(25 days)
No
The summary describes image processing, registration, and navigation based on electromagnetic tracking, but does not mention AI or ML.
No
UroNav is a stereotaxic accessory primarily for image-guided interventional and diagnostic procedures, not directly for therapy. It aids in treatment planning and guidance, but the device itself does not deliver therapy.
Yes
The device explicitly states in its "Intended Use / Indications for Use" section that it is for "diagnostic procedures" and in its "Device Description" that it provides "diagnostic information" and functions "As a diagnostic system".
No
The device description explicitly states that the UroNav system consists of hardware components including an Electromagnetic Measurement System (EMMS) with a Field Generator, System Control Unit, and System Interface Unit(s), as well as a System Unit with a CPU/monitor, medical-grade power supply, and mobile cart. While it includes software, it is not solely software.
Based on the provided information, UroNav is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- UroNav's Function: UroNav is a medical image processing workstation used for image-guided interventional and diagnostic procedures of the prostate gland. It works with imaging modalities like Ultrasound, MR, and CT to visualize the prostate, fuse images, and guide instruments like biopsy needles within the patient's body.
- Focus on In Vivo Procedures: The description clearly states its use in "interventional and diagnostic procedures in a clinical setting," "soft tissue biopsies," "soft tissue ablations," and "placement of fiducial markers." These are all procedures performed on the patient (in vivo).
- No Specimen Analysis: There is no mention of UroNav analyzing biological specimens or providing diagnostic information based on laboratory tests of samples taken from the patient. Its diagnostic role is related to the interpretation and guidance based on medical imaging.
Therefore, UroNav falls under the category of a medical device used for image-guided procedures and diagnosis based on imaging, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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, gridplate 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.
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 image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.
Product codes
LLZ
Device Description
UroNav is a medical image processing workstation that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either preprocedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR), Computed Tomography (CT), etc. When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system.
The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms.
UroNav is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle guides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate.
The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval.
Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-reqistration may be based on another series of ultrasound images or DICOM images.
The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
In addition to standard transrectal procedures, UroNav also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (US), Magnetic Resonance (MR), Computed Tomography (CT)
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in the clinic or hospital; Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.
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 and performance testing has been performed by designated individuals as required by Invivo Corporation's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode. UroNav has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical and performance testing has been performed by designated individuals as required by Invivo Corporation's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode. UroNav has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. The UroNav has been designed to comply with the applicable standards:
- IEC 60601-1:2005
- IEC 60601-1-2:2007
- EN/ISO 14971:2007
- IEC 62366:2007
- IEC 60601-1-6:2010
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 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 symbol that resembles three overlapping human profiles or faces, depicted in a dark color.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K153073
Trade/Device Name: Uronav (Version 2.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21 2015 Received: October 22, 2015
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 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.
1
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 D'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
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K153073 |
|---|---|
| Device Name | UroNav (Version 2.0) |
| Indications for Use (Describe) |
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, gridplate 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.
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 image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue
ablations and placement of fiducial markers.
| 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) |
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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (All) 143-641)
EF
3
(i) Invivo
510(k) Summary
| Submitted by: | Invivo Corporation
3545 SW 47th Avenue
Gainesville, FL 32608 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Name: | Invivo Corporation |
| Establishment
Registration Number: | 1056069 |
| Contact Person: | Kenneth Revennaugh
Director, Quality and Requlatory
Invivo Corporation
3545 SW 47th Avenue
Gainesville, FL 32608
Phone: (352) 384-8590
Email: kenrevennaugh@philips.com |
| Date Prepared: | October 5, 2015 |
| Trade Name: | UroNav (Version 2.0) |
| Common Name: | Medical Image Processing Workstation |
| Classification Name: | System, Image Processing, Radiological |
| Classification
Regulation Number: | 892.2050 |
| Classification: | Class II |
| Classification Panel: | Radiology |
| Product Code: | LLZ |
4
Device Description
UroNav is a medical image processing workstation that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either preprocedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR), Computed Tomography (CT), etc. When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system.
The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms.
UroNav is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle guides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav
5
System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate.
The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval.
Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-reqistration may be based on another series of ultrasound images or DICOM images.
The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
In addition to standard transrectal procedures, UroNav also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.
6
Intended Use
UroNav is a stereotaxic accessory for image-quided 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, gridplate 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.
UroNav is intended for treatment planning and quidance 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 image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.
| Predicate Devices Name | Predicate 510(k) Submission
References |
|-------------------------|-------------------------------------------|
| 3-D Imaging Workstation | K081093 (Primary) |
| BioJet | K122329 (Reference) |
| PercuNav | K121498 (Reference) |
Predicate Device Information & Comparison
The design, function, and specifications of UroNav are similar to the identified legally marketed predicate devices. Similar to the devices from Eigen, LLC (K081093), Jet Soft, SRL (K122329) and Philips Healthcare (K121498), UroNav provides image-guided interventional planning and navigation for prostate procedures, the ability to view and capture live 2D ultrasound data to create reconstructed 3D ultrasound images/models and the ability to fuse and register these images with those acquired and imported from other DICOM-based imaging devices. Similar to all of the above listed predicate devices, UroNav also performs other viewing and image-processing functions such as image registration, multi-planar reformats and includes tools to segment, measure and annotate images. Each of the devices can also output selected image views, processed data and user-defined reports.
7
The main difference between UroNav and the Eigen 3-D Imaging Workstation (K081093) and BioJet (K122329) devices is the method used for procedure navigation and tracking. The UroNav system utilizes an Electromagnetic Measurement System (EMMS) for procedure navigation and tracking while the 3-D Imaging Workstation and BioJet devices utilize a mechanical encoding system to determine the location of the ultrasound probe. This difference in navigation and tracking technique does not significantly affect the use of the device, nor does it raise new or additional safety risks. This difference between UroNav and the Eigen 3-D Imaging Workstation and BioJet devices does not impact device safety or effectiveness.
UroNav and PercuNav (K121498) utilize the identical commercially available Electromagnetic Measurement System (EMMS) for procedure navigation and tracking. UroNav and PercuNav also share common software source code for basic system functionality such as multi-modality image viewing, segmentation, registration, EM navigation, annotation and DICOM functionality.
The differences between UroNav and PercuNav (K121498) include a limited number of indications, options and features of the predicate device, which are not included in the submitted device. While both devices support interventional and diagnostic procedures, the UroNav system does not include support for all of the anatomic locations indicated for PercuNav (e.g., liver, lung, pancreas, etc.). The absence of these anatomic locations does not significantly affect the use of the device, nor does it raise new or additional safety risks. This difference between UroNav and the PercuNav device does not impact device safety or effectiveness.
Other differences between UroNav and the identified predicate devices include minor user interface variations such as GUI design, screen colors and image viewing layouts. These differences are cosmetic in nature do not significantly affect the use of the device, nor do they raise new or additional safety risks. These differences between UroNav and the legally marketed predicate devices do not impact device safety or effectiveness.
Safety and Effectiveness
The UroNav 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 Invivo's Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product (software and hardware) development process, verification and validation testing.
8
Nonclinical Testing and Performance Information
Nonclinical and performance testing has been performed by designated individuals as required by Invivo Corporation's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode. UroNav has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. The UroNav has been designed to comply with the applicable standards:
- IEC 60601-1:2005
- IEC 60601-1-2:2007
- EN/ISO 14971:2007
- IEC 62366:2007
- IEC 60601-1-6:2010
Technological Characteristics
UroNav is a diagnostic and interventional accessory that is comprised of a mobile computer workstation, a commercially-available navigation device and software with functions that are commonly found in various medical imaging applications. It provides convenient options for visualizing diagnostic and interventional information in support of routine clinical procedures of the prostate gland. The device does not directly contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the UroNav system but by Radiologists, Clinicians and referring Physicians.
A physician, providing ample opportunity for competent human intervention interprets the images and information being displayed and maintains control of the clinical procedure at all times.
The UroNav utilizes the same technological characteristics as the predicate devices. Both:
- are PC based software applications that provide 2D and 3D medical image ー acquisition including ultrasound video image acquisition arid visualization of the prostate gland
- । use Windows operating systems
- allow co-registration of live ultrasound images to previously created 3-0 image sets based on previously collected live ultrasound image sets or DICOM images sets
- include image enhancements such as contrast and brightness, zoom and pan capabilities
9
- provide patient and clinical data management features
- deal with live ultrasound images received from commercially available imaging devices
- use graphic overlays to define segmentations
- calibrate ultrasound video images -
- create a report
- allow for image measurements such as volume, length, and angle measurements -
- 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 or of any treatment process what so ever
- are only intended for use on the prostate gland
Following is the comparison of technological characteristics between UroNav and predicate devices:
| Product | Submitted Device:
Invivo
UroNav (Version
2.0) | Primary Predicate
Device:
Eigen, LLC
3-D Imaging
Workstation
K081093 | Reference
Predicate Device:
Jet Soft SRL
BioJet
K122329 | Reference
Predicate Device:
Philips Healthcare
PercuNav
K121498 |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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, gridplate
or probe on a
computer monitor | The 3-D Imaging
Workstation is
intended to be
used by physicians
in the clinic or
hospital for 2-D and
3-D visualization of
ultrasound images
of the prostate
gland. Additional
software features
include patient data
management,
multi-planar
reconstruction,
segmentation,
image
measurement and
3-D image
registration. | The BioJet
software is
intended to be
used by physicians
in the clinic or
hospital for 2D 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. | PercuNav is a
stereotaxic accessory
for Computed
Tomography (CT),
Magnetic Resonance
(MR), Ultrasound
(US), Positron
Emission Tomography
(PET), Single Photon
Emission Computed
Tomography
(SPECT), Rotational
Fluoroscopy,
Endoscopy, and other
imaging systems. CT,
Ultrasound, PET, MR,
and Rotational
Fluoroscopy may be
fused in various
combinations, such as
CT with MR, MR with
ultrasound, etc. It may
include
instrumentation to
display the simulated
image of a tracked
insertion tool such as
a biopsy needle,
guidewire or probe on
a computer monitor |
| Product | Submitted Device:
Invivo
UroNav (Version
2.0) | Primary Predicate
Device:
Eigen, LLC
3-D Imaging
Workstation
K081093 | Reference
Predicate Device:
Jet Soft SRL
BioJet
K122329 | Reference
Predicate Device:
Philips Healthcare
PercuNav
K121498 |
| | 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,
multiplanar
reconstruction,
segmentation,
image
measurements and
2D/3D image
registration.
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 image fusion for
diagnostic clinical
examinations and
procedures, soft
tissue biopsies, soft
tissue ablations
and placement of
fiducial markers. | | | screen that shows
images of the target
organs and the
current and the
projected future path
of the interventional
instrument taking into
account patient
movement. This is
intended for treatment
planning and
guidance for clinical,
interventional and/or
diagnostic
procedures. The
device also supports
an image free mode
in which the proximity
of the interventional
device is displayed
relative to another
device. The device is
intended to be used in
interventional and
diagnostic procedures
in a clinical setting.
The device is also
intended for use in
clinical interventions
to determine the
proximity of one
device relative to
another. Example
procedures include,
but are not limited to:
• Image fusion for
diagnostic clinical
examinations and
procedures
• Soft tissue
biopsies (liver,
lung, kidney,
breast, pancreas,
bladder, adrenal
glands, lymph
node, mesentery,
etc.)
• Soft tissue
ablation (liver,
kidney, breast,
pancreas, lung,
etc.)
• Bone ablation
• Bone biopsies
• Nerve Blocks &
Pain Management
• Drainage
placements |
10
11
| Product | Submitted Device:
Invivo
UroNav (Version
2.0) | Primary Predicate
Device:
Eigen, LLC
3-D Imaging
Workstation
K081093 | Reference
Predicate Device:
Jet Soft SRL
BioJet
K122329 | Reference
Predicate Device:
Philips Healthcare
PercuNav
K121498 |
|---------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | • Hydrodissections
• Bladder
Stimulation
• Fiducial
placements
• Tumor resections
• Sinus procedures
• Intranasal
procedures
• Transphenoidal
procedures |
| Decision Date | Pending | 05/01/2008 | 08/16/2012 | 12/14/2012 |
| Product Code | LLZ | LLZ | LLZ | JAK |
| Class | II | II | II | II |
| Target
Anatomy | Prostate | Prostate | Prostate | Multiple |
| Anatomy
Access | Transrectal &
Transperineal | Transrectal &
Transperineal | Transrectal &
Transperineal | Multiple (including
Transrectal) |
| Software | | | | |
| Windows O.S. | Yes | Yes | Yes | Yes |
| Medical
Imaging
Software | Yes | Yes | Yes | Yes |
| Image
Display | | | | |
| Multi-Modality
Support | Yes | Yes | Yes | Yes |
| General Image
2D/3D Review | Yes | Yes | Yes | Yes |
| 3D Rendering
View | Yes | Yes | Yes | Yes |
| Live 2D
Ultrasound | Yes | Yes | Yes | Yes |
| Image
Processing | | | | |
| 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 |
| Connectivity | | | | |
| DICOM
Import/Export | Yes | Yes | Yes | Yes |
| Ultrasound
Video | Yes | Yes | Yes | Yes |
| Review Tools | | | | |
| Standard
Image Viewing
Tools | Yes | Yes | Yes | Yes |
| Product | Submitted Device:
Invivo
UroNav (Version
2.0) | Primary Predicate
Device:
Eigen, LLC
3-D Imaging
Workstation
K081093 | Reference
Predicate Device:
Jet Soft SRL
BioJet
K122329 | Reference
Predicate Device:
Philips Healthcare
PercuNav
K121498 |
| Measurement
Tools | Yes | Yes | Yes | Yes |
| Annotation
Tools | Yes | Yes | Yes | Yes |
| Segmentation
Tools | Yes | Yes | Yes | Yes |
| Reporting
Tools | Yes | Yes | Yes | Yes |
| Video Capture | Yes | Yes | No | Yes |
| Image
Overlays | Yes | Yes | Yes | Yes |
| Planning &
Navigation | | | | |
| Import Prior
Plans | Yes | Yes | Yes | Yes |
| Import/Add
Targets | Yes | Yes | Yes | Yes |
| Plan/Mark
Locations | Yes | Yes | Yes | Yes |
| Navigation
Type | Electromagnetic | Mechanical | Mechanical | Electromagnetic |
12
The new device and predicate devices are substantially equivalent in the areas of technological characteristics such as basic design, features, energy source, method of operation, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Conclusion
The 510(k) Pre-Market Notification for UroNav contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate devices. Invivo has determined that its device, UroNav, is substantially equivalent to the identified predicate devices listed above. A comparison with the legally marketed predicate devices indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate devices.
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