(64 days)
The Radii Diagnostic Electrophysiology Catheter is intended to be used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.
The Radii Diagnostic Electrophysiology Catheter is a 7 F steerable, deflectable, quadrapolar catheter. It has a 4 mm tip electrode and three 1 mm ring electrodes in the flexible distal tip and a handle at the proximal end. The catheter is available in several curve sizes, two shaft stiffnesses, and two electrode spacings. The four electrodes at the distal end of the catheter include one 4 mm electrode at the distal tip, and three 1 mm ring electrodes placed at specified distances proximal to the tip electrode. One interelectrode spacing configuration is 2 mm, 5 mm, and 2 mm (2,5,2) and the other interelectrode spacing configuration is 2 mm, 2 mm, and 2 mm (2,2,2). Each of the electrodes is attached to a conductor that extends from the electrode to a specific pin in the connector in the handle. The shaft has two lumens, one for the electrode wires and the other for the pull-wire. To facilitate the transmission of rotational force, the shaft includes braiding sandwiched between layers of tubing. At the proximal end of the handle (i.e., farthest from the shaft), there is a connector for connecting the device to an external stimulator and electrophysiologic recorder. The knob utilized to deflect the tip is on the distal end of the handle (i.e., nearest to the shaft). This knob is connected to the tip by the pull-wire. Pulling the knob toward the connector causes the tip to deflect, with the extent of deflection controlled by the extent of movement of the knob. Pushing the knob toward the shaft causes the tip to straighten. Rotating the handle to the right rotates the catheter tip counterclockwise or clockwise, respectively (as viewed from the handle). The Radii Catheter connects to an electrophysiologic recorder using an EGM Cable designed specifically for the connector configuration on the recorder. Each cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the recorder. Within the insulated cable bundle, each conductor is insulated. A separate cable is utilized for connecting the Radii Catheter to an external stimulator. Like the EGM Cables, this cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the stimulator. Each conductor within the insulated cable bundle is insulated. Because many pacing stimulators do not contain protected-pin attachments (these are designed into the Cardiac Pathways cable), a Pin Adaptor is provided with the cable to allow for a variety of connection situations.
The provided text describes a medical device, the Radii Diagnostic Electrophysiology Catheter, and its 510(k) summary for premarket notification. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through:
- Device Description: Detailing the physical characteristics, materials, and functionality.
- Intended Use/Indications: Clearly stating the purpose of the device.
- Performance Data (Engineering Bench Testing): Summarizing that the device underwent electrical, mechanical, and biocompatibility testing and "met the specifications." This is typical for demonstrating safety and basic functionality in a 510(k) for such a device, rather than a clinical performance study with detailed statistical results.
Therefore, many of the requested elements (sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not found in this document because the type of study described is a series of engineering and bench tests, not a clinical trial or performance evaluation employing those methodologies.
Here's a breakdown of what can be extracted from the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Electrical Specifications (e.g., continuity, short circuits, DC/AC impedance, capacitance, dielectric strength, current leakage) | "The device met the specifications." | Specific quantitative values for "specifications" are not provided. |
| Mechanical Specifications (e.g., joint strengths, ability to withstand multiple deflections) | "The device met the specifications." | Specific quantitative values for "specifications" are not provided. |
| Biocompatibility | "Biocompatibility testing was performed to verify that the devices did not elicit toxicological responses." | Indicates compliance with biocompatibility standards, but specific test results or thresholds are not detailed. |
Study Details (Based on available information)
- Sample size used for the test set and the data provenance: Not explicitly detailed. The "test set" refers to physical units of the device and cables used for engineering bench testing, not a clinical data set. Data provenance is not applicable in the context of bench testing of physical devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is based on predefined technical specifications and measurements, not expert clinical consensus.
- Adjudication method for the test set: Not applicable. Engineering tests rely on objective pass/fail criteria against specifications.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was NOT done. This type of study is relevant for diagnostic imaging or interpretation where human readers' performance is evaluated. The Radii Catheter is a diagnostic device for recording signals and delivering pacing, not for interpretation of complex clinical data by humans that would require an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Radii Catheter is a physical medical device, not an algorithm, so standalone algorithm performance is not a concept that applies.
- The type of ground truth used: For the electrical and mechanical tests, the ground truth was the predetermined engineering specifications and standards set for the device's components and overall function. For biocompatibility, it was compliance with biocompatibility standards to ensure no toxicological responses.
- The sample size for the training set: Not applicable. This refers to the training of an algorithm, which is not relevant to this device.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
The 510(k) summary focuses on demonstrating that the Radii Diagnostic Electrophysiology Catheter (and its associated cables) is substantially equivalent to existing legally marketed predicate devices. This is achieved by showing that it has the same intended use, similar technological characteristics, and that its performance (through electrical, mechanical, and biocompatibility bench testing) "met the specifications." The document confirms that the FDA reviewed this data and found the device substantially equivalent. The information provided is consistent with the requirements for a Class II medical device seeking 510(k) clearance, which primarily involves demonstrating safety and effectiveness through substantial equivalence, often relying heavily on non-clinical performance data (bench testing) rather than extensive clinical efficacy trials typically seen for novel, higher-risk devices or software.
§ 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).