The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy.

The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.

The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

Device Description

The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

IQQA-Guide supports the imaging-based 3D model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. The model of segmentation results may also be loaded from saved reports of the IQOA-BodyImaging software (K141745). Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.

The IQQA-Guide system consists of an EM tracking system, software, and a computer system. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specification)	Reported Device Performance (IQQA-Guide)
System Registration Accuracy (phantom studies)	2.35 ± 1.23 mm (Hospital Site 1)
	2.23 ± 0.82 mm (Hospital Site 2)
System Registration Accuracy (patient studies)	4.62 ± 3.07 mm (Hospital Site 1)
	4.9 ± 1.9 mm (Hospital Site 2)
Electromagnetic Compatibility	Complies with IEC 60601-1-2 standard
Electrical Safety	Complies with IEC 60601-1 standard
Software Functionality	Satisfies design intent
Major Functionalities in Clinical Intervention	Validated by physicians

2. Sample Size and Data Provenance for Test Set

The provided text only mentions "experiments involving intervention on phantoms" and "experiments involving patient studies." It does not specify the exact sample size (number of phantoms or patients) used for the test set.

Data Provenance: The testing was conducted at "two hospital sites". This suggests retrospective or prospective clinical data, though details are not provided. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document mentions that "physicians use the IQQA-Guide during clinical interventional procedures" and "provide feedback along the line of the intended use of the system." It also states "Test results were reviewed by designated technical professionals." However, it does not specify the number of experts or their detailed qualifications (e.g., years of experience, subspecialty) used to establish the ground truth for the test set.

4. Adjudication Method for Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only states that "physicians use the IQQA-Guide" and "provide feedback," and "Test results were reviewed by designated technical professionals."

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

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is mentioned in the provided text. The device is a "stereotactic accessory" for guidance, not an AI for image interpretation or diagnosis.

6. Standalone (Algorithm Only) Performance

The device, IQQA-Guide, is described as a "stereotactic accessory" that displays simulated images of interventional instruments and anatomical models. It relies on physician input for confirmed segmentation results and interactive adjustments. Therefore, it is not a standalone algorithm in the sense of making independent diagnostic or interventional decisions without human-in-the-loop. Its performance is evaluated in the context of aiding a physician.

7. Type of Ground Truth Used

The ground truth for the registration accuracy in phantom studies would likely be based on precisely known physical measurements of the phantom and instrument positions. For patient studies, the ground truth for accuracy would be based on "physician's confirmed segmentation results of patient's image scans" and potentially real-time imaging modalities, but the document does not explicitly state the definitive ground truth method for patient accuracy.

8. Sample Size for the Training Set

The document does not mention the sample size used for any training set. The device is described as an upgrade from already cleared software (IQQA-BodyImaging K141745), but information about its original development or training data is not provided in this 510(k) summary.

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

Since no training set is mentioned, information on how its ground truth was established is not available in the provided text.

Summary

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

November 20, 2015

EDDA Technology % Daniel Kamm Submission Correspondent 5 Independence Way PRINCETON NJ 08540

Re: K151414 Trade/Device Name: IQQA-Guide Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 22, 2015 Received: October 27, 2015

Dear Mr. Kamm:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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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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/Resourcesfor You/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.

Michael O'Hara

For

Robert Ochs, Ph.D. 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) K151414

Device Name IQQA-Guide

Indications for Use (Describe)

The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.

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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EDDA Technology 510(k) Summary K151414 5 Independence Way Princeton, NJ 08540 Tel: 609-919-9889 Fax: 609-919-9779 Contact: Xiaolan Zeng, Executive Vice President Date prepared: November 14, 2015

1. Identification of the Device:
  Proprietary - Trade Name: IQQA-Guide Common Name: Computer assisted image-guided system Classification Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: Class II Product Code: JAK
1. Substantially equivalent legally marketed devices:

Manufacturer	Name of the Predicate Device	FDA 510(k) Number	FDA Clearance Date	CFR/Product Code
Veran MedicalTechnologies	ig4 Image Guided System	K093995	01/27/2010	21 CFR892.1750JAK
Traxtal Technologies	ABARIS, Computer assisted,image-guided system	K053610	04/19/2006	21 CFR892.1750JAK

1. Indications for Use (intended use):
  The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

1. Description of the device:
  The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows

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the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

The EM sensor and accessories that are compatible with the IQQA-Guide are cleared by the FDA in K092619, including eTRAXTM Needle System, General Purpose Sensor, and VirtuTRAX Instrument Navigator. They are not part of the IQQA-Guide system and are sourced separately.

The compatible EM sensor and accessories are connected to the submitted device IQQA-Guide by plugging the connector part of the K092619 sensor into the receptacles on the front panel of the EM tracking system contained in the IQQA-Guide.

The software contained in the submitted device IQQA-Guide (v1.0), is an upgrade from the already cleared IQQA-BodyImaging (K141745).

	Device of 510(k) submission:IQQA-Guide (version 1.0)	Predicate Device:ig4 Image Guided SystemK093995	Predicate Device:ABARIS, Computerassisted, image-guidedsystem K053610
Manufacturer	EDDA Technology	Veran Medical Technologies	Traxtal Technologies
Indications forUse	The IQQA-Guide System is astereotactic accessory for ComputedTomography (CT). It displayssimulated image of interventionalinstruments (such as biopsy needle,ablation needle, probe) on a computermonitor that also shows an imaging-based 3D model of the patientanatomy, and the current and theprojected future path of theinterventional instruments. The systemsupports the imaging-based modelderived from physician's confirmedsegmentation results of patient's imagescans, including intra-operative CT,pre-procedural CT, and CT or MRpreviously acquired before surgicalprocedures. Additionally, overlayingultrasound images (when available)may be displayed with the model ofpatient anatomy. The system supportsa workflow based on automated imageregistrations of spatial mapping fromone image space to another image	The ig4TM Image Guided System is astereotactic accessory for ComputedTomography (CT) or 3Dfluoroscopic x-ray systems.The ig4 System is indicated forinterventional displaying aninstrument such as a biopsy needle,an aspiration needle, or ablationneedle on a computer monitor thatalso displays a CT-based or 3Dfluoroscopic X-ray-based model ofthe target organ(s). The ig4TMSystem is additionally indicated foroverlaying Ultrasound images ontothe model of the target organ(s). Theig4TM System compensates for thepatient's respiratory phases.The ig4TM System is intended foruse in clinical interventions and foranatomical structures wherecomputed tomography, 3Dfluoroscopic x-ray, or ultrasound arecurrently used for visualizing suchprocedures.	ABARIS is a stereotaxicaccessory for ComputedTomography (CT), Magnetic(MR), Resonance, Ultrasound(US), Positron EmissionTomography (PET), SinglePhoton Emission ComputedTomography (SPECT),Fluoroscopy, Endoscopy andother imaging systems. Itdisplays the simulated image ofa tracked insertion tool such as abiopsy needle, guidewire orprobe on a computer monitorscreen that shows images of thetarget organs and the current andthe projected future path of theinterventional instrument takinginto account movementsof the patient. This is intendedfor treatment planning and intra-operative guidance for surgicalprocedures. The device alsosupports an image-free mode in
	Device of 510(k) submission:IQQA-Guide (version 1.0)	Predicate Device:ig4 Image Guided SystemK093995	Predicate Device:ABARIS, Computerassisted, image-guidedsystem K053610
	space, or from image space to physicalspace. Physician may interactivelyadjust and confirm registration results,and evaluate 3D visualization andquantitative information in terms ofdistance, size, and spatial locationassociated with patient anatomy andinstruments. The system is intendedfor intra-operative guidance forsurgical procedures. It is intended foruse by trained physicians in clinicalintervention and for structures whereimaging is currently used forvisualizing such procedures.		which the proximity of theinterventional device isdisplayed relative to anotherdevice. The device is intendedto be used in clinicalinterventions and for anatomicalstructures where imaging iscurrently used for visualizingsuch procedures. The device isalso intended for use in clinicalinterventions to determine theproximity of one device relativeto another.
Trackingtechnology	Electromagnetic trackingtechnology	same	same
ComputerHardwareConfiguration	standard PC hardware	standard PC hardware	standard PC hardware
User Interface	A graphical user interface forusers to interact with thesoftware, select tools and driveworkflow	A graphical user interface forusers to interact with thesoftware, select tools anddrive workflow	A graphical user interfacefor users to interact withthe software, select toolsand drive workflow
Instrumentdisplay	Displaying dynamically thesimulated image of trackedinstrument	same	same
Patientimagingdisplay	Use of acquired patientimaging for anatomy structure:-CT during intervention-CT pre-procedural- Previously acquired CT, MR-Ultrasound during interventionwhen available	Use of acquired patientimaging for anatomystructure:CT, 3D fluoroscopic X-ray,ultrasound	Use of acquired patientimaging for anatomystructure:CT, MR, PET, SPECT,Ultrasound, Fluoroscopyetc
Combineddisplay	Combine the display ofsimulated instrument anddisplay of patientimaging/anatomy model	same	Same
clinicalenvironmentto be used in	Used in clinical interventionsand for anatomical structurewhere imaging is currently usedfor visualizing such procedures	Used in clinical interventionsand for anatomical structurewhere imaging is currentlyused for visualizing suchprocedures	For all stages of surgery.Including hospitaloperating rooms,outpatient surgery centersand procedure rooms
Used by	For use by trained physicians	same	same

5. Comparison with predicate devices - IFU and Technological characteristics

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IQQA-Guide has the same intended use and similar technological/functional features as the predicate devices in providing tools and workflow designs to support physician users to visualize and evaluate tracked interventional instrument with respect to patient imaging data.

The IQQA-Guide device is utilized only by trained professionals. The trained professionals, providing ample opportunity for competent human intervention interpret images and information being displayed. They are competent to determine whether the images and information being displayed can be useful in the decision of patient management. Physicians make all final patient management decision.

IQQA-Guide and predicate devices are substantially equivalent in the areas of technical characteristics, principles of operation, and functional features. IQQA-Guide does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

1. Safety and Effectiveness:
  The IQQA-Guide labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via the company's design control and risk management procedures. Potential hazards are controlled via development and verification and validation testing. The device complies with the following standards:

	Standards No.	Standards Organization	Standards Title	Version	Date
1	PS 3.1 - 3.18(2009)	NEMA	Digital Imaging and Communications inMedicine (DICOM) Set	3	2009
2	ANSI/AAMI/IEC60601-1	ANSI/AAMI/IEC	Medical Electrical Equipment – Part 1: GeneralRequirements forBasic Safety and Essential Performance (ThirdEdition, Amendment 1 2012).	3Ed	2012
3	ANSI/AAMI/IEC60601-1-2	ANSI/AAMI/IEC	Medical Electrical Equipment,Part 1-2: General Requirements for Safety andEssential Performance - Collateral Standard:Electromagnetic Disturbances – Requirementsand Tests. 4th Ed. (2014).	4th Ed	2014

7. Testing Information and Performance:

All product specifications were verified and validated. Testing was performed according to internal company procedures and applicable standards.

The system was tested for electromagnetic compatibility and electrical safety according to the IEC60601-1 and IEC 60601-1-2 standards.

Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals. Additionally, to supplement system and software validation for IQQA-Guide, the company has

conducted testing at clinical site. The purpose of the testing is to have physicians use the IQQA-

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Guide during clinical interventional procedures, validate major functionalities provided by the system, and provide feedback along the line of the intended use of the system. Regarding system registration performance, experiments involving intervention on phantoms showed accuracy of 2.35±1.23mm and 2.23±0.82mm at two hospital sites respectively, and experiments involving patient studies showed accuracy of 4.62±3.07mm and 4.9±1.9mm at two hospital sites respectively.

In all instances, test results support the conclusion that actual device performance satisfies the design intent.

8. Conclusion

The IQQA-Guide has the same intended use as the predicate devices. Test results demonstrate that the device is safe, effective, and does not raise any new potential safety risks. In all material respects, the IQQA-Guide is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.