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 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:

NaviENT Cart
Tracking System
Laptop Computer
NaviENT Instruments

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NaviENT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
System Accuracy: The text states, “All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those specified by the FDA cleared predicate devices.” For the predicate device (NPU system, K964229), the text mentions a claimed accuracy of 2.56mm.	The NaviENT system demonstrates performance in 3D positional accuracy with average error of less than 2mm. This performance was determined using 3 different human head models in an OR simulated environment with all of the typical navigation instruments.
Software Validation: Software requirements met and performs as intended.	Successful testing verifying the software requirements are met and software performs as intended.
Cleaning and Sterilization: Components can withstand recommended cleaning, disinfection, and sterilization processes, achieving a Sterility Assurance Level (SAL) of 10^-6.	Re-usable NaviENT components were tested and validated that they can withstand the recommended cleaning, disinfection, and sterilization processes, achieving an SAL of 10^-6. Sterilization validation was conducted according to ISO 17665-1:2006.
Bench Testing: All planned performance tests meet their acceptance criteria.	All planned performance tests were executed as planned, and all of them succeeded in meeting their acceptance criteria.
Electrical and EMC Testing: Adherence to IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2007 (electromagnetic compatibility), and IEC 62471:2006 (photobiological safety of lights).	The NaviENT system was tested for electrical safety and essential performance according to the requirements IEC 60601-1:2005. It passed all relevant requirements of IEC 60601-1-2:2007 and IEC 62471:2006.
Biocompatibility Testing: Patient-contacting components are biocompatible.	The patient-contacting NaviENT components were tested according to the requirements of ISO 10993-1 and were deemed to be biocompatible.
Human Factors: Demonstrate substantial equivalence with regards to differences in system user interface and use scenarios from the predicate.	Human factors report and validation testing provided sufficient data to support their conclusion of substantial equivalence with regards to differences in system user interface and use scenarios from the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: For accuracy testing, 3 different human head models were used.
Data Provenance: The testing was conducted in an OR simulated environment. The country of origin of the data is not explicitly stated, but the submission is from ClaroNav Inc. in Toronto, Canada. Given the context of a 510(k) submission, this would be considered a prospective performance study designed for regulatory approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not explicitly provided in the document. The accuracy testing was done using "human head models," which typically implies a phantom-based or simulated setup for objective measurement rather than expert-derived ground truth on clinical data.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the document. For benchtop accuracy testing using physical models, an adjudication method like 2+1 or 3+1 by human experts is typically not necessary. The ground truth would be based on precise physical measurements of the models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study is not mentioned in the document. The study described is a device performance and accuracy study, not one designed to evaluate the clinical effectiveness of human readers using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The study described is a standalone performance study of the NaviENT system's accuracy and various other aspects (software, sterility, electrical safety, biocompatibility, human factors). It evaluates the device's inherent performance characteristics rather than how it performs with a human in a clinical setting. The device itself is described as a "computerized surgical navigation system," implying an algorithmic core.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the accuracy testing, the ground truth was established by physical measurements on human head models within an OR simulated environment. This is a form of engineered or phantom-based ground truth, where the true positions are precisely known or measurable. For other tests (sterilization, biocompatibility, electrical safety), the ground truth is against established ISO and IEC standards and their specific test methodologies.

8. The Sample Size for the Training Set:

This information is not provided in the document. The document describes a medical device with an image guidance component, but it does not detail any machine learning or AI models that would require a separate "training set" in the conventional sense. The "NaviENT software" processes data, but it's not indicated as a learning-based system with a distinct training phase in this submission.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned (see point 8), this information is not applicable/provided.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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 10Toronto, OntarioCanada - M3K 2A2
Company Phone:	(647) 951-1525
Company Fax:	(647) 951-1524
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.

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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. Registration: NaviENT uses landmark based registration followed by trace based registration. This stage provides step by step instructions to perform registration process.
1. 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:

SUBSTANTIAL EQUIVALENCE

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

PredicateCompany	PredicateTrade Name	510(k) #	Predicate Intended Use
Karl Storz	Karl StorzNavigationPanel Unit(NPU) System	K122096	The Navigation Panel Unit System (NPU) is anintraoperative image guided localization system thatlinks a freehand probe tracked by a passive markersensor system to a virtual computer image space on apatient's preoperative diagnostic image data set. Thesystem is intended to be used as a positioning aid fornavigation in ENT surgery, including but not limited toendoscopic surgery. The NPU is indicated for anymedical condition in which the use of stereotacticsurgery may be appropriate and where a reference toa rigid anatomical structure can be identified relativeto the radiological imaging-based model of theanatomy. Surgery procedures include but are notlimited to the following: transphenoidal procedures,maxillary antrostomnies, ethmoidectomies,sphenoidectomies, sphenoid explorations, turbinateresections, frontal sinusotomnies, intranasalprocedures, intranasal tumor resections, otologicsurgery, 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/Characteristic	Karl Storz NPU (predicate)	NaviENT	Rationale for anydifferences
Class/ProductCode/ClassificationName	Class II/ HAW/ 882.4560 (Stereotaxic Instrument)	Class II/ PGW/ 882.4560 (Stereotaxic Instrument)	Same
Indications for Use	The Navigation Panel Unit System(NPU) is an intraoperative imageguided localization system that linksa freehand probe tracked by apassive marker sensor system to avirtual computer image space on apatient's preoperative diagnosticimage data set. The system isintended to be used as a positioningaid for navigation in ENT surgery,including but not limited toendoscopic surgery. The NPU isindicated for any medical conditionin which the use of stereotacticsurgery may be appropriate andwhere a reference to a rigidanatomical structure can beidentified relative to theradiological imaging-based model ofthe anatomy. Surgery proceduresinclude but are not limited to thefollowing: transphenoidalprocedures, maxillaryantrostomnies, ethmoidectomies,sphenoidectomies, sphenoidexplorations, turbinate resections,frontal sinusotomnies, intranasalprocedures, intranasal tumorresections, otologic surgery, andENT skull base surgery.	NaviENT is a computerizedsurgical navigation systemintended to guide sinus andtrans-nasal skull base endoscopicsurgery by dynamicallypresenting the location of the tipof a surgical instrument mappedto a corresponding location in apre-acquired CT scan of thepatient's head. The device isintended for use by a qualifiedENT surgeon (otolaryngologist).NaviENT is indicated for anymedical condition in which theuse of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the skull, canbe identified relative to images ofthe anatomy. Surgeryprocedures include but are notlimited to the following:transphenoidal procedures,maxillary antrostomnies,ethmoidectomies,sphenoidectomies, sphenoidexplorations, turbinateresections, frontalsinusotomnies, intranasalprocedures, intranasal tumorresections, and ENT related skullbase surgery.	Same indications,phrased differently.
Feature/Characteristic	Karl Storz NPU (predicate)	NaviENT	Rationale for anydifferences
Main functions	Locating anatomical locations insidepatient.	Locating anatomical locationsinside patient	Same.
Use Environment	Operating Room	Operating Room	Same.
Target Population	Patients who has to go underendoscopic sinus surgery or ENTskull base surgery.	Patients who has to go underendoscopic sinus surgery or ENTskull base surgery.	Same.
Users	ENT Surgeons(Otolaryngologist)	ENT Surgeons(Otolaryngologist)	Same.
TechnologicalCharacteristics
Input imaging modality	CT and MRI	CT	Navient supports asubset of the predicate'sinputs, therefore anyinput suitable forNaviENT is suitable forthe predicate device aswell.
Dynamic object posemeasurementtechnology	Stereoscopic Optical Trackingsystem	Stereoscopic Optical Trackingsystem	Same.
Illumination oftracking targets	Infra-red light	Infra-red light	Same.
Patient to CT imageregistration	Landmark based registrationfollowed by surface matching	Landmark based registrationfollowed by surface matching	Same.
Standard NavigationInstruments	1. Patient Tracker2. Navigation Probe3. Frontal Sinus Probe4. DrillCut-X ShaverHandpiece5. Microscope Probe6. Optical InstrumentTracker	1. Patient Tracker2. Bayonet pointer3. Frontal Ostium Seeker4. Universal Tag5. Registration Pointer6. Maxillary OstiumSeeker7. Calibrator	Similar.NaviENT provides extrainstruments ofRegistration Pointer,Maxillary Ostium Seekerand Calibrator. This isintended to improveusability.NaviENT does not requirethe use of a MicroscopeProbe and OpticalInstrument Tracker.
Mount for camera anddisplay	Both Camera and display mountedon the cart	Both camera and the displaymounted on the cart.	Similar.NaviENT cart has foldablearm where as NPU cart ispull up/down bar.
Instruments TipCalibration	By touching Patient Tracker	By touching Calibratorinstrument.	Similar.NaviENT has provided adesignated instrument tocalibrate instrument tipswhere as NPU is usingpatient tracker.
Presentation ofnavigation guidance	3D graphics presentation ofinstrument position, angle relativeto patient image.	3D graphics presentation ofinstrument position, anglerelative to patient image.	Same.
Software Equivalence
Clinical SoftwareFeatures	DICOM image visualization in 3Dand 2D views (axial, coronal,sagittal), Patient to imageregistration features	DICOM image visualization in 3Dand 2D views (axial, coronal,sagittal), Patient to imageregistration features	Similar. Minordifferences, mainly inuser interface to thesame underlyingfunctions.
PerformanceCharacteristics
System Accuracy	N/A	Average Error less than 2.0	Similar. A directpublished accuracy datafor the predicate is notavailable however thepredicate to NPU system(i.e. K964229) claimsaccuracy of 2.56mm.
MaterialsEquivalence
Patient Mucosalmembrane contactingparts	Navigation ProbeFrontal Sinus Probe	Bayonet pointerFrontal Ostium SeekerMaxillary Ostium Seeker	Similar.NPU Navigation probe isequivalent to NaviENTBayonet probe.NaviENT provides bothFrontal and MaxillaryOstium seekers. Thisimproves usability.
Patient contactingInstruments 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.

. 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 TO STANDARDS AND REGULATIONS

The following FDA approved standards are met by the Navident system as demonstrated through performance testing:

ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices

AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.

ISO 15223-1 Second Edition 2012-07-01, medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements.

AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical Devices - part 1: evaluation and testing within a risk management process.

AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod)

AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3)

IEC 62471 First edition 2006-07, photobiological safety of lamps and lamp systems. (Radiology)

SUMMARY OF PERFORMANCE TESTING

Safety and performance testing of the NaviENT system was conducted in accordance with all above referenced standards and regulations. All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those specified by the FDA cleared predicate devices.

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Image /page/11/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, and radiating lines extending from the center. To the right of the design, the text "ClaroNav" is displayed above the text "Kolahi", with the latter set against a black background.

The following safety and performance testing was conducted:

1. Software Validation: Successful testing verifying the software requirements are met and software performs as intended.
1. Cleaning and Sterilization: A representative sample of the re-usable NaviENT components were tested to validate that the components can withstand the recommended cleaning, disinfection and sterilization processes and that a sterility assurance level (SAL) of 10-6 can be achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the re-usable NaviENT components can be sterilized to reach an SAL of 10-6.
1. Bench Testing: All planned performance tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. Accuracy testing was conducted to ensure that the NaviENT system met the prescribed requirement for accuracy. The NaviENT system demonstrates performance in 3D positional accuracy with average error of less than 2mm. this performance was determined using 3 different human head models in an OR simulated environment with all of the typical navigation instruments.
1. Electrical and EMC Testing: The NaviENT system was tested for electrical safety and essential performance according to the requirements IEC 60601-1:2005 In addition, NaviENT passed all the relevant requirements of the IEC 60601-1-2:2007 and IEC 62471:2006 standards demonstrating that the device meets the applicable electromagnetic compatibility requirements as well as and that the lights used in the NaviENT system are safe to be used as intended.
1. Biocompatibility Testing: The patient contacting NaviENT components were tested according to the requirements of ISO 10993-1 and were deemed to be biocompatible.
1. Human Factors: NaviENT human factors report and validation testing provided sufficient data to support their conclusion of substantial equivalence with regards to differences in system user interface and use scenarios from the predicate.

CONCLUSION

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. The only differences relate to minor differences in the markers used by the tracking devices; the instruments provided and the type of image data input. These differences do not impact the safety and effectiveness of either device in performing its intended use.

In conclusion, NaviENT and its identified predicate systems are substantially equivalent.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).

Eric A. Mann -S

Indications for Use

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510(k) SUMMARY

SUBMITTER INFORMATION

DEVICE IDENTIFICATION

DEVICE DESCRIPTION

NaviENT Clinical Workflow:

SUBSTANTIAL EQUIVALENCE

Comparison of Technological Characteristics

Determination of Substantial Equivalence

COMPLIANCE TO STANDARDS AND REGULATIONS

SUMMARY OF PERFORMANCE TESTING

CONCLUSION

§ 882.4560 Stereotaxic instrument.

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