(360 days)
The Hexapolar Electrode Balloon Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following:
- Temporary use in electrophysiology studies;
- Intra-cardiac ECG; and
- Electrical stimulation.
The Hexapolar Electrode Balloon Flotation Catheter (HEBFC) is furnished in both five and seven French sizes. The device has an electrode mounted at the distal tip with a latex balloon proximal to the tip electrode. There are five electrodes mounted on the shaft proximal to the balloon. The shaft has bands every ten centimeters. At the manifold, the extension with a Stopcock is connected to the Air Lumen. The electrode wire are connected to wire extensions with pin connectors. These are coded with numbers for identification.
The provided FDA 510(k) summary for the Hexapolar Electrode Balloon Flotation Catheter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification (510(k)) seeking substantial equivalence to a predicate device. The information provided focuses on:
- Device Description: Comparing the new device (Hexapolar Electrode Balloon Flotation Catheter) to a previously approved predicate device (J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter).
- Technological Characteristics: Highlighting similarities in materials, design, and assembly, and the addition of four electrodes with expanded functions (electrophysiology studies and intracardiac ECG recording).
- Performance Data: Stating that mechanical strengths and electrical tests remain the same as with the Predicate Device.
- Safety Statement: Emphasizing inherent hazards of invasive procedures are identified, and that the basic design has been in use for a long time by many physicians.
- Intended Use/Indications for Use: Listing the specific applications for the device.
- FDA Clearance: The letter from the FDA confirming substantial equivalence.
Therefore, I cannot populate the requested table and answer the study-related questions based on the input text.
Here's why and what's missing:
- Acceptance Criteria & Performance: The document states that "The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device." It does not provide what those specific performance data points or acceptance criteria are, nor does it present new test results for the Hexapolar device against those criteria. It implies that since the core technology is similar, the existing predicate device's performance data applies.
- Study Details: There is no mention of a specific study, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically required for novel devices or when significant changes warrant new performance testing. For a 510(k) based on substantial equivalence, especially for a device that is essentially an enhanced version of an existing product, extensive new performance studies are often not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness.
§ 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).