It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

Device Description

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US).

It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy.

It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument.

The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system.

The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory.

The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient.

It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pari-path Surgical Navigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the Pari-path surgical navigation system. Instead, it describes a more general approach to demonstrating substantial equivalence to predicate devices through various tests.

The reported device performance is also described in general terms, emphasizing that the device "performs according to its specifications" and is "substantially equivalent to its predicate devices." No specific numerical performance metrics (e.g., accuracy, precision) are provided in this summary.

Table (Based on implied criteria and general performance statements):

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety & EMC	Met IEC 60601-1 and IEC 60601-1-2 standards
Software Performance	Verified to perform according to SRS and SDS specifications
Overall Functionality	Demonstrated through bench testing
No New Safety/Effectiveness Issues	Confirmed through testing in comparison to predicate devices
Substantial Equivalence	Established based on performance testing

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

Sample Size for Test Set: The document does not specify a sample size for any of the tests (software verification, electrical safety, or bench testing).
Data Provenance: The document does not provide information regarding the country of origin of data or whether it was retrospective or prospective. It only states that the testing was "performed."

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

The document does not mention using experts to establish ground truth for any test set. The testing described appears to be internal validation (e.g., against specifications, electrical standards, or through bench testing).

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This suggests that the testing likely involved objective measurements against established standards or internal specifications, rather than subjective expert review that would require adjudication.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. The focus of this 510(k) summary is on the substantial equivalence of the device itself, not on comparative human performance with or without the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The primary testing described appears to be standalone testing of the device's components and overall system functionality (e.g., electrical safety, software validation, bench testing). The document does not describe "human-in-the-loop" studies in the context of performance metrics for the device for its 510(k) submission. Its purpose is to guide human operators, so a standalone performance of "algorithm only" in a clinical decision-making sense would not be directly applicable for this device type.

7. Type of Ground Truth Used

The ground truth used for the described testing appears to be based on:

Industry Standards: For electrical safety and electromagnetic compatibility (IEC 60601-1 and IEC 60601-1-2).
Internal Specifications: For software performance (Software Requirements Specifications (SRS) and Software Design Specifications (SDS)).
Engineering Benchmarks: For bench testing to demonstrate performance and accuracy.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in this document.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a surgical navigation system that utilizes electromagnetic tracking and displays instruments relative to an image model; it is not described as an AI/ML algorithm that requires a traditional "training set" for model development. The software validation mentioned refers to verifying its performance against specifications, not training an AI model.

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

Since no training set is mentioned as part of the device's development or validation process in this document, there is no information on how ground truth for a training set was established.

Summary

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JUN 2 7 2014

KB33901
Page 1 of 8

Section 2 510(K) Summary

510 (k) Summary Paritic Inc Traditional 510 (k) pari-path surgical navigation system

Date Prepared: Dec. 10, 2013

Pari-Path

510(k) Applicant: PARITIC, INC 760 PARKSIDE AVENUE BROOKLYN NY 11226 TEL: 718-3042236 Fax: 718-3042233

Premarket Notification 510(K) Submission

Contact name: Kevin Barrett, kevinb@paritic.com

Device Information

Trade Name: pari-path surgical navigation system Common Name: surgical navigation system Regulation/Classification Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750, Regulation Class: II Classification/Product Code: JAK

Device Description:

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US).

It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy.

It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that

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Section 2 510(K) Summary

shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument.

The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system.

The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient.

It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

Indications for Use:

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography (CT) and Ultrasound (US).

It displays the simulated image of an interventional instrument (a tracked insertion tool), such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of patient's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures.

Paritic Inc

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Section 2 510(K) Summary

Comparison chart

	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice
ProductName	Pari-Pathsurgicalnavigationsystem	ig4TM ImageGuidedSystem	ABARISComputerassisted,image-guidedsurgerysystem	SonixGPSNeedleSensor	ElectromagneticTrackingSystem
510(k)Number	K123720	K093146	K053610	K111818	K092619
Manufacture	Paritic Inc	VeranMedicalTechnologiesInc	TraxtalTechnologiesInc	UltrasonixMedicalCorporation	CIVCOMedicalInstrumentsCo.
Intended Use	The Pari-Pathsurgicalnavigationsystem is astereotacticaccessory forComputedTomography(CT) andUltrasound(US).It displays thesimulatedimage of aninterventionalinstrument (atrackedinsertion tool),such as abiopsy needle,an ablation	The ig4TMImage GuidedSystem is astereotacticaccessory forComputedTomography(CT) or 3Dfluoroscopicx-ray systems.The ig4System isindicated fordisplaying aninterventionalinstrumentsuch as abiopsy needle,an aspirationneedle, orablation	ABARIS is astereotaxicaccessory forComputedTomography(CT),MagneticResonance(MR),Ultrasound(US), PositronEmissionTomography(PET), SinglePhotonEmissionComputedTomography(SPECT),Fluoroscopy,Endoscopy	The deviceis intendedto providephysicianswith toolsfor electromagnetictracking ofinstrumentswith respectto imagedata. Thedevice isavailable intwo models0.55mmand 0.9mmin diameter.	The device isintended toprovidephysicianswith tools forelectromagnetictracking ofinstrumentswith respectto imagedata.
Pari-Path			Section 2 510(K) Summary
needle, orprobe, on acomputermonitorscreen thatshows animage modelof the targetorgans and thecurrent andthe projectedfuture path oftheinterventionalinstrument.Ultrasoundimaging isincorporatedwith thePari-pathsurgicalnavigationsystem for thesituation inwhich thetarget organsmay movebecause ofpatient'srespiratory.It is intendedfor treatmentplanning andintra-operativeguidance forsurgicalprocedures. Itis intended foruse in clinicalinterventionsand for	needleon a computermonitor thatalso displays aCT-based or3Dfluoroscopicx-ray-basedmodel of thetargetorgan(s). Theig4 TM Systemcompensates.for thepatient'srespiratoryphases.The ig4 TMSystem isintended foruse in clinicalinterventionsand foranatomicalstructureswherecomputedtomographyor 3Dfluoroscopicx-ray arecurrently usedfor visualizingsuchprocedures.	and otherimagingsystems. Itdisplays thesimulatedimage of atrackedinsertion toolsuch as abiopsyneedle, guidewire or probeon a computermonitorscreen thatshows imagesof the targetorgans and thecurrent andthe projectedfuture path oftheinterventionalinstrumenttakinginto accountmovements ofthe patient.This isintended fortreatmentplanning andintra-operativeguidance forsurgicalprocedures.The devicealso supportsan image-freemode in
				Section 2 510(K) Summary
	anatomicalstructureswhereimaging iscurrently usedfor visualizingsuchprocedures.		which theproximity oftheinterventionaldevice isdisplayedrelative toanotherdevice.The device isintended to beused inclinicalinterventionsand foranatomicalstructureswhereimaging iscurrently usedfor visualizingsuchprocedures.The device isalso intendedfor use inclinicalinterventionsto determinethe proximityof one devicerelative toanother.
Trackingtechnology	Electromagnetictrackingtechnology	Same	Same	Same	Same
Instrumentimages	Displayingdynamicallythe simulated	Same	Same	Same	N/A

Paritic Inc

2-3

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. . .

・

Paritic Inc

・

2-4

・

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Paritic Inc

2-5

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Pari-Path				Section 2 510(K) Summary
	images oftrackedinstruments.
Patientimaging	Use ofacquiredpatientimaging foranatomystructure	Same	Same	Same	Same
Combiningtwo kind ofImages	Combiningthe simulatedimages oftrackedinstrumentswith theacquiredpatientimaging.	Same	Same	Same	N/A
RespiratoryConcern	Useultrasoundimaging tomonitor thereal-timetarget organs'movementcaused bypatient'srespiratory,and displayupdatedspatialpositions ofthe simulatedinsertioninstrumentwith respect tothe ultrasoundimage in realtime.	N/A(ig4TMSystem doesnot useultrasound)	Same(when used inconjunctionwithan ultrasoundsystem)	Same	N/A

Paritic Inc

2-6

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Section 2 510(K) Summary

The intended use among new device and predicate devices is same.

All predicate and new devices have the same intended use for physicians to tr ack and display the simulated instrument with respect to images of the target organs of a patient on a computer monitor screen.
Like the predicate devices: SonixGPS Needle Sensor (K111818) and ABARIS ● Computer assisted, image-guided surgery system (K053610), the new subject d evice. Pari-path surgical navigation system incorporates ultrasound imaging whi ch can observe the movement of anatomy structures caused by the patient's re spiration in real time, and displays the spatial position of the simulated inserti on instrument with respect to the ultrasound image in real time.

The new device presents no new issues of safety and effectiveness and the features of intended use are substantially equivalent between the new and predicate devices.

Furthermore, the new device has the same technological characteristics as predicate devices. The new device and predicate devices are substantially equivalent with respect to the design and technology.

The subject device has different software interface than predicate devices. The software interface does not affect performance and functionality. The software interface does not raise different questions of safety and effectiveness than the predicate devices.

The differences for subject device in sensor diameter, length and connection type compared to the predicate devices do not affect performance and functionality. The differences do not raise different questions of safety and effectiveness than the predicate devices.

The device labeling includes an instruction manual which provides technical description, intended use, cautions, warnings, contraindications and instructions to ensure safe and effective use of the device.

Testing and Performance Data:

A set of software and bench testing were performed in order to demonstrate the performance and accuracy of the surgical navigation system and to verify that it does not raise any new safety and

effectiveness issues in comparison to its predicate devices.

The testing included the following:

Paritic Inc

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K133901
Page 8 of 8

Section 2 510(K) Summary

Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 . (and amendments), and IEC 60601-1-2 (and amendment) standards.
. Software verification and validation testing was conducted to evaluate the performance of the surgical navigation and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS) and Software Design Specifications (SDS).
. Bench test.

Conclusions

The pari-path surgical navigation system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Based on the performance testing results. including software validation, bench testing, it has been established that the pari-path system is substantially equivalent to its predicate devices.

Reference:

Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, CDHR, ODE August 12,2005
Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, CDRH ODE May 11, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2014

PARITIC INC KEVIN BARRETT VICE PRESIDENT 760 PARKSIDE AVENUE BROOKLYN NY 11226

Re: K133901

Trade/Device Name: Pari-path Surgical Navigation System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 15, 2014 Received: June 18, 2014

Dear Mr. Barrett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any routh all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Barrett

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.p)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133901

Device Name Pari-path Surgical Navigation System

Indications for Use (Describe)

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

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