(364 days)
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
Diagnostic Electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. EP catheter designs all incorporate a connector, a handpiece, a flexible polymeric shaft, and a distal tip containing two or more electrodes. The distal tips of steerable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
This looks like a 510(k) clearance letter for reprocessed diagnostic electrophysiology (EP) catheters, noting the FDA's acceptance of supplemental validation data. Unfortunately, the provided document does not contain the detailed acceptance criteria or the specific study results that confirm the device meets these criteria. The letter primarily states that the reprocessed devices are found to be substantially equivalent to legally marketed predicate devices, and lists the specific models cleared.
The letter explicitly mentions "supplemental validation data as required for reprocessed single-use devices," but it does not describe the methodologies or the outcomes of this validation.
Therefore, I cannot provide the requested information based solely on the text provided. The document you've given is a regulatory clearance letter, not a detailed study report.
To provide the requested details, I would need access to the actual "supplemental validation data" mentioned in the letter, which would typically be included in the 510(k) submission itself (a much larger document).
However, I can extract what is implied or stated generally about the device and its intended use:
- Device Name: Electrophysiology (EP) Catheter (reprocessed)
- Intended Use/Indications for Use: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
- Technological Features Comparison: The document states, "Since reprocessing does not significantly change any of these parameters, the reprocessed catheters are the same as the original devices." This implies that the performance characteristics (e.g., integrity, electrical properties, mechanical properties) after reprocessing are expected to be equivalent to new devices.
Without the actual validation study report, I must state that the following information is NOT available in the provided text:
- Table of acceptance criteria and reported device performance: Not provided.
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish ground truth and their qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study effect size: This type of study is more common for diagnostic imaging AI devices, not typically for reprocessed catheters. The document does not mention it.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not provided. For reprocessed catheters, the "ground truth" would likely involve comparison to original device specifications and performance rather than a clinical ground truth like pathology for a diagnostic imaging device.
- Sample size for the training set: Not applicable; this is not an AI/ML device that requires a training set.
- How ground truth for the training set was established: Not applicable.
§ 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).