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.

Device Description

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.

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.

AI/ML Overview

The document provides information on the Breast Volume Navigator (BVN), a device intended to assist with 3D breast ultrasound image processing.

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional/Accuracy)	Reported Device Performance
Accuracy and Precision of Distance Measurement	5 mm
Accuracy and Precision of Clock Face Angle Measurement	5 degrees
Accuracy of Anatomical Plane Angle Measurement (Coronal, Transverse, Sagittal)	5 degrees

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: The document explicitly states "9 test locations in 4 layers" for the design validation tests. This refers to 36 distinct points (9 locations x 4 layers) on a test phantom where measurements were taken.
Data Provenance: The testing was conducted "in-house by trained personnel in a simulated work-environment using phantoms." This indicates a prospective and controlled laboratory setting using simulated data (phantoms) rather than human patient data. There is no mention of country of origin as it was a simulated environment.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for the test set. Given that the testing was performed on a phantom in a simulated environment, the "ground truth" for distance and angle measurements would likely be derived from the known physical specifications of the phantom and the calibrated measurement tools used, rather than expert consensus on medical images.

4. Adjudication Method (Test Set)

The document does not specify an adjudication method. Since the testing was conducted on a phantom with known physical properties, the ground truth would be objectively verifiable through the phantom's design and measurement instruments, not through clinical adjudication.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or any comparison of human readers with vs. without AI assistance. The study focuses purely on the device's technical performance with phantoms.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Performance, Verification and Validation testing" and "DESIGN VALIDATION TESTS - NON-CLINICAL TESTING" sections describe tests performed on the device (Breast Volume Navigator system) in a simulated environment using phantoms, without human intervention for interpretation of the results from the device itself. The device is assessed for its ability to accurately measure distances and angles of targets on the phantom.

7. Type of Ground Truth Used (Test Set)

The ground truth used for the test set was based on the known physical dimensions and configurations of a test phantom. This is a form of engineered or objective ground truth, as opposed to expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for Training Set

The document does not provide any information regarding a training set sample size. The tests described are purely performance verification and validation against design specifications using simulated data, not an AI or machine learning model that would require a training set.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned or implied by the type of device and testing described, there is no information on how ground truth for a training set was established. The BVN appears to be a hardware/software system for navigation and 3D data acquisition/processing, not a diagnostic AI algorithm that learns from data.

Summary

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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.

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.

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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" (21CFR 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,

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

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Indications for Use

510(k) Number (if known) K141870

Device Name Breast Volume Navigator (BVN)

Indications for Use (Describe)

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)

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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)

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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

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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.

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.

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Breast Volume Navigator (BVNT™)

510(K) Number: K141870

SUBSTANTIAL EQUIVALENCE CHART

Substantial Equivalence Parameters		MetriTrack -Breast VolumeNavigator(BVN™)	TomTec -DigitalUltrasoundImage AnalysisSystem	Acuson - 3DOrganAssessmentwith MagneticPositionSensing	U-Systems –ABUSDiagnosticUltrasoundSystem
Indicationsfor Use	Use together with amedical ultrasound scanner	Yes	Yes	Yes	Yes
	Intended to controlposition and movement ofultrasound transducers forthe systematic acquisitionof 2 dimensional imageslices throughout a volumeof interest	Yes	Yes	No	Yes
	Collecting 3D data duringultrasound scanning	Yes	Yes	Yes	Yes
	Apply collected 3D data inlater image processing	Yes	Yes	Yes	Yes
	The BVN will allowexporting to any third partyapplication that has theappropriate level of DICOMcompliance.	Yes	No	Yes	No
	The BVN is intended as ageneral purpose digital 3Dbreast ultrasound imageprocessing tool forradiology and surgery.	Yes	Yes	Yes	Yes
	The device is indicated foruse as an adjunct tomammography for B-modeultrasonic imaging of apatient's breast when usedwith an automatic scanninglinear array transducer.	Yes	No	No	Yes
Patient Population		This System isintended to	Anyoneneeds an	Anyoneneeds an	This System isintended to
Substantial Equivalence Parameters	MetriTrack -Breast VolumeNavigator(BVN™)	TomTec -DigitalUltrasoundImage AnalysisSystem	Acuson - 3DOrganAssessmentwith MagneticPositionSensing	U-Systems -ABUSDiagnosticUltrasoundSystem
	be used onprimarilywomenpatients.	ultrasoundexaminationfor aninternalorganincludingbreast.	ultrasoundexaminationfor aninternalorganincludingbreast.	be used onprimarilywomenpatients.
Design	Using amagneticpositionsensing unitto collect 3Dspatialpositioninformation.	The Device isa highperformancecomputersystem basedon IntelmotherboardandMicrosoftDOS/Windows standardsand itincorporatesa proprietaryimagedigitizercircuit boardandproprietarysoftware fortheacquisition,analysis,storage andretrieval of3Dultrasound	Using amagneticpositionsensing unitto collect 3Dspatialpositioninformation.	Automatedcontrol ofcustom BModeultrasoundprobe duringthe scan.Probescannerlocated onbreast witharticulatingarm.
Substantial Equivalence Parameters	MetriTrack -Breast VolumeNavigator(BVN™)	TomTec -DigitalUltrasoundImage AnalysisSystem	Acuson - 3DOrganAssessmentwith MagneticPositionSensing	U-Systems -ABUSDiagnosticUltrasoundSystem
		image datasets.
Where Used	ClinicalRadiologyDepartment,Physicians'offices forultrasoundexamination	Same	Same	Same
End User	Qualifiedmedicalimagingpersonnelthat arefamiliar withtraditionalbreastultrasoundproceduresandtechniques.	Same	Same	Same

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Breast Volume Navigator (в́νλ̀™)

510(K) Number: K141870

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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.

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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.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.