(24 days)
Not Found
No
The description focuses on 3D visualization and display of ultrasound data, without mentioning any AI/ML algorithms for analysis or interpretation. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a software application for visualizing and analyzing ultrasound volume data of musculoskeletal structures; it does not directly treat or provide therapy.
Yes
The device is described as a software application that allows users to "observe images and perform analyses of musculoskeletal structures" using ultrasound data, and provides "clinicians with three-dimensional models of the joint anatomy." Observations and analyses of anatomical structures are inherently diagnostic in nature.
No
The device description explicitly states that the system includes hardware components such as ultrasound systems (SonixOne or SonixTouch Q+), a linear transducer, a driveBAY™ tracking unit, electromagnetic sensors, and a foot switch. While the core functionality is software-based visualization, it is integrated with and dependent on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "display and 3D visualization of ultrasound volume data" and to "observe images and perform analyses of musculoskeletal structures using the ultrasound volume data". This is focused on imaging and visualization of structures within the body.
- Device Description: The description reinforces this by explaining how it uses ultrasound signals to "visualize musculoskeletal structures in three dimensions" and provides "three-dimensional models of the joint anatomy".
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a patient's health status. This device does not involve the analysis of such specimens.
The device is an imaging software application used in conjunction with an ultrasound scanner to visualize internal structures, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
JointVue's 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scamer. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.
Product codes
LLZ
Device Description
JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions.
The 3D Echo software is pre-loaded on one of the following two ultrasound systems: 1) SonixOne, a tablet-based system; or 2) SonixTouch Q+ with linear transducer (BK Ultrasound model L14-5/38 GPS) and driveBAY™ tracking unit (Ascension Technology Corporation). There are also two electromagnetic (EM) sensors (Ascension 6DOF sensors, model 800, part #600786) included with the JointVue 3D echo software to identify the relative location of the ultrasound probe. Finally, there is a foot switch (stuete model MKF-2-MED GP25) included as an input device.
The major software functions of the JointVue 3D Echo system include the following: 1) the ability to display axial, sagittal, coronal and oblique 2D images; 2) the ability to display the 3D surface of musculoskeletal structures; 3) the ability to display axial images with 3D visualization; and 4) the ability to provide contouring and US image visualization.
The device is intended to be used in a clinical or hospital environment.
JointVue's 3D Echo ultrasound system utilizes raw ultrasound signals to detect tissue interfaces and visualize joint anatomy in three dimensions. The system provides clinicians with three-dimensional models of the joint anatomy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound volume data
Anatomical Site
musculoskeletal structures, joint anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals including physicians, nurses, and technicians.
Clinical or hospital environment.
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, sample size, AUC, MRMC, standalone performance, key results)
Benchtop testing using a phantom was presented to demonstrate safety and effectiveness of the device with the same accuracy and precision as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JointVue, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K172513
Trade/Device Name: 3D Echo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2017 Received: August 21, 2017
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
Image /page/0/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird or a human figure. The logo is black and white.
September 14, 2017
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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.
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172513
Device Name 3D Echo
Indications for Use (Describe)
JointVue's 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scamer. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.
| 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) |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
-
- SUBMITTER JointVue, LLC 2099 Thunderhead Rd., Suite 104 Knoxville TN, 37922 Tel: (877) 725-6920 x101
| Contact Person: | Mohamed R. Mahfouz, |
|---|---|
| Title: | President/CEO |
| Date Prepared: | August 4, 2017 |
| II. DEVICE | |
|---|---|
| Name of Device: | 3D Echo |
| Classification Name: | Picture Archiving and Communications System |
| Regulation: | 21 CFR 892.2050 |
| Regulatory Class: | Class II |
| Product Classification Code: | LLZ |
III. PREDICATE DEVICE
| Predicate Manufacturer: | Samsung Medison CO., LTD |
|---|---|
| Predicate Trade Name: | 5D Viewer |
| Predicate 510(k): | K161955 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions.
The 3D Echo software is pre-loaded on one of the following two ultrasound systems: 1) SonixOne, a tablet-based system; or 2) SonixTouch Q+ with linear transducer (BK Ultrasound model L14-5/38 GPS) and driveBAY™ tracking unit (Ascension Technology Corporation). There are also two electromagnetic (EM) sensors (Ascension 6DOF sensors, model 800, part #600786) included with the JointVue 3D echo software to identify the relative location of the ultrasound probe. Finally, there is a foot switch (stuete model MKF-2-MED GP25) included as an input device.
The major software functions of the JointVue 3D Echo system include the following: 1) the ability to display axial, sagittal, coronal and oblique 2D images; 2) the ability to display the 3D surface of musculoskeletal structures; 3) the ability to display axial
4
images with 3D visualization; and 4) the ability to provide contouring and US image visualization.
The device is intended to be used in a clinical or hospital environment.
JointVue's 3D Echo ultrasound system utilizes raw ultrasound signals to detect tissue interfaces and visualize joint anatomy in three dimensions. The system provides clinicians with three-dimensional models of the joint anatomy. Figure 5-1 outlines the overall system flowchart for 3D joint visualization.
Image /page/4/Figure/5 description: The image shows a flowchart with 10 steps. The first step is "Hardware Initialization (1)", followed by "Input Patient Information (2)", "Intialize Session (3)", "Femur Scan (4)", and "Tibia Scan (5)". From "Tibia Scan (5)", the process goes to "Femur and Tibia Registration (6)", then "Femur and Tibia Morphing (7)", "Inspection (8)", "Create Case File and Complete (9)", and finally "Export Case Data (10)".
Figure 5-1. Overall system flow chart
> INDICATIONS FOR USE
JointVue 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analysis of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scanner. Typical users of this system are trained professionals, including physicians, nurses, and technicians.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- Intended Use / Indications for Use The predicate and subject device have . equivalent intended use.
- . Materials - Not applicable, because both are software devices and do not have patient contact.
- Design Features The predicate and subject device design features are . summarized in comparison Table 5-1.
- . Enerav Source - Subject device is operated on SonixOne or SonixTouch Q+ that can operate via battery or mains power, while the predicate is loaded on a computer that can operate via battery or mains power.
- . Performance Testing - The predicate and subject device have equivalent precision and accuracy based upon benchtop testing using a phantom.
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Table 5-1
| Feature | Subject Device (3D Echo) | Predicate Device (5D Viewer) |
|---|---|---|
| Computer Operating System | Windows 7 | Windows 7 |
| 2D Image Display | ||
| Axial | Yes | Yes |
| Sagittal | Yes | Yes |
| Coronal | Yes | Yes |
| Oblique | Yes | Yes |
| 3D Visualization | Yes (Surface Visualization) | Yes (Volumetric Visualization) |
| View Mode Render | Yes (Display Axial Image with | |
| 3D visualization) | Yes (Display Axial image with | |
| 3D image) | ||
| Contouring | Yes | Yes |
| US Image Visualization | Yes | Yes |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Not Applicable to the subject device, because the device is software. Accessory that has patient contact is already used for another 510(k) cleared device that has equivalent duration of contact and type of contact.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable to the subject device, because the device is software. Accessory that runs the software is already 510(k) cleared device that has been evaluated for electrical safety and EMC.
Software Verification and Validation Testing
Software verification and validation testing was provided to demonstrate safety and efficacy of the subject device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC), because the software is an accessory to a Class 2 ultrasound system.
Mechanical and acoustic Testing
Benchtop testing using a phantom was presented to demonstrate safety and effectiveness of the device with the same accuracy and precision as the predicate device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the 3D Echo software.
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VIII. CONCLUSIONS
The subject device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics and benchtop testing.