(329 days)
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No
The summary describes a standard electrophysiology catheter for recording and stimulation, with no mention of AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies," which are therapeutic interventions.
Yes
Explanation: The device is described as being used for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies," which directly indicates its function in diagnosing conditions.
No
The device description explicitly states it is a "multiple-electrode electrophysiology recording catheter and its connecting cable," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices 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.
- Device Function: The IBI-1100" Steerable Electrophysiology Catheter is used inside the body for electrogram recording and cardiac stimulation. It directly interacts with the heart tissue.
Therefore, based on its intended use and how it functions, this device falls under the category of an invasive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IBI-1100" Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Irvine Biomedical, Inc. IB1-1100" Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
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
The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
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)
The sterilized, finished (BI-1100" Steerable Electrophysiology Catheter has passed the biocompatibility and performance tests.
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.
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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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§ 870.1220 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
APR 11 1997
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SUMMARY OF SAFETY AND EFFECTIVENESS
03-97 1HD 62:01 FM Fri 16 16 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
く
The Irvine Biomedical, Inc. IB1-1100" Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle. The IBI-1100" Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
The components of the IBI-1100™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished (BI-1100" Steerable Electrophysiology Catheter has passed the biocompatibility and performance tests. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and yalidated sterilization process. Therefore, we believe the IBI-1100" Steerable Electrophysiology Catheter on this submission to be safe and effective.
The accessory cables used to connect the IBI-1100" Steerable Electrophysiology Catheters to a recorder are conventional and comply with Section 12A of the Underwriters Laboratories UL 544 Standard for Safety.