(30 days)
Not Found
Not Found
No
The provided text describes a standard balloon catheter for angioplasty and does not mention any AI or ML components or functionalities.
Yes
The device is a "PTA Dilatation Catheter" intended "to treat obstructive lesions" in arteries and fistulae, which are therapeutic medical interventions.
No
The device description clearly states its purpose is for "percutaneous transluminal angioplasty of lesions," which is a treatment procedure, not a diagnostic one.
No
The device description clearly describes a physical balloon catheter, which is a hardware medical device, 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 of 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 Diagnostic Testing: The description focuses on the mechanical function of the balloon catheter for dilation, not on analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies listed (tensile tests, balloon deflation/burst/fatigue tests, balloon profile) are all related to the physical properties and function of the catheter itself, not to the accuracy or reliability of a diagnostic test.
This device is an interventional medical device used for a therapeutic procedure, not a diagnostic test performed in vitro.
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
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 illo 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, 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 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
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
OCT 2 2 2003
Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
510(k) Summary
Submitted Bv:
Karen Bradburn, RAC Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Wav, PO Box 489 Bloomington, IN 47402 812-339-2235 September 19, 2003
Device:
| Trade Name: |
|---|
| Proposed Classification: |
ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Catheter, Angioplasty, Peripheral, Transluminal (74 DQY)
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 angioplasty 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 illo 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
Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
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:
- 1 -Tensile tests
-
- Balloon deflation tests
-
- Balloon burst tests
-
- Balloon compliance
-
- 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
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
OCT 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook, Incorporated c/o Ms. Karen Bradburn, RAC Regulatory Affairs Coordinator 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K032931
Trade Name: ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 19, 2003 Received: September 22, 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, RAC
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 (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.
Ashley B. Bairn
for
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
4032331 510(k) Number (if known):
Device Name: PTA Balloon Catheter
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)
OR
Prescription Use (Per 21 CFR 801.109)
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Elias Mallis
on Sigif-Only Devices
KO32931 510(k) Number_
1