(280 days)
Medtronic CardioRhythm Torqr catheter, Bard Intracardiac Electrode catheter
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No
The description focuses on the physical characteristics and function of a diagnostic electrophysiology catheter, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as a "diagnostic electrophysiology catheter" used to "record electrical activity" and for "EP diagnostic study" to "assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions." It is not described as directly providing therapy.
Yes
The text explicitly states, "A diagnostic electrophysiology catheter is used to record electrical activity from within the heart... Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions." This indicates its purpose is to diagnose conditions and inform treatment decisions.
No
The device description clearly details a physical catheter with electrodes, wires, and a connector, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart. This is an in vivo procedure, meaning it is performed inside the living body.
- No Specimen Analysis: The device does not analyze any specimens taken from the body. It directly interacts with and measures activity within the heart.
Therefore, based on the provided information, this diagnostic electrophysiology catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder 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
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Device Description
The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
within the heart and coronary vessels
Indicated Patient Age Range
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Intended User / Care Setting
physician
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)
The results of non-clinical and in-vivo testing quantitated and confirmed the adequacy of electrical and mechanical performance and reliability of the Platinum catheters. These tests support the equivalence of the Platinum catheters with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic CardioRhythm Torqr catheter, Bard Intracardiac Electrode catheter
Reference Device(s)
Not Found
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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§ 870.1220 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
K953185
Attachment VII 510(k) SUMMARY As of July 7, 1995
Device Name Platinum™ Series of Diagnostic Electrophysiology Catheters
Device Description
The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.
Intended Use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder 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 Platinum series of EP catheters is substantially equivalent to the Medtronic CardioRhythm Torqr catheter and the Bard Intracardiac Electrode catheter.
Catheter Testing Results and Conclusion
The Platinum catheter is constructed of similar materials to those found in Medtronic CardioRhythm's Torgr catheter. All materials in the Platinum that are patient contacting are identical to those similarly exposed in the Torqr, therefore all biocompatibility testing was fulfilled.
The results of non-clinical and in-vivo testing quantitated and confirmed the adequacy of electrical and mechanical performance and reliability of the Platinum catheters. These tests support the equivalence of the Platinum catheters with the predicate device.
Image /page/0/Picture/12 description: The image contains the words "Platinum 510(k)". The text is in bold font. There are also some abstract shapes in the image.