K Number

Device Name

3D Echo v1.1

Manufacturer

JointVue LLC

Date Cleared

2021-06-25

(28 days)

Product Code

LLZ IYO

Regulation Number

892.2050

Intended 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 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. - 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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172513

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software application for 3D visualization of ultrasound data and lists hardware modifications. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on visualization and measurement accuracy compared to a predicate device.

Therapeutic

No.
The device is described as a software application for display and 3D visualization of ultrasound volume data to observe images and perform analyses; it is not designed to treat a disease or condition.

Diagnostic

Yes
The device is described as a software application "for the display and 3D visualization of ultrasound volume data" and designed to "allow the user to observe images and perform analyses of musculoskeletal structures." This indicates its role in providing visual data and tools for analysis, which are characteristic functions of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly mentions and includes hardware components such as the Terason 3200T+ Ultrasound system, a transducer, a tracking unit, a system cart, and a custom transducer/sensor holder. While it is a software application, it is part of a larger system that includes hardware.

IVD (In Vitro Diagnostic)

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.
Device Function: JointVue's 3D Echo v1.1 is a software application that processes and visualizes ultrasound volume data acquired directly from a patient's body using an ultrasound system. It does not analyze samples taken from the body.
Intended Use: The intended use is for the display and 3D visualization of musculoskeletal structures using ultrasound data, and for performing analyses of these structures based on the images. This is a form of medical imaging and analysis, not in vitro testing.

Therefore, while it is a medical device used for diagnosis and analysis, it falls under the category of medical imaging and image processing software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LLZ, IYO

Device Description

1. software is updated for interoperability with Terason 3200T+ Ultrasound system
1. 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.
1. Custom transducer/sensor holder now attaches an 800 model EM sensor to the exterior of the ultrasound transducer
1. Designed for use with medically approved probe cover

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound volume data

Anatomical Site

musculoskeletal structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical professionals including physicians, nurses, and technicians.

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)

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.

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.
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: 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 risk analysis introduced new usability risks which would require re-validation or repeating of human factor validation from the previous 510(K).
Animal Study: Not required.
Human Clinical Performance Testing: Not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172513

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K211656

Device Name 3D Echo v1.1

Indications for Use (Describe)

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 - K211656

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

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
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

1. software is updated for interoperability with Terason 3200T+ Ultrasound system
1. 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
1. Designed for use with medically approved probe cover

INDICATIONS FOR USE V.

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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

	3D Echo v1.1 - K211656	3D Echo - K172513	Comparison
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.	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 Scanner.
Typical users of this system are trained
medical professionals including physicians,
nurses, and technicians.	The subject and predicate
device have the same
intended use and users.
The only difference in the
intended use statements is
the name of off the shelf
US system the device is
deployed on.
This new deployment
platform didn't change the
intended use or users of
the device.
Computer
Operating System	Windows 10	Windows 7	OS change based on
operating system of the
new Terason platform.
3D Visualization	Yes (Surface Visualization)	Yes (Surface Visualization)	Same
View Mode
Render	Yes (Display Ultrasound Image with 3D
Visualization)	Yes (Display Ultrasound Image with 3D
Visualization)	Same
Contouring	Yes	Yes	Same
US Image
Visualization	Yes	Yes	Same

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

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.

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

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.

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.

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.