Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures. The Navient system 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 a CT, MR-based anatomy model.

Indications:

Example procedures include but are not limited to:

ENT Procedures:

Transsphenoidal procedures
Maxillary antrostomies
Ethmoidectomies
sphenoidotomies
Sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures
Intranasal tumor resections
All ENT related skull base surgery

Device Description

Navient is an image guided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via optical tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory set.

Navient's guidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Navient Image Guided Navigation System (ENT) do not contain information about the study design or acceptance criteria for AI/algorithm-based performance evaluations. Instead, the document focuses on the system's accuracy, software validation, electrical safety, biocompatibility, and reprocessing validation, all typical for traditional medical devices rather than AI/ML-powered ones.

The document states: "Full system accuracy bench testing: Navient has been validated to the positional accuracy of ≤ 2.0 mm (mean=1.52 mm, STD=0.93 mm, 99% confidence interval of 3.68 mm), with the angular error of ≤ 2.0 deg (mean=1.13 deg, STD=0.43 deg, 99% confidence interval of 2.13 deg). This performance was determined using representative phantoms with system components that are deemed the worst-case in the Navient clinical applications."

This validation refers to the physical navigation system's accuracy in positioning, not the performance of an AI algorithm in tasks like image interpretation or diagnosis. Therefore, I cannot generate the requested table and study details related to AI acceptance criteria and performance based on the specific content provided in this 510(k) document.

The "Navient navigation software" mentioned is described as having a workflow for loading images, planning, setting up, registration, and navigation. This suggests a traditional software interface for guiding the user, rather than an AI/ML algorithm performing diagnostic or predictive functions that would require a ground truth, expert consensus, or MRMC studies.

If we were to hypothetically extract the closest equivalent to "acceptance criteria" for this device, it would be its spatial accuracy, which is a key performance metric for image-guided navigation systems.

Here's a hypothetical structure based on the provided spatial accuracy data, while acknowledging it's not AI-specific:

Hypothetical Acceptance Criteria and System Performance (based on provided spatial accuracy)

Recognizing that the provided document details a traditional image-guided navigation system and not an AI-powered diagnostic/interpretive device, the "acceptance criteria" presented here refer to the system's demonstrated physical accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Positional Accuracy	≤ 2.0 mm	Mean = 1.52 mm
		STD = 0.93 mm
		99% CI = 3.68 mm
Angular Error	≤ 2.0 deg	Mean = 1.13 deg
		STD = 0.43 deg
		99% CI = 2.13 deg

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated as a "test set" in the context of an AI model. The performance data is derived from "Full system accuracy bench testing" using "representative phantoms." The number of measurements or phantom tests isn't specified.
Data provenance: Not directly applicable as it's a bench test on phantoms, not clinical patient data. The testing was conducted internally by ClaroNav.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for positional and angular accuracy in bench testing is defined by precision measurement equipment and physical phantoms, not human experts.

4. Adjudication method for the test set:

Not applicable. Bench testing does not involve human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study (MRMC) is typically performed for AI devices that aid human interpretation (e.g., radiologists reading images with AI assistance). The Navient system is a guidance system, not an interpretive AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The "Full system accuracy bench testing" represents the standalone performance of the navigation system's hardware and software integration in terms of its ability to track instruments accurately relative to images. It's not an AI algorithm performing a task without human input in the sense of a diagnostic or predictive AI.

7. The type of ground truth used:

The ground truth for the positional and angular accuracy was established through precise measurements on representative phantoms using calibrated equipment, which is standard for validating the accuracy of surgical navigation systems.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that undergoes a training phase on a dataset of examples. Its software processes sensor data and medical images according to deterministic algorithms.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set in the context of AI/ML for this device's reported validation.

Summary

FDA 510(k) Clearance Letter - Navient Image Guided Navigation System (ENT)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 20, 2025

ClaroNav
Karen Wu
Director of Regulatory Affairs
1140 Sheppard Avenue West Unit 10
Toronto, ON M3K2A2
Canada

Re: K243053
Trade/Device Name: Navient Image Guided Navigation System (ENT)
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: PGW
Dated: May 22, 2025
Received: May 22, 2025

Dear Karen Wu:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K243053 - Karen Wu
Page 2

June 20, 2025

ClaroNav
Karen Wu
Director of Regulatory Affairs
1140 Sheppard Avenue West Unit 10
Toronto, ON M3K2A2
Canada

Dear Karen Wu:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Page 3

K243053 - Karen Wu
Page 3

Sincerely,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K243053

Device Name: Navient Image Guided Navigation System (ENT)

Indications for Use (Describe)

Navient Image Guided Navigation System (ENT):

Indications:

Example procedures include but are not limited to:

ENT Procedures:

Transsphenoidal procedures
Maxillary antrostomies
Ethmoidectomies
sphenoidotomies
Sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures
Intranasal tumor resections
All ENT related skull base surgery

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

Page 5

510(K) SUMMARY

ClaroNav
Navient
510(K) SUMMARY K243053
Page 1 of 12

510(K) SUMMARY

NAVIENT IMAGE GUIDED NAVIGATION SYSTEM (ENT)

Sponsor: ClaroNav
1140 Sheppard Avenue West, Unit 10
Toronto, Ontario, M3K 2A2
Canada

Contact Person: Karen Wu
Director of Regulatory Affairs
Phone: +1 647 552 1489
e-mail: ra@claronav.com

Date Prepared: June 20, 2025

Device Proprietary Name: Navient Image Guided Navigation System (ENT)

Common Name: Navient

Product Code: PGW

Class: Class II

Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic instrument

Classification Panel: Ear Nose & Throat

Predicate Devices
Primary predicate:
NaviENT System (K163439)

Indications for Use

Page 6

ClaroNav
Navient
510(K) SUMMARY K243053
Page 2 of 12

Indications:

Example procedures include but are not limited to:

ENT Procedures:

Transsphenoidal procedures
Maxillary antrostomies
Ethmoidectomies
sphenoidotomies
Sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures
Intranasal tumor resections
All ENT related skull base surgery

Technological Characteristics

Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.

o ENT Accessory Kit (955-NE-ACCK)*

*a second set of the ENT Accessory Kit, called Set B, is included in the Navient system. Set B allows use of navigation on back-to-back OR cases without having to wait for sterilization of the main set. Set B part numbers are similar to the main set, except it is affixed with "-B". It is also marked with a different serial number.

Page 7

ClaroNav
Navient
510(K) SUMMARY K243053
Page 3 of 12

Indications:

Example procedures include but are not limited to:

ENT Procedures:

Transsphenoidal procedures
Maxillary antrostomies
Ethmoidectomies
sphenoidotomies
Sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures
Intranasal tumor resections
All ENT related skull base surgery

Technological Characteristics

o ENT Accessory Kit (955-NE-ACCK)*

Page 8

ClaroNav
Navient
510(K) SUMMARY K243053
Page 4 of 12

Navient Software Workflow:

Navient software operation proceeds sequentially through 5 stages:

Images: Load the CT or MR images, review and explore images and perform image fusion.
Planning: The planning stage
Set Up: attach the Patient reference, adjust the tracking system position and verify the instruments' tip calibration accuracy.
Registration: Using Registrator, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.
Navigation: Navigate the position of the tip of various instruments in the image volume.

Performance Data

Navient's performance testing included:

Reprocessing validation:
Reprocessing instructions are available in the user manual. Navient instrument (worst case) was validated for manual and automated cleaning in accordance with AAMI TIR 30: 2011(R) 2016, and steam sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013 for (SAL) of ≤10⁻⁶.
Biocompatibility Testing:
Patient contacting instrument (worst case) was validation for biocompatibility based on the identified endpoints for product with limited (less than 24 hours) breached or compromised surface contact: cytotoxicity, sensitization, irritation, material mediated pyrogenicity, and acute systemic toxicity. Results indicate the body-contacting Navient instruments do not introduce any toxic or biologically harmful reactions and are therefore safe to be used for body-contacting applications when used as intended.
Software:
In accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions (June 14, 2023), the documentation level selected for the submission was Enhanced Documentation.
Electrical Safety and Electromagnetic Compatibility (EMC):
Comprehensive performance testing has been conducted on the Navient device in accordance with IEC 60601- 1 and IEC 60601-1-2.
Full system accuracy bench testing:

Navient has been validated to the positional accuracy of ≤ 2.0 mm (mean=1.52 mm, STD=0.93 mm, 99% confidence interval of 3.68 mm), with the angular error of ≤ 2.0 deg (mean=1.13 deg, STD=0.43 deg, 99% confidence interval of 2.13 deg). This performance was determined using representative phantoms with system components that are deemed the worst-case in the Navient clinical applications.

Human factors/usability:
Usability/human factor evaluation was performed in accordance with IEC 62366-1:2015+AMD1:2020.

Substantial Equivalence:

The subject Navient system (Model 955-NC-NC) is substantially equivalent to the predicate device NaviENT system, model 955-NE-NE, which is the previous generation of the subject device. The predicate was previously cleared under K163439.

Both subject and predicate devices are essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory set. Both are intended for ENT applications/procedures. A comparison of subject Navient system and the predicate NaviENT system is presented in Table 1 below:

Page 9

ClaroNav
Navient
510(K) SUMMARY K243053
Page 5 of 12

Table 1. Comparison of Indications for use and Technological Characteristics

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
Class/Product Code/Classification Name	Regulation Number: 21 CFR 882.4560Regulation Name: Stereotaxic InstrumentRegulatory Class: Class II	K163439Regulation Number: 21 CFR 882.4560Regulation Name: Stereotaxic InstrumentRegulatory Class: Class II	Identical classification and applicable regulation number.
Intended Use	Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures.	Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures.	Identical. The subject Navient system and the predicate NaviENT system are intended to be used clinically as surgical navigation systems.
Indications for Use	The Navient system 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 a CT, MR based model of the anatomy.	The Navient system 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 a CT, MR based model of the anatomy.	Identical. The subject Navient system and the predicate NaviENT system have the same indications for use.

Page 10

ClaroNav
Navient
510(K) SUMMARY K243053
Page 6 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
	Example procedures include but are not limited to:• Transsphenoidal procedures• Maxillary antrostomies• Ethmoidectomies• Sphenoidotomies• Sphenoid explorations• Turbinate resections• Frontal sinusotomies• Intranasal procedures• Intranasal tumor resections• All ENT related skull base surgery	Example procedures include but are not limited to:• Transphenoidal procedures• Maxillary antrostomnies• Ethmoidectomies• Sphenoidectomies• Sphenoid explorations• Turbinate resections• Frontal sinusotomnies• Intranasal procedures• Intranasal tumor resections• All ENT related skull base surgery
Use Environment	Surgical setting	Surgical setting	Identical
Target Population	Patients for whom stereotactic image-guided surgery (ENT) is appropriate	Patients for whom stereotactic image-guided surgery (ENT) is appropriate	Identical
Users	Medical practitioners (ENT Surgeons, i.e. Otolaryngologist)	Medical practitioners (ENT Surgeons, i.e. Otolaryngologist)	Identical
Operating Principles	Surgical navigation system with optical tracking technology	Surgical navigation system with optical tracking technology	Identical
Input imaging modality	CT and MR	CT and MR	Identical
Dynamic object pose	Stereoscopic Optical Tracking	Stereoscopic Optical Tracking	Identical

Page 11

ClaroNav
Navient
510(K) SUMMARY K243053
Page 7 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
measurement technology	system	system
Localization Technology/Illumination of tracking targets	Optical	Optical	Identical
Scanner Interface Technology (to imaging devices)	Network ConnectivityCD, DVD, USBDICOM	Network ConnectivityCD, DVD, USBDICOM	Identical
General Device Components	Require a platform/cart, software, surgical and reference instruments	Require a platform/cart, software, surgical and reference instruments	In general, both subject Navient system and predicate NaviENT system require a platform/cart, software, surgical and reference instruments.
Platform/Cart	Platform/cart:- Computer unit (All-in-one PC [AIO])- Navient Camera for optical tracking- Cart: o Lightweight 30kg o 40 (W) x 50 (D) x 135 (H) cm (when	Platform/cart:- Computer unit (MacBook Laptop)- Navient Camera for optical tracking- Cart with laptop stand: o Lightweight 26kg o 40 (W) x 45 (D) x 100 (H) cm (when	Platform/cart:- Computer: o Subject system utilizes an All-in-one PC (AIO) with touch screen monitor o Predicate system utilizes a MacBook Laptop- Camera: Navient camera is identical for the subject and predicate systems.

Page 12

ClaroNav
Navient
510(K) SUMMARY K243053
Page 8 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
	extended: 190 (H) cm)o Omni directional front wheels	extended: 160 (H) cm)o Omni directional front wheels	- Cart: subject and predicate devices utilize similar adjustable-height carts, which must hold the computer unit and the camera. o Predicate cart: ▪ Includes a laptop holder and holds the camera around the mid-section of the cart. o Subject cart: ▪ All-in-one PC (AIO) is directly attached to the cart, and the camera is placed at the top of the cart.
Software	Software:- Navient software with the following workflow:1. Images: Load the CT or MR images, review and explore images, and perform image fusion.2. Planning	Software:- Navient software with the following workflow:1. Images: Load the CT or MR images, review and explore images, and perform image fusion.2. Planning	Software: Identical Navient software and workflow

Page 13

ClaroNav
Navient
510(K) SUMMARY K243053
Page 9 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
	o Landmarks: Mark easily identifiable anatomical landmarks on the patient scan.o Segmentation: Generate a 3D model of the tumor or sinus.3. Set Up: attach the Patient reference, adjust the tracking system position, and verify the instruments' tip calibration accuracy.4. Registration: Using the Registration Probe, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.	o Landmarks: Mark easily identifiable anatomical landmarks on the patient scan.o Segmentation: Generate a 3D model of the tumor or sinus.3. Set Up: attach the Patient reference, adjust the tracking system position, and verify the instruments' tip calibration accuracy.4. Registration: Using the Registration Probe, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.

Page 14

ClaroNav
Navient
510(K) SUMMARY K243053
Page 10 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
	o Landmarks: Mark easily identifiable anatomical landmarks on the patient scan.o Segmentation: Generate a 3D model of the tumor or sinus.3. Set Up: attach the Patient reference, adjust the tracking system position, and verify the instruments' tip calibration accuracy.4. Registration: Using the Registration Probe, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.	o Landmarks: Mark easily identifiable anatomical landmarks on the patient scan.o Segmentation: Generate a 3D model of the tumor or sinus.3. Set Up: attach the Patient reference, adjust the tracking system position, and verify the instruments' tip calibration accuracy.4. Registration: Using the Registration Probe, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.
	5. Navigation: Navigate the position of the tip of various instruments in the image volume.	5. Navigation: Navigate the position of the tip of various instruments in the image volume.
Instrumentation	Surgical reference instruments for optical localization/tracking:- Patient Tracker (2 sets) (950-NE-PT)- Maxillary Seeker (950-NE-MS)- Frontal Seeker (950-NE-FS)- Bayonet Probe (950-NE-BP)- Registration Probe (950-NE-RP)- Tip Calibrator (950-NE-TC)- Universal Tracker (2 sets) (950-NE-UT1, 950-NE-UT2)- Four C-Clamps (950-NE-UTCS, 950-NE-UTCM, 950-NE-UTCL, 950-NE-UTCXL)Note: instruments are to be steam sterilized by the user prior to use in the ENT Sterilization Tray (950-NE-STE)	Surgical reference instruments for optical localization/tracking:- Patient Tracker (2 sets) (950-NE-PT)- Maxillary Seeker (950-NE-MS)- Frontal Seeker (950-NE-FS)- Bayonet Probe (950-NE-BP)- Registration Probe (950-NE-RP)- Tip Calibrator (950-NE-TC)- Universal Tracker (2 sets) (950-NE-UT1, 950-NE-UT2)- Four C-Clamps (950-NE-UTCS, 950-NE-UTCM, 950-NE-UTCL, 950-NE-UTCXL)Note: instruments are to be steam sterilized by the user prior to use in the ENT Sterilization Tray (950-NE-STE)	Surgical reference instruments for optical localization/tracking:- Identical instrumentation

Page 15

ClaroNav
Navient
510(K) SUMMARY K243053
Page 11 of 12

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC)	Predicate DeviceNaviENT System (955-NE-NE)	Justification of difference
Localization Referencing	Camera for optical tracking	Camera for optical tracking	Identical
Patient to CT image registration	Landmark based registration followed by surface matching	Landmark based registration followed by surface matching	Identical
Performance Accuracy	Accuracy with ≤2.0mm error	Accuracy with ≤2.0mm error	Identical
3D Image Support	3D Registration and Navigation	Support 3D Registration and Navigation	Identical

Page 16

ClaroNav
Navient
510(K) SUMMARY K243053
Page 12 of 12

Conclusions

Navient system has been shown through testing and technical comparison to be substantially equivalent to the identified predicate device when used as intended.

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).