BREAST VOLUME NAVIGATOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 7, 2014 MetriTrack, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K141870 Trade/Device Name: Breast Volume Navigator Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: July 29, 2014 Received: July 30, 2014 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. 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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, FDA for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K141870 Device Name Breast Volume Navigator (BVN) #### Indications for Use (Describe) The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The BVN is intended to acquire, and retrieve digital ultrasound images for computerized 3-dimensional image processing. The BVN will allow exporting to any third party application that has the appropriate level of DICOM compliance. The BVN is intended as a general purpose digital 3D breast ultrasound image processing tool for radiology and surgery. The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/2/Picture/17 description: The image shows a signature over the FDA logo. The signature is illegible, but it appears to be written in cursive. The FDA logo is in the background, and it is partially obscured by the signature. The image is in black and white. 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Breast Volume Navigator (Βνλί™) 510(K) Number: K141870 Submitter's Name: MetriTrack, LLC Address: 4415 W. Harrison Street Suite 230 Hillside, IL 60162 Telephone Number: (708) 498-3578 Contact Person: Mirela Wohlford Date Prepared: July 28, 2014 Name of Device: Breast Volume Navigator (βνλ™) #### Address of Sponsor: MetriTrack, LLC 4415 W. Harrison Street Suite 230 Hillside, IL 60162 Common or Usual Name: System, Imaging, Pulsed Echo, Ultrasonic Regulation Number: 21 CFR 892.1560 Product Code: IYO Device Class: Class II #### Predicate Devices: TomTec Digital Ultrasound Image Analysis System (K963807) Acuson 3D Organ Assessment with Magnetic Position Sensing (K002807) U-Systems ABUS Diagnostic Ultrasound System (K052355) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MetriTrack. The logo consists of the letters "MT" in a stylized font, with the "M" in blue and the "T" in black. The letters are surrounded by three curved lines, resembling radio waves. To the right of the letters is the word "MetriTrack", with "Metri" in blue and "Track" in black. Breast Volume Navigator (BVǸ™) 510(K) Number: K141870 ### Intended Use / Indications for Use: The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The BVN is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3dimensional image processing. The BVN will allow exporting to any third party application that has the appropriate level of DICOM compliance. The BVN is intended as a general purpose digital 3D breast ultrasound image processing tool for radiology and surgery. The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography. ### Technological Characteristics The Breast Volume Navigator (BVN) System comprises hardware components and a software element, including the following components: a magnetic position tracking device, sensor attaching pieces used to attach the magnetic sensors to the skin and ultrasound probe, a central control unit, and software for controlling the system, collecting and processing images and positional data, and performing automated annotation. The Breast Volume Navigator (BVN) has a touch-screen user interface and a push-button for power on the system. The User Interface can be placed on a stand next to the examination table for ease of use and ergonomic adaptation. The BVN has a USB port available for transferring data files via USB Memory Stick. The BVN has an Ethernet port for connection to a PACS system, using DICOM. The BVN has a VGA/DVI Input Ports for capturing images from an ultrasound imaging scanner. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MetriTrack. The logo consists of the letters "MT" in a stylized font, with the "M" in blue and the "T" in black. There are three curved lines above the letters, resembling radio waves. To the right of the letters is the word "MetriTrack", with "Metri" in blue and "Track" in black. Breast Volume Navigator (BVǸ™) #### 510(K) Number: K141870 The Breast Volume Navigator (BVN) System receives ultrasound DICOM images from the US machine via the network connection and telemetry data from a position tracking system. The BVN automatically detects when the image is being frozen on the US machine and takes a snapshot of the telemetry data at that time. Later, when the BVN receives the DICOM image, it associates the telemetry data to the image from the time when the image was frozen on the US machine. The customer's existing ultrasound probe securely attaches to the BVN probe sensor. During a scan, the operator applies constant pressure to the transducer against the patient's breast tissue and can rotate the transducer (pitch and roll) to accommodate for the physical characteristics of the breast. Exam data is subsequently reviewed on standard radiological viewing stations. Any lesions or anomalies discovered during the review process can be evaluated using the localization and measurement tools included in the software. Pursuant to 809.92(a)(6), MetriTrack, LLC claims that the Breast Volume Navigator (BVN) system is substantially equivalent to the devices previously cleared by FDA in K963807, K002807 and K052355. MetriTrack, LLC claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical and operational specifications compared to the predicate devices. The applicant's device (Breast Volume Navigator) and the predicated devices listed above are accessories to an Ultrasonic Pulsed Echo Imaging System that have a Moderate Level of Concern. The MetriTrack Breast Volume Navigator Software Application is Safety Class B according to ANSI/AAMI/IEC 62304: 2006. Determination of the LOC and Safety Class is the result of risk assessment activities per ISO 14971. Further, MetriTrack, LLC has determined that its device advances the field without deviating from the scope and spirit of the Act by enabling the user to visualize the ultrasound probe position and orientation over the patient's breast diagram in real time and perform automatic annotation in a stand-alone device that works with any standard ultrasound imaging system which have been previously cleared by FDA under the 510(k) process. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for MetriTrack. The logo consists of the letters 'MT' enclosed in a circular design, with the word 'MetriTrack' written to the right of the circular design. The 'M' in 'MT' and the word 'MetriTrack' are in a light blue color, while the 'T' in 'MT' is in black. ## Breast Volume Navigator (BVNT™) ## 510(K) Number: K141870 # SUBSTANTIAL EQUIVALENCE CHART | Substantial Equivalence Parameters | | MetriTrack -<br>Breast Volume<br>Navigator<br>(BVN™) | TomTec -<br>Digital<br>Ultrasound<br>Image Analysis<br>System | Acuson - 3D<br>Organ<br>Assessment<br>with Magnetic<br>Position<br>Sensing | U-Systems –<br>ABUS<br>Diagnostic<br>Ultrasound<br>System | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Indications<br>for Use | Use together with a<br>medical ultrasound scanner | Yes | Yes | Yes | Yes | | | Intended to control<br>position and movement of<br>ultrasound transducers for<br>the systematic acquisition<br>of 2 dimensional image<br>slices throughout a volume<br>of interest | Yes | Yes | No | Yes | | | Collecting 3D data during<br>ultrasound scanning | Yes | Yes | Yes | Yes | | | Apply collected 3D data in<br>later image processing | Yes | Yes | Yes | Yes | | | The BVN will allow<br>exporting to any third party<br>application that has the<br>appropriate level of DICOM<br>compliance. | Yes | No | Yes | No | | | The BVN is intended as a<br>general purpose digital 3D<br>breast ultrasound image<br>processing tool for<br>radiology and surgery. | Yes | Yes | Yes | Yes | | | The device is indicated for<br>use as an adjunct to<br>mammography for B-mode<br>ultrasonic imaging of a<br>patient's breast when used<br>with an automatic scanning<br>linear array transducer. | Yes | No | No | Yes | | Patient Population | | This System is<br>intended to | Anyone<br>needs an | Anyone<br>needs an | This System is<br>intended to | | Substantial Equivalence Parameters | MetriTrack -<br>Breast Volume<br>Navigator<br>(BVN™) | TomTec -<br>Digital<br>Ultrasound<br>Image Analysis<br>System | Acuson - 3D<br>Organ<br>Assessment<br>with Magnetic<br>Position<br>Sensing | U-Systems -<br>ABUS<br>Diagnostic<br>Ultrasound<br>System | | | | be used on<br>primarily<br>women<br>patients. | ultrasound<br>examination<br>for an<br>internal<br>organ<br>including<br>breast. | ultrasound<br>examination<br>for an<br>internal<br>organ<br>including<br>breast. | be used on<br>primarily<br>women<br>patients. | | | Design | Using a<br>magnetic<br>position<br>sensing unit<br>to collect 3D<br>spatial<br>position<br>information. | The Device is<br>a high<br>performance<br>computer<br>system based<br>on Intel<br>motherboard<br>and<br>Microsoft<br>DOS/Window<br>s standards<br>and it<br>incorporates<br>a proprietary<br>image<br>digitizer<br>circuit board<br>and<br>proprietary<br>software for<br>the<br>acquisition,<br>analysis,<br>storage and<br>retrieval of<br>3D<br>ultrasound | Using a<br>magnetic<br>position<br>sensing unit<br>to collect 3D<br>spatial<br>position<br>information. | Automated<br>control of<br>custom B<br>Mode<br>ultrasound<br>probe during<br>the scan.<br>Probe<br>scanner<br>located on<br>breast with<br>articulating<br>arm. | | | Substantial Equivalence Parameters | MetriTrack -<br>Breast Volume<br>Navigator<br>(BVN™) | TomTec -<br>Digital<br>Ultrasound<br>Image Analysis<br>System | Acuson - 3D<br>Organ<br>Assessment<br>with Magnetic<br>Position<br>Sensing | U-Systems -<br>ABUS<br>Diagnostic<br>Ultrasound<br>System | | | | | image data<br>sets. | | | | | Where Used | Clinical<br>Radiology<br>Department,<br>Physicians'<br>offices for<br>ultrasound<br>examination | Same | Same | Same | | | End User | Qualified<br>medical<br>imaging<br>personnel<br>that are<br>familiar with<br>traditional<br>breast<br>ultrasound<br>procedures<br>and<br>techniques. | Same | Same | Same | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for MetriTrack. The logo consists of the letters 'MT' enclosed within a stylized circular design, with the word 'MetriTrack' displayed to the right of the symbol. The word 'Metri' is in a light blue color, while 'Track' is in black. # Breast Volume Navigator (в́νλ̀™) ## 510(K) Number: K141870 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for MetriTrack. The logo consists of the letters MT inside of a circle with curved lines above and below it. To the right of the logo is the word "MetriTrack" with "Metri" in a lighter blue color and "Track" in black. #### Breast Volume Navigator (Βνλί™) #### 510(K) Number: K141870 #### Electrical Testing EMC testing per IEC 60601-1-2, Edition 3.0 Issued: March 2007 and Electrical Safety Testing per IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) were performed for the Breast Volume Navigator. All test results were acceptable for the Breast Volume Navigator. #### Performance Data Performance, Verification and Validation testing for the Breast Volume Navigator was performed per internal procedures, which are compliant with 21 CFR Part 820.30, to ensure that all functional requirements have been met, and that core functions execute as expected. {9}------------------------------------------------ Breast Volume Navigator (BVǸ™) ### 510(K) Number: K141870 Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional, accuracy and precision test results. DESIGN VERIFICATION TEST: The design specifications of the Breast Volume Navigator (BVN) system were tested and verified to confirm that the product performance fulfilled those specification requirements. DESIGN VALIDATION TESTS - NON-CLINICAL TESTING: System Validation Testing was performed on a test phantom with 9 test locations in 4 layers above the test phantom, these layers were intended to cover the height of the operative volume, which is 35cm. In this environment the BVN system has achieved the following: - Accuracy and Precision of 5 mm for measuring the distance of a target. - Accuracy and Precision of 5 degrees for measuring the Clock Face Angle of a target. ● - Accuracy of 5 degrees for measuring the angles of the test phantom relative to the examination bed in different anatomical planes, i.e. Coronal, Transverse, and Sagittal planes. ### Substantial Equivalence The Breast Volume Navigator is as safe and effective as the predicated devices: TomTec Digital Ultrasound Image Analysis System (K963807), Acuson 3D Organ Assessment with Magnetic Position Sensing (K002807), and U-Systems ABUS Diagnostic Ultrasound System (K052355). The Breast Volume Navigator has the same indicated uses and similar indications, technological characteristics, and principles of operations as its predicate devices. The minor technological differences between the Breast Volume Navigator and its predicate devices raise no new issues of safety and effectiveness. Performance data demonstrate that the Breast Volume Navigator is as safe and effective as its predicate devices. Thus, the Breast Volume Navigator is substantially equivalent.