(109 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon dilatation catheter, with no mention of AI or ML.
Yes.
The device is intended for percutaneous transluminal angioplasty of lesions in peripheral arteries and for post-dilatation of balloon-expandable peripheral vascular stents, which are therapeutic interventions.
No
The device is described as a dilatation catheter used for angioplasty and post-dilatation of stents, which are therapeutic procedures, not diagnostic ones. Its "Intended Use" clearly outlines its role in treating lesions and not in identifying or diagnosing conditions.
No
The device description clearly outlines physical components like a nylon balloon, nylon shaft, and connector, indicating it is a hardware device, not software-only.
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 performed within the body (percutaneous transluminal angioplasty) to treat lesions in blood vessels and fistulae. 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 derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body for a therapeutic procedure.
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 All-Terrain Balloon PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The ATB All-Terrain™ Balloon Dilatation Catheter is comprised of a nylon balloon and a nylon shaft. It is used percutaneously over a pre-positioned wire guide. The and a nylen bhat. Tela connector which provides access to the end hole proximal ona mer connector which permits access to the balloon inflation lumen.
The catheter component of this device measures a nominal 5.0 French in outside diameter. The overall catheter lengths of 40, 80 and 120 cm are available. The catheter is offered with inflated balloon diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 2, 3, 4, 6 and 8 cm. 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been performed to evaluate the ability of the ATB All-The follow Balloon PTA Dilatation Catheter to perform in accordance with the requirements of the design plan.
- Balloon Minimum Burst Strength Testing ם
- Balloon Compliance Testing ਹ
- Balloon Inflation/Deflation Performance Testing ם
- Balloon Fatigue Testing σ
- Bond Strength Testing a
- Catheter Hub Tensile Strength Testing ପ
- Diameter and Profile Testing ロ
- Balloon Minimum Burst Strength within a Stent ם
- Balloon Fatigue within a Stent σ
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 for peripheral angioplasty and post-dilatation of peripheral vascular stents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022552, K023504, K031766, K032931, K983055
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Safety and Effectiveness Information
| Submitted By: | Karen Bradburn, RAC
Regulatory Affairs Coordinator
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
(812) 339-2235 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | ATB All-Terrain™ Balloon PTA Dilatation Catheter
Percutaneous Catheter (DQY)
21 CFR §870.1250 |
Predicate Devices:
The ATB All-Terrain™ Balloon PTA Dilatation Catheter is similar in terms of intended rne ATB Air Tonain Studions and technological characteristics to the predicate devices reviewed.
Device Description
The ATB All-Terrain™ Balloon Dilatation Catheter is comprised of a nylon balloon and a nylon shaft. It is used percutaneously over a pre-positioned wire guide. The and a nylen bhat. Tela connector which provides access to the end hole proximal ona mer connector which permits access to the balloon inflation lumen.
The catheter component of this device measures a nominal 5.0 French in outside diameter. The overall catheter lengths of 40, 80 and 120 cm are available. The catheter is offered with inflated balloon diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 2, 3, 4, 6 and 8 cm. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.
Substantial Equivalence
The ATB All-Terrain™ Balloon PTA Dilatation Catheter is similar to many devices in commercial distribution for dilatation and stent deployment. These devices include oommordial diethbut.on Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055.
The similar indications for use and technological characteristics of the ATB All-Terrain™ Balloon PTA Dilatation Catheter as compared to the predicate devices supports a determination of substantial equivalency.
1
Performance Data
The following tests have been performed to evaluate the ability of the ATB All-The follow Balloon PTA Dilatation Catheter to perform in accordance with the requirements of the design plan.
- Balloon Minimum Burst Strength Testing ם
- Balloon Compliance Testing ਹ
- Balloon Inflation/Deflation Performance Testing ם
- Balloon Fatigue Testing σ
- Bond Strength Testing a
- Catheter Hub Tensile Strength Testing ପ
- Diameter and Profile Testing ロ
- Balloon Minimum Burst Strength within a Stent ם
- Balloon Fatigue within a Stent σ
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 for peripheral angioplasty and post-dilatation of peripheral vascular stents.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
Cook Incorporated Ms. Karen Bradbum Regulatory Affairs P.O. Box 489 Bloomington, IN 47402-0489
Re: K033875
ATB All-Terrain PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: March 25, 2004 Received: March 26, 2004
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 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) 594-4648. 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.
Duna R. Vochmel
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K033875
Device Name: ATB All-Terrain Balloon PTA Dilatation 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. The ATB All-Terrain Balloon PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/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)
Duna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K033875
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