(90 days)
The Mercator Atrial High Density Array Catheter is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). When used in conjunction with electrogram recording equipment and stimulators, the system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.
The Mercator Atrial High Density Array Catheter can be used with:
- the Cardiac Pathways' Model 8100 Arrhythmia Mapping System and the Model 8300 . Signal Acquisition Module in conjunction with a stimulator, and
- Cardiac Pathways' EGM Adapter Cables (Models 2036, 2043, and 2044) in conjunction . with intracardiac electrogram recording equipment.
Prescription Use
(Per 21 CFR 801.109)
The Mercator High Density Array Catheter has an 8.5F catheter shaft with a collapsible, spheroid-shaped. 32-bipole-electrode array (64 electrodes) on the distal end, and an integrated cable/connector assembly on the proximal end. The device is designed to connect/mate directly with the Cardiac Pathways' Arrhythmia Mapping System and with Cardiac Pathways' EGM Adapter Cables. The EGM Adapter Cables can be connected to electrogram recording equipment.
The Mercator High Density Array Catheter has been described previously in the 510(k) Summary and the Device Description section in the 510(k) submission file number K982540.
There are three different EGM Adapter Cables for use with the Mercator Catheter. The distal end of the cable is identical in each of the three cable types and defined as the end that connects to the Mercator High Density Array Catheter. The proximal end connects to electrogram recording equipment.
The distal end of the EGM Adapter Cables is a threaded-body style connector that has contacts for each of the 64 electrodes of the Mercator High-Density Array Catheter and a contact for a shield wire. The proximal end of the cable distinguishes the three EGM Adapter Cables. The Model 2036 EGM Adapter Cable allows for general connection of individual electrodes to electrogram recorders and stimulators. This cable has 64 independent connectors on the proximal end. Model 2043 and Model 2044 EGM Adapter Cables have connector configurations that can mate with Prucka CardioLab recording systems. These cables have two connectors on the proximal end. On each of these two connectors, 33 contacts connect 32 electrodes and 1 shield wire from the Mercator High-Density Array Catheter to the inputs on the Prucka system. The two Prucka connector cable models differ in that one model has pin-type contacts and the other model has socket-type contacts to adapt to suitable models of the Prucka recording system. The EGM Adapter Cables are not sterilized since they are not in the sterile field during a procedure.
The provided text describes a 510(k) summary for the Mercator Atrial High Density Array Catheter and Cardiac Pathways EGM Adapter Cables. It focuses on device description, indications for use, and a statement of substantial equivalence to a predicate device (K982540). The document mentions that the Mercator catheter was subjected to bench, animal, and clinical testing, and the EGM Adapter Cables underwent electrical and mechanical tests.
However, the specific details required to answer your questions regarding acceptance criteria and the comprehensive study that proves the device meets them are not provided in the given text. The document states that the testing for the catheter has been "described previously in the 510(k) Summary for the 510(k) submission file number, K982540," and for the cables, it only states that "The device met the specifications" without listing those specifications or the details of the tests.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the catheter in this document. For the cables, it only states "met the specifications" for electrical and mechanical tests, but the specifications themselves are not detailed.
- Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country, retrospective/prospective) is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment details are provided.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a catheter and adapter cables, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers assessing AI performance is not relevant to this product.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth information is provided.
- The sample size for the training set: Not applicable, as this is a hardware device, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
The document essentially refers to a prior 510(k) summary (K982540) for the performance data of the Mercator Catheter and provides only a very high-level summary for the EGM Adapter Cables. To answer your questions comprehensively, the original 510(k) summary (K982540) would need to be reviewed.
§ 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).