(28 days)
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No
The summary describes a physical medical device (a balloon catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is used for percutaneous transluminal angioplasty and post-dilatation of balloon-expandable peripheral vascular stents to treat obstructive lesions, which are therapeutic interventions.
No
The device description clearly states it is a "PTA Dilatation Catheter" intended for "percutaneous transluminal angioplasty of lesions" and to "treat obstructive lesions." The summary of performance studies also discusses "dilatation balloon catheter" performance, all of which indicate a therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical balloon catheter and the performance studies focus on physical properties and performance of the balloon and catheter, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states that this device is a "PTA Dilatation Catheter" used for "percutaneous transluminal angioplasty." This is a procedure performed inside the body to widen narrowed arteries.
- Lack of Mention of Samples or Testing: The document does not mention any collection or analysis of biological samples. The device's function is mechanical (balloon inflation) within the body.
Therefore, based on the provided information, this device is a therapeutic medical device used for a procedure within the body, not an in vitro diagnostic device.
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. Intended to trout because 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 iliac. 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 quidewire. It will be supplied sterile, intended for one-time use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile tests 1 -
- Balloon inflation/deflation tests 2.
- Balloon burst tests 3.
-
- Balloon compliance
- Balloon fatigue tests 5.
-
- Balloon profile
- Balloon burst within a stent 7.
- Balloon fatigue within a stent 8.
Summary of Performance Studies
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
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG 2 5 2005
K052036
p. 1 of 2
40
510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Wav. PO Box 489 Bloomington, IN 47402 812-339-2235 July 27, 2005
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 iliac. 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 quidewire. 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 device meets the requirements for section 510(k) substantial equivalence.
1
Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
Test Data:
The ATB™ Advance PTA 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 tests 1 -
- Balloon inflation/deflation tests 2.
- Balloon burst tests 3.
-
- Balloon compliance
- Balloon fatigue tests 5.
-
- Balloon profile
- 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 and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter.
KOS2036 0. 2042
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
AUG 25 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
K052036 Re:
ATB-All terrain Balloon PTA Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: July 27, 2005 Received: July 28, 2005
Dear Ms. Bradburn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is registly the enactment date of the Medical Device Amendments, or to commerce proof to May 20, 1970, are excerdance with the provisions of the Federal Food, Drug, de necs that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, manies of the Act include requirements for annual registration, listing of general oonlively provisiveing 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to been it 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. 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 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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Donner R. bochner
(A 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): _ Kos2036
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. Intended to trout because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
Prescription Use × (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)
Dina P. Jackson
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 5 30 3 6