The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

Device Description

The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® System consists of three main sub-systems:

The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.

AI/ML Overview

The provided text describes the SOLOPASS® System, a neuronavigational system that collects intraoperative ultrasound imaging and positional data to aid in the frontal placement of an intra-ventricular catheter. The document details the device's comparison to a predicate device and summarizes non-clinical testing performed to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on two key performance metrics related to accuracy: "System Targeting Accuracy" and "System Imaging Accuracy."

Acceptance Criteria	Reported Device Performance
System Targeting Accuracy: +/- 3mm target at 6cm	+/- 3mm target at 6cm
System Imaging Accuracy: +/- 2mm target at 4cm-7cm	+/- 2mm target at 4cm-7cm

Additionally, other acceptance criteria are implicitly met by passing various tests:

Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, negative for acute systemic toxicity, bacterial endotoxins < 2.15 Eu/device.
Thermal, Electrical, Mechanical Safety: Pass IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIM 7351731, IEC/EN 60529 (IPX7).
Cleaning, Disinfection, Sterilization: Pass validation for cleaning and VHP sterilization of Ultrasound Probe (SAL 10^-6), and gamma sterilization of single-use PID (SAL 10^-6).
Ship and Shelf Life Functional Test: Pass ISTA 3A, ISO 11607-1, and shelf-life aging (PID shelf life: 12 months).
2D Imaging Qualification: Pass verification of ultrasound requirements (imaging depth, image accuracy, active element check, and other specifications).
Cranial Mounting Mechanical Testing: Met acceptance criteria for mean pullout strength of anchor and mean ratio of yield strength vs. insertion torque.
Hardware Verification: Pass verification of system electrical design requirements.
Software Verification and Validation: Pass, demonstrating that all software requirements were appropriately implemented and conformity to IEC 62304.
Design Validation Study: Pass, user needs were successfully validated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The provided text does not explicitly state the numerical sample size for the test set for each specific performance test (e.g., how many measurements were taken for targeting accuracy, or how many units were tested for biocompatibility). The studies are listed as "Nonclinical Testing," "Verification Bench Testing," and "Design Validation," which typically imply controlled laboratory or simulated environments rather than patient data.

Data Provenance: The studies are "Nonclinical" and "Bench Testing," suggesting they are laboratory or simulation-based rather than patient data. There is no information provided about the country of origin or whether data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

The document does not mention the involvement of experts in establishing the "ground truth" for the non-clinical and bench testing. These types of tests typically rely on highly controlled physical setups and precise measurement tools to establish ground truth, rather than human interpretation.

For the Design Validation Study, "user needs were successfully validated." While this implies user involvement, the number and qualifications of "users" (presumably clinicians or surgeons) are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. For non-clinical bench testing, adjudication methods for human interpretation are not typically used. The results are quantitative measurements against predefined criteria.

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. The document describes a medical device for surgical guidance, not an AI/CAD system intended to assist human readers in image interpretation or diagnosis. The focus is on the device's accuracy and safety as a tool in a surgical setting.

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

The performance metrics like "System Targeting Accuracy" and "System Imaging Accuracy" are inherently standalone performances of the device's capabilities, measured in a controlled environment. The device provides "intra-procedural, image guided localization and navigation," which implies it provides data for human users, but the accuracy metrics presented are for the device's output itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the accuracy metrics, the ground truth was established through physical measurements against known standards or reference points in controlled bench test environments. This is typical for navigations systems where accuracy is quantitatively measured directly. The document states:

"System Targeting Accuracy: Measure targeting accuracy. Acceptance criteria defined based on Reference Device, V-Guide for Ventriculostomies (K141559)."
"System Imaging Accuracy: Measure imaging accuracy."

This indicates that ground truth was derived from precisely measured physical setups and comparison to a known reference.

8. The sample size for the training set:

Not applicable. The SOLOPASS® System is described as a medical device for navigation and imaging, not as an AI or machine learning system that requires a "training set" in the context of model development. The software component mentioned (and verified against IEC 62304) is for operating the device and processing the imaging/positional data, not for learning from a dataset to perform interpretations or predictions.

9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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August 27, 2021

inTRAvent Medical Partners, LP % Connie Qiu Regulatory Consultant M Squared Associates, Inc. 127 West 30th Street. 9th Floor New York, New York 10001

Re: K203251

Trade/Device Name: SOLOPASS System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, IYN Dated: December 3, 2020 Received: December 4, 2020

Dear Connie Qiu:

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) K203251

Device Name SOLOPASS® System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor:	inTRAvent Medical Partners, LP1125 Greenwood Dr.Hummelstown, PA 17036
Contact:	Connie QiuM Squared Associates, Inc.127 West 30th Street, 9th FloorNew York, NY 10001
Date Prepared:	August 27, 2021
Trade Name:	SOLOPASS® System
Common Name:	Neurological stereotaxic instrument
Classification:	II
Product Code:	HAW, 21 CFR 882.4560, Neurological Stereotaxic InstrumentIYN, 21 CFR 892.1550, System, Imaging, Pulsed Doppler, Ultrasonic

Predicate Devices:

Sonowand Invite System, K083597, K112469

Reference Devices

. Medtronic Navigus Trajectory Guide Kit, K992304
V-Guide for Ventriculostomies K141559

Description of Device:

The SOLOPASS® System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.

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1. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
1. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.

Indications for Use:

Comparison to Predicate Device:

Comparison of intended use and technological characteristics between the SOLOPASS® System to the predicate device, Sonowand Invite System (K083597, K112469), is presented in the following table. The differences between the two devices do not affect the intended use, and do not raise new questions of safety and effectiveness.

	Subject Device	Predicate Device	Substantial EquivalenceComparison
	SOLOPASS® System	SonoWand Invite™K083597, K112469	N/A
Product Codes	HAW, IYN	HAW, IYN	Same
Indications forUse	The SOLOPASS®System is a tool thatobtains ultrasoundimages andpositional data toprovide intra-procedural, imageguided localizationand navigation, toaid in the frontalplacement of anintra-ventricularcatheter.	The SonoWandInvite™ System isintended for use as atool to aidintraoperativeultrasound imagingand image guidedsurgery duringneurosurgery. It isalso intended for useas a standardneuronavigationsystem and as astand-aloneUltrasound scanner.The intended use of alocalizer is to enable	Same intended use aretools used to assist thesurgeon in planning andguiding the placement ofinstruments duringneurosurgical procedures,such as catheterplacement, with imageguidance provided byultrasound or otherimaging modality.Predicate device hasadditional indicationsregarding other imagingmodalities. Thesedifferences do not raise
		navigation byshowing the positionof surgicalinstruments orpointers relative toMR, CT, orUltrasound images.The general purposelocalizers withadapters areintended to be usedto attach surgicaltools manufacturedby other vendors.SonoWand Invite™System will displayposition andorientation of thetools in the medicalimages on thescreen.	new questions of safetyor effectiveness.
Planned UseEnvironment	Operating Room(OR), PatientBedside outside ofOR	Operating Room	Similar. Both devices areintended for use in theOR. The subject device isdesigned as a mobileworkstation to allow foruse at the patient bedsideoutside of the OR byqualified clinicians. Whilethis adds a useenvironment, theintended use andqualifications of theintended users areequivalent to those of thepredicate device.Electrical safety andelectromagneticcompatibility testing usingrecognized test standardssupport the safety of theSOLOPASS as a mobilesystem. Therefore, these.

Planned User	Surgeon orintensivists	Surgeon	differences do not raisenew questions of safetyand effectiveness.Similar. Typically thisprocedure is performedby HCP such as a surgeonor intensivist.
Anatomic regionUse forneurosurgicalcatheter/instrumentplacement	CranialYes	CranialYes	SameSame
Main SystemComponents	Ultrasound ImagingSystem;Skull mountedmechanical module;Software Modulefor trajectoryplanning;Workstation/Display;Cart.	Ultrasound ImagingSystem;Not skull mounted(Localizer andNavigation Trackerson probe);Radiographic fiducialmarkers;Software module forinstrument tracking;Workstation/ Display;Cart.	Similar. Both devicesutilize an ultrasoundimaging system withcustom software moduleto aid in instrument (e.g.catheter) placement, andconsist of a workstationwith display on a cart. Thesubject device offers thebenefit of intraoperativeultrasound imagesupdated in real-time tofacilitate trajectoryplanning and potentiallyreduce risks associatedwith targeting. There aredifferences in how eachsystem helps track/guideplacement of theinstruments. Verificationtesting demonstrates thatthe subject device fulfillsits design inputs includingcomparable accuracy tothe predicate device. Thedifferences between themain system componentsdo not raise newquestions of safety andeffectiveness.

Image guidance	UltrasoundIntra-op 2D imagingdata withsimultaneouslycaptured locationdata is used to build3D model ofanatomy	CT: Pre-opMRI: Pre-opUltrasound: Intra-op(Intra-op MRI onlyavailable if MRIsurgical suiteavailable)Provides 2D and 3Dimaging.	Both devices provideintra-op ultrasoundimaging, and provide 2Dand 3D imaging. Thepredicate device offersadditional imagingmodalities not offered bythe subject device. Thisdifference does not raisenew questions of safetyand effectiveness.
Trajectory guidefunction	Yes	Yes	Same
Patient fixation	Skull-mountedframe (PatientInterface Device,PID) serves asreference forinstruments andcatheters	No patient fixationcomponent.Disposableradiographic markersare placed on or nearcraniotomy site.	Different. While thesubject device includes acomponent that is fixedto the patient to guideplacement of theultrasound probe andinstruments/ catheters,the predicate device doesnot have a patientfixation component. Thetwo devices' designsutilize different methodsof determining thepatient's position foracquiring imaging andreference points. Benchtesting of the SOLOPASS® .System verifies the PIDdesign and performanceto fulfill its intended use.These differences do notraise new questions ofsafety and effectiveness.
Manuallyoperated	Yes	Yes	Same
Instrument/Cathetercompatibility	Catheters with3.4mm or 2.8mmouter diameter	Does not specifylimitation ininstrument and/orcatheter sizecompatibility	Different. The subjectdevice specifiescompatibility ofinstrument/ catheter sizesbased on the design of

			the fixation componentthat limits the size ofthese devices. Thepredicate device does nothave a similar componentthat would restrict thesize of compatibleinstruments/ catheters.This difference does notimpact the sharedintended use andfundamental technologycomparison between thesubject and predicatedevices. Performancetesting verifies thecompatible device sizesfor the SOLOPASS®.Therefore, thesedifferences do not raisenew questions of safetyand effectiveness.
Localizationmethod	Encoders on PatientInterface Device totrack motion ofinstruments/catheters	Localizers withadapters that attachto instruments totrack position.Adhesiveradiographic markersplaced nearcraniotomy site.	Similar. Both devicesinclude componentsdesigned to track positionof instruments/ cathetersto aid in their placementto the surgical site duringprocedures. Thedifferences between thelocalization methods donot raise new questionsof safety andeffectiveness.
Transducer Type	Phased array probe	Linear array probe,phased array probe	Same. Both systems offerphased array probes. Thepredicate device providesan additional linear arrayprobe.
TransducerFrequency	5 MHz1 transducer	5-10 MHzMultiple transducersavailable	Similar. 5 MHz transducerfrequency is offered inboth systems. Predicatedevice provides additional
			transducers withadditional frequencies.These differences do notraise new questions ofsafety and effectiveness.
Transducer Style	"Burr-hole" style(craniotomy)	"Burr-hole" style(craniotomy)	Same
Acoustic OutputDisplay & FDALimits	Track 3	Unknown	The subject device metacoustic output testingacceptance criteria andFDA guidelines. Anydifferences in acousticoutput display are notexpected to raise newquestions of safety andeffectiveness.
Imaging Mode	B Mode	B Mode	Same
General SafetyandEffectivenessInformation	1. Total ImageDepth 0-10 cm2. Optimal ImageRange 2.5 – 8cm	1. Total ImageDepth 0-9cm2. Optimal ImageRange 0-5 cm	Similar. Based oninformation about thepredicate device availablefor comparison, bothsystems have similarparameters with somedifferences in range.Electrical safety, EMC,acoustic output,verification, andvalidation testing supportthe performance of thesubject device, that thesedifferences do not raisenew questions of safetyor effectiveness.
Accuracy	Targeting accuracy:+/- 3mmImaging accuracy:+/- 2mm	Imaging accuracy:$±2mm1$	Similar. The subject andpredicate devicesdemonstrate similarimaging accuracy.SOLOPASS® has
User Interfaces	Graphical touchscreen, Foot switch	Graphical touchscreen, Foot switch	additionally been verifiedfor targeting accuracy toaid the surgeon in placinginstruments/ catheters.This does not raise newquestions of safety andeffectiveness.
Electrical Safety	Conformity toIEC 60601-1IEC 60601-1-2	Conformity toIEC 60601-1IEC 60601-1-2	Same
BiocompatibilityPatientContactingComponents	Conformity to ISO10993-1Limited contact (<24hours)• Patient InterfaceDevice (Anchor,etc.)• Ultrasonic probeused with sheathand acoustic gel	Conformity to ISO10993-1Limited contact (<24hours)• Radiographicmarkers• Ultrasonic probeused with drapeand acoustic gel	Similar. Both devicesshare common durationand type of intendedtissue contact. Bothdevices satisfiedapplicablebiocompatibilityevaluation. Therefore,any differences in patient-contacting materials donot raise new questionsof safety andeffectiveness.
Sterilization	PID: Sterile, single-use, GammaUltrasound Probe:Reusable, sterilizedby user by VHP	Spheres: Sterile,single-useUltrasound Probe:Reusable, cannot besterilized, must beused with steriledrapeLocalizers andnavigators: Autoclave	Similar. Both devices havecomponents deliveredsterile or non-sterile, andhave met applicableacceptance criteria forsterilization validation.Therefore, anydifferences in sterilitymethods do not raise newquestions of safety andeffectiveness.

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1 Lindseth, Frank et al. "Accuracy evaluation of a 3D ultrasound-based neuronavigation system." Computer aided surgery : official journal of the International Society for Computer Aided Surgery vol. 7,4 (2002): 197-222. doi:10.1002/igs.10046

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Nonclinical Testing Summary:

The following performance data are provided in support of the substantial equivalence determination between the proposed device, SOLOPASS® System, and the predicate device, Sonowand Invite System (K083597, K112469).

		Table 1 Summary of Non-Clinical Performance Data
--	--	--------------------------------------------------

TEST	TITLE/TEST METHOD SUMMARY	RESULTS
Biocompatibility
ISO 10993-5	Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity	Non-cytotoxic
ISO 10993-10	Biological evaluation of medical devices –Part 10: Tests for irritation and skinsensitization	Non-sensitizingNon-irritating
ISO 10993-11	Biological evaluation of medical devices –Part 11: Tests for systemic toxicity	Non-pyrogenicNegative for acute systemictoxicity
ANSI/AAMI ST72,USP <85>, USP<161>	Bacterial endotoxins test	Pass, all samples demonstratedless than 2.15 Eu/devicerequired for devices withcerebrospinal fluid contact
Thermal, Electrical, Mechanical Safety
IEC 60601-1/ANSI AAM ES60601-1	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance	Pass
IEC 60601-1-2	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral	Pass
IEC 60601-2-37	Particular Requirements for the safety ofultrasonic medical diagnostic and monitoringequipment.	Pass
AIM 7351731	Medical Electrical Equipment and SystemElectromagnetic Immunity Test for Exposureto Radio Frequency Identification Readers	Pass
IEC/EN 60529	Degrees of protection provided byenclosures (IPX7)	Pass
Cleaning, Disinfection, Sterilization
Ultrasound ProbeCleaning Validation	Validation of cleaning and disinfectionmethod for reusable ultrasound probes.	Pass
Ultrasound ProbeVHP SterilizationValidation	Validation of VHP sterilization method forreusable ultrasound probes.	Pass, SAL 10-6
AAMI/ANSI/ISO11137-1.11137-2	Validation of gamma sterilization method forsingle-use PID.	Pass, SAL 10-6
Ship and Shelf LifeFunctional Test	Verify functional performance of devicecomponents following testing per ISTA 3A,ISO 11607-1, and shelf-life aging.	PassPID Shelf life: 12 months
Verification Bench Testing
2D ImagingQualification	Verification of ultrasound requirementsincluding imaging depth, image accuracy,active element check and otherspecifications.	Pass
System TargetingAccuracy	Measure targeting accuracy. Acceptancecriteria defined based on Reference Device,V-Guide for Ventriculostomies (K141559).	+/- 3mm target at 6cm
System ImagingAccuracy	Measure imaging accuracy.	+/- 2mm target at 4cm-7cm
Cranial MountingMechanical Testing	Verify performance of SOLOPASS® screw andanchor compared to Reference DeviceMedtronic Navigus Trajectory Guide Kit(K992304). Test methods based on ASTMF543.	Met acceptance criteria for:mean pullout strength ofanchor, mean ratio of yieldstrength vs. insertion torque.
HardwareVerification	Verify performance of system electricaldesign requirements in addition to electricalsafety and EMC.	Pass
Software Verification and Validation
SoftwareVerification andValidation	Demonstrate that all software requirementswere appropriately implemented in thesoftware. Software development processdemonstrates conformity to IEC 62304.	Pass
Design Validation
Design validationstudy	Validation study in simulated use conditionsto demonstrate that SOLOPASS® final designmet user needs.	Pass, user needs weresuccessfully validated

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Conclusions:

In summary, the SOLOPASS® System and predicate device, Sonowand Invite System (K083597, K112469), are substantially equivalent with respect to intended use. Non-clinical testing results support that the subject and predicate devices are substantially equivalent in function for use as neuro-navigation systems with intraoperative ultrasound imaging. The differences between the two devices do not raise new questions of safety and effectiveness.

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).