3D Echo v1.1

K211656 · Jointvue, LLC · LLZ · Jun 25, 2021 · Radiology

Device Facts

• Record ID: K211656
• Device Name: 3D Echo v1.1
• Applicant: Jointvue, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jun 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

JointVue's 3D Echo v1.1 is a software application for the display and 3D visualization of ultrasound volume data derived from the Terason uSmart3200T ultrasound system. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Terason ultrasound scanner. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

Device Story

Software application for 3D visualization/analysis of musculoskeletal structures; inputs raw ultrasound signals from Terason uSmart3200T system; utilizes EM tracking (NDI 3D Guidance trakSTAR) to correlate ultrasound data; produces 3D bone models (femur/tibia); used in clinical settings by physicians, nurses, or technicians; assists in anatomical landmark identification and surgical planning; benefits patient through improved visualization of musculoskeletal anatomy.

Clinical Evidence

No clinical data. Bench testing only. Performance validated using physical phantom models of knee (femur/tibia). Compared 3D Echo v1.1 generated models against CAD ground truth; measured RMS surface error and angular rotation error. Results showed statistically equivalent or superior performance to the predicate device.

Technological Characteristics

Software-based medical image management and processing system. Operates on Windows 10. Integrates with Terason uSmart3200T ultrasound and NDI 3D Guidance trakSTAR EM tracking unit. Uses EM sensor (NDI Model 800) attached to transducer. Complies with IEC 62304 (software), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for trained medical professionals (physicians, nurses, technicians) to display and perform 3D visualization and analysis of musculoskeletal structures using ultrasound volume data from the Terason uSmart3200T system.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• 3D Echo (K172513)

Submission Summary (Full Text)

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June 25, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

JointVue LLC % Mr. Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K211656

Trade/Device Name: 3D Echo v1.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, IYO Dated: May 27, 2021 Received: May 28, 2021

Dear Mr. Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211656

Device Name 3D Echo v1.1

#### Indications for Use (Describe)

JointVue's 3D Echo v1.1 is a software application for the display and 3D visualization of ultrasound volume data derived from the Terason uSmart3200T ultrasound system. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Terason ultrasound scanner. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif;">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY - K211656

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 2450 E.J. Chapman Drive Suite 104A Knoxville, TN 37996, USA +1.410.258.2770

Contact Person: Maja Ward Date Prepared: June 22, 2021

| II. DEVICE | |
|------------------------------|------------------------------------------------|
| Name of Device: | 3D Echo v1.1 |
| Classification Name: | Medical image management and processing system |
| Regulation: | 21 CFR § 892.2050 |
| Regulatory Class: | Class II |
| Product Classification Code: | Primary: LLZ<br>Secondary: IYO |

PREDICATE DEVICE ||| .

| Predicate Manufacturer: | JointVue, LLC |
|-------------------------|---------------|
| Predicate Trade Name: | 3D Echo |
| Predicate 510(k): | K172513 |

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 v1.1 includes the following device modifications from 3D Echo v1.0:

- 1. software is updated for interoperability with Terason 3200T+ Ultrasound system
- 2. the ultrasound hardware is Terason 3200T+ Ultrasound with Terason 14L3 Linear transducer instead of the SonixOne tablet-based portable ultrasound system
- the NDI 3D Guidance driveBAY™ tracking unit is replaced by the 3D Guidance trakSTAR™ 3. tracking unit (same system but with an internal power supply))
- Different GCX system cart designed for Terason 3200T+ Ultrasound 4.
- ર. Custom transducer/sensor holder now attaches an 800 model EM sensor to the exterior of the ultrasound transducer
- 6. Designed for use with medically approved probe cover

#### INDICATIONS FOR USE V.

JointVue's 3D Echo v1.1 is a software application for the display and 3D visualization of ultrasound volume data derived from the Terason uSmart3200T ultrasound system. It is designed to allow the user to

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observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Terason ultrasound scanner. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

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#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

| | 3D Echo v1.1 - K211656 | 3D Echo - K172513 | Comparison |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | JointVue's 3D Echo v1.1 is a software application<br>for the display and 3D visualization of<br>ultrasound volume data derived from the<br>Terason uSmart3200T ultrasound system. It is<br>designed to allow the user to observe images<br>and perform analyses of musculoskeletal<br>structures using the ultrasound volume data<br>acquired with the Terason ultrasound scanner.<br>Typical users of this system are trained medical<br>professionals including physicians, nurses, and<br>technicians. | JointVue's 3D Echo is a software application<br>for the display and 3D visualization of<br>ultrasound volume data derived from the<br>Sonix Ultrasound Scanner. It is designed to<br>allow the user to observe images and<br>perform analyses of musculoskeletal<br>structures using the ultrasound volume data<br>acquired with the Sonix Ultrasound Scanner.<br>Typical users of this system are trained<br>medical professionals including physicians,<br>nurses, and technicians. | The subject and predicate<br>device have the same<br>intended use and users.<br>The only difference in the<br>intended use statements is<br>the name of off the shelf<br>US system the device is<br>deployed on.<br>This new deployment<br>platform didn't change the<br>intended use or users of<br>the device. |
| Computer<br>Operating System | Windows 10 | Windows 7 | OS change based on<br>operating system of the<br>new Terason platform. |
| 3D Visualization | Yes (Surface Visualization) | Yes (Surface Visualization) | Same |
| View Mode<br>Render | Yes (Display Ultrasound Image with 3D<br>Visualization) | Yes (Display Ultrasound Image with 3D<br>Visualization) | Same |
| Contouring | Yes | Yes | Same |
| US Image<br>Visualization | Yes | Yes | Same |

#### Table 1 – Comparison of 3D Echo v1.1 with 3D Echo (K172513)

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Image /page/6/Picture/2 description: The image shows the user interface of the 3D Echo v1.1 software. The software is functionally identical to the 3D Echo v1.0 (K172513) but has some small improvements. The improvements include displaying patient information on the top banner, acoustic indices, and an active EM field warning in 2D B.

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Image /page/7/Figure/2 description: The image shows a screen capture of the JointVue software. The software is being used to digitize the lateral femur. The left side of the screen shows a menu with options such as Position Patient, Attach References, Femur, Tibia, Register, Morph, Inspection, and Complete. The right side of the screen shows a 3D model of the femur with a series of blue lines on it.

The subject device and predicate device have equivalent indications for use and technological characteristics, with the exception of:

- 1. Software is updated for interoperability with Terason 3200T+ Ultrasound system.
- 2. The ultrasound hardware is Terason 3200T+ Ultrasound with Terason 14L3 Linear transducer instead of the SonixOne tabletbased portable ultrasound system.
- 3. The NDI 3D Guidance driveBAY™ tracking unit is replaced by the 3D Guidance trakSTAR™ tracking unit (same system but with an internal power supply).
- 4. System cart is designed for the Terason 3200T+ Ultrasound by the same manufacturer as the predicate device (GCX).
- 5. Custom transducer/sensor holder now attaches an NDI Model 800 EM sensor to the ultrasound transducer.
- 6. Designed for use with medically approved Sheathes probe covers (K153212).

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#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Sterilization & Shelf-life Testing

Not applicable to this 510(k) notification. The subject device is software and therefore sterilization and shelf-life are not applicable to the subject device. The accessories used with the software are non-sterile and therefore sterilization validation is not applicable to the accessories either. Shelf-life is not applicable to the accessories because of low likelihood of time-dependent product degradation. Therefore, no sterilization validation or aging data is required to demonstrate device safety and effectiveness.

#### Biocompatibility Testing

The subject device is software and therefore biocompatibility is not applicable (i.e. there are no direct or indirect tissue-contacting components associated with the software itself). All patient contacting components are accessories to the software that have already been cleared by the FDA, and biocompatibility data for those accessories is provided in those submissions.

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety testing in accordance with IEC 60601-1 and EMC testing in accordance with IEC 60601-1-2 was performed for the EM Tracking unit. All other electrical safety and EMC testing is found in the FDA submissions for the accessory devices.

## Software Verification Testing

Risk analysis and software verification testing was provided to demonstrate safety and efficacy of the subject device in accordance with IEC 62304.

## Benchtop Performance Testing

3D Echo v1.1 system performance was validated through a non-clinical benchtop testing performed on physical phantom models simulating knee, including:

-A 3D Echo v1.1 system was utilized to obtain a sample (equivalent in size to that of the predicate validation test) of 3D models of the femur and tibia bone models.

-The surface of these models was compared to the manufacturer provided CAD models to determine the RMS error of the 3D Echo v1.1 generated models.

-Key anatomical landmarks were identified on the surface of both the 3D Echo generated models and provided models which were then used to identify the target axes of the model. These axes were compared between 3D Echo model and provided model to assess the angular error in degrees.

-The surface and angular error in the sample models were statistically analyzed against both the accuracy requirements and performance of the predicate system.

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#### Testing Conclusion

The 3D Echo v1.1 system generated models contained statistically less surface error and measured angular rotation errors than the predicate device. Every model generated by the system met accuracy requirements of the system. Taken with complete verification, software meets all predicate requirements with no additional human factor risks identified in the risk analysis and the 3D Echo v1.1 system has been validated as equivalent in performance and safety as the predicate 3D Echo v1.0 (K172513).

## Mechanical and acoustic Testing

Tip testing was performed on the mobile cart provided with the device to demonstrate safety of the mobile cart.

## Usability Testing

3D Echo version 1.1 has been modified to operate on the Terason 3200+ Ultrasound platform integrated with the 3D Ascension (now NDI) Guidance System used in the predicate device. No significant changes were made to the user interface or functionality of the software, and no change has been done to the core algorithm for signal detection or morphing. No changes to the product requirements, functionality or r r sk analysis introduced new usability risks which would require re-validation or repeating of human factor validation from the previous 510(K).

#### Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

#### Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

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# VIII. CONCLUSIONS

Both subject and predicate device has the same intended use. There was no change between subject and predicate device in: 1) user interface workflow. 2) core algorithm for signal processing. 3) core algorithm for 3D bone reconstruction. Non-clinical, simulated use testing was conducted to compare the performance of the subject device and the predicate device using identical inputs. Testing results demonstrated that performance of the subject device is equivalent to the predicate device for each of the technical specifications.

A risk analysis was completed, and risk controls were implemented. The ergonomics of patient and user interfaces have not been altered from the predicate version of the device. Performance testing results support claims that the subject device is substantially equivalent to the predicate device with regard to safety and efficacy.