K Number

Device Name

EQ Balance

Manufacturer

Highmark Innovations Inc. DBA Highmark Interactive

Date Cleared

2019-08-16

(148 days)

Product Code

LXV

Regulation Number

N/A

Intended Use

EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.

Device Description

EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device. EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.

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

K121590

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions an "algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer," but there is no mention of AI, ML, training data, or learning processes. The performance study focuses on statistical agreement with a predicate device, not on the performance of a learning model.

Therapeutic

No.
The device is intended to assess body tilt as an indicator of balance, not to provide therapy or treatment.

Diagnostic

The "Device Description" explicitly states, "EQ Balance does not function as a diagnostic test."

SaMD (Software as a Medical Device)

Yes

The device is described as a mobile application that runs on standard mobile devices (iOS or Android) and utilizes the device's internal accelerometer. It does not include or require any specialized hardware components beyond the commercially available mobile device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze specimens from the human body. The description of EQ Balance clearly states it measures body tilt using the device's accelerometer and analyzes subject movements. It does not involve the analysis of biological samples like blood, urine, or tissue.
The intended use is to assess body tilt as an indicator of balance. This is a functional assessment of a physical capability, not a diagnostic test performed on a biological specimen.
The device description explicitly states "EQ Balance does not function as a diagnostic test". This directly contradicts the definition of an IVD.

Therefore, EQ Balance is a medical device used for balance assessment, but it does not fall under the category of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EQ Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.

Product codes

LXV

Device Description

EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

13-65

Intended User / Care Setting

Qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Use in an indoor setting free from obstructions and free from excessive noise or visual distractions.

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

Clinical testing was completed under an IRB-approved study at a sports medicine and concussion clinic in Mississauga, Ontario under the oversight of a principle investigator from the Department of Neurosurgery at the University of Toronto.
Sample size: 70 male and female subjects (25 males; 45 females; mean age: 37.8 ± 14.8, range: 13-65) with and without balance impairment, determined by failure of the modified Balance Error Scoring System (mBESS) test (26 balance-impaired).
Annotation protocol: Participants performed three postures, that were analyzed, while holding the mobile device against their chest. Balance measures were then obtained simultaneously with Sway Balance and EQ Balance during each of the stances, which included the double leg stance, right tandem stance, and left tandem stance. Participants held a device holder that secured two devices: one iPhone 6s (Apple, Cupertino, CA, USA) with EQ Balance and a second iPhone 6s with Sway Balance. The amount of movement was calculated by each balance test application algorithm using data generated by the mobile device accelerometer. The primary output ("3-pose average") was calculated as the average of the balance performance on the 3 stances.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Testing:
Device testing was conducted to evaluate conformance to product specification. EQ Balance met specification.
Nonclinical ("bench") testing analyzed the accuracy of the tilt angles coming from the accelerometer in the mobile devices that are compatible with the EQ Balance application. Accuracy with EQ Balance were comparable.
Testing was conducted using a sample of Apple device models running the iOS operating system and sample of Samsung device models running the Android operating system.
The design and testing was conducted according to IEC 62304 Medical Device Software –Software Life Cycle Processes and ISO 14971 Medical Device -Application of Risk Management to Medical Devices.

Clinical Study:
Study Type: Performance testing for statistical agreement and substantial equivalence.
Sample Size: 70 male and female subjects (25 males; 45 females; mean age: 37.8 ± 14.8, range: 13-65) with and without balance impairment (26 balance-impaired).
Key Results:
Performance testing verified that EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement.
According to the Spearman's analysis, the 3-pose average measures calculated by EQ Balance were in statistical agreement with the 3-pose average obtained with Sway Balance for both normal and balance-impaired groups, and for all three stances (double leg, tandem right and left).
The Deming Regression Model showed agreement between the 3-pose average balance measures (the primary device output), as well as 23 of the 27 additional analyses that were conducted.
Poorer balance scores were observed for subjects with balance impairments.
No adverse effects or complications were encountered during or after performance testing.
Consistency of the EQ Balance measure was conducted by calculating the intra-class correlation (ICC) on two consecutive EQ Balance tests. The ICC for the cohort was ICC=0.75 (p

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows 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.

August 16, 2019

Highmark Innovations Inc. DBA Highmark Interactive % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K190735

Trade/Device Name: EQ Balance Regulation Name: Vestibular Analysis Apparatus Regulatory Class: Unclassified Product Code: LXV Dated: July 12, 2019 Received: July 18, 2019

Dear E.J. Smith:

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 (OS) 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,

Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K190735

Device Name EQ Balance

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)

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."

Image /page/3/Picture/1 description: The image is a logo for Highmark Interactive. The logo features a blue graphic above the words "HIGHMARK interactive". The graphic is a stylized representation of two hemispheres, possibly representing a brain, with lines dividing each hemisphere into sections.

510(k) Summary

Trade Name	EQ Balance
Common Name	Balance Test Application
Classification	Unclassified
Product Code	LXV
Predicate Device	Sway Balance™ by Capacity Sports, LLC (K121590)
Company Name:	Highmark Interactive
Company Address:	1 University Avenue, 3rd Floor
Toronto, Ontario, Canada M5J 2P1
Telephone:	416.320.0286
email:	david@highmark.tech
Contact Person:	David Crane, Senior Product Manager
Summary Preparation Date:	August 14, 2019

PREDICATE DEVICE:

Manufacturer	Brand Name	510(k) Number
Capacity Sports, LLC	Sway BalanceTM	K121590

DEVICE DESRIPTION:

INDICATIONS FOR USE:

Features	Highmark Interactive	Capacity Sports, LLC	Comments
Identify	EQ Balance	Sway Balance™
Predicate
Device
510(k)	K190735	K121590
Number:
Indications
for use
statement	EQ Balance is intended to
assess body tilt as an
indicator of balance.
Individual suitability for
assessment must be judged
on a case by case basis, by
a qualified individual
including those certified
and/or licensed in their state
to prescribe and/or use
balance devices such as
certified athletic trainers and
coaches, physical therapists,
nurses and physicians.
Interpretation of EQ Balance
results should only be made
by a healthcare professional,	The Sway™ Balance System
is intended for use to assess
sway as an indicator of
balance. Individual suitability
for assessment must be
judged on a case by case
basis, by a qualified individual
including those certified and/or
licensed in their state to
prescribe and/or use balance
devices such as certified
athletic trainers and coaches,
physical therapists, nurses and
physicians. Conditions
affecting postural sway include
nausea, headache, orthopedic
injury, ear infection,	Substantially
Equivalent
Features	Highmark Interactive	Capacity Sports, LLC	Comments
	as part of a multifaceted
assessment of balance.
Conditions affecting postural
sway include nausea,
headache, orthopedic injury,
ear infection, medications,
head injury, dehydration and
fatigue. EQ Balance should
be used in an indoor setting
free from obstructions and
free from excessive noise or
visual distractions. EQ
Balance should be only be
used as directed by your
healthcare practitioner. EQ
Balance may be used on
mobile devices running iOS
or Android operating
systems.	medications, head injury,
dehydration and fatigue. The
Sway™ Balance System can
be used wherever an iOS
mobile operating device is
available.
Use
Environment
/ Where used	Mobile tablet/phone running
iOS and Android operating
systems.
The testing is intended to be
done on a firm and flat
surface in an area free from
visual or auditory distraction.	Mobile tablet/phone running
iOS and Android operating
systems.
A controlled environment on a
flat, hard surface.
(Sway's website:
https://swaymedical.com/
resources/faqs)	Substantially
Equivalent
Target
Population	Individual suitability for
assessment must be judged
on a case-by-case basis, by
a qualified individual
including those certified
and/or licensed in their state
to prescribe and/or use
balance devices such as
certified athletic trainers and
coaches, physical therapists,
nurses and physicians.	Individual suitability for
assessment must be judged on
a case-by-case basis, by a
qualified individual including
those certified and/or licensed
in their state to prescribe
and/or use balance devices
such as certified athletic
trainers and coaches, physical
therapists, nurses and
physicians.	Substantially
Equivalent
Features	Highmark Interactive	Capacity Sports, LLC	Comments
Stand Alone
Software	Yes	Yes	Same
Electronically
record
objective
performance
measurement
(speed and
accuracy)	Yes	Yes	Same
Design	Android and iOS-based
mobile software application	Android and iOS-based mobile
software application	Substantially
equivalent
Materials	EQ Balance is a software-
only solution that uses the
hardware via the Apple iOS
and Android OS mobile
operating systems for
products.
The built-in accelerometer is
accessed to analyze motion
during a balance test.	The Sway BalanceTM System
is a software only solution that
uses the hardware of the Apple
iOS mobile operating system*
for products such as the
iPhone 3G, 3GS, 4, 4S, iPad,
iPad2 and iPod Touch.
The built-in accelerometer is
accessed to analyze motion
during a balance test.
*Now also compatible with
Android OS	Substantially
equivalent

PREDICATE PRODUCT COMPARISON TABLE:

DISCUSSION OF TECHNOLOGICAL DIFFERENCES:

EQ Balance and Sway Balance both run on iOS and Android mobile devices. EQ Balance is compatible with iPhone, iPad and iPod touch devices running iOS version 10 and up as well as devices using Android OS version 6 and up. EQ Balance will continually update to run on future generations of these mobile devices. Sway Balance functions on iPhone, iPad and iPod touch devices running version iOS 9.3 or later, or Android OS version 6 and up, according to the app store marketplaces where this app is distributed.

Both applications use built-in iOS mobile device accelerometers to calculate the output balance score. The output score reflects how much movement occurred during each assessment. Balance scores are measured on a 0 to 100 scale. Scores closer to 100 are considered closer to normal with 100 being a perfect score. The point spread may vary between EQ Balance and Sway based on differences in algorithms, however the output scores are comparable and repeatable.

NONCLINICAL TESTING:

Device testing was conducted to evaluate conformance to product specification. EQ Balance met specification. Nonclinical ("bench") testing analyzed the accuracy of the tilt angles coming from the accelerometer in the mobile devices that are compatible with the EQ Balance application. Accuracy with EQ Balance were comparable. Testing was conducted using a sample of Apple device models running the iOS operating system and sample of Samsung device models running the Android operating system.

Test documentation has been provided according to the FDA Guidance for the Content of Premarket Submissions for Software, including software Verification and Validation reports and Bench Testing. The design and testing was conducted according to IEC 62304 Medical Device Software –Software Life Cycle Processes and ISO 14971 Medical Device -Application of Risk Management to Medical Devices.

CLINICAL STUDY:

Performance testing verified that EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement.

Clinical testing was completed under an IRB-approved study at a sports medicine and concussion clinic in Mississauga, Ontario under the oversight of a principle investigator from the Department of Neurosurgery at the University of Toronto. EQ Balance and Sway Balance testing were performed simultaneously (two trials) for a total of 70 male and female subjects (25 males; 45 females; mean age: 37.8 ± 14.8, range: 13-65) with and without balance impairment, determined by failure of the modified Balance Error Scoring System (mBESS) test (26 balance-impaired). Participants performed three postures, that were analyzed, while holding the mobile device aqainst their chest. Balance measures were then obtained simultaneously with Sway Balance and EQ Balance during each of the stances, which included the double leg stance, right tandem stance, and left tandem stance. Participants held a device holder that secured two devices: one iPhone 6s (Apple, Cupertino, CA, USA) with EQ Balance and a second iPhone 6s with Sway Balance. The amount of movement was calculated by each balance test application algorithm using data generated by the mobile device accelerometer. The primary output ("3-pose average") was calculated as the average of the balance performance on the 3 stances.

The following table summarizes EQ Balance scores by pose and by group: Healthy vs. Impaired balance

	Healthy balance (N=44)
Pose:	Feet
together	Tandem left	Tandem right	3-pose
average
Minimum	87.7	40.7	62.5	70.5
5th percentile	87.8	74.4	68.0	83.0
Median	94.0	90.0	91.4	91.0
95th percentile	96.2	95.2	94.8	94.3
Max	96.7	96.4	95.0	95.4

Impaired balance (N=26)

| Pose: | Feet
together | Tandem left | Tandem right | 3-pose
average |
|-----------------|------------------|-------------|--------------|-------------------|
| Minimum | 78.8 | 42.6 | 28.0 | 49.8 |
| 5th percentile | 79.2 | 42.7 | 31.2 | 51.2 |
| Median | 89.4 | 75.5 | 73.3 | 78.9 |
| 95th percentile | 97.5 | 94.0 | 92.8 | 93.0 |
| Max | 98.0 | 95.0 | 93.2 | 93.1 |

5% percentile means 5% of the data is below this value; 95% percentile means 95% of the data below this value

According to the Spearman's analysis, the 3-pose average measures calculated by EQ Balance were in statistical agreement with the 3-pose average obtained with Sway Balance for both normal and balance-impaired groups, and for all three stances (double leg, tandem right and left). The Deming Regression Model showed agreement between the 3-pose average balance measures (the primary device output), as well as 23 of the 27 additional analyses that were conducted . The statistical agreement between the two tests supports substantial equivalence of EQ Balance to Sway Balance. Poorer balance scores were observed for subjects with balance impairments. No adverse effects or complications were encountered during or after performance testing.

Consistency of the EQ Balance measure was conducted by calculating the intra-class correlation (ICC) on two consecutive EQ Balance tests. The ICC for the cohort was ICC=0.75 (p