3D Echo

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> | #### 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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: - 1. 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. {5}------------------------------------------------ #### 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<br>3D visualization) | Yes (Display Axial image with<br>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. {6}------------------------------------------------ ## 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.