(55 days)
Not Found
No
The summary describes a standard intravascular ultrasound catheter and imaging system without mentioning any AI or ML capabilities for image processing, analysis, or interpretation.
No
The device is described as an imaging catheter used for evaluation of vascular morphology and providing cross-sectional images, serving as an adjunct to angiographic procedures. Its purpose is diagnostic imaging, not therapeutic intervention.
Yes
The device is designed for "use in the evaluation of vascular morphology blood vessels" and to "provide an image of the vessel lumen and wall structures," which are diagnostic purposes. It also functions as an "adjunct to conventional angiographic procedures."
No
The device description explicitly details a physical catheter with an ultrasound transducer at the tip, which is a hardware component.
Based on the provided information, the JOVUS Eagle Eye™ F/X catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- JOVUS Eagle Eye™ F/X Function: The description clearly states that the JOVUS Eagle Eye™ F/X catheter is a device that is introduced into the patient's vascular system to obtain images of blood vessels in situ (within the body). It uses ultrasound energy applied directly to the vessel wall.
Therefore, since the device operates within the patient's body and does not analyze specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is an in vivo imaging device.
N/A
Intended Use / Indications for Use
JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology, such as lesion grometry in blood vessels of the coronary and peripheral vasculature by providing a cr ss-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunt to conventional angiographic procedures to provide an image of the vessel lumen and wall structures, during devic
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
JOMED INC. April 21, 2003
510 (K) Summary JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter
| Dave Prepared: | April 15, 2003 | |
|---|---|---|
| Submitted by: | JOMED Inc. | |
| 2870 Kilgore Rd. | ||
| Rancho Cordova, CA 95670 | JUN 2 3 2003 | |
| Contact person: | Lorry W. Huffman | |
| Regulatory Affairs Manager | ||
| Phone number: | ||
| Facsimile number: | (916) 638-9404 | |
| (916) 638-8112 | ||
| Device Name: | JOVUS Eagle Eye™ Intravascular Ultrasound Imaging Catheter | |
| (Eagle Eye™ IVUS Catheter) |
| Classification name: | Class | |
|---|---|---|
| • | 870.1200 Diagnostic Intravascular catheter | II |
| • | 892.1560 Ultrasonic pulsed echo imaging system | II |
Predicate Device:
The JOMED Inc. JOVUS Ear:le Eye™ F/X 2.9F Intravascular Ultrasound (IVUS) Imaging Diagnostic Catheter is substantially equivalent to the Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter cleared under K000820 on June 5, 2000.
Device Description:
The JOVUS Eagle Eye™ F/X catheters contain a catheter-tip ultrasound device that applies ultrasound energy dir ctly into the interior vessel wall of the patient to obtain an image of the vessel. This device is not currently indicated for use in cerebral vessels. The JOVUS Eagle Eye F/X catheter accommodates a 0.014" guide wire.
The JOVUS Eagle Eye™ F/X catheter utilizes an integral guide wire lumen in which the catheter tracks over the guide wire at the distal tip. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip.
1
The JOVUS Eagle Eye™ F/% catheter is introduced percutaneously or via surgical cutdown into the vascular sy:tem. A linear array ultrasonic transducer situated circumferentially near the tip of the catheter produces real time cross-sectional images of coronary and peripheral vessels.
The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.
Intended Use:
JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology, such as lesion grometry in blood vessels of the coronary and peripheral vasculature by providing a cr ss-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunt to conventional angiographic procedures to provide an image of the vessel lumen and wall structures, during devic