(37 days)
Not Found
No
The device description focuses on the physical characteristics and performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a medical procedure aimed at addressing a health condition.
No
This device is a balloon dilatation catheter used for angioplasty, a therapeutic procedure to open narrowed arteries. It is not described as being used to diagnose a condition, but rather to treat one.
No
The device description clearly details a physical medical device (a balloon catheter) with hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vector™ PTA Balloon Dilatation Catheter is a medical device used within the body (in vivo) for a therapeutic procedure (angioplasty) to open narrowed arteries and fistulae. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's vascular system.
- Device Description: The description details the physical components and how it's used for inflation and visualization during the procedure, not for analyzing biological samples.
Therefore, the Vector™ PTA Balloon Dilatation Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.
The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
femoral, iliac, popliteal, and renal arteries and ... native or synthetic arterio-venous 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 Vector 4™ PTA Balloon Dilatation Catheter is tested and meets all its physical and performance specifications including:
- Balloon rated burst pressure .
- Balloon compliance ●
- Critical dimension verifications .
- Guidewire and introducer compatibility .
- Fluoroscopic visualization .
- . Inflation/deflation times
- . Repeat inflation
- Leak
- Tensile
- . Kink
- . Torque
- Corrosion ●
- . Luer lock compatibility
- Coating integrity .
- Distribution ●
In addition, the device was tested for biocompatibility ISO 10993-1 for short duration contact with blood (
§ 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
K.121385
510(k)A001 Page 9
510(k) Summary
JUN 1 4 2012
Administrative Information
Primary Contact Person
Sew-Wah Tay, PhD Regulatory Consultant, Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-801-6782 Fax: 763-477-6357 Email: swtay@libramed.com
Date Prepared: 4/3/2012
Sponsor's Contact
Michael Hoch r4 Vascular, Inc. 7550 Meridian Circle North, Suite 150 Maple Grove, MN 55369 Phone: 763-494-8400 x.10 Fax: 763-494-8484 Email: mhoch@r4vascular.com
Device Name
Trade Name
Vector TM
| Common Name | Percutaneous Catheter |
|---|---|
| Classification Name | Percutaneous Catheter |
| Classification | II |
| Product Code | DQY, LIT |
Predicate Device
The device is substantially equivalent to the Bard Conquest PTA catheter (K083657).
Indications for Use/Intended Use
The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents
Device Description and Technological Characteristics
The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon
1
minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.
The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
Performance Data
The Vector 4™ PTA Balloon Dilatation Catheter is tested and meets all its physical and performance specifications including:
- Balloon rated burst pressure .
- Balloon compliance ●
- Critical dimension verifications .
- Guidewire and introducer compatibility .
- Fluoroscopic visualization .
- . Inflation/deflation times
- . Repeat inflation
- Leak
- Tensile
- . Kink
- . Torque
- Corrosion ●
- . Luer lock compatibility
- Coating integrity .
- Distribution ●
In addition, the device was tested for biocompatibility ISO 10993-1 for short duration contact with blood (