(131 days)
Invivo Corporation UroNav K153073
No
The summary describes image processing, segmentation, 3D reconstruction, and image fusion/registration, but does not mention AI, ML, or related terms.
No
The device is described as an accessory for image-guided interventional and diagnostic procedures, assisting with visualization, image segmentation, and 3D reconstruction. It guides instrument placement during diagnostic and treatment procedures but does not directly perform therapy itself.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended to be used in diagnostic and treatment procedures" and can be used to obtain "diagnostic information from prostate tissue."
No
The device description explicitly states that the SmartTarget software is designed for fusion/registration of TRUS images with 3D images, implying it interacts with and processes data from imaging hardware (TRUS, MRI, CT). While the summary focuses on the software's functions, it is an accessory to image-guided procedures and relies on input from medical imaging devices, making it more than just standalone software.
Based on the provided information, the SmartTarget device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SmartTarget device is used for image-guided procedures directly on the patient's prostate gland. It processes and visualizes medical images (TRUS, MRI, CT) and assists in guiding instruments within the body.
- The intended use and device description focus on image processing, visualization, and guidance during interventional and diagnostic procedures. There is no mention of analyzing biological samples or providing diagnostic information based on the analysis of such samples.
- The performance studies described are bench testing using phantoms, not clinical studies involving the analysis of human specimens.
The SmartTarget device is clearly intended as an accessory for image-guided procedures, providing enhanced visualization and guidance for physicians during interventions on the prostate. This falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 positioned externally to the prostate so that treatment can be delivered to prostate tissue, 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 (brachytherapy); and locally-injected drug therapies.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transrectal ultrasound TRUS, Magnetic Resonance (MR), Computed Tomography (CT), x-ray computed tomography (CT)
Anatomical Site
prostate gland, prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / clinic and hospital settings
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical / Bench: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
image alignment error was 2.0mm. The overall needle-tip placement error was 2.9mm.
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.
Invivo Corporation UroNav K153073
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.
Focal Heathcare Inc. Fusion Bx K153166, Jet Soft SRL BioJet K122329
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
§ 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).
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
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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)
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)
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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
Uronav
K153073 | Reference Device 1
Fusion Bx
K153166 | Reference Device 2
BioJet
K122329 | SmartTarget
Proposed Device |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | UroNav is a stereotaxic
accessory for image-guided
interventional and diagnostic
procedures of the prostate
gland. It provides 2D and 3D
visualization of Ultrasound
(US) images and the ability to
fuse and register these images
with those from other
imaging modalities such as
Magnetic Resonance (MR),
Computed Tomography, etc.
It also provides the ability to
display a simulated image of
a tracked insertion tool such
as a biopsy needle, guidewire,
grid plate or probe on a
computer monitor screen that
shows images of the target
organ and the current and the
projected future path of the
interventional instrument
taking into account patient
movement. Other software
features include patient data
management, multi-planar
reconstruction, segmentation,
image measurements and
2D/3D image registration. | Fusion Bx is intended for
use by physicians for
enhanced visualization of
ultrasound imaging of
the prostate in clinic and
hospital settings. It
provides 2D and 3D image
visualization including
review, manipulation, and
analysis tools.
Additional features
include patient data
management,
image measurement,
multiplanar reconstruction,
3D image registration,
segmentation, image
annotation, and recording
of the locations where the
biopsies were acquired
during the
procedure. | The BioJet software is intended to
be used by physicians in the
clinic or hospital for 20 and 3D
visualization of ultrasound
images of the prostate gland.
Additional software features
include patient data management,
multiplanar reconstruction,
segmentation, image
measurements, and 3-D
registration. | 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
positioned externally to the
prostate so that treatment can
be delivered to prostate tissue,
or diagnostic information
obtained from prostate tissue. | |
| | UroNav is intended for
treatment planning and
guidance for clinical,
interventional and/or
diagnostic procedures. The
device is intended to be used
in interventional and
diagnostic procedures in a
clinical setting. | | | 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. | |
| Target
anatomy | Prostate | Prostate | Prostate | Prostate | |
| Anatomy
access | Transperineal
Transrectal | Transrectal | Transperineal
Transrectal | Transperineal | |
| Windows OS | Yes | Yes | Yes | Yes | |
| Medical
imaging
software | Yes | Yes | Yes | Yes | |
6
510(k) Summary
7
| Summary 15, 2017 15 of 8
05
| 510(k) |
|---|
| Feature | Predicate
Uronav
K153073 | Reference Device 1
Fusion Bx
K153166 | Reference Device 2
BioJet
K122329 | SmartTarget
Proposed Device |
|---------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3D rendering
view | Yes | Yes | Yes | Yes |
| Multi-modality
Support | Yes | Yes | Yes | Yes |
| Live 2D
ultrasound | Yes | Yes | Yes | Yes |
| Gland
segmentation | Yes | Yes | Yes | Yes |
| Image
registration | Yes | Yes | Yes | Yes |
| Rigid
registration | Yes | Yes | Yes | Yes |
| Elastic
registration | Yes | Yes | No | Yes |
| Multi-planar
reformatting
(MPR) | Yes | Yes | Yes | Yes |
| DICOM
import/export | Yes | Yes | Yes | Import but no export |
| Ultrasound
video | Yes | Yes | Yes | Yes |
| Standard
Image
viewing tools | Yes | Yes | Yes | Yes |
| Measurement
tool | Yes | Yes | Yes | No |
| Annotation
tool | Yes | Yes | Yes | Yes |
| Segmentation
tool | Yes | Yes | Yes | Yes |
| Feature | Predicate
Uronav
K153073 | Reference Device 1
Fusion Bx
K153166 | Reference Device 2
BioJet
K122329 | SmartTarget
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
attached to US probe | Position encoders attached
to an articulated arm that
holds a TRUS probe (part
of device) | BioJet works with commercially
available mechanical stepper and
stabilizer assemblies that holds the
ultrasound probe and tracks the
probe position while the physician
performs a normal ultrasound
imaging procedure of the subject
prostate. [This is an off-the-shelf
device] | Position encoders attached to a
mechanical US probe stepper
device, which holds and secures
the US probe by means of a
cradle and clamping mechanism
(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.