SALIENT CHARACTERISTICS 1.pdf

Salient Characteristics:

1. General: ENT Navigation System with Electromagnetic (EM) Tracking Technology.

2. Technical Breakdown:

a. Display Streaming Video / Endoscope Integration

b. HD Video Capability

c. Virtual Endoscopy Capability

i. Provides a simulated 3D endoscopic view of the sinuses to visualize anatomy, pathology and preoperative plans inaccessible with a traditional endoscope.

Combined with Stealth3D™ Software, virtual endoscope allows surgeons to see relative positions of anatomy and pathology from a view similar to their surgical endoscope

d. Unit integration into Endoscope tower capability

e. Partial or full screen endoscope viewing capability

3. Image Processing Capability

a. StealthMerge™ Software capability

i. Allows you to combine an exams and view them during the procedures: CT, MR, MR-T1, MR-T2.

b. Stealth3D™ Software capability

i. Create 3D models of anatomy or pathology from CT and/or MR. Create multiple models and blend them together. Automated tools available for: skin, bone, brain, vessels.

4. Instrument Capabilities

a. 6 instrument ports – can track up to 5 instruments at a time.

b. Instrument Trackers and Patient Trackers synonymous with legacy Fusion™ Navigation

System.

c. NuVent™ EM Sinus Dilation System – balloon dilation with Integrated navigation.

i. Frontal, maxillary and sphenoid designs

d. 35 Navigated Instruments

i. Hind-tracked and tip-tracked

ii. Malleable instruments

5. Product Software Features ENT

a. Surgical Planning - Create a surgical pathway by creating entry and target points and view progress along the planned path and distance to target.

b. Stealth3D™ Software - Create 3D models of anatomy or pathology from CT and/or MR.

Create multiple models and blend them together. Automated tools available for: skin, bone, brain, vessels.

c. Virtual Endoscopy - Provides a simulated 3D endoscopic view of the sinuses to visualize anatomy, pathology and preoperative plans inaccessible with a traditional endoscope.

Combined with Stealth3D™ Software, virtual endoscope allows surgeons to see relative positions of anatomy and pathology from a view similar to their surgical endoscope

d. StealthMerge™ Software - Allows you to combine an exams and view them during the procedures: CT, MR, MR-T1, MR-T2.

e. Annotations - Allows the physician to create a pre-operative path and can be placed at the point of navigation to mark a location. Trail of annotation can also be made following the navigation probe.

f. Customization of software flow specific to each surgeon and procedure

i. Surgeon specific workflows

ii. Instrument preference

iii. CT windowing

iv. Orthogonal view placement

6. Registration Capabilities – Included

a. Touch Registration

b. Trace Registration

c. 3-Point Touch Registration - Allows the user to orient the registration before tracing through the use of 3 system-specified touch points

d. Combination Touch and Trace Registration capability

e. Opional foot pedal

f. Landmarks

g. Registration Accuracy Value

h. Zones of Accuracy

7. Certification / Standards:

a. Must meet FDA regulated standards as a Class II Stereotaxic Instrument;

under FDA Product Code: PGW

b. K162309 Trade/Device Name: Stealthstation S8 System Platforms and StealthStation

Cranial Software

c. Regulation Number: 21 CFR 882.4560

d. Regulation Name: Stereotaxic Instrument

e. Regulatory Class: Class II

f. Product Code: HAW, OLO, PGW

g. Dated: August 16, 2016

h. Received: August 17, 2016