Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes automated image registration and 3D modeling based on physician-confirmed segmentation, but does not mention AI, ML, or deep learning. The performance metrics are based on accuracy measurements, not typical AI/ML performance metrics like AUC.

Therapeutic

No
The device is described as an intra-operative guidance system that displays simulated images of instruments and patient anatomy. It is a stereotactic accessory for CT and aids in navigation, not directly providing therapy or treatment.

Diagnostic

No

The device is an intra-operative guidance system that displays a 3D model of patient anatomy and instruments for surgical procedures. It does not provide a medical diagnosis or disease identification.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the IQQA-Guide system consists of an EM tracking system, software, and a computer system, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the IQQA-Guide System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IQQA-Guide System's Function: The IQQA-Guide System is a surgical guidance system that uses imaging data (CT, MR, Ultrasound) to help physicians navigate instruments during procedures. It works with the patient's anatomy directly, not with specimens taken from the patient.
Intended Use: The intended use clearly states "intra-operative guidance for surgical procedures." This is a surgical tool, not a diagnostic test performed on a sample.

While the system uses imaging data and performs image processing, its purpose is to guide surgical intervention, not to analyze biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

JAK

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

intra-operative CT, pre-procedural CT, CT, MR, Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physicians in clinical intervention

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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-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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: 2.35±1.23mm (phantom), 2.23±0.82mm (phantom), 4.62±3.07mm (patient), 4.9±1.9mm (patient).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093995, K053610

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K141745, K092619

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 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 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.

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 Medical
Technologies	ig4 Image Guided System	K093995	01/27/2010	21 CFR892.1750
JAK
Traxtal Technologies	ABARIS, Computer assisted,
image-guided system	K053610	04/19/2006	21 CFR892.1750
JAK

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.

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.

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.

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.

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 System
K093995 | Predicate Device:
ABARIS, Computer
assisted, image-guided
system K053610 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | EDDA Technology | Veran Medical Technologies | Traxtal Technologies |
| Indications for
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. 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 | The ig4TM Image Guided System is a
stereotactic accessory for Computed
Tomography (CT) or 3D
fluoroscopic x-ray systems.
The ig4 System is indicated for
interventional displaying an
instrument such as a biopsy needle,
an aspiration needle, or ablation
needle on a computer monitor that
also displays a CT-based or 3D
fluoroscopic X-ray-based model of
the target organ(s). The ig4TM
System is additionally indicated for
overlaying Ultrasound images onto
the model of the target organ(s). The
ig4TM System compensates for the
patient's respiratory phases.
The ig4TM System is intended for
use in clinical interventions and for
anatomical structures where
computed tomography, 3D
fluoroscopic x-ray, or ultrasound are
currently used for visualizing such
procedures. | ABARIS is a stereotaxic
accessory for Computed
Tomography (CT), Magnetic
(MR), Resonance, Ultrasound
(US), Positron Emission
Tomography (PET), Single
Photon Emission Computed
Tomography (SPECT),
Fluoroscopy, Endoscopy and
other imaging systems. It
displays the simulated image of
a tracked insertion tool such as a
biopsy needle, guidewire or
probe on a computer monitor
screen that shows images of the
target organs and the current and
the projected future path of the
interventional instrument taking
into account movements
of the patient. This is intended
for treatment planning and intra-
operative guidance for surgical
procedures. The device also
supports an image-free mode in |
| | Device of 510(k) submission:
IQQA-Guide (version 1.0) | Predicate Device:
ig4 Image Guided System
K093995 | Predicate Device:
ABARIS, Computer
assisted, image-guided
system K053610 |
| | 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. | | which the proximity of the
interventional device is
displayed relative to another
device. The device is intended
to be used in clinical
interventions and for anatomical
structures where imaging is
currently used for visualizing
such procedures. The device is
also intended for use in clinical
interventions to determine the
proximity of one device relative
to another. |
| Tracking
technology | Electromagnetic tracking
technology | same | same |
| Computer
Hardware
Configuration | standard PC hardware | standard PC hardware | standard PC hardware |
| User Interface | A graphical user interface for
users to interact with the
software, select tools and drive
workflow | A graphical user interface for
users to interact with the
software, select tools and
drive workflow | A graphical user interface
for users to interact with
the software, select tools
and drive workflow |
| Instrument
display | Displaying dynamically the
simulated image of tracked
instrument | same | same |
| Patient
imaging
display | Use of acquired patient
imaging for anatomy structure:
-CT during intervention
-CT pre-procedural

Previously acquired CT, MR
-Ultrasound during intervention
when available | Use of acquired patient
imaging for anatomy
structure:
CT, 3D fluoroscopic X-ray,
ultrasound | Use of acquired patient
imaging for anatomy
structure:
CT, MR, PET, SPECT,
Ultrasound, Fluoroscopy
etc |
| Combined
display | Combine the display of
simulated instrument and
display of patient
imaging/anatomy model | same | Same |
| clinical
environment
to be used in | Used in clinical interventions
and for anatomical structure
where imaging is currently used
for visualizing such procedures | Used in clinical interventions
and for anatomical structure
where imaging is currently
used for visualizing such
procedures | For all stages of surgery.
Including hospital
operating rooms,
outpatient surgery centers
and procedure rooms |
| Used by | For use by trained physicians | same | same |

5. Comparison with predicate devices - IFU and Technological characteristics

5

6

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
1	PS 3.1 - 3.18
(2009)	NEMA	Digital Imaging and Communications in
Medicine (DICOM) Set	3	2009
2	ANSI/AAMI/IEC
60601-1	ANSI/AAMI/IEC	Medical Electrical Equipment – Part 1: General
Requirements for
Basic Safety and Essential Performance (Third
Edition, Amendment 1 2012).	3Ed	2012
3	ANSI/AAMI/IEC
60601-1-2	ANSI/AAMI/IEC	Medical Electrical Equipment,
Part 1-2: General Requirements for Safety and
Essential Performance - Collateral Standard:
Electromagnetic Disturbances – Requirements
and 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.