(90 days)
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No
The description focuses on the physical characteristics and function of a catheter for angiographic visualization and measurement using radiopaque markers, with no mention of AI or ML.
No
The device is used for angiographic visualization and measurement, not for treating a disease or condition.
No
Explanation: While the device aids in visualization of the vasculature, its primary function is to deliver contrast media and provide linear measurements, not to diagnose a disease or condition. It is a tool for obtaining images rather than interpreting them for diagnostic purposes.
No
The device description clearly states it is a physical catheter with radiopaque marker bands, a luer adapter, and distal ports, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EVT AngioScale angiography catheter is used within the body to deliver contrast media for imaging and to provide a scaled ruler for measurement during an angiographic procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system." This is an in-vivo procedure, not an in-vitro diagnostic test.
The device is an angiography catheter, which is a type of medical device used in interventional radiology and cardiology.
N/A
Intended Use / Indications for Use
The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
21 CFR 870.1200, Class II
Device Description
The EVT AngioScale angiography catheter is a PEBAX pigtail catheter with 11 to 20 radiopaque platinum marker bands on the catheter tubing. This 6 - 7 French catheter rides over a .038" guide wire. A standard polycarbonate luer adapter at the proximal end allows for injection of contrast media. Distal ports disperse the contrast media for angiographic visualization.
The EVT AngioScale angiography catheter has multiple radiopaque platinum marker bands so that the entire length of the marked catheter image can be used as a scaled ruler.
The EVT AngioScale angiography catheter is provided sterile to the end user. It is disposable, with a useable life of one procedure.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
MAY - 8 1997
SUMMARY AND CERTIFICATION II.
Summary of Safety and Effectiveness
Manufacturer:
EndoVascular Technologies, Inc. 1460 O'Brien Drive Menlo Park, CA 94025-1436 Contact: Luanne Termeer
Device Name:
The EVT® AngioScale™ angiographic catheter is a diagnostic intravascular catheter, 21 CFR 870.1200, Class II.
Substantial Equivalence:
The EVT® AngioScale™ angiographic catheter is substantially equivalent to the Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006, Class II), the Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007, Class II), the Cordis Quanticor Marker Catheter (Class II), and the Cordis Ducor Angiographic Catheter (Class II).
Device Description:
The EVT AngioScale angiography catheter is a PEBAX pigtail catheter with 11 to 20 radiopaque platinum marker bands on the catheter tubing. This 6 - 7 French catheter rides over a .038" guide wire. A standard polycarbonate luer adapter at the proximal end allows for injection of contrast media. Distal ports disperse the contrast media for angiographic visualization.
The EVT AngioScale angiography catheter has multiple radiopaque platinum marker bands so that the entire length of the marked catheter image can be used as a scaled ruler.
The EVT AngioScale angiography catheter is provided sterile to the end user. It is disposable, with a useable life of one procedure.
Intended Use:
The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.