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The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.

The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a hand held, monopolar, radiofrequency ablation device powered by the Cardioblate® 68000 Generator (cleared via K060400, K080509). It has a saline irrigation system that delivers fluid at the contact point between tissue and electrode tip to cool tissue during radiofrequency energy delivery. The device can also be used with the Medtronic Model 2090/2290 Programmer/Analyzer and the Medtronic Model 5388/5348 External Temporary Pacemaker for two pole sensing of the ventricle or the atrium and two pole stimulation (pacing) of the atrium. The device is intended for intermittent operation. The device is provided sterile (via ethylene oxide sterilization), nonpyrogenic, disposable and for single use only.

The provided text is a 510(k) summary for the Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and performance data in the format requested.

Therefore, the document does not contain the detailed information required to fill out the table and answer all questions in the requested format. Specifically, it lacks:

• Explicit acceptance criteria for device performance.
• Quantified reported device performance against those criteria.
• Details about sample sizes for test sets, training sets, or data provenance.
• Information on expert qualifications, adjudication methods, or multi-reader multi-case studies.
• A clear distinction between "standalone" performance and human-in-the-loop performance.
• Detailed descriptions of how ground truth was established for training and testing data.

Instead, the submission relies on demonstrating equivalence through:

• Comparison of Indications for Use: Stating that the MAPS device has the same indications for use as a predicate device (Cardioblate® Monopolar Pen).
• Functional Equivalence Claims: Asserting that the MAPS device produces irrigated, monopolar radiofrequency ablations functionally equivalent to the Cardioblate® Monopolar Pens and performs bipolar sensing, mapping, and pacing functionally equivalent to the Detect device.
• Non-Clinical Performance Data: Mentioning "Verification and validation testing, including bench testing and animal studies," which demonstrated equivalence to predicate devices. However, no specific performance metrics or results from these tests are provided in this summary.

In summary, based solely on the provided text, it is not possible to complete the requested table and answer the questions. The document is a regulatory submission for substantial equivalence, which typically does not include the granular detail of a clinical study report with explicit acceptance criteria and corresponding performance data.

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