(17 days)
Not Found
Not Found
No
The summary describes a standard PTA balloon catheter and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is used for percutaneous transluminal angioplasty (PTA) to treat lesions in peripheral arteries and obstructive lesions in arteriovenous dialysis fistulae, which are medical interventions aimed at restoring function and health.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, used for treating obstructive lesions, which is a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical catheter with lumens, connectors, and radiopaque markers, and the performance studies include physical tests like tensile, burst, and bond strength tests, as well as animal testing.
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 lesions in blood vessels. IVDs are used to examine specimens from the body (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a balloon catheter designed to be inserted into blood vessels. This is a therapeutic device used for a medical procedure, not a diagnostic test performed on a sample.
- No mention of analyzing biological samples: The description focuses on the physical characteristics and function of the catheter for angioplasty. There is no mention of collecting or analyzing biological samples.
Therefore, the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is a medical device used for a therapeutic procedure, 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 and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
DQY
Device Description
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter measures a nominal 5.0 French in outside diameter. Catheter lengths of 80 and 135 cm are available. It is used percutaneously over a pre-positioned wire guide. The proximal end includes a Luer connector which provides access to the end hole lumen and a Luer connector which permits access to the balloon inflation lumen. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during 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
Not Found
Summary of Performance Studies
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile test
- Balloon inflation/deflation test
- Balloon burst test
- Balloon compliance test
- Balloon fatigue test
- Bond strength test
- Animal test
- Shelf life test
- Sterility test
- Biocompatibility test
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
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009
510(k) Summary
Submitted By:
Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 April 17, 2009
Device:
Trade Name:
Advance® 35LP Low Profile 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 and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Devices:
The Advance® 35LP Low Profile 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® 35LP Low Profile PTA Balloon Dilatation Catheter measures a nominal 5.0 French in outside diameter. Catheter lengths of 80 and 135 cm are available. It is used percutaneously over a pre-positioned wire guide. The proximal end includes a Luer connector which provides access to the end hole lumen and a Luer connector which permits access to the balloon inflation lumen. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.
Substantial Equivalence:
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter. The identical indications for use and similar technological characteristics of the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter as compared to the predicate devices support a determination of substantial equivalency.
JUN 1 2 2009
K091527 -65-
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K091527 page 2 of 2
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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009
Test Data:
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
-
- . Tensile test
-
- Balloon inflation/deflation test
-
- Balloon burst test
-
- Balloon compliance test
-
- Balloon fatigue test
-
- Bond strength test
-
- Animal test
-
- Shelf life test
- ੇ. Sterility test
-
- Biocompatibility test
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.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve and converge. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
Cook Incorporated C/O Nathan Simon Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402
Re: K091527
Trade/Device Name: Advance 35LP Low Profile Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 22, 2009 Received: May 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
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Dunia R. Kirchner
\Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009
- K091527 510(k) Number (if known):
Device Name: Advance® 35LP Low Profile 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) lot 1
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
unia R. Valassa
ision Sian-C Division of Cardiovascular Device
510(k) Number K091627