(30 days)
Not Found
No
The 510(k) summary describes a physical medical device (a balloon catheter) and its mechanical performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a percutaneous transluminal angioplasty (PTA) dilatation catheter, which is used to treat lesions in arteries and dialysis fistulae, and also for post-dilatation of stents, indicating its direct therapeutic application.
No
The device description clearly states its purpose is for "percutaneous transluminal angioplasty (PTA) of lesions" and "post dilatation of balloon-expandable peripheral vascular stents." These are therapeutic procedures, not diagnostic ones. The performance studies also focus on physical properties related to performance (burst strength, compliance, fatigue, etc.) rather than diagnostic accuracy.
No
The device description clearly describes a physical catheter with a balloon, intended for insertion into the body for angioplasty. This 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/Indications for Use: The intended use describes a procedure performed on the patient (percutaneous transluminal angioplasty) to treat lesions in blood vessels. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a catheter with a balloon used for mechanical dilation of blood vessels. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to physically treat a condition within the body.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.
Product codes
LIT, DQY
Device Description
The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. 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 iliofemoral; 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 reliable design and performance under the specified testing parameters. These tests were comprised of:
- Balloon Minimum Burst Strength - Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met.
- Balloon Compliance - Testing shows that, under simulated body temperature conditions. each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met.
- Balloon Profile - Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with an 8 Fr sheath (
§ 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 PTA Balloon Catheter: ATB Advance® PTA Dilatation Catheter Cook Incorporated 4 November 2011
DEC - 9 2011
510(k) Summary
Submitted By:
Elysia Poor Regulatory Affairs Specialist Cook Incorporated 750 Daniels Wav, P.O. Box 489 Bloomington, IN 47402 812-339-2235
Device:
ATB Advance® PTA Dilatation Catheter Trade Name: Proposed Classification: Catheter, Percutaneous (74 DQY)
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.
Predicate Devices:
ATB Advance® PTA Dilatation Catheter cleared under the following 510(k) Premarket Notifications:
Device Description:
The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the ATB Advance PTA Dilatation Catheter. The identical indications for use and technological characteristics of the ATB Advance® PTA Dilatation Catheter as compared to the predicate device support a determination of substantial equivalency. The ATB Advance® PTA Dilatation Catheter has
1
Special 510(K) Premarket Notification PTA Balloon Catheter: ATB Advance® PTA Dilatation Catheter Cook Incorporated 4 November 2011
been modified from the predicate ATB Advance® PTA Dilatation Catheter to include a balloon size combination of 14 mm diameter x 2 cm length.
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:
- 1 . Balloon Minimum Burst Strength - Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met.
-
- Balloon Compliance - Testing shows that, under simulated body temperature conditions. each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met.
-
- Balloon Profile - Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with an 8 Fr sheath (