exchange PTA Balloon Dilatation Catheter. The similar indications for use and technological characteristics of the Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter as compared to the predicate devices support a determination of substantial equivalency.
1
Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009
Test Data:
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter was subjected to the following The Auvance reliable design and performance under the specified testing parameters. These tests go were comprised of:
-
- Tensile test
- Balloon inflation/deflation test 2.
- Balloon burst test 3.
-
- Balloon compliance test
-
- Balloon fatigue test
- Bond strength test 6.
- Animal test 7.
-
- Shelf life test
- Sterility test 9.
- Biocompatibility test 10.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, rendered in a simple, stylized manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2009
Cook, Incorporated c/o Nathan Simon Regulatory Affairs Specialist 750 Daniels Way, PO Box 489 Bloomington, IN 47402
Re: K090822
Trade/Device Name: Advance 14Rx Rapid Exchange PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 24, 2009 Received: March 26, 2009
Dear Mr. Simon:
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 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 with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page - 2 - Mr. Simon
device-related adverse events) (21 CFR 803); 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.
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 entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
buna R. V. humn
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009
510(k) Number (if known):
Device Name: Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use X (Per 21 CFR 801 Subpart D) 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)
Duma R. Vc lme
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ko9_0822