(29 days)
The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.
The AtriCure 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 the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. 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 radiofrequency (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 provided text is a 510(k) summary for the AtriCure Coolrail Linear Pen (MCR1). It describes a submission for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance. Instead, it makes a general statement about meeting predetermined criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Design Verification | The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K122611 MCR1 device. No new safety or performance issues were raised during testing. |
| Reliability Testing | Completed per AtriCure's Quality System, implying conformance. |
| Thermistor Testing | Completed per AtriCure's Quality System, implying conformance. |
| Mechanical Testing | Completed per AtriCure's Quality System, implying conformance. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It describes non-clinical bench testing. The data provenance is internal to AtriCure, Inc., as the testing was completed "per AtriCure's Quality System." The testing is described as "Non-clinical Bench Testing," which by nature would be prospective for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study involves bench testing of a medical device, which typically relies on established engineering and performance specifications rather than expert ground truth in a clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study involves engineering and performance characteristics of a physical device, not subjective interpretations requiring adjudication.
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
This information is not applicable and not provided. The device described is an electrosurgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device is a physical electrosurgical pen; there is no "algorithm only" component.
7. The Type of Ground Truth Used
For this device, the "ground truth" is based on engineering specifications and established performance standards for electrosurgical devices. The testing (Reliability, Thermistor, Mechanical) verifies that the device performs according to these pre-defined, objective criteria. This is not clinical 'ground truth' like pathology or outcomes data, but rather a demonstration of physical device performance.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a hardware product, not a software algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided since there is no training set for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.