(107 days)
The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
The NEUROMARK® System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK® System is composed of the NEUROMARK® Device and the NEUROMARK® Radiofrequency (RF) Console. The NEUROMARK® Device is a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK® Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK® Device is intended for single use and provided sterile (EO). The NEUROMARK® Device is designed for use with the NEUROMARK® Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console. The NEUROMARK® Console delivers, monitors and controls RF energy to the Device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK® Console works in conjunction with software.
This document describes the 510(k) summary for the NEUROMARK® System (K222032). However, it does not contain details about specific acceptance criteria and the study proving the device meets them in the format requested.
The document states that:
- The NEUROMARK® System (K222032) is substantially equivalent to the predicate NEUROMARK® System (K212666).
- "Performance testing of the NEUROMARK® System consisted of design verification testing, biocompatibility, software, and electrical and thermal safety testing to support the device modifications listed above. All testing passed and showed that the device meets design specifications and performed as intended."
This implies that there were acceptance criteria and studies (performance testing), but the specifics requested in your prompt (e.g., a table of criteria/performance, sample size, expert details, MRMC study, standalone performance) are not provided in this regulatory summary.
Therefore, I cannot populate the requested sections with information from this document. It merely confirms that such testing was conducted and passed, without detailing the results or methodology.
§ 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.