Search Results

The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode.

The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The Isolator Transpolar Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The Isolator Linear Pen (MLP1) utilizes radiofrequency (RF) energy from a RF generator 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 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 Pen (MAX1, MAX5) is 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 is powered by a radiofrequency (RF) generator. When the 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 Coolrail Linear Pen (MCR1) is a hand-held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by a radiofrequency (RF) generator. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar RF energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The Isolator Synergy Clamps (EMR2, EML2) are single-patient use, electrosurgical instruments designed for use with a radiofrequency (RF) generator and are indicated to ablate cardiac tissue. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch. The AtriCure Isolator Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type grip handle/ actuation and button release mechanisms.

The Isolator Synergy EnCompass Clamps (OLH, OSH) are a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The clamps utilize bipolar energy generated from a radiofrequency (RF) generator.

The Isolator Synergy Access Clamp (EMT1) is a handheld, single use, bipolar radiofrequency (RF) surgical instrument intended for the ablation of cardiac tissue. EMT1 is part of the AtriCure Bipolar (Transpolar) System which includes an accessory instrument guide (Glidepath Tape). The EMT1 clamp is connected via an integral cable to a radiofrequency (RF) generator.

The ASU/ASB Generator is the original RF energy source for the cleared handpieces listed above. The ASU/ASB Generator will continue to be available for use and is unchanged from the original clearances.

The Multifunctional Ablation Generator (MAG) is an alternate RF energy source to the currently cleared ASU/ASB generator for each handpiece system above. The MAG RF generator is a portable reusable device that produces and delivers monopolar and bipolar RF energy at 460 kHz. It provides a pass-thru to an external sense and pace system (feature relates to the Pen devices). The MAG consists of several circuit boards, power supplies, a power entry module, a footswitch interface, and an LCD display with an integrated touchscreen. Like the ASU/ASB generator, the main function of the MAG is to deliver and control of voltage and current output to the selected handpiece. Upon reaching a predetermined threshold (voltage and/or current relationship or a preset time), the RF generator will provide visual and audible indications to signal the end of the ablation cycle and decrease the energy level until RF is stopped or the time limit is reached. A footswitch and a Start-Stop button on the touchscreen are included in the system to start and stop RF ablation. The output of the MAG generator is designed to be equivalent to the ASU/ASB generator when connected to each handpiece listed above.

This looks like a 510(k) summary for a medical device called the AtriCure RF Pen and Clamp Handpieces, which are electrosurgical devices intended to ablate cardiac tissue. The summary is primarily aimed at demonstrating substantial equivalence to previously cleared predicate devices, with the main change being the addition of an alternative radiofrequency (RF) generator, the Multifunctional Ablation Generator (MAG).

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics. Instead, the entire submission hinges on demonstrating equivalence to predicate devices. The "reported device performance" is the finding that the system with the MAG generator is "equivalent" to the system with the predicate ASU/ASB generator.

The tables (Table 2 to Table 7) list various technological characteristics for each specific device (Isolator Synergy Clamps EMR2 & EML2, Isolator Synergy Access System EMT1, EnCompass OLH/OSH, Isolator Transpolar Pen MAX1/5, and Multifunctional Linear Pen MLP1, Coolrail Linear Pen MCR1). For almost all features, the comparison is "Same," meaning the proposed device/system feature is identical to the current/predicate device.

The key "acceptance criteria" here implicitly are:

• Identical Intended Use: The proposed device must have the same intended use as the predicate device (verified in row 3 of each table, with minor language adjustments noted as "Equivalent - Adjusted language to align with AtriCure's other RF devices" but indicating no change in core intent).
• Equivalent RF Generator Performance: The MAG generator must demonstrate equivalent RF energy output, algorithms, frequency, and duration to the ASU/ASB generator (verified in rows 13-15 or 14-17 of each table, marked as "Equivalent" for the generator itself, and "Same" for algorithm, frequency, and duration).
• No Change in Handpiece Design: The single-use handpieces themselves must be unchanged from the predicate systems.
• Conformance to Standards: The device must meet recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Packaging, Sterilization, Biocompatibility: These aspects must remain the same and meet relevant standards (ISO 10993 for biocompatibility, 10-6 SAL for sterility assurance).
• System Performance Equivalence: Bench testing and ex-vivo lesion equivalency testing must confirm that system performance with the MAG generator is equivalent to performance with the ASU/ASB generator.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for "test sets" in the traditional sense of clinical or statistically powered performance studies. The testing described is primarily bench testing and ex-vivo lesion equivalency testing.

• Sample Size: Not explicitly stated as a number of devices or data points from a large population. It mentions "System testing with each handpiece" which implies a representative number of each device type was tested.
• Data Provenance: The data provenance is from "Bench testing" and "ex-vivo lesion equivalency testing." This indicates the testing was done in a laboratory setting, likely on animal tissue or synthetic models, not human subjects. There is no mention of country of origin for the data, but given the company is US-based and seeking FDA clearance, the testing would generally align with US regulatory expectations and likely performed in the US or by a recognized international testing facility. The data is retrospective in the sense that it's performed to support a pre-market notification, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

This information is not provided in the document. For bench and ex-vivo testing, "ground truth" might be established by direct physical measurements or comparisons to established baselines, rather than expert interpretation of complex data like medical images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of bench and ex-vivo performance testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments where multiple experts need to agree on a "ground truth" diagnosis or outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is critical for evaluating the impact of AI or new technologies on human reader performance, typically in diagnostic imaging. The device described is an electrosurgical device, and the focus of this submission is on the equivalence of a new power generator, not on changing human diagnostic performance.

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

The specific context of "standalone algorithm performance" as it relates to AI is not directly applicable here. The "algorithm" referenced (Algorithm G, B, C, L in the tables) refers to the proprietary algorithms within the RF generator controlling power output based on tissue impedance.

However, the bench testing and ex-vivo lesion equivalency testing essentially represent standalone performance of the device's ability to ablate tissue. These tests evaluate the device's technical capabilities (e.g., power output characteristics, lesion depth/quality) without human intervention beyond operating the device according to its instructions. The equivalence was demonstrated by comparing the MAG generator's performance in these standalone bench tests to the ASU/ASB generator's performance.

7. The Type of Ground Truth Used

For the bench and ex-vivo testing, the "ground truth" would be established through direct physical measurement and characterization of the ablations. This could involve:

• Physical measurements: Lesion dimensions (depth, width), temperature profiles.
• Histopathology: For ex-vivo tissue, microscopic examination to confirm lesion extent and cellular changes (though not explicitly stated, this is standard for lesion equivalency).
• Electrical measurements: Characterizing RF power output, frequency, and current delivery under various load conditions.

8. The Sample Size for the Training Set

This information is not applicable as the document describes an electrosurgical device system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "proprietary algorithm which senses tissue impedance" within the generator would have been developed and refined through engineering processes and testing, not a machine learning training paradigm of external data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device