NaviENT

K163439 · Claronav, Inc. · HAW · Sep 1, 2017 · Neurology

Device Facts

• Record ID: K163439
• Device Name: NaviENT
• Applicant: Claronav, Inc.
• Product Code: HAW · Neurology
• Decision Date: Sep 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist). NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.

Device Story

NaviENT is a cart-based, image-guided surgical navigation system for ENT surgeons. It uses pre-acquired patient CT scans to provide real-time visualization of surgical instrument tips relative to patient anatomy. The system comprises a cart, a stereoscopic NIR tracking camera, an IR LED light source, a laptop running NaviENT software, and trackable instruments marked with black-and-white patterns. In the OR, the surgeon performs landmark-based and trace-based registration to align the physical patient with the CT data. During surgery, the system tracks instrument position and superimposes it onto 2D axial, coronal, and sagittal views on the display. This guidance assists surgeons in navigating complex sinus and skull base anatomy, potentially improving surgical precision and safety.

Clinical Evidence

Bench testing only. No clinical data. Performance validated using three human head models in a simulated OR environment. Primary endpoint: 3D positional accuracy, with results showing an average error of less than 2mm. Biocompatibility, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and photobiological safety (IEC 62471) testing were performed and met all acceptance criteria.

Technological Characteristics

Cart-based system with stereoscopic NIR tracking camera and IR LED illumination. Instruments made of medical-grade stainless steel. Connectivity via Thunderbolt port to a laptop. Software runs on Windows 10. Sterilization of reusable components validated to SAL 10^-6 per ISO 17665-1. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993-1.

Indications for Use

Indicated for patients undergoing endoscopic sinus or ENT skull base surgery where stereotactic guidance is appropriate and rigid anatomical structures (e.g., skull) can be referenced to pre-acquired CT images. Procedures include transphenoidal, maxillary antrostomies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomies, intranasal procedures, and tumor resections.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Karl Storz Navigation Panel Unit (NPU) System (K122096)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2017

Claronav Inc. Ahmad Kolahi CEO 1140 Sheppard Avenue West - Unit 10 Toronto, M3K 2A2 CA

Re: K163439

Trade/Device Name: Navient Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: August 2, 2017 Received: August 3, 2017

Dear Ahmad Kolahi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

NaviENT

Indications for Use (Describe)

NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).

NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains a logo with two distinct parts. On the left, there is a circular graphic with alternating black and white quadrants, each containing radiating lines. To the right of the graphic, the text "ClaroNav" is displayed above a black rectangle containing the word "Kolahi" in white font.

# 510(k) SUMMARY

#### SUBMITTER INFORMATION

| Company Name: | ClaroNav Kolahi Inc. |
|-----------------------|-----------------------------------------------------------------------------|
| Company Address: | 1140 Sheppard Avenue West - Unit 10<br>Toronto, Ontario<br>Canada - M3K 2A2 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Ahmad Kolahi, CEO |
| Date Summary Prepare: | August 2nd 2017 |

#### DEVICE IDENTIFICATION

| Trade/Proprietary Name: | NaviENT |
|------------------------------|---------------------------------------------------------|
| Classification: | II |
| Generic Device Name: | Surgical Navigation System |
| Product Code: | PGW |
| Classification Names: | Stereotaxic Instrument |
| Classification Regulation #: | 21 CFR 882.4560 |
| Classification Panel: | ENT |
| Predicate Device: | Karl Storz Navigation Panel Unit (NPU) System (K122096) |

#### DEVICE DESCRIPTION

NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.

Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.

NaviENT consists of four main components:

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Image /page/4/Picture/0 description: The image contains the logo for ClaroNav Kolahi. On the left side of the logo is a black and white circular design. To the right of the design is the text "ClaroNav" in black, and below that is the text "Kolahi" in white on a black background.

- 1. NaviENT Cart: Its main purpose is to hold the laptop computer and the tracking camera. The cart is light weight and the arm height can be adjusted. This allows the user to easily position the system in the operating room.
- 2. Tracking System: It contains a stereoscopic camera and an IR LED light source, both operating in the near infrared (NIR) light spectrum. The tacking system identifies and pin-points checkered marker patterns affixed on the NaviENT instruments.
- 3. Laptop Computer: The NaviENT software runs on a 15.4" Apple Mac Book Pro laptop. Windows 10 operating system is installed on the laptop. The tracking camera's live video stream is received by the laptop via a thunderbolt port and is processed by the NaviENT application.
- 4. NaviENT Instruments: The instruments are marked with Black & White patterns which make them trackable by the NaviENT Tracking system. It includes 950-NE-PT Patient Tracker, 950-NE-RP Registration Pointer, 950-NE-FS Frontal Seeker, 950-NE-MS Maxillary Seeker, 950-NE-BP Bayonet Probe, 950-NE-TC Tip Calibrator and 950-NE-UT Universal Tag.

#### NaviENT Clinical Workflow:

NaviENT Software workflow provides step by step instructions on how to set up and use the system in the Operating room. The software has been pre-installed on the NaviENT laptop. The shortcut for the NaviENT application is placed on the desktop. When started it opens the data browser window, allowing the user to load, import and delete patient image data. Once data is loaded, NaviENT operation proceeds sequentially through 5 stages as follows:

- 1. Verify: This stage displays the 3D data as well as 2D axial, coronal and sagittal reformatted slice views and allows the user to rotate, zoom and explore the data.
- 2. Mark Landmarks: This stage walks the user through selecting a few anatomical landmarks on the 3D scan. The names of each landmark and an illustration of its approximate locations are displayed for convenience.
- 3. Set Up: This stage provides step by step instructions to place the patient tracker and position the tracking device. The live video stream displayed on the side panel makes it very intuitive to position the camera.
- 4. Registration: NaviENT uses landmark based registration followed by trace based registration. This stage provides step by step instructions to perform registration process.
- 5. Navigation: Presents real-time location of the instrument tip super imposed on the 2D images of sagittal, axial and coronal views of the patient scan.

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Image /page/5/Picture/0 description: The image contains the logos for ClaroNav and Kolahi. The ClaroNav logo is on the top line, and the Kolahi logo is on the second line. Below the logos, the text "INDICATIONS FOR USE" is written.

NaviENT has the following Indications for Use:

NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).

NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.

#### SUBSTANTIAL EQUIVALENCE

NaviENT shares technological, performance and clinical features and has an identical intended use as the Karl Storz Navigation Panel Unit (NPU) System:

| Predicate<br>Company | Predicate<br>Trade Name | 510(k) # | Predicate Intended Use |
|----------------------|--------------------------------------------------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Karl Storz | Karl Storz<br>Navigation<br>Panel Unit<br>(NPU) System | K122096 | The Navigation Panel Unit System (NPU) is an<br>intraoperative image guided localization system that<br>links a freehand probe tracked by a passive marker<br>sensor system to a virtual computer image space on a<br>patient's preoperative diagnostic image data set. The<br>system is intended to be used as a positioning aid for<br>navigation in ENT surgery, including but not limited to<br>endoscopic surgery. The NPU is indicated for any<br>medical condition in which the use of stereotactic<br>surgery may be appropriate and where a reference to<br>a rigid anatomical structure can be identified relative<br>to the radiological imaging-based model of the<br>anatomy. Surgery procedures include but are not<br>limited to the following: transphenoidal procedures,<br>maxillary antrostomnies, ethmoidectomies,<br>sphenoidectomies, sphenoid explorations, turbinate<br>resections, frontal sinusotomnies, intranasal<br>procedures, intranasal tumor resections, otologic<br>surgery, and ENT skull base surgery. |

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Image /page/6/Picture/0 description: The image contains a logo with a black and white design. On the left side, there is a circular pattern with alternating black and white sections and radiating lines. To the right of the pattern, the text "ClaroNav" is displayed in a bold, sans-serif font above a black rectangle. Within the black rectangle, the word "Kolahi" is written in a similar bold, sans-serif font.

# Comparison of Technological Characteristics

NaviENT shares many clinical, technological and performance characteristics with a predicate device, the Karl Storz Navigation Panel Unit (NPU) System. These characteristics are outlined in the following table:

| Feature/<br>Characteristic | Karl Storz NPU (predicate) | NaviENT | Rationale for any<br>differences |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class/Product<br>Code/Classification<br>Name | Class II/ HAW/ 882.4560 (<br>Stereotaxic Instrument) | Class II/ PGW/ 882.4560 (<br>Stereotaxic Instrument) | Same |
| Indications for Use | The Navigation Panel Unit System<br>(NPU) is an intraoperative image<br>guided localization system that links<br>a freehand probe tracked by a<br>passive marker sensor system to a<br>virtual computer image space on a<br>patient's preoperative diagnostic<br>image data set. The system is<br>intended to be used as a positioning<br>aid for navigation in ENT surgery,<br>including but not limited to<br>endoscopic surgery. The NPU is<br>indicated for any medical condition<br>in which the use of stereotactic<br>surgery may be appropriate and<br>where a reference to a rigid<br>anatomical structure can be<br>identified relative to the<br>radiological imaging-based model of<br>the anatomy. Surgery procedures<br>include but are not limited to the<br>following: transphenoidal<br>procedures, maxillary<br>antrostomnies, ethmoidectomies,<br>sphenoidectomies, sphenoid<br>explorations, turbinate resections,<br>frontal sinusotomnies, intranasal<br>procedures, intranasal tumor<br>resections, otologic surgery, and<br>ENT skull base surgery. | NaviENT is a computerized<br>surgical navigation system<br>intended to guide sinus and<br>trans-nasal skull base endoscopic<br>surgery by dynamically<br>presenting the location of the tip<br>of a surgical instrument mapped<br>to a corresponding location in a<br>pre-acquired CT scan of the<br>patient's head. The device is<br>intended for use by a qualified<br>ENT surgeon (otolaryngologist).<br>NaviENT is indicated for any<br>medical condition in which the<br>use of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the skull, can<br>be identified relative to images of<br>the anatomy. Surgery<br>procedures include but are not<br>limited to the following:<br>transphenoidal procedures,<br>maxillary antrostomnies,<br>ethmoidectomies,<br>sphenoidectomies, sphenoid<br>explorations, turbinate<br>resections, frontal<br>sinusotomnies, intranasal<br>procedures, intranasal tumor<br>resections, and ENT related skull<br>base surgery. | Same indications,<br>phrased differently. |
| Feature/<br>Characteristic | Karl Storz NPU (predicate) | NaviENT | Rationale for any<br>differences |
| Main functions | Locating anatomical locations inside<br>patient. | Locating anatomical locations<br>inside patient | Same. |
| Use Environment | Operating Room | Operating Room | Same. |
| Target Population | Patients who has to go under<br>endoscopic sinus surgery or ENT<br>skull base surgery. | Patients who has to go under<br>endoscopic sinus surgery or ENT<br>skull base surgery. | Same. |
| Users | ENT Surgeons(Otolaryngologist) | ENT Surgeons(Otolaryngologist) | Same. |
| Technological<br>Characteristics | | | |
| Input imaging modality | CT and MRI | CT | Navient supports a<br>subset of the predicate's<br>inputs, therefore any<br>input suitable for<br>NaviENT is suitable for<br>the predicate device as<br>well. |
| Dynamic object pose<br>measurement<br>technology | Stereoscopic Optical Tracking<br>system | Stereoscopic Optical Tracking<br>system | Same. |
| Illumination of<br>tracking targets | Infra-red light | Infra-red light | Same. |
| Patient to CT image<br>registration | Landmark based registration<br>followed by surface matching | Landmark based registration<br>followed by surface matching | Same. |
| Standard Navigation<br>Instruments | 1. Patient Tracker<br>2. Navigation Probe<br>3. Frontal Sinus Probe<br>4. DrillCut-X Shaver<br>Handpiece<br>5. Microscope Probe<br>6. Optical Instrument<br>Tracker | 1. Patient Tracker<br>2. Bayonet pointer<br>3. Frontal Ostium Seeker<br>4. Universal Tag<br>5. Registration Pointer<br>6. Maxillary Ostium<br>Seeker<br>7. Calibrator | Similar.<br><br>NaviENT provides extra<br>instruments of<br>Registration Pointer,<br>Maxillary Ostium Seeker<br>and Calibrator. This is<br>intended to improve<br>usability.<br><br>NaviENT does not require<br>the use of a Microscope<br>Probe and Optical<br>Instrument Tracker. |
| Mount for camera and<br>display | Both Camera and display mounted<br>on the cart | Both camera and the display<br>mounted on the cart. | Similar.<br><br>NaviENT cart has foldable<br>arm where as NPU cart is<br>pull up/down bar. |
| Instruments Tip<br>Calibration | By touching Patient Tracker | By touching Calibrator<br>instrument. | Similar.<br><br>NaviENT has provided a<br>designated instrument to<br>calibrate instrument tips<br>where as NPU is using<br>patient tracker. |
| Presentation of<br>navigation guidance | 3D graphics presentation of<br>instrument position, angle relative<br>to patient image. | 3D graphics presentation of<br>instrument position, angle<br>relative to patient image. | Same. |
| Software Equivalence | | | |
| Clinical Software<br>Features | DICOM image visualization in 3D<br>and 2D views (axial, coronal,<br>sagittal), Patient to image<br>registration features | DICOM image visualization in 3D<br>and 2D views (axial, coronal,<br>sagittal), Patient to image<br>registration features | Similar. Minor<br>differences, mainly in<br>user interface to the<br>same underlying<br>functions. |
| Performance<br>Characteristics | | | |
| System Accuracy | N/A | Average Error less than 2.0 | Similar. A direct<br>published accuracy data<br>for the predicate is not<br>available however the<br>predicate to NPU system<br>(i.e. k964229) claims<br>accuracy of 2.56mm. |
| Materials<br>Equivalence | | | |
| Patient Mucosal<br>membrane contacting<br>parts | Navigation Probe<br>Frontal Sinus Probe | Bayonet pointer<br>Frontal Ostium Seeker<br>Maxillary Ostium Seeker | Similar.<br>NPU Navigation probe is<br>equivalent to NaviENT<br>Bayonet probe.<br>NaviENT provides both<br>Frontal and Maxillary<br>Ostium seekers. This<br>improves usability. |
| Patient contacting<br>Instruments Material | Medical grade Stainless Steel | Medical grade Stainless Steel | Same. |

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Image /page/7/Picture/0 description: The image contains the logo for ClaroNav Kolahi. On the left side of the logo is a black and white circular design with lines radiating from the center. To the right of the design, the word "ClaroNav" is written in black, and below that, the word "Kolahi" is written in white on a black background.

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Image /page/8/Picture/0 description: The image contains the logo for ClaroNav Kolahi. The logo is split into two sections, with the left side containing a black and white circular design with radiating lines. The right side of the logo contains the text "ClaroNav" in white above a black rectangle with the text "Kolahi" in white.

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Image /page/9/Picture/0 description: The image contains a logo with a geometric design on the left and text on the right. The geometric design features a circle divided into quadrants with alternating black and white sections, surrounded by radiating lines. To the right of the design, the text "ClaroNav" is displayed above a black rectangle containing the word "Kolahi" in white. The text is in a sans-serif font and appears to be the name of a company or product.

# Determination of Substantial Equivalence

NaviENT is identical to the predicate device in indications for use, intended target populations, the target users, the principles of operation and the indications for use.

NaviENT has very similar technological characteristics to the predicate device. The supported Tracking device, image modality, registration techniques and software are very similar. Minor technological differences between NaviENT and predicate device include:

- . Markers: Both NaviENT and the predicate device are using Optical Tracking system with very similar principle of operation. The only minor difference is that, NPU is using spherical shape marker where as NaviENT is using multi-facet flat markers. This difference does not impact the safety and effectiveness of either device in performing its intended use.
- Instruments: NaviENT provides dedicated instruments to perform the Registration process, while the predicate device uses its Navigation Probe to perform registration process as well. NaviENT provides a dedicated instrument to perform Calibration process, while the predicate device uses its Patient Tracker not only to track the patient but also to perform the Calibration process. NaviENT also provides additional dedicated instrument of Maxillary Ostium Seeker, while the predicate does not provide such an instrument. The dedicated instruments improves the usability. NaviENT does not provide Microscope Probe and Optical Instrument Tracker.

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Image /page/10/Picture/0 description: The image contains a logo with two distinct parts. On the left, there is a circular graphic with alternating black and white sections, resembling a stylized target or compass. To the right of the graphic, the text "ClaroNav" is displayed above the word "Kolahi", with the latter set against a solid black background.

- While the predicate device permits using MRI data and NaviENT does not, equivalence is maintained for all cases where CT data input is used.
The above design differences relate solely to the usability aspects of the devices, not to the core functions they perform, which are substantially identical. These differences do not impact the safety and effectiveness of either device in performing its intended use.

In conclusion, the systems are substantially equivalent.

# COMPLIANCE…