(139 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 describes a 510(k) premarket notification for a medical device, the Coolrail Linear Pen (MCR1). However, the document is an FDA clearance letter for a modified version of an existing device, emphasizing its substantial equivalence to a previously cleared predicate device.
Crucially, this document is a regulatory clearance letter and does not contain the details of a study that proves the device meets specific performance acceptance criteria in the manner requested (e.g., using a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance).
The document states:
- "The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K183065 MCR1 device."
- "The results of the verification and validation testing: o Demonstrated the subject device met the predetermined performance specifications o Did not raise any new risks or issues of safety."
This indicates that internal verification and validation testing was performed, but the specifics of that testing (e.g., the criteria themselves, the methodology, sample sizes, ground truth establishment, or expert involvement) are not detailed in this FDA letter. The focus of this 510(k) is on the safety and effectiveness of a modified circuit board in a device already cleared by the FDA, primarily by demonstrating that the modifications did not introduce new risks and maintained the performance of the predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, because those specific details are not present in the provided text. The text does not describe a clinical study of the type that would involve a test set, expert readers, MRMC studies, or specific performance metrics like sensitivity/specificity for diagnostic AI, for example. It is a regulatory submission for a physical electrosurgical device with a minor internal modification.
§ 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.