(88 days)
The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, percutaneous, and open. Applications include those when access to the is limited, such as Neurosurgical/ Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following:
- Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation/CH)
- Intraventricular Tumors/Cysts
The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue.
The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.
The NICO Myriad NOVUS is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The handpiece is capable of precise tissue shaving and rapid tissue debulking.
The NICO Automated Preservation System™ is a group of accessories for collection and preservation of resected tissue, it is comprised of three parts:
- Specimen Collector with filter element which collects tissue;
- Specimen Infusion Valve (SIV) which provides the desired biological environment;
- Specimen Preserver which provides the desired thermal condition
For standard handpieces, the Myriad-LX™ high intensity light source, handpiece sleeve, and illumination fiber combine to deliver illumination to the surgical field to aid in visualization.
The provided text describes the NICO Myriad NOVUS device and its substantial equivalence to a predicate device (NICO Myriad cleared under K182340). However, it does not contain details about specific acceptance criteria, reported device performance metrics with quantitative values, or a study design involving test sets, expert ground truth, adjudication methods, or comparative effectiveness studies (MRMC or standalone AI performance).
The document primarily focuses on:
- Device Description: What the NICO Myriad NOVUS is, its components, and its intended use (resection and removal of soft tissue and fluids).
- Comparison to Predicate: Highlighting the similarities and differences, specifically mentioning the addition of illumination and a console software update as key changes.
- Nonclinical Testing: Listing various tests performed to demonstrate compliance with design and performance requirements and support substantial equivalence. These tests are largely related to engineering, material science, and software validation, not clinical performance metrics in terms of accuracy or efficacy for specific diagnostic or prognostic tasks.
Therefore, I cannot provide the requested information from the given text. The text does not detail an AI/ML-driven medical device evaluation study as outlined in your request.
§ 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.