(92 days)
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No
The summary describes a diagnostic catheter with electrodes for pacing and recording electrical signals. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies focus on bench and biocompatibility testing, not algorithmic performance.
No
The device is described as a "Diagnostic Catheter" intended to "pace and record monophasic action potentials (MAPs)". Its primary function is diagnostic, not therapeutic.
Yes
The device explicitly states in its "Intended Use / Indications for Use" that it is a "Diagnostic Catheter" and is intended to "record monophasic action potentials (MAPs) from the endocardial surface of the heart," which is a diagnostic function.
No
The device description clearly describes a physical catheter with electrodes, indicating it is a hardware device, not software-only.
Based on the provided information, the Fidus Rhyder Diagnostic Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart." This involves interacting directly with the patient's internal tissues (the heart) to obtain physiological signals.
- Device Description: The device is a catheter with electrodes designed to be inserted into the body.
- Anatomical Site: The specified anatomical site is the "endocardial surface of the heart," which is inside the patient's body.
- Nature of the Measurement: The device is recording electrical signals (MAPs) directly from the heart tissue and potentially delivering electrical stimulation (pacing).
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue samples) to provide information for diagnostic purposes. The Fidus Rhyder Diagnostic Catheter does not examine specimens in vitro (outside the body); it interacts directly with the patient in vivo (inside the body).
This device falls under the category of a medical device used for diagnostic and potentially therapeutic (pacing) purposes, but not an IVD.
N/A
Intended Use / Indications for Use
The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.
Product codes
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Device Description
The Fidus Rhyder Diagnostic Catheter is a flexible catheter with two pairs of electrodes at the distal tip. One pair of electrodes consisting of tip (active) and side (indifferent) electrodes is used for recording ECG signals. The second pair of electrodes, located adjacent to the catheter's tip, are used for pacing. The Rhyder Diagnostic Catheter is available with three distal tip designs.
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
endocardial surface of the heart
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
The results of bench testing (thermal cycling test, impedance testing, tensile test, tip buckling test, deflection test, tortional test, connector test, leakage current test, joint seal test, radiopacity) and biocompatibility testing support the substantial equivalence claims of the Rhyder Diagnostic Catheter for its intended use in the coronary vasculature. Results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the Rhyder Diagnostic Catheter's substantial equivalence to the predicate device.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON
Ted Ormsby VP Engineering and Product Development Fidus Medical Technology Corporation 47929 Fremont Blvd. Fremont, CA 94538
DEVICE NAME
Rhyder Diagnostic Catheter; Class II
DEVICE DESCRIPTION
The Fidus Rhyder Diagnostic Catheter is a flexible catheter with two pairs of electrodes at the distal tip. One pair of electrodes consisting of tip (active) and side (indifferent) electrodes is used for recording ECG signals. The second pair of electrodes, located adjacent to the catheter's tip, are used for pacing. The Rhyder Diagnostic Catheter is available with three distal tip designs.
INDICATIONS FOR USE
The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.
PREDICATE DEVICES
- EP Technologies, Inc. Franz™ Combination Map Catheter (K900452) �
- Daig Response™ Electrophysiology Catheter (K894500, K942379) ●
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TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION
The results of bench testing (thermal cycling test, impedance testing, tensile test, tip buckling test, deflection test, tortional test, connector test, leakage current test, joint seal test, radiopacity) and biocompatibility testing support the substantial equivalence claims of the Rhyder Diagnostic Catheter for its intended use in the coronary vasculature. Results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the Rhyder Diagnostic Catheter's substantial equivalence to the predicate device.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS
Substantial equivalence is based on the fact that the Rhyder Diagnostic Catheter is substantially equivalent in regard to intended use and technological characteristics as the predicate devices. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the Rhyder Diagnostic Catheter. Therefore, it can be concluded that the Rhyder Diagnostic Catheter is substantially equivalent to the predicate devices.