VESTIBULAR ANALYSIS APPARATUS

K121590 · Capacity Sports, LLC · LXV · Sep 20, 2012 · EN

Device Facts

• Record ID: K121590
• Device Name: VESTIBULAR ANALYSIS APPARATUS
• Applicant: Capacity Sports, LLC
• Product Code: LXV · EN
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Software as a Medical Device

Intended Use

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, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

Device Story

Sway Balance™ is a mobile software application that assesses balance by measuring thoracic sway. It utilizes the built-in accelerometer of Apple iOS mobile devices (iPhone, iPad, iPod Touch) as input. The software processes accelerometer data to calculate stability scores, providing an objective measure of postural sway. The device is used in various settings where an iOS device is available; it is operated by qualified individuals, including physicians, physical therapists, nurses, athletic trainers, and coaches. Healthcare providers use the output stability scores to evaluate patient balance and monitor conditions affecting postural sway, such as head injury or fatigue. By providing a portable, accessible method for balance assessment, the device assists clinicians in making informed decisions regarding patient stability and recovery.

Clinical Evidence

Clinical testing compared the Sway Balance™ System to force platform assessment tools. Study results showed a positive correlation between the two devices with no significant difference (p < 0.05). Mean stability scores were 1.41±0.90 on the force platform versus 1.38±0.72 using the mobile device. Additional studies evaluated performance across tasks of varying difficulty, confirming consistency with expected outcomes and within-subject reliability under acceleration forces.

Technological Characteristics

Software-only application for Apple iOS devices. Utilizes the device's internal ST Microelectronics MEMS accelerometer for motion sensing. Operates as a standalone mobile application without peripheral hardware. No specific materials of construction; relies on commercial off-the-shelf (COTS) mobile hardware.

Indications for Use

Indicated for assessment of postural sway as an indicator of balance in individuals. Applicable to patients with conditions affecting postural sway, including nausea, headache, orthopedic injury, ear infection, medication effects, head injury, dehydration, and fatigue. Use determined on a case-by-case basis by qualified healthcare professionals, athletic trainers, or coaches.

Predicate Devices

• Korebalance™ by SPORTKAT, LLC (K070676)

Submission Summary (Full Text)

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SEP
20
2012

# 510(k) Summary

## K Number

K121590

General Information

Classification

Trade Name

Sway Balance™

Unclassified

Submitter

Capacity Sports, LLC 624 S. Boston Ave., Suite 700 Tulsa, OK 74119 Tel: [phone] Fax: [phone]

Contact

Pamela M. Buckman, MSN Buckman Company, Inc. 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 Tel: [phone] Fax: [phone]

#### Indications for Use

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, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

#### Predicate Device(s)

Korebalance™ by SPORTKAT, LLC (K070676)

#### Device Description

The Sway Balance™ System is a mobile measurement system that analyzes balance through thoracic sway, using the built in accelerometer of a mobile device. The Sway Balance™ System is a stand-alone mobile operating system software application that does not include any peripheral hardware add-ons.

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# <121590

#### Materials

The Sway Balance™ System is a software only solution that utilizes 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.

#### Testing

Device testing was conducted to evaluate conformance to product specification. The results showed the system met specification. Product verification consisted of studies comparing the Sway Balance™ System to force platform technology. Bench testing analyzed the sensitivity of the software program to access data from the ST Microelectronics MEMS Accelerometer built into the smartphone compatible with the Sway Balance™ Software. Sensitivity scores using the Sway Balance™ Software were comparable.

Clinical testing included studies comparing the Sway Balance™ System to force platform assessment tools to establish positive correlations between the two devices. Results showed no significant difference between the two data sets (p = <0.05). Mean Actual Stability Scores on the balance platform was 1.41±0.90 compared to 1.38±0.72 using the mobile device.

Studies also analyzed performance of balance tasks of varying difficulty to measure the device's effectiveness in determining levels of stability. Data showed that the Sway Balance™ System results were consistent with expected outcomes. Within subject reliability was evaluated under conditions of instantaneous acceleration forces.

### Summary of Substantial Equivalence

The Sway Balance™ System is equivalent to the predicate product. The intended use, targeted population and basic premise underlying the balance assessment are equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 20 2012

Capacity Sports, LLC c/o Pamela M. Buckman, MSN Buckman Company, Inc. 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523

Re: K121590

Trade/Device Name: Sway Balance™ Regulation Name: Vestibular Analysis Apparatus Regulatory Class: Unclassified Product Code: LXV Dated: August 8, 2012 Received: August 10, 2012

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The read haly annous provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviteration. 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 finay of subject to additions, 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 I lease of devices that I Drimination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I odetar states and the equirements, including, but not limited to: registration and listing (21 Comply will an the Fee Broques and 801); medical device reporting (reporting of medical

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## Page 2 - Pamela M. Buckman. MSN

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Evdelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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# K12159D

# Intended/Indications for Use

510(k) Number:

K121590

Device Name:

Sway Balance™ System

Indications for Use:

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, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

Prescription Use

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

X

(21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

.K121590

510(k) Number