SmartTarget

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) 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 | 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 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: 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. # 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. {4}------------------------------------------------ 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 (brachytherapy); and locally-injected drug therapies. # 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. {5}------------------------------------------------ 510(k) Summary able 1 Comparison of Predicate and Reference Devices to Subject Device | Feature | Indications for Use | Predicate<br>Uronav<br>K153073 | Reference Device 1<br>Fusion Bx<br>K153166 | Reference Device 2<br>BioJet<br>K122329 | SmartTarget<br>Proposed Device | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | UroNav is a stereotaxic<br>accessory for image-guided<br>interventional and diagnostic<br>procedures of the prostate<br>gland. It provides 2D and 3D<br>visualization of Ultrasound<br>(US) images and the ability to<br>fuse and register these images<br>with those from other<br>imaging modalities such as<br>Magnetic Resonance (MR),<br>Computed Tomography, etc.<br>It also provides the ability to<br>display a simulated image of<br>a tracked insertion tool such<br>as a biopsy needle, guidewire,<br>grid plate or probe on a<br>computer monitor screen that<br>shows images of the target<br>organ and the current and the<br>projected future path of the<br>interventional instrument<br>taking into account patient<br>movement. Other software<br>features include patient data<br>management, multi-planar<br>reconstruction, segmentation,<br>image measurements and<br>2D/3D image registration. | Fusion Bx is intended for<br>use by physicians for<br>enhanced visualization of<br>ultrasound imaging of<br>the prostate in clinic and<br>hospital settings. It<br>provides 2D and 3D image<br>visualization including<br>review, manipulation, and<br>analysis tools.<br><br>Additional features<br>include patient data<br>management,<br>image measurement,<br>multiplanar reconstruction,<br>3D image registration,<br>segmentation, image<br>annotation, and recording<br>of the locations where the<br>biopsies were acquired<br>during the<br>procedure. | The BioJet software is intended to<br>be used by physicians in the<br>clinic or hospital for 20 and 3D<br>visualization of ultrasound<br>images of the prostate gland.<br>Additional software features<br>include patient data management,<br>multiplanar reconstruction,<br>segmentation, image<br>measurements, and 3-D<br>registration. | The SmartTarget device is<br>intended as an accessory for<br>image-guided interventional<br>and diagnostic procedures<br>involving the prostate gland,<br>and to be used by physicians<br>for enhanced visualization of<br>two-dimensional (2D)<br>transrectal ultrasound TRUS<br>images of the prostate in clinic<br>and hospital settings. It allows<br>the user to segment medical<br>images and it performs three-<br>dimensional (3D)<br>reconstruction of digitized<br>TRUS video images to form a<br>3D TRUS volume. The<br>SmartTarget software provides<br>2D and 3D image visualization<br>features, including the ability<br>to review images, generate<br>multi-planar views, annotate<br>images, and identify and<br>record the locations of<br>instruments inserted during the<br>procedure.<br><br>The device is intended to be<br>used in diagnostic and<br>treatment procedures in a | | | | | | clinical setting in which a<br>needle or other instrument is<br>inserted into the prostate<br>through the perineum or<br>urethra, or instruments that are<br>positioned externally to the<br>prostate so that treatment can<br>be delivered to prostate tissue,<br>or diagnostic information<br>obtained from prostate tissue. | | | | UroNav is intended for<br>treatment planning and<br>guidance for clinical,<br>interventional and/or<br>diagnostic procedures. The<br>device is intended to be used<br>in interventional and<br>diagnostic procedures in a<br>clinical setting. | | | Example procedures include,<br>but are not limited to: needle<br>biopsy in which tissue samples<br>are removed from the prostate;<br>in situ diagnostic techniques,<br>such as those based on optical<br>sensing; thermal tissue<br>ablation using radiofrequency,<br>microwave, laser, cryotherapy,<br>or high-intensity focused<br>ultrasound; photodynamic<br>therapy; irreversible<br>electroporation; radioactive<br>source implantation<br>(brachytherapy); and locally-<br>injected drug therapies. | | | Target<br>anatomy | Prostate | Prostate | Prostate | Prostate | | | Anatomy<br>access | Transperineal<br>Transrectal | Transrectal | Transperineal<br>Transrectal | Transperineal | | | Windows OS | Yes | Yes | Yes | Yes | | | Medical<br>imaging<br>software | Yes | Yes | Yes | Yes | | {6}------------------------------------------------ 510(k) Summary {7}------------------------------------------------ | Summary 15, 2017 15 of 8<br>05<br>510(k) | |------------------------------------------| | | | Feature | Predicate<br>Uronav<br>K153073 | Reference Device 1<br>Fusion Bx<br>K153166 | Reference Device 2<br>BioJet<br>K122329 | SmartTarget<br>Proposed Device | |---------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 3D rendering<br>view | Yes | Yes | Yes | Yes | | Multi-modality<br>Support | Yes | Yes | Yes | Yes | | Live 2D<br>ultrasound | Yes | Yes | Yes | Yes | | Gland<br>segmentation | Yes | Yes | Yes | Yes | | Image<br>registration | Yes | Yes | Yes | Yes | | Rigid<br>registration | Yes | Yes | Yes | Yes | | Elastic<br>registration | Yes | Yes | No | Yes | | Multi-planar<br>reformatting<br>(MPR) | Yes | Yes | Yes | Yes | | DICOM<br>import/export | Yes | Yes | Yes | Import but no export | | Ultrasound<br>video | Yes | Yes | Yes | Yes | | Standard<br>Image<br>viewing tools | Yes | Yes | Yes | Yes | | Measurement<br>tool | Yes | Yes | Yes | No | | Annotation<br>tool | Yes | Yes | Yes | Yes | | Segmentation<br>tool | Yes | Yes | Yes | Yes | | Feature | Predicate<br>Uronav<br>K153073 | Reference Device 1<br>Fusion Bx<br>K153166 | Reference Device 2<br>BioJet<br>K122329 | SmartTarget<br>Proposed 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 sensors<br>attached to US probe | Position encoders attached<br>to an articulated arm that<br>holds a TRUS probe (part<br>of device) | BioJet works with commercially<br>available mechanical stepper and<br>stabilizer assemblies that holds the<br>ultrasound probe and tracks the<br>probe position while the physician<br>performs a normal ultrasound<br>imaging procedure of the subject<br>prostate. [This is an off-the-shelf<br>device] | Position encoders attached to a<br>mechanical US probe stepper<br>device, which holds and secures<br>the US probe by means of a<br>cradle and clamping mechanism<br>(third-party device) | PDF Page 11 of 55 {8}------------------------------------------------ # 510(k) Summary {9}------------------------------------------------ # 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. {10}------------------------------------------------ # 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.