(18 days)
Not Found
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) dilatation catheter, used to treat obstructive lesions in peripheral arteries, which is a therapeutic intervention.
No
The device is described as a "PTA Dilatation Catheter" intended for "percutaneous transluminal angioplasty of lesions" and "post-dilatation of balloon-expandable peripheral vascular stents." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly describes a physical balloon catheter made of nylon tubing, intended for percutaneous transluminal angioplasty. The performance studies also focus on physical characteristics of the balloon and catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a medical procedure (percutaneous transluminal angioplasty) performed on a patient's body to treat lesions in blood vessels. This is an in vivo procedure.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic device used directly within the body.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance PTA Dilatation Catheter is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
Product codes
DQY
Device Description
The ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including illac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-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 ilio femoral; 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 ATB™ Advance PTA Dilatation Catheter was subjected to the following tests to assure The ATD … Auvance TTA Blatation Outhoter was catholor was cathers. These tests were comprised of:
- Tensile tests 1.
- Balloon inflation/deflation tests 2.
- Balloon burst tests 3.
- Balloon compliance 4.
- Balloon fatigue tests 5.
- Balloon profile റ്.
- Balloon burst within a stent 7.
- Balloon fatigue within a stent 8.
The results of these tests provide reasonable assurance that the device has been designed i The results of these tests provide roubonable addrance and a PTA dilatation balloon catheter.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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) Summary
Submitted By:
Karen Bradburn, RAC Senior Requlatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 October 26, 2006
NOV 1 4 2006
- Lot 2
Device:
Trade Name: Proposed Classification: ATB™ Advance PTA Dilatation Catheter Catheter, Angioplasty, Peripheral, Transluminal (74 DQY)
Predicate Devices:
The ATB™ Advance PTA 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 ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including illac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
1
Test Data:
The ATB™ Advance PTA Dilatation Catheter was subjected to the following tests to assure The ATD … Auvance TTA Blatation Outhoter was catholor was cathers. These tests were comprised of:
- Tensile tests 1.
- Balloon inflation/deflation tests 2.
- Balloon burst tests 3.
- Balloon compliance 4.
- Balloon fatigue tests 5.
- Balloon profile റ്.
- Balloon burst within a stent 7.
- Balloon fatigue within a stent 8.
The results of these tests provide reasonable assurance that the device has been designed i The results of these tests provide roubonable addrance and a PTA dilatation balloon catheter.
KO63252 p. 20f2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2006
Cook Incorporated c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
Re: K063252 ATB Advanced PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: October 26, 2006 Received: October 27, 2006
Dear Ms. Bradburn:
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.
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
3
Page 2 - Ms. Karen Bradburn
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 af 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Duma R. balmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
510(k) Number (if known): K063252
PTA Balloon Catheter Device Name:
Indications for Use:
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance PTA Dilatation Catheter is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
Prescription Use __ × (Per 21 CFR 801 Subpart D)
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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)
pring R. Jackner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 0 63252