The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clinic and hospital settings. It allows the user to segment medical images and it performs three-dimensional (3D) reconstruction of digitized TRUS video images to form a 3D TRUS volume. The SmartTarget software provides 2D and 3D image visualization features, including the ability to review images, generate multi-planar views, annotate images, and identify and record the locations of instruments inserted during the procedure.

The device is intended to be used in diagnostic and treatment procedures in a clinical setting in which a needle or other instrument is inserted into the prostate through the perineum or urethra, or instruments that are positiond externally to the prostate so that treatment can be delivered to prostate insue, or diagnostic information obtained from prostate tissue.

Example procedures include, but are not limited to: needle biopsy in which tissue samples are removed from the prostate; in situ diagnostic techniques, such as those based on optical sensing; thermal tissue ablation using radiofrequency, microwave, laser, cryotherapy, or high-intensity focused ultrasound; photodynamic therapy; irreversible electroporation; radioactive source implantation (brachy-injected drug therapies

Device Description

The SmartTarget software is designed for the fusion/registration of transrectal ultrasound (TRUS) images of the prostate with three-dimensional (3D) images, such as a magnetic resonance image (MRI) or x-ray computed tomography (CT) image etcetera, during procedures for which TRUS is used to provide real-time imaging of the prostate, nearby anatomical structures, and instruments inserted into the prostate to guide instrument placement. The software supports the following tasks: computer-assisted surgical planning, allowing target regions to be defined within the prostate in a diagnostic/planning image and TRUS images; reconstruction of 3D TRUS images from multiple US video frames, captured at pre-set intervals as the TRUS probe is translated or rotated; and image fusion/registration wherein the spatial relationship between prostate in the diagnostic/planning image and TRUS images is calculated. The system software reproduces and supplements the visual information provided by real-time TRUS images, and superimposes a graphical representation of one or more target regions on to the reproduced TRUS images. The target region(s) may represent a tumor, another tissue structure visible in the diagnostic/planning image, or a location of clinical relevance (such as a region from which tissue samples are to be removed).Displayed target regions provide additional information to the TRUS image, enabling the operating clinician to direct instruments to these regions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the SmartTarget device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance)	Reported Device Performance (SmartTarget)
Image alignment error (linear distance between image-visible target after registering ultrasound and MRI volumes)	2.0 mm
Overall needle-tip placement error	2.9 mm

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state a specific "test set" in the context of clinical images or patient data. The performance claims are based on "careful laboratory experiments" using "Test phantoms incorporating synthetic prostates."

Sample Size: Not specified for the phantoms, but implied to be sufficient for "careful laboratory experiments."
Data Provenance: Synthetic prostates within test phantoms. No specific country of origin or retrospective/prospective nature is applicable as it's a bench test.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The ground truth for the bench testing was established through precise measurements within the controlled environment of laboratory experiments using phantoms. No human experts were involved in establishing the ground truth for these phantom tests.

4. Adjudication Method for Test Set

Not applicable. As the ground truth was established through physical measurements on phantoms, there was no need for expert adjudication.

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

No. The document describes non-clinical/bench testing. It does not mention any MRMC study comparing human readers with and without AI assistance. The SmartTarget device is an accessory for visualization and guidance, rather than an AI diagnostic tool that directly impacts human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, in essence. The reported performance metrics (image alignment error and needle-tip placement error) are derived from the device's algorithmic and mechanical accuracy during bench testing. This represents the standalone performance of the system in a controlled environment, demonstrating its precision in rendering and guiding.

7. Type of Ground Truth Used

Physical measurements within phantoms/laboratory experiments. The document states: "Test phantoms incorporating synthetic prostates were used to verify the accuracy of both the image registration/fusion functionality and physical instrument placement error during guided needle insertion."

8. Sample Size for Training Set

Not specified. The document primarily focuses on the device's functionality, comparison to predicates, and non-clinical performance testing. It does not provide details about a training set for machine learning models, as the device's core functionality appears to be image processing, registration, and visualization rather than a machine learning-based diagnostic algorithm requiring extensive training data.

9. How Ground Truth for Training Set Was Established

Not applicable. As no training set information is provided, the method for establishing its ground truth is also not mentioned.

Summary

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

June 7, 2017

SmartTarget, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K170250

Trade/Device Name: SmartTarget Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 18, 2017 Received: May 19, 2017

Dear Mr. Job:

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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

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,

Michael D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170250

Device Name

SmartTarget

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary May 15, 2017 Page 1 of 8 Official Contact: Dean Barratt SmartTarget. Ltd The Network Building (c/o UCL Business PLC), 97 Tottenham Court Road London, UK W1T4TP Tel: +44 (0)20 7993 2390 Proprietary or Trade Name: SmartTarget Common/Usual Name: Picture archiving and communications system Classification Name: Picture archiving and communications system LLZ, Class II, 21 CFR 892.2050 Predicate Device: Invivo Corporation UroNav K153073 Reference Devices: Focal Heathcare Inc. Fusion Bx K153166 Jet Soft SRL BioJet K122329

Device Description:

Indications for Use:

The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of twodimensional (2D) transrectal ultrasound TRUS images of the prostate in clinic and hospital settings. It allows the user to segment medical images and it performs three-dimensional (3D) reconstruction of digitized TRUS video images to form a 3D TRUS volume. The SmartTarget software provides 2D and 3D image visualization features, including the ability to review images, generate multi-planar views, annotate images, and identify and record the locations of instruments inserted during the procedure.

The device is intended to be used in diagnostic and treatment procedures in a clinical setting in which a needle or other instrument is inserted into the prostate through the perineum or urethra, or instruments that are positioned externally to the prostate so that treatment can be delivered to prostate tissue, or diagnostic information obtained from prostate tissue.

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Contraindications:

None

Device Comparison

Table 1 compares the subject device to the predicate UroNav (K153073) and the reference devices Fusion Bx (K153166) and BioJet (K122329). The reference devices have been included to support use of mechanical encoder technology whereas the predicate had used electromagnetic tracking.

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510(k) Summary

able 1 Comparison of Predicate and Reference Devices to Subject Device

Feature	Indications for Use	PredicateUronavK153073	Reference Device 1Fusion BxK153166	Reference Device 2BioJetK122329	SmartTargetProposed Device
		UroNav is a stereotaxicaccessory for image-guidedinterventional and diagnosticprocedures of the prostategland. It provides 2D and 3Dvisualization of Ultrasound(US) images and the ability tofuse and register these imageswith those from otherimaging modalities such asMagnetic Resonance (MR),Computed Tomography, etc.It also provides the ability todisplay a simulated image ofa tracked insertion tool suchas a biopsy needle, guidewire,grid plate or probe on acomputer monitor screen thatshows images of the targetorgan and the current and theprojected future path of theinterventional instrumenttaking into account patientmovement. Other softwarefeatures include patient datamanagement, multi-planarreconstruction, segmentation,image measurements and2D/3D image registration.	Fusion Bx is intended foruse by physicians forenhanced visualization ofultrasound imaging ofthe prostate in clinic andhospital settings. Itprovides 2D and 3D imagevisualization includingreview, manipulation, andanalysis tools.Additional featuresinclude patient datamanagement,image measurement,multiplanar reconstruction,3D image registration,segmentation, imageannotation, and recordingof the locations where thebiopsies were acquiredduring theprocedure.	The BioJet software is intended tobe used by physicians in theclinic or hospital for 20 and 3Dvisualization of ultrasoundimages of the prostate gland.Additional software featuresinclude patient data management,multiplanar reconstruction,segmentation, imagemeasurements, and 3-Dregistration.	The SmartTarget device isintended as an accessory forimage-guided interventionaland diagnostic proceduresinvolving the prostate gland,and to be used by physiciansfor enhanced visualization oftwo-dimensional (2D)transrectal ultrasound TRUSimages of the prostate in clinicand hospital settings. It allowsthe user to segment medicalimages and it performs three-dimensional (3D)reconstruction of digitizedTRUS video images to form a3D TRUS volume. TheSmartTarget software provides2D and 3D image visualizationfeatures, including the abilityto review images, generatemulti-planar views, annotateimages, and identify andrecord the locations ofinstruments inserted during theprocedure.The device is intended to beused in diagnostic andtreatment procedures in a
				clinical setting in which aneedle or other instrument isinserted into the prostatethrough the perineum orurethra, or instruments that arepositioned externally to theprostate so that treatment canbe delivered to prostate tissue,or diagnostic informationobtained from prostate tissue.
	UroNav is intended fortreatment planning andguidance for clinical,interventional and/ordiagnostic procedures. Thedevice is intended to be usedin interventional anddiagnostic procedures in aclinical setting.			Example procedures include,but are not limited to: needlebiopsy in which tissue samplesare removed from the prostate;in situ diagnostic techniques,such as those based on opticalsensing; thermal tissueablation using radiofrequency,microwave, laser, cryotherapy,or high-intensity focusedultrasound; photodynamictherapy; irreversibleelectroporation; radioactivesource implantation(brachytherapy); and locally-injected drug therapies.
Targetanatomy	Prostate	Prostate	Prostate	Prostate
Anatomyaccess	TransperinealTransrectal	Transrectal	TransperinealTransrectal	Transperineal
Windows OS	Yes	Yes	Yes	Yes
Medicalimagingsoftware	Yes	Yes	Yes	Yes

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510(k) Summary

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Summary 15, 2017 15 of 805510(k)

Feature	PredicateUronavK153073	Reference Device 1Fusion BxK153166	Reference Device 2BioJetK122329	SmartTargetProposed Device
3D renderingview	Yes	Yes	Yes	Yes
Multi-modalitySupport	Yes	Yes	Yes	Yes
Live 2Dultrasound	Yes	Yes	Yes	Yes
Glandsegmentation	Yes	Yes	Yes	Yes
Imageregistration	Yes	Yes	Yes	Yes
Rigidregistration	Yes	Yes	Yes	Yes
Elasticregistration	Yes	Yes	No	Yes
Multi-planarreformatting(MPR)	Yes	Yes	Yes	Yes
DICOMimport/export	Yes	Yes	Yes	Import but no export
Ultrasoundvideo	Yes	Yes	Yes	Yes
StandardImageviewing tools	Yes	Yes	Yes	Yes
Measurementtool	Yes	Yes	Yes	No
Annotationtool	Yes	Yes	Yes	Yes
Segmentationtool	Yes	Yes	Yes	Yes
Feature	PredicateUronavK153073	Reference Device 1Fusion BxK153166	Reference Device 2BioJetK122329	SmartTargetProposed Device
Video capture	Yes	Yes	Yes	Yes
Image overlays	Yes	Yes	Yes	Yes
Import prior plans	Yes	Yes	Yes	Yes
Import/Add targets	Yes	Yes	Yes	Yes
Plan/Mark locations	Yes	Yes	Yes	Yes
Navigation type	3D electromagnetic sensorsattached to US probe	Position encoders attachedto an articulated arm thatholds a TRUS probe (partof device)	BioJet works with commerciallyavailable mechanical stepper andstabilizer assemblies that holds theultrasound probe and tracks theprobe position while the physicianperforms a normal ultrasoundimaging procedure of the subjectprostate. [This is an off-the-shelfdevice]	Position encoders attached to amechanical US probe stepperdevice, which holds and securesthe US probe by means of acradle and clamping mechanism(third-party device)

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510(k) Summary

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Substantial Equivalence Discussion

We discuss the table above.

Indications for Use / Patient Population / Environment of Use:

As in comparison of Indications for Use above, we can conclude that the indications for use for the SmartTarget and the predicate are substantially equivalent. When compared to the reference device taking into consideration the device description, the SmartTarget and Fusion Bx are substantially equivalent. Discussion:

The differences in proposed indications for use are minor: The UroNav device supports TRUS-guided procedures wherein instruments are inserted via either the transperineal or transrectal route, whereas SmartTarget does not support transrectal instrument insertion. These minor differences do not raise new risk or safety concerns, and the subject device can be found substantially equivalent.

Prescriptive:

The Smart Target, reference and predicate are prescription devices.

Discussion:

There are no differences, thus the subject device can be found substantially equivalent.

Design and Technology:

The SmartTarget utilizes the same technological characteristics as the predicate device. Both:

. are PC based software applications that provide 2D and 3D medical image acquisition including ultrasound video image acquisition arid visualization of the prostate
. use the Windows operating systems
allow co-registration of digitized live US images, which are reconstructed to form a 3D US image, to ● previously a created 3D image, transferred and stored as a set of DICOM image slices
include image enhancements, such as contrast and brightness control ●
provide patient and clinical data management features
permit the digitization of live US video images received from commercially available imaging devices
. use graphical overlays to represent target regions of interest (such as tumors)
calibrate US video images
create a report
allow multi-planar reformatting
allow manual planning of instrument positioning including biopsy needle placement and planning
allow the user to plan and mark the reached positions of the biopsies and instruments
do not steer or in any way control the positioning of the instruments used
do not control or influence in any way devices or processes used to treat tissue ●
. are only intended for use in TRUS-guided procedures involving the prostate.

The UroNav includes an Electromagnetic Measurement System (EMMS) for procedure navigation and instrument tracking. In this system, small EM sensors, attached to the TRUS probe, measure the 3D physical position and orientation of the SmartTarget interfaces with a third-party mechanical stepper device (such as CIVCO EX3 Stepper 510(k) K 131161) fitted with digital position encoders to determine the 3D position and orientation of the probe. This technology is similar to the reference devices which use position encoders.

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Discussion:

The highlighted difference in navigation and tracking technique employed in the UroNav and SmartTarget devices does not significantly affect the use of the device and does not raise new or additional safety risks since these techniques may be considered alternative yet equivalent means of determining the location of the TRUS probe. The tracking technique is similar to the reference device (Fusion Bx) which uses position encoders attached to an articulated arm that holds a TRUS probe. In all other respects, the design and technology of the two devices are substantially equivalent.

Performance and Specifications:

Both the UroNav and SmartTarget have been subjected to non-clinical and performance testing procedures by designated individuals as required by the quality procedures of the respective manufacturers. Both devices, verification and validation test plans were designed to evaluate all input functions, and actions performed by each device in each operational mode.

Discussion:

There are no differences, thus the subject device can be found substantially equivalent.

Compliance with Standards:

SmartTarget uses commercial off-the-shelf hardware that is separately approved and that comply with AAMI/ANSVES 60601-1 and IEC 60601-1-2. The Uronav includes hardware and complies with IEC 60601-1 and IEC 60601-1-2.

Discussion:

Both the SmartTarget and the predicate device comply with the relevant standards and thus can be found substantially equivalent.

Nonclinical / Bench:

The SmartTarget was tested against its design specifications and all were met. Test phantoms incorporating synthetic prostates were used to verify the accuracy of both the image registration/fusion functionality and physical instrument placement error during guided needle insertion. From careful laboratory experiments, the measured image alignment error, determined as the linear distance between the locations of an image-visible target after registering ultrasound and MRI volumes was 2.0mm. The overall needle-tip placement error was 2.9mm. These errors are considered to be acceptable for the clinical applications for which the SmartTarget system is to be used.

Biocompatibility:

There are no patient contact parts of the SmartTarget device.

Substantial Equivalence Conclusion

Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance we believe we have demonstrated that the SmartTarget is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

SmartTarget

Indications for Use (Describe)

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Device Description:

Indications for Use:

Contraindications:

Device Comparison

510(k) Summary

Substantial Equivalence Discussion

Indications for Use / Patient Population / Environment of Use:

Prescriptive:

Discussion:

Design and Technology:

Discussion:

Performance and Specifications:

Discussion:

Compliance with Standards:

Discussion:

Nonclinical / Bench:

Biocompatibility:

Substantial Equivalence Conclusion

§ 892.2050 Medical image management and processing system.

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