(90 days)
Medtronic CardioRhythm Marinr EP catheter, Bard EP-XT Steerable, Elecath Genesis
Not Found
No
The description focuses on the physical characteristics and function of a diagnostic electrophysiology catheter, which records and stimulates electrical activity. There is no mention of AI or ML being used for data analysis, interpretation, or any other function.
No
The device is described as a "diagnostic electrophysiology catheter" used to record electrical activity and stimulate the heart for diagnostic purposes, not for providing therapy directly.
Yes
The "Intended Use / Indications for Use" section explicitly states, "A diagnostic electrophysiology catheter is used to record electrical activity from within the heart..." and "Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions." The "Device Description" also refers to it as a "diagnostic electrophysiology catheter."
No
The device description clearly details a physical catheter with electrodes, wires, a shaft, and a handle, 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:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the device is a diagnostic electrophysiology catheter used to record electrical activity from within the heart and to stimulate the heart. This is an in vivo procedure, meaning it is performed within the living body.
- Specimen Examination: The device does not examine specimens derived from the human body in vitro. It directly interacts with the heart's electrical system inside the body.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulatorrecorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
Product codes
Not Found
Device Description
The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 non-clinical and in-vivo testing were conducted in accordance with applicable FDA quidance and per GLP. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Performr catheters. These tests support the substantial equivalence of the Performr catheters with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic CardioRhythm Marinr EP catheter, Bard EP-XT Steerable, Elecath Genesis
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
1-13-1997 4 : 39PM ران پارٽ پنجي ته جي ته جي ويو جي ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو
JAN 2 3 1997
SECTION 6. 510(k) SUMMARY
The following 510(k) Summary of Safety and Effectiveness information is provided per 21 CFR $807.92.
Device Name
Performr Series of Diagnostic Electrophysiology Catheters
Device Description
The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
Intended Use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulatorrecorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
Substantial Equivalence
The Performr series of EP catheters is substantially equivalent to the Medtronic CardioRhythm Marinr EP catheter, as well as the Bard EP-XT Steerable and Elecath Genesis catheters.
Catheter Testing Results and Conclusion
The Performr catheter is constructed of similar materials to those found in the Medironic CardioRhythm Marinr catheter. All materials in the Performr that are patient contacting are identical to those similarly exposed in the Marint. Therefore, all biocompatibility testing was fulfilled via the predicate device.
The non-clinical and in-vivo testing were conducted in accordance with applicable FDA quidance and per GLP. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Performr catheters. These tests support the substantial equivalence of the Performr catheters with the predicate device.
P. 3