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The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source: - Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery. - The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.

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 NICO Myriad™ 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. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site 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) - Intraventricular Tumors/Cysts

The Myriad 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 disposable handpiece is capable of precise tissue shaving and rapid tissue debulking. The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS 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

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary Brain Tumors - · Vascular Abnormalities/Malformations · Intraventricular Tumors/Cysts

The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts. The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.

The NICO Myriad™ 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. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site 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) - · Intraventricular Tumors/Cysts

The Myriad 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 disposable handpiece is capable of precise tissue shaving and rapid tissue debulking. In addition to the system and handpiece accessories or replacement parts, this submission also covers the Tissue Preservation System (TPS). The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS 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 ● These TPS accessories can be arranged in a multitude of ways depending on the desired setup. Refer the handpiece IFU for additional details. The following tables outline the system, components, accessories, and various handpieces sizes.

The NICO TRIOwand is a disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.

The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field. This submission covers a single configuration of the device: - . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°) The direct patient contacting materials consist of PEBA and stainless steel. The indirect contacting materials are PVC, TPV, polycarbonate, ABS, PC/ABS, silicone, and glue.

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary Brain Tumors - Vascular Abnormalities/Malformations - Intraventricular Tumors/Cysts

The NICO BrainPath and Accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts. The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm surgical corridor to the lesion or abnormality. The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).

Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.

The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field. This submission covers a single configuration of the device: - . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°) The direct patient contacting materials consist of PEBAX® and stainless steel. The indirect contacting materials are Tygon®, polycarbonate, ABS, PC/ABS, silicone, and Dymax glue.

To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).