(30 days)
Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple 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 provided text is a 510(k) Pre-Market Notification for the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than a clinical study proving device performance against specific acceptance criteria.
Therefore, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance. The submission relies on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria & Reported Device Performance: Not mentioned. The focus is on substantial equivalence, not a direct performance comparison against predefined metrics in a clinical study.
- Sample size for test set & data provenance: Not applicable. This isn't a clinical trial with a test set of patient data.
- Number of experts for ground truth & qualifications: Not applicable for a 510(k) that isn't a clinical study.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This device is not an AI-assisted diagnostic tool.
- Standalone algorithm performance: Not applicable. This is a physical medical device, not an algorithm.
- Type of ground truth: Not applicable.
- Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device.
Instead, the document states:
- "The components of the IBI-1100™ Bi-directional 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 a Electrophysiology Catheter has passed the biocompatibility and performance test."
- "Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process."
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This indicates that the "proof" for this submission is biocompatibility testing, performance testing (likely bench testing or non-clinical trials demonstrating functionality), adherence to manufacturing standards, and comparison to existing, legally marketed predicate devices. It is not a clinical study with detailed acceptance criteria as one would expect for a novel diagnostic algorithm.
§ 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).