The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Device Description

The NaviNetics D1 Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned.

The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four self-tapping bone anchor screws. The Key serves as the common attachment platform for the D1 Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible interventional instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the device to approach the target from a multitude of directions. Linear adjustments can move the arc-quadrant, medial/lateral (X), anterior/posterior (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of the third-party planning software provides the values of the target coordinates (XT, YT, ZT) and the surgical trajectory (CT, AT) which dictate the settings of the D1 stereotactic device.

AI/ML Overview

The provided document is a 510(k) summary for the NaviNetics D1 Stereotactic System. It outlines the device's characteristics, intended use, and substantial equivalence to a predicate device, the Leksell® Vantage™ Stereotactic System.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Results
Accuracy	Mechanical Accuracy: Assembly to position known stereotactic test points at the focus of the arc-quadrant.	All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device. Stated mechanical accuracy: 0.9 mm.
	Systemic Image Accuracy: Accuracy of selecting an image target on CT or MRI and positioning the selected point at the focus of the arc-quadrant.	All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device.
	Systemic Surgical Accuracy: Accuracy of placing a DBS lead, including implantation technique, as verified by post-implant CT scan.	All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device.
	Handling and process step accuracy (e.g., repeated mounting of parts to each other and scale setting accuracy) during mechanical and repeatability accuracy testing.	All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device.
	Displacement due to head weight.	Skull anchor key design renders displacement due to head weight as inconsequential.
MR Safety	Compliance with FDA guidance for MR environment safety and compatibility, including ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503.	Substantial equivalence to the predicate device is demonstrated through passing results to FDA guidance and these consensus standards.
Cleaning	Validation of manual cleaning and cleaning with a washer-disinfector methods using instructions in the IFU and artificial blood.	Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.
Sterilization	Validation for steam sterilization at 132°C (270°F) for 4 minutes to obtain a sterility assurance level (SAL) of at least 10^-6.	Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.
Biocompatibility	Evaluation of patient-contacting materials for biocompatibility according to ISO10993-1, ISO10993-5, ISO10993-10, and ISO10993-11.	Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the accuracy tests. It only mentions "All test cases" for the accuracy results. This typically implies a limited, in-house testing setup rather than a large clinical study.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a physical stereotactic system, not an AI diagnostic tool, so such a study would not be applicable in the context of human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the device's accuracy was done, as indicated by the "Accuracy" section under "Summary of Non-Clinical Performance Data." However, this refers to the mechanical and systemic accuracy of the device itself, not an algorithm's standalone diagnostic performance. The device is a "Stereotaxic Instrument" and not an AI-powered diagnostic algorithm.

7. Type of Ground Truth Used

For the accuracy tests, the ground truth appears to be:

Mechanical Accuracy: Known stereotactic test points. This implies a precisely manufactured phantom or reference system.
Systemic Image Accuracy: Selected image targets on CT or MRI. This would rely on the accuracy of the imaging system and potentially human identification of targets as a reference for the device's ability to locate them.
Systemic Surgical Accuracy: Post-implant CT scan verification for DBS lead placement. This uses objective imaging results as the ground truth for surgical outcome.

For the other tests (MR Safety, Cleaning, Sterilization, Biocompatibility), the 'ground truth' is compliance with established standards and protocols.

8. Sample Size for the Training Set

The document does not mention a training set, as the device is a mechanical stereotactic system and not a machine learning or AI model that requires training data.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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June 17, 2021

NaviNetics, Inc Patrick Gora V.P. Regulatory Affairs and Quality 206 S Broadway, Suite 700 Rochester, Minnesota 55904

Re: K210700

Trade/Device Name: NaviNetics D1 Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 17, 2021 Received: May 18, 2021

Dear Patrick Gora:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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-regulatoryassistance/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,

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) K210700

Device Name NaviNetics D1 Stereotactic System

Indications for Use (Describe)

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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NaviNetics D1 Stereotactic System 510(k) Summary

Date Prepared: June 17, 2021

Submitter's Name / Contact Person

Manufacturer	Contact Person
NaviNetics, Inc.206 South Broadway, Suite 700Rochester, MN 55904Tel 507.361.3570	Patrick GoraVP Regulatory Affairs and Qualitygora.patrick@navinetics.com507.361.3570

General Information

Device Trade Name	NaviNetics D1 Stereotactic System
Common / Usual Name	Stereotaxic Instrument
Classification Name	Stereotaxic Instrument, 21 CFR 882.4560 Class II
Product Code	HAW
Predicate Device(s)	K190887 – Leksell® Vantage™ Stereotactic System(clearance August 1, 2019)

Device Description

Intended Use

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Summary of Technological Characteristics Compared to Predicate

The NaviNetics D1 Stereotactic System has equivalent technological characteristics as its predicate device, Leksell® Vantage™ Stereotactic System. It utilizes the same coordinate system and center-ofarc principle which allows guidance of compatible interventional instruments at any trajectory angle to the brain target.

Substantial Equivalence

The NaviNetics D1 Stereotactic System has equivalent technology, features, and characteristics as the predicate device. K190887, the Leksell® Vantage™ Stereotactic System. The table below provides a comparison of technological characteristics between the NaviNetics D1 Stereotactic System (subject device) and the Leksell® Vantage™ Stereotactic System (predicate device).

	Subject Device	Predicate Device
Device Name	NaviNetics D1 Stereotactic System	K190887Leksell® Vantage™ Stereotactic System
Regulation Number	21 CFR 882.4560	21 CFR 882.4560
Product Code	HAW	HAW
Product Class	II	II
Indications for use	The Intended Purpose of theNaviNetics D1 Stereotactic System isintended to be used for targetlocalization and fixation of the patienthead in a coordinate system in orderto perform stereotactic neurosurgicalprocedures, for example; deep brainstimulation, lesioning, biopsies,targeted injections, aspirations andminimal invasive tumor treatments.	The Intended Purpose of Leksell®Vantage™ Stereotactic System isintended to be used for targetlocalization and fixation of the patienthead in a coordinate system in orderto perform stereotactic neurosurgicalprocedures, for example; deep brainstimulation, lesioning, biopsies,targeted injections, aspirations andminimal invasive tumor treatments.
Description	The NaviNetics D1 StereotacticSystem is included in the arccentered category of stereotacticframes which provide an arcquadrant and a 3D slide to move thearc quadrant about the head. Aminimally intrusive Skull Anchor Keyattaches to the patient's skull with theuse of four (4) skull anchor screws.used to affix the arc centered deviceto the skull of the patient. The D1Stereotactic device mounts to theSkull Anchor Key allowing it topinpoint intracranial targets andguide neurosurgical instruments tothese brain targets.	The Leksell® Vantage™ StereotacticSystem is a device used forminimally invasive neurosurgicalprocedures. It enables coordinatereferencing and fixation of thepatient's skull and brain during imageacquisition and treatment. Thecoordinate referencing enables targetlocalization and accurate stereotactictreatment of brain targets.The system consists of a head framethat is fixated to the patient skull byminimally invasive disposable fixationpins and a number of accessories forframe application and imaging aswell as a stereotactic arc and
	Subject Device	Predicate Device
		operating room accessories for thesterile surgical procedure.
Coordinate System	NaviNetics Coordinate System usingCartesian coordinates. The X axisruns left/right, the Y axis runsanterior/posterior and the Z axis runsinferior posterior. The origin of thecoordinate system is located to theright, posteriorly, and superiorly tothe patient's head. The center of thework envelope, located near thecenter of the cranial cavity, has acoordinate of (100,100,100)	Leksell Coordinate System usingCartesian coordinates. The X axisruns left/right, the Y axis runsanterior/posterior and the Z axis runsinferior posterior. The origin of thecoordinate system is located to theright, posteriorly, and superiorly tothe patient's head. The center of thework envelope, located near thecenter of the cranial cavity, has acoordinate of (100,100,100)
Fixation	Minimally intrusive Skull Anchor Keywith three fixation pins and four self-tapping screws.	Head frame attached to patient skullwith four fixation pins driven into theouter table of the skull.
Fixation Pins/Screws	Single use titanium pins and self-tapping titanium screws that securethe minimally intrusive Skull AnchorKey to the patient skull.	Single use fixation pins and insertsthat secure the Vantage head frameto the patient skull using LeksellVantage keys.
Principles of Use	The NaviNetics D1 StereotacticSystem uses arc center stereotacticprinciple in which the two angulardegrees of freedom rotateorthogonally to each other about asingle point called the "focus. A 3Dslide alters the position of the focuswithin the brain. The D1 System hasan arc radius of 150mm. This is40mm less that the predicate whichhelps reduce the mechanical error byreducing the length of instrumentsbeing projected from the arc.The D1 Skull Anchor Keyimmobilizes the patient within thestereotactic coordinate system calledthe work envelope. The Skull AnchorKey provides the commonattachment site for all components ofthe D1 System.comprises a Skull Anchor key, a3D slide, and arc is target centered defines the surgical targets asCartesian (x,y,z) coordinateswithin the work envelope of thesystem	Leksell® Vantage™ StereotacticSystem is Center of the arc principlestereotactic device in which the twoangular degrees of freedom rotateorthogonally to each other about asingle point called the "focus. Theworking radius of the arc is 190mm.The head frame of the Leksellsystem immobilizes the patient withinthe stereotactic coordinate systemcalled the work envelope. Theheadframe provides the commonattachment site for all components ofthe Leksell system. Cartesiancoordinates applied to the brain ofthe patient by the use of a headframe fixated to the skull. comprises a headframe, a 3Dslide and arc is target centered defines the surgical targets asCartesian (x,y,z) coordinateswithin the work envelope of thesystem utilizes fiducial markers on CTand/or MRI images to locate the
	Subject Device	Predicate Device
	utilizes fiducial markers on CT and/or MRI images to locate the images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target	images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target
Materials	Invasive components:	Invasive components:
	Titanium	PEEK with Aluminum tip
	Skull Anchor Key:Delrin®Arc:Aluminum	Head Frame:Glass fiber reinforced EpoxyArc:Aluminum
Accuracy	0.9mm (mechanical)	0.9mm (mechanical)
Accessories	Neurosurgical instruments designedfor a 150 mm working length	Neurosurgical instruments designedfor a 190 mm working length

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Summary of Non-Clinical Performance Data

Test	Method/Summary	Results
Accuracy	• Mechanical: assembly to positionknown stereotactic test points atthe focus of the arc-quadrant	All test cases were shown acceptablefor expected outcome. Overallsystem accuracy is equivalent to thepredicate device.
	• Systemic Image: Accuracy ofselecting an image target on CT orMRI and positioning the selectedpoint at the focus of the arc-quadrant
	• Systemic Surgical: Accuracy ofplacing a DBS lead, includingimplantation technique, as verifiedby post-implant CT scan
	• Handling and process stepaccuracy (e.g., repeated mountingof parts to each other and scalesetting accuracy) duringmechanical and repeatabilityaccuracy testing
	Skull anchor key design rendersdisplacement due to head weight asinconsequential

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Test	Method/Summary	Results
MR Safety Testing	The device was subjected to andcomplies with all FDA guidance forMR environment safety andcompatibility, including the followingsafety standards:	Substantial equivalence to thepredicate device is demonstratedthrough passing results to FDAguidance and these consensusstandards.
	• ASTM F2052• ASTM F2119• ASTM F2182• ASTM F2213• ASTM F2503
Cleaning- reusableparts	Validated for manual cleaning andcleaning with a washer-disinfectorManual and washer/disinfectorcleaning methods were validatedusing instructions in the IFU usingartificial blood	Parts passed final validation and metall pre-determined acceptancecriteria while demonstrating predicatedevice substantial evidence.
Sterilization- reusableparts	Performed on the subject device,reusable parts were validated forsteam sterilization. The validationwas used to show the device canobtain a sterility assurance level(SAL) of at least 10-6 when steamsterilized at 132°C (270°F) for 4minutes	Parts passed final validation and metall pre-determined acceptancecriteria while demonstrating predicatedevice substantial evidence.
Biocompatibility	Patient-contacting materials wereevaluated for biocompatibility to thefollowing tests: ISO10993-1,ISO10993-5, ISO10993-10 andISO10993-11	Parts passed final validation and metall pre-determined acceptancecriteria while demonstrating predicatedevice substantial evidence.

Summary of Clinical Performance Data

Based on product classification and predicate devices, clinical testing is not required to demonstrate substantial equivalence.

Conclusion

The performance testing presented demonstrates the NaviNetics D1 Stereotactic System is substantially equivalent with the predicate device, the Leksell® Vantage™ Stereotactic System cleared under K190887.

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).