(27 days)
Not Found
No
The summary describes image processing and automated annotation, but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on accuracy and precision of measurements, not on classification or prediction tasks typically associated with AI/ML in medical imaging.
No
The device is described as an "add-on accessory for existing ultrasound imaging systems" intended for "systematic acquisition of 2 dimensional image slices" and "digital 3D breast ultrasound image processing" for "radiology and surgery." Its function is to acquire and process images for diagnostic purposes, not to treat a condition.
Yes
The BVN system is intended to acquire and process 3D breast ultrasound images, and its purpose is described as a "general purpose digital 3D breast ultrasound image processing tool for radiology and surgery." It allows for the review of exam data and the evaluation of "lesions or anomalies" using localization and measurement tools. This functionality, particularly the identification and measurement of potential anomalies for radiological and surgical use, indicates a diagnostic purpose.
No
The device description explicitly states that the system comprises both hardware components and a software element, listing several hardware components like a magnetic position tracking device, sensors, and a central control unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BVN Function: The Breast Volume Navigator (BVN) is described as an add-on accessory for existing ultrasound imaging systems. Its primary function is to control the position and movement of ultrasound transducers to acquire 2D image slices for 3D processing. It processes and displays images obtained from the patient's body using ultrasound, not on samples taken from the patient's body.
- Intended Use: The intended use clearly states it's for "B-mode ultrasonic imaging of a patient's breast" and as a "general purpose digital 3D breast ultrasound image processing tool." This involves imaging the breast in vivo, not analyzing samples in vitro.
- Device Description: The components and operation described relate to image acquisition, processing, and display based on ultrasound signals, not laboratory analysis of biological samples.
Therefore, the BVN falls under the category of a medical imaging device, specifically an accessory for ultrasound systems, rather than an in vitro diagnostic device.
N/A
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, 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.
Product codes
IYO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Patient's breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical imaging personnel that are familiar with traditional breast ultrasound procedures and techniques.
Clinical Radiology Department, Physicians' offices for ultrasound examination.
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
Not Found
Summary of Performance Studies
STUDY TYPE: Design Verification Test, Design Validation Tests - Non-Clinical Testing
SAMPLE SIZE: Not explicitly stated, phantoms were used with 9 test locations in 4 layers.
AUC: Not Found
MRMC: Not Found
STANDALONE PERFORMANCE: Not Found
KEY RESULTS:
- 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.
Key Metrics
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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" (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
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)
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Image /page/3/Picture/0 description: The image shows the logo for MetriTrack. The logo consists of the letters "MT" in a light blue color, with three curved lines above the letters. To the right of the letters is the word "MetriTrack", with "Metri" in light blue and "Track" in black. The logo is simple and modern, and the use of color is effective in creating a visually appealing design.
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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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.
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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 -
Breast Volume
Navigator
(BVN™) | TomTec -
Digital
Ultrasound
Image Analysis
System | Acuson - 3D
Organ
Assessment
with Magnetic
Position
Sensing | U-Systems –
ABUS
Diagnostic
Ultrasound
System |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications
for Use | Use together with a
medical ultrasound scanner | Yes | Yes | Yes | Yes |
| | Intended to control
position and movement of
ultrasound transducers for
the systematic acquisition
of 2 dimensional image
slices throughout a volume
of interest | Yes | Yes | No | Yes |
| | Collecting 3D data during
ultrasound scanning | Yes | Yes | Yes | Yes |
| | Apply collected 3D data in
later image processing | Yes | Yes | Yes | Yes |
| | The BVN will allow
exporting to any third party
application that has the
appropriate level of DICOM
compliance. | Yes | No | Yes | No |
| | The BVN is intended as a
general purpose digital 3D
breast ultrasound image
processing tool for
radiology and surgery. | Yes | Yes | Yes | Yes |
| | The device 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. | Yes | No | No | Yes |
| Patient Population | | This System is
intended to | Anyone
needs an | Anyone
needs an | This System is
intended to |
| Substantial Equivalence Parameters | MetriTrack -
Breast Volume
Navigator
(BVN™) | TomTec -
Digital
Ultrasound
Image Analysis
System | Acuson - 3D
Organ
Assessment
with Magnetic
Position
Sensing | U-Systems -
ABUS
Diagnostic
Ultrasound
System | |
| | be used on
primarily
women
patients. | ultrasound
examination
for an
internal
organ
including
breast. | ultrasound
examination
for an
internal
organ
including
breast. | be used on
primarily
women
patients. | |
| Design | Using a
magnetic
position
sensing unit
to collect 3D
spatial
position
information. | The Device is
a high
performance
computer
system based
on Intel
motherboard
and
Microsoft
DOS/Window
s standards
and it
incorporates
a proprietary
image
digitizer
circuit board
and
proprietary
software for
the
acquisition,
analysis,
storage and
retrieval of
3D
ultrasound | Using a
magnetic
position
sensing unit
to collect 3D
spatial
position
information. | Automated
control of
custom B
Mode
ultrasound
probe during
the scan.
Probe
scanner
located on
breast with
articulating
arm. | |
| Substantial Equivalence Parameters | MetriTrack -
Breast Volume
Navigator
(BVN™) | TomTec -
Digital
Ultrasound
Image Analysis
System | Acuson - 3D
Organ
Assessment
with Magnetic
Position
Sensing | U-Systems -
ABUS
Diagnostic
Ultrasound
System | |
| | | image data
sets. | | | |
| Where Used | Clinical
Radiology
Department,
Physicians'
offices for
ultrasound
examination | Same | Same | Same | |
| End User | Qualified
medical
imaging
personnel
that are
familiar with
traditional
breast
ultrasound
procedures
and
techniques. | Same | Same | Same | |
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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
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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.