(17 days)
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Not Found
No
The 510(k) summary describes a mechanical balloon catheter and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is a "PTA Dilatation Catheter" used for "percutaneous transluminal angioplasty" to treat "obstructive lesions" in various arteries and fistulae, with the goal of restoring blood flow, which is a therapeutic intervention.
No
The device is a dilatation catheter used for angioplasty, which is a therapeutic procedure to treat narrowed arteries or fistulae, not a diagnostic procedure to identify a condition.
No
The device description clearly identifies the device as a physical catheter with a balloon, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous transluminal angioplasty, which is a medical procedure performed in vivo (within the body) to widen narrowed arteries. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a balloon catheter, which is a surgical tool used during the angioplasty procedure. This is a therapeutic device, not a diagnostic one.
- No mention of analyzing biological samples: The description does not mention the device being used to analyze blood, urine, tissue, or any other biological specimen.
Therefore, the ATB™ All-Terrain Balloon™ PTA 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 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.
Product codes
74 DQY
Device Description
The ATB™ All-Terrain Balloon™ 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 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 and 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™ All-Terrain Balloon™ 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
- Balloon deflation tests
- Balloon burst tests
- Balloon compliance
- Balloon fatigue tests
- Balloon profile
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)
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 A Balloon Catheter COOK INCORPORATED
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence begins with the letter 'K', followed by the numbers '031766', and then the number '24' is written below the last two digits of the previous number. The handwriting is in black ink on a white background, and the characters are somewhat stylized.
510(k) Summary
JUN 2 6 2003
Submitted By:
Karen Bradburn, RAC Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way, PO Box 489 Bloominaton, IN 47402 812-339-2235 August 1, 2002
Device:
Trade Name:
ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Proposed Classification: Catheter, Angioplasty, Peripheral, Transluminal (74 LIT)
Predicate Devices:
The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is similar in terms of intended use, materials of constructions and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous anqioplasty of vessel lumens which are narrowed or obstructed.
Device Description:
The ATB™ All-Terrain Balloon™ 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 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™ All-Terrain Balloon™ 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 deflation tests
- ന് Balloon burst tests
- Balloon compliance ধ .
-
- Balloon fatigue tests
-
- Balloon profile
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
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2003
Cook Incorporated c/o Ms. Karen Bradburn Regulatory Affairs Coordinator 750 Daniels Way, PO Box 489 Bloomington, IN 47402
Re: K031766
ATB™ All-Terrain™ Balloon PTA Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: 74 DQY Dated: June 6, 2003 Received: June 9, 2003
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.
3
Page 2 - Ms. Karen Bradburn
Please be advised that FDA s issuance of a substantial equivalence determination docs 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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Dale Hill
ram 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 COOK INCORPORATED
510(k) Number (if known): K031766
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K031766 |
|---|---|
| --------------- | --------- |