Search Results

The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

The StableMapr Series of EP Diagnostic Catheters are used to record electrical activity from within the heart and its vasculature and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

The StableMapr Catheters are closed-lumen diagnostic electrophysiology catheters with a variable number of platinum allov recording/stimulating electrodes fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The StableMapr Catheters include addition mapping electrodes and a preformed distal tip section, as well as other minor modifications for improved manufacturability. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curvature of the catheter tip. All models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.

The provided text describes the Medtronic StableMapr Steerable Intracardiac Electrode Catheters. However, it does not contain the specific information required to complete the detailed acceptance criteria and study analysis requested.

Here's a breakdown of why the requested information cannot be fully provided:

• Acceptance Criteria and Reported Device Performance: The document states that "The non-clinical testing were conducted in accordance with applicable FDA guidance. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Marinr catheters." And "These tests support the substantial equivalence of the StableMapr catheters with the predicate device." However, it does not provide specific numerical acceptance criteria (e.g., "electrical resistance must be

Ask a specific question about this device

A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulatorrecorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.

This document, a 510(k) summary for the Performr Series of Diagnostic Electrophysiology Catheters (K964272), does not contain the specific information required to complete the requested table and study description. It is focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a standalone study with defined acceptance criteria and ground truth.

Here's a breakdown of why the information is not available and what is present:

Information NOT available in the provided text for the requested table and study description:

• Explicit Acceptance Criteria: The document does not define specific numerical or qualitative acceptance criteria for "device performance."
• Reported Device Performance: While it states "electrical and mechanical performance and reliability" were confirmed, it doesn't provide specific metrics (e.g., accuracy, sensitivity, specificity, or quantitative measurements for electrical/mechanical aspects).
• Sample size for the test set: Not mentioned.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts for ground truth: Not mentioned, as ground truth isn't explicitly discussed in the context of device performance metrics.
• Qualifications of experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Effect size of human readers improving with/without AI assistance: Not applicable, as this device is a diagnostic catheter, not an AI-powered diagnostic system.
• Standalone (algorithm-only) performance data: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not mentioned, as performance evaluation is described as "quantified and confirmed the adequacy of electrical and mechanical performance and reliability," implying engineering and physiological testing rather than diagnostic accuracy against a clinical ground truth.
• Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• How ground truth for the training set was established: Not applicable.

What the document does state regarding testing:

• Biocompatibility: Fulfilled via the predicate device (Medtronic CardioRhythm Marinr catheter) because materials are identical.
• Non-clinical and in-vivo testing: Conducted according to applicable FDA guidance and GLP (Good Laboratory Practice).
• Purpose of testing: "quantified and confirmed the adequacy of electrical and mechanical performance and reliability."
• Conclusion: These tests support the substantial equivalence of the Performr catheters with the predicate device.

In summary:

This 510(k) summary focuses on demonstrating that the new Performr catheter is "substantially equivalent" to existing, legally marketed predicate devices. For physical devices like this, substantial equivalence is often established by showing similar materials, design, intended use, and performance characteristics (which are often evaluated through engineering tests, biocompatibility, and sometimes limited animal or human use studies to ensure safety and functionality, rather than extensive diagnostic accuracy studies against a "ground truth" derived from expert consensus like an AI diagnostic system).

To fill out the requested table adequately, one would need a different type of document, typically a detailed study report or clinical trial results, which are not part of this 510(k) summary.

Ask a specific question about this device

A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.

This 510(k) summary for the K953185 Platinum™ Series of Diagnostic Electrophysiology Catheters does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. The document is from 1995, and regulatory submission requirements regarding clinical study specifics were different then.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. It mentions "in-vivo testing," implying biological testing, but details on human subjects or animals, their origin, or the study design (retrospective/prospective) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This device is an electrophysiology catheter for recording and stimulating, not an imaging device requiring expert interpretation for ground truth. The "ground truth" would relate to the accuracy of its electrical and mechanical measurements, which would be assessed by engineers/biomedical scientists through non-clinical and in-vivo testing, not expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for this type of device and study. Adjudication methods like 2+1 are relevant for interpreting diagnostic images where human variability exists. For direct measurement devices, performance is typically assessed against engineering specifications or known electrical/mechanical properties.

5. 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

• No. This is not an AI-assisted diagnostic imaging device. An MRMC study is not relevant for an electrophysiology catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its electrical and mechanical properties, not an algorithm that operates independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The "ground truth" for this device's performance would be established through:
  • Engineering specifications and standards: For electrical parameters (impedance, signal integrity) and mechanical properties (flexibility, durability, steerability).
  • Biocompatibility testing results: Assessed against ISO standards or similar.
  • In-vivo measurements: Actual recorded electrical signals and stimulation effects within a living system (animal or human), compared against expected physiological responses.
  • Comparison to predicate device performance: Showing equivalence in various test parameters.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

Summary of what is known:

• Study Type: Non-clinical (benchtop) and in-vivo testing.
• Purpose: To quantitate and confirm the adequacy of electrical and mechanical performance and reliability, and to support equivalence with predicate devices.
• Predicate Devices: Medtronic CardioRhythm Torqr catheter and Bard Intracardiac Electrode catheter.
• Biocompatibility: Fulfilled because patient-contacting materials are identical to those in the predicate Medtronic CardioRhythm Torqr catheter.

Ask a specific question about this device