Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.

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.

Indications:

Example procedures include but are not limited to:

Cranial Procedures:
Tumor resections
· Cranial biopsies
· Craniotomies
· Pediatric Catheter Shunt Placement
General Catheter Shunt Placement

Device Description

Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) 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 sets intended for specific clinical applications.

Navient's quidance 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.

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.

Cranial Accessory Kit (955-NC-AKC) o
Biopsy Accessory Kit (955-NC-AKB) O

Disposable tracker instruments are also available based on user preference.

AI/ML Overview

The provided document is a 510(k) summary for the ClaroNav Navient Image Guided Navigation System, Cranial. This document describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Navient system is its accuracy, specifically in terms of positional and angular error. The document states: "Navient has been validated to a mean positional error of ≤ 2.0 mm and a mean anqular error of ≤ 2.0deq."

Here's a table summarizing the acceptance criteria and reported device performance:

Acceptance Criterion	Requirement	Reported Device Performance (Mean)	Standard Deviation	99% Confidence Interval
Positional Error (mm)	≤ 2.0 mm (mean)	1.36 mm	0.66 mm	2.89 mm
Angular Error (degree)	≤ 2.0 deg (mean)	1.01 deg	0.40 deg	1.95 deg
Accuracy when exchanging cranial reference frame	< 1 mm (distance/movement)	(Validated, specific value not provided, but stated as less than 1mm)	N/A	N/A

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described under the "Performance Data" section, specifically "Full system accuracy bench testing (overall accuracy)".

1. A table of acceptance criteria and the reported device performance:
(See table above)

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

Sample Size for the Test Set: The document does not explicitly state the numerical sample size (e.g., number of measurements or trials) for the "Full system accuracy bench testing." It mentions using "representative phantoms."
Data Provenance: The data is based on bench testing using phantoms. The country of origin of the data is not specified, but the applicant is from Canada. The study is a prospective experimental study conducted by the manufacturer to demonstrate performance.

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

This is a bench testing study, not an AI or human-in-the-loop clinical study where expert review of images or clinical outcomes would establish ground truth. The "ground truth" for this accuracy testing would be the known, precise measurements and positions of the targets on the phantoms. Therefore, no external experts are typically involved in establishing this type of ground truth for a physical device's mechanical/measuring accuracy. The expertise lies in the engineering and quality control personnel performing the measurements.

4. Adjudication method for the test set:

Not applicable in the context of bench testing device accuracy. Adjudication typically refers to resolving discrepancies among multiple human readers or ground truth experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of a surgical navigation system, which primarily aids surgeons in real-time positioning based on pre-acquired images. It is not an AI-based diagnostic tool intended to assist human readers in interpreting medical images or improving diagnostic accuracy.
The study described is a bench study evaluating the physical accuracy of the navigation system, not the diagnostic performance or reader improvement.

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

Yes, in a sense, the "Full system accuracy bench testing" represents the standalone performance of the device's navigational accuracy. The measurements of positional and angular error were likely performed by the device and then compared against the known ground truth of the phantom. This is the performance of the algorithm and hardware working together in a controlled environment.
It's important to differentiate this from "standalone AI performance" if the device were an AI diagnostic algorithm. Here, "standalone" refers to the device's ability to accurately track and report positions, irrespective of a surgeon's subjective assessment.

7. The type of ground truth used:

The ground truth used for the full system accuracy bench testing was engineered ground truth based on known, precise measurements of target points on "representative phantoms." These phantoms are designed with known spatial relationships that serve as the gold standard for accuracy verification.

8. The sample size for the training set:

Not applicable. This document describes a surgical navigation system, not an AI algorithm that undergoes machine learning training. Therefore, there is no "training set" in the context of deep learning models.
The "training" for such a device involves calibration, manufacturing processes, and software development, which are different from data-driven machine learning training.

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

Not applicable. As stated above, there is no "training set" in the machine learning sense for this device.
For the development and calibration of the device, the inherent accuracy of manufacturing, calibration tools, and metrology standards would serve as the "ground truth" for ensuring the device performs as designed.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 5, 2025

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

Re: K241327

Trade/Device Name: Navient Image Guide Navigation System (955-NC-NC) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 3, 2025 Received: January 6, 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 (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/cdrb/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.

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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" (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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory

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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).

Sincerely,

Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Adam D. Pierce. The date of the signature is 2025.02.05, and the time is 16:57:21 -05'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241327

Device Name

Navient Image Guided Navigation System, Cranial

Indications for Use (Describe)

Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.

Indications:

Example procedures include but are not limited to:

Cranial Procedures:
Tumor resections
· Cranial biopsies
· Craniotomies
· Pediatric Catheter Shunt Placement
General Catheter Shunt Placement

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)

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510(K) SUMMARY

ClaroNav Navient

Doc #: 985-05003-IR2025

510(K) SUMMARY NAVIENT IMAGE GUIDED NAVIGATION SYSTEM

Sponsor:	ClaroNav1140 Sheppard Avenue West, Unit 10Toronto, Ontario, M3K 2A2Canada
Contact Person	Karen Wu
	Director of Regulatory Affairs
Phone	+1 647 552 1489
e-mail	ra@claronav.com
Date	February 5, 2025
Device Proprietary Name	Navient Image Guided Navigation System, Cranial
Common Name	Navient
Product Code	HAW
Class	Class II
Regulation Number	21 CFR 882.4560
Regulation Name	Stereotaxic instrument
Classification Panel	Neurology

Predicate Devices

Primary predicate: StealthStation S8 Cranial (K212397)

Indications for Use

Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.

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510(K) SUMMARY

Doc #: 985-05003-IR2025

Indications:

Example procedures include but are not limited to: Cranial Procedures:

Tumor resections .
. Cranial biopsies
Craniotomies .
Pediatric Catheter Shunt Placement •
. General Catheter Shunt Placement

Technological Characteristics

Cranial Accessory Kit (955-NC-AKC) o
Biopsy Accessory Kit (955-NC-AKB) O

Disposable tracker instruments are also available based on user preference.

Navient Software Workflow:

Navient software operation proceeds sequentially through 5 stages:

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Doc #: 985-05003-IR2025

Images: Load the CT or MR images, review and explore images and perform image fusion. 1.
1. Planning: The planning stage, depending on the procedure types
Set Up: attach the Patient reference, adjust the tracking system position and verify the 3. instruments' tip calibration accuracy.
ধা 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.
1. 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 intact skin or mucosal membrane contact and contact tissue/bone/dentin: cytotoxicity, sensitization and irritation, material mediated pyroqenicity and acute systemic toxicity. Results indicate the body-contacting Navient instruments do not introduce anv 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.

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. Full system accuracy bench testing (overall accuracy):

Navient has been validated to a mean positional error of ≤ 2.0 mm and a mean anqular error of ≤ 2.0deq. Table below summarizes the full system accuracy test of Navient cranial module. This performance was determined using representative phantoms with system components that are deemed the worst-case in the Navient clinical applications.

FullSystemAccuracy(NavientCranialModule)	Positional Error (mm)			Angular Error (degree)
	Mean	StandardDeviation	99%ConfidenceInterval	Mean	StandardDeviation	99%ConfidenceInterval
	1.36mm	0.66mm	2.89mm	1.01 deg	0.40 deg	1.95deg

Accuracy test when exchanging cranial reference frame ●

As part of the Navient cranial workflow, the user is expected to perform registration with cranial reference frame 950-NC-CRF-A (in non-sterile environment) and then remove it and place cranial reference frame 950-NC-CRF-B (which is sterile) after the patient is draped. The accuracy requirement reqarding the exchange of the cranial reference frames has been validated with a distance/movement of less than 1mm. The validation was performed on a representative phantom with the Navient system.

● Human factors/usability:

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

Substantial Equivalence:

The subject Navient system is substantially equivalent to the predicate devices StealthStation S8 Cranial (K212397). Navient system and StealthStation S8 have the same intended use and similar technological characteristics, but Navient does not raise new safety/effectiveness questions and was tested in non-clinical studies in accordance with an appropriate methodology. A comparison of the subject Navient system and the predicate device is presented in Table 1 below:

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Doc #: 985-05003-IR2025

Table 1. Comparison of Indications for use and Technological Characteristics

Feature/Characteristic	Subject DeviceNavient System (955-NC-NC) –cranial (including biopsy)application	PredicateStealthStation S8 (Cranial)	Justification ofdifference
Intended UseClass/ProductCode/ClassificationName	Regulation Number: 21 CFR882.4560Regulation Name: StereotaxicInstrumentRegulatory Class: Class II	K212397Regulation Number: 21 CFR 882.4560Regulation Name: Stereotaxic InstrumentRegulatory Class: Class II	Identical classification andapplicable regulationnumber.
Intended Use	Navient is a computerized surgicalnavigation system intended as anaid for precisely locating anatomicalstructures in either open orpercutaneous neurosurgicalprocedures.	The StealthStation™ S8 System isintended as an aid for precisely locatinganatomical structures in either open orpercutaneous neurosurgical procedures.	Subject Navient has thesame general intendeduse as the predicatedevice and:"as an aid for preciselylocating anatomical
Feature/Characteristic	Subject Device	Predicate	Justification ofdifference
	Navient System (955-NC-NC) –cranial (including biopsy)application	StealthStation S8 (Cranial)
			structures in either openor percutaneousneurosurgical procedures."
Indications for Use	The Navient system is indicated forany medical condition in which theuse of stereotactic surgery may beappropriate, and where reference toa rigid anatomical structure, such asthe skull, can be identified relativeto a CT, MR based model of theanatomy.Example procedures include but arenot limited to:Cranial Procedures:• Tumor resections• Cranial biopsies• Craniotomies	It is indicated for any medical condition inwhich the use of stereotactic surgery maybe appropriate, and where reference to arigid anatomical structure, such as theskull, can be identified relative to imagesof the anatomy.This can include, but is not limited to, thefollowing cranial procedures (includingstereotactic frame-based and stereotacticframe alternatives-based procedures):• Tumor resections• General ventricular catheterplacement	Similar. Although theexample cranialprocedures listed mayslightly differ, both thesubject device andpredicate device specifyany medical condition inwhich the used ofstereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure canbe identified relative toimages of the anatomy.
Feature/Characteristic	Subject DeviceNavient System (955-NC-NC) –cranial (including biopsy)application	PredicateStealthStation S8 (Cranial)	Justification ofdifference
	Pediatric Catheter ShuntPlacement General Catheter ShuntPlacement	Pediatric ventricular catheterplacement Depth electrode, lead, and probeplacement Cranial biopsies
Use Environment	Surgical setting	Surgical setting	Identical
Target Population	Patients for whom stereotacticimage guided surgery is appropriate	Patients for whom stereotactic imageguided surgery is appropriate	Identical
Users	Medical practitioner	Medical practitioner	Identical
Technological Characteristics
Operating Principles	Surgical navigation system withoptical (infrared) trackingtechnology	Surgical navigation system with optical(infrared) and EM tracking technology	Identical optical tracking.Navient does not supportEM tracking.
Input imaging modality	CT and MR	X-ray, MR, and nuclear medicine	Subject Navient supports asubset of the predicate's
Feature/Characteristic	Subject DeviceNavient System (955-NC-NC) -cranial (including biopsy)application	PredicateStealthStation S8 (Cranial)	Justification ofdifference
			inputs MR and CT (whichis x-rays based imaging).
Dynamic object posemeasurementtechnology	Stereoscopic Optical Trackingsystem	Stereoscopic Optical TrackingSystem and EM tracking technology	Identical optical tracking.Navient does not supportEM tracking.
LocalizationTechnology/Illuminationof tracking targets	Optical (infra-red)	Optical (infra-red)/ electromagnetictracking	Identical infra-redtechnology. Navient doesnot support EM tracking.
Scanner InterfaceTechnology (to imagingdevices)	Network ConnectivityCD, DVD, USBDICOM	Network ConnectivityCD, DVD, USBDICOM	Identical
General DeviceComponents	Platform/cart, software, surgical andreference instruments	Platform/carts (2), software, surgical andreference instruments	Subject Navient requires 1cart to support the opticaltracking system while thepredicate device requires a
Feature/Characteristic	Subject DeviceNavient System (955-NC-NC) –cranial (including biopsy)application	PredicateStealthStation S8 (Cranial)	Justification ofdifference
			main cart and 1 cameracart.
Localization Referencing	Camera for optical tracking	Camera for optical tracking oran emitter and instrument interface forelectromagnetic tracking	Subject Navient supports asubset of the predicate'sreferencing functionality(optical tracking).
Compatible Instruments	Instruments for opticallocalization/tracking, including:• Patient tracker• Pointer/registrators• Optical trackers• Reference frames• Adapters• Calibrating instruments	Instruments for optical andelectromagnetic (EM)localization/tracking, including:• Patient tracker• Pointer/registrators• Optical trackers• Reference frames• Adapters• Calibrating instruments• Dilating balloon• Blades• Suction tip	Subject Navient supportsoptical tracking but doesnot support EM tracking.Within the optical trackinginstruments, subjectNavient system supports asubset of the predicate'sinstrumentation.

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K241327 Page 7 of 11

ClaroNav Navient

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Feature/Characteristic	Subject DeviceNavient System (955-NC-NC) -cranial (including biopsy)application	PredicateStealthStation S8 (Cranial)	Justification ofdifference
Patient to CT imageregistration	Landmark based registrationfollowed by surface matching	Landmark based registrationfollowed by surface matching	Identical
Performance Characteristics
Performance Accuracy	$\leq$ 2.0mm, $\leq$ 2° mean error	$\leq$ 2.0mm, $\leq$ 2° mean error	Identical
3D Image	Support 3D Registration andNavigation	Support 3D Registration and Navigation	Identical

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510(K) SUMMARY

Doc #: 985-05003-IR2025

Conclusions

Navient system has been shown through testing and technical comparison to be substantially equivalent to the identified predicate and referenced devices 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).