DARI Health

K180880 · Scientific Analytics, Inc. · LXJ · Mar 7, 2019 · Physical Medicine

Device Facts

• Record ID: K180880
• Device Name: DARI Health
• Applicant: Scientific Analytics, Inc.
• Product Code: LXJ · Physical Medicine
• Decision Date: Mar 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physial therapy, and the like.

Device Story

DARI Health is a markerless, 3D human motion capture and analytical software system. It utilizes off-the-shelf video cameras and computer hardware to record patient movement in real-time. The system generates a digital skeleton to identify joint centers and segments for the cervical spine, trunk, and extremities. Data is processed by the DARI Insight Engine—either locally or via a secure cloud-based server—to calculate kinematics and kinetics, including ground reaction forces. Outputs are displayed as raw datasets or graphical reports via a web portal or local application. Used in clinical settings (e.g., physical therapy) by healthcare providers to monitor patient progress and inform clinical decision-making. The system requires no physical contact with the patient and delivers no energy, providing a non-invasive method for biomechanical assessment.

Clinical Evidence

Bench and clinical studies demonstrate equivalence to marker-based systems and force plates. In a study comparing DARI to a marker-based system, no statistically significant differences were found in joint angles (p=0.33). Comparison against force plates showed no significant differences in peak/mean force (p>0.05) with high correlation (r=0.995, r²=0.989). Repeatability study of 9,120 bone segments showed joint center/segment length identification within 0.811mm (99% confidence) and 1.02% total skeletal change between sessions, exceeding predicate marker-based repeatability.

Technological Characteristics

Markerless 3D optical motion capture system. Uses off-the-shelf cameras and Linux-based computing hardware. Performs 3D trajectory reconstruction and kinetic calculations (including ground reaction forces) via digital skeleton modeling. Connectivity via local database or secure cloud-based server. Non-sterile, non-contact, no energy delivery. Complies with IEC 60601-1 and IEC 60601-1-2. Software developed per ANSI/AAMI/IEC 62304.

Indications for Use

Indicated for assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and similar clinical applications for patients requiring movement pattern quantification.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Peak Motus Motion Measurement System (K030714)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 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.

March 7, 2019

Scientific Analytics, Inc. % Evan Phelps Principal OFW Law 600 New Hampshire Ave., NW Suite 500 Washington, District of Columbia 20037

Re: K180880

Trade/Device Name: DARI Health Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: December 18, 2018 Received: December 18, 2018

Dear Evan Phelps:

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.

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Vivek J.

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K180880

Device Name DARI Health

Indications for Use (Describe)

DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physial therapy, and the like.

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)

### 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 announly the and review the collection of information. Send comments regarding this burden estimate or any other spect 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 [e-mail]

"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

### "510(k) Summary" As required by section 807.92(c) For DARI Health

#### February 4, 2019

1. Company Name and Address

a. Sponsor/Manufacturer

Scientific Analytics, Inc. 2100 Magnum Circle Suite 7 Lincoln, NE 68522

b. Consultant/Contact

Evan P. Phelps OFW Law 600 New Hampshire Ave, Ste. 500 Washington D.C. 20037 [e-mail] Tel: [phone] Fax: [phone]

2. Establishment Registration Number:

Not yet assigned

- 3. Device Name:
- a. Trade Name: DARI Health b. Common/Usual Name: Motion Measurement System System, Optical Position/Movement Recording
- c. Classification Name:

Image /page/3/Picture/13 description: The image shows a dark, blurry object against a light background. The object appears to be long and rectangular, with some indistinct features. Due to the blurriness, it is difficult to determine the exact nature or details of the object.

Page 14 27
1

{4}------------------------------------------------

- 4. Device Classification:
- a. 21 C.F.R. § 890.5360 (Class II)
- b. Product Code: LXJ
- c. Classification Panel: Physical Medicine
- 5. Legally Marketed Predicate Devices
- a. Peak Motus Motion Measurement System
- i. 510(k) Owner: Peak Performance Technologies, Inc.
- ii. 510(k) Number: K030714
- iii. 21 C.F.R. § 890.5360 (Class II)
- iv. Product Code: LXJ
- 6. Device Description

DARI's existing motion capture technology system has been utilized in non-clinical biomechanical research, fitness applications, and performance evaluation for may years. In view of experience with this technology, its numerous uses, and its demonstrated value, there's an need for the development of its use in clinical applications.

DARI Health is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, off-the-shelf computer hardware, off-theshelf motion analysis software, and proprietary DARI Health Software (consisting of DARI Connect, DARI Capture plug-in, DARI Insight Engine, and DARI Rerort Engine) or DARA quantify, and document full-body human kinematics and kinetics during patient movement

Motions are recorded in real-time, using a digital "skeleton" to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the paint. The captured video can be viewed after recording has ended or at some later point.

During movement, the DARI Health interfaces with the capture software (off-the-shelf, Captury Live) tracks all segments and joint centers as they move in all planes of more the with resulting output is sent to The DARI Insight Engine processing software-either housed it ally on the computer used for capture or in a security-compliant, cloud-based server-where thered drant can be used to calculate all kinetic data produced during the revor d more one more one Such data is then displayed in different report formats-from large, raw datasets to simple, grahital reports that track key biomechanical metrics.

Healthcare providers can access patient biomechanical data remotely through a secure webportal or locally on the computer database application to monitor patient progress and view prior or current motion analyses.

There is no direct contact with the patient by the DARI Health system, and no energy is delivered to the subject at any point during the usage of the system.

{5}------------------------------------------------

#### 7. Intended Use

DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.

# 8. Technological Characteristics and Substantial Equivalence Evaluation

The technological characteristics of the DARI Health System device are based on the capture of three-dimensional motion information obtained from the subject under study. The video feed from the patient in motion is then recorded and stored on a computer where it is available for analysis of human motion using the DARI Health product. The DARI Insight Engine provided by DARI Health is used for data presentation to the healthcare professional. The data are accessible from a remote, security-compliant server for remote evaluations by the healthcare professional.

The DARI Health is substantially equivalent in terms of intended use, operating principles, and operational specifications to the Peak Motus Motion Measurement System (K030714) which is a legally marketable Optical Position/Movement Recording Systems classified pursuant to 21 C.F.R. §890.5360 under Product Code LXJ. As with the Peak Motus device, the DARI Health is intended to be used to quantify, analyze, document for remote access, visually display threedimensional human kinematics, kinetics, and patient performance metrics related to human movement patterns for uses such as assessment and training of limb or body motion in applications where such analysis is relevant to the clinician's decision-making processes.

This equivalency is summarized in the Tables below where Table 1 discusses the equivalency of the indications for use between the DARI device and the predicates. Table 2 discusses the technological characteristics between the DARI device and the predicates to demonstrate substantial equivalency.

Page 2

3

{6}------------------------------------------------

| | Substantial Equivalence to Predicate Devices<br>Table 1: Indications for Use | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peak Motus<br>K030714 | DARI Health |
| Indications<br>for Use | Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like. | DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like. |

DARI Motion 510(k) Submission

# #

THANN ALER LE

**Page**

4

{7}------------------------------------------------

| Table 2: Technological Characteristics Comparison | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peak Motus<br>K030714 | DARI Health |
| Motion Capture<br>Principles<br>of<br>Operation | Optical cameras<br>Software/Hardware system that<br>uses off-the-shelf cameras,<br>sensors, and computers to<br>collect, quantify, and document<br>human movement in two-<br>dimensional or three-<br>dimensional space. This system<br>tracks and provides visual<br>feedback of patient movement<br>while reporting on kinematic<br>parameters such as velocity and<br>joint angles measured during<br>movement | Optical cameras<br>Use of off-the-shelf optical cameras<br>or motion sensing technology, and<br>computing equipment as the user<br>interface and software, to collect,<br>quantify, and document human<br>movement in three-dimensional<br>space. The DARI Health calculates<br>such outputs as validated<br>biomechanics and performance<br>metrics vis cloud-based or local<br>processing software. |
| Analysis<br>and<br>Interface Tools | Peak Motus uses software<br>modules (Vicon) to capture,<br>calculate, and represent patient<br>biomechanical data | DARI Health uses software modules<br>to capture, calculate, and display<br>patient biomechanical data, and<br>offers remote access to prior analyses<br>via web-based portal and database. |
| Software<br>and<br>Hardware<br>Compatibility | Peak Motus uses software and<br>hardware that are compatible<br>with Microsoft Windows | DARI Health hardware and software<br>are compatible with Linux operating<br>systems. |
| Operating System | Microsoft Windows | Linux-based OS |
| Markerless Motion<br>Live Capture and<br>Post-Processing | Live capture video requires use<br>of position markers on subject's<br>body.<br>Post-processing motion analysis<br>may be done without position<br>markers on body. | DARI Health provides live<br>markerless motion capture of the<br>subject and the ability to post-process<br>video for motion analysis.<br>No position markers required for live<br>capture or post-processing analysis. |
| Trajectory<br>Reconstruction | 2D and/or 3D reconstruction | 3D reconstruction |
| Kinetic Calculations | | |
| | Requires integration with force<br>plates to measure kinetic data<br>such as ground reaction force. | DARI Health uses subject and digital<br>skeleton data to perform ground<br>reaction force calculations. |
| External<br>Measurement<br>Device Integration | Electromyography<br>(EMG)<br>integration.<br>Event synchronization units.<br>Analog-to-digital interface (64<br>sensors) | None |
| Contraindications | None | None |
| Electrical Safety:<br>Energy Used /<br>Delivered | No energy is delivered to the<br>patient | No energy is delivered to the patient |
| Biocompatibility | Not applicable | Not applicable |
| Mechanical,<br>Thermal, Chemical<br>Safety | Safety not an issue per 510k<br>summary | No thermal, chemical, or safety<br>issues during DARI Health motion<br>analysis |
| Radiation Safety<br>Electromagnetic<br>Compatibility | System does not emit radiation<br>EMC and EMI Compliant | System does not emit radiation<br>EMC and EMI Compliant |
| Sterility | Non-sterile device | Non-sterile device |

Image /page/7/Picture/2 description: The image shows the word "Page" followed by the number 2017. Below that is the number 1, and below that is the letter D. The text appears to be extracted from a document.

{8}------------------------------------------------

#### 9. Summary of Performance Data

DARI Health performance characteristics have been verified by independent, peerreviewed studies proving the accuracy of the system's calculations of human kinematics and kinetics as compared to both traditional, gold-standard marker-based analysis and forces plate output. Likewise, DARI Health internal studies demonstrate repeatability metrics that or or exceed predicate and motion analysis industry standards. In addition, software validation a ot testing were completed for the device and functioned as intended and all results onsemally were those expected.

- a. Non-Clinical Performance Summary
Safety

DARI Health utilizes common technical equipment to execute motion analysis with demonstrated safety. The system requires no contact with the patient, and poses no electrical, chemical, mechanical, thermal, or radiation safety concerns; therefore, there are

Image /page/8/Picture/7 description: The image shows the word "Page" in a bold, sans-serif font at the top left corner. To the right of the word "Page" is a blacked out section. Below the word "Page" is the number 6, which appears to be handwritten.

{9}------------------------------------------------

no safety issues associated with its use. The DARI Health complies with IEC 60601-1 and IEC 60601-1-2.

#### Effectiveness

Bench testing demonstrates the DARI Health motion capture methodology's accuracy in representing and tracking digital skeletal segments.

- b. Clinical Performance Summary
#### Effectiveness

Clinical studies demonstrate the equivalency to predicate marker-based capture of human kinematics and industry-standard force plate output for evaluation of human kinetics.

Specifically, when compared to a predicate marker-based Vicon (Peak Motus) system in an independent, peer-reviewed study, the DARI Health system showed no statistically significant differences in the clinically relevant joint angles being measured for investigation (p =0.33).

The DARI Health system was also tested against standard force plate output in an independent, peer-reviewed study, where DARI's force calculation methodology demonstrated no statistically significant differences in peak force, mean force, or now force as compared to simultaneous measurements derived from a force plate (p > 0.05). Additionally, comparison of force-time curves with regression yiald ( > > 0.03). correlation between modalities (r = 0.995, 2 = 0.989, SEM = 11.1 NN.

A clinical study also supports the repeatability of the DARI Health System.

Specifically, the repeatability of segment length and joint center calculation over successive scans of 9,120 bone segments demonstrated the ability to identify the joint centers and segment lengths within 0.811mm with 99% confidence, exhibiting only 1.02% total skeletal change between sessions with 0.002 mm of variance. This exceeds prelicate repeatability associated with marker analysis and inter-test repeatability of goniometers claimed by predicate JRS v2.0.

10. System Validation for Software Design, Documentation, and Hazard Analysis

The DARI Health software is of "modcrate" level of concern based upon FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Consistent with FDA guidance and other applicable requirements, all hazards have been mitigated through appropriate controls, product labeling, while maintaining sufficient secve to may see protect the software and data.

**DARI Motion 510(k) Submission**

Page 24 of 217

{10}------------------------------------------------

The DARI Health motion analysis software underwent a standardized approach consistent with the requirements of the Quality System Regulation (21 C.F.R. § 820.30) and ANSI 62304 for appropriate design, risk assessment, document, and validation control for software classed as "moderate level of concern."

DARI Health conforms to the following FDA recognized standards and associated FDA guidance documents:

- Medical Device Software-Software Life Cycle Processes ANSI/AAMI/ IEC 62304: 2006 . & A1:2016
- Guidance on the use of AGILE practices in the development of medical device software . AAMI TIR45:2012
- 11. Substantial Equivalence Conclusion

The aforementioned testing dominstrate substantial equivalence between the DARI Health System and the Peak Motus Motion Measurement System (K020214).