Search Results

The Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode. The Isolator linear pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Multifunctional Linear Pen (MLP1) utilizes radiofrequency (RF) energy from the RF generator (ASU) to create lines of ablation on cardiac tissue. The MLP1 device is comprised of an end effector, shaft, handle, and cable. This end effector consists of one pair of ablation electrodes separated with insulating material, with the electrodes used for the pacing and sensing functions. When the Isolator Multifunctional Linear Pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator Transpolar Pens (MAX1, MAX5; hereafter MAX devices) are a hand-held, single use bipolar surgical instrument intended for the ablation of cardiac tissue and for use by trained surgeons only. It is composed of a handpiece with a bipolar electrode configuration at its distal end with integral cable and a re-usable ablation and sensing unit (ASU). When a Transpolar pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The provided text is a 510(k) Premarket Notification from the FDA regarding two electrosurgical devices, the Isolator Transpolar Pen (MAX) and the Isolator Multifunctional Linear Pen (MLP1). This document primarily focuses on a proposed material change (an alternate resin for electrode separation) for these devices and demonstrates their substantial equivalence to previously cleared versions.

However, the provided document does not contain the information requested regarding acceptance criteria and the study that proves the device meets specific performance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) beyond general statements of "verification and validation testing."
• How ground truth was established for training or test sets.

The document states: "The Isolator Linear and Transpolar Pen devices met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K163408 MLP1 device, and K061593 MAX device. No new safety or performance issues were raising during testing." This indicates that some performance testing was done against predetermined criteria, but the specifics of those criteria and the study results are not detailed in this publicly available 510(k) summary.

In summary, based on the provided text alone, it is not possible to answer the detailed questions about acceptance criteria and the specific study proving the device meets those criteria, as these details are not present in this document. The document focuses on demonstrating substantial equivalence primarily due to a material change, rather than providing a comprehensive performance study that would typically be required for a novel AI/software-based device.

Ask a specific question about this device