BALANCEBACK MOBILE INTUITIVE VNG SYSTEM

K070729 · Fall Prevention Technologies, LLC · GWN · Mar 30, 2007 · Neurology

Device Facts

• Record ID: K070729
• Device Name: BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
• Applicant: Fall Prevention Technologies, LLC
• Product Code: GWN · Neurology
• Decision Date: Mar 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The balanceback ™ Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Story

Mobile VNG system captures eye movement data for balance disorder assessment. Patient wears goggles equipped with IR light sources and IR cameras; system records continuous monochromatic video stream of eyes. Device includes projector for visual stimuli during tests (caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, high-frequency head shake). Video digitized and processed by computer software to track, record, analyze, and display eye movements. Clinicians review output to evaluate balance sensors and processing systems. Used in doctor's offices or healthcare facilities by trained clinicians. Provides data for clinical decision-making; does not provide automated diagnoses or recommendations.

Clinical Evidence

No clinical data provided. Verification performed via bench testing of hardware and software against specified requirements and recognized standards (ANSI Z-136.1, IEC 60601-1 series, UL 60601-1).

Technological Characteristics

System includes IR-illuminated goggles with integrated cameras, control box, and laptop computer. Connectivity via digital interface. Software performs signal processing and eye movement tracking. Standards: ANSI Z-136.1 (2000), IEC 60601-1 (1988/1991/1995), IEC 60601-1-1 (2000), IEC 60601-1-2 (2001), UL 60601-1 (2003).

Indications for Use

Indicated for recording, viewing, and analyzing eye movements in human subjects to assist in identifying balance disorders. Intended for use by trained physicians or clinicians in clinical settings. No specific age or gender restrictions noted.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• balanceback™ Intuitive VNG System (K042529)

Submission Summary (Full Text)

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balanceback™ Mobile VNG 510 (k) Submission BBQMS M00100 ISO13485 4.2, 5.0, 7.3

#### Doc ID: MAR 3 0 2007

#### 510(k) Summary E

070729

| Submitter's Name: | Fall Prevention Technologies, LLC | | | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------|---------------|-----------------------------------|---------|
| Submitter's Address: | 4601 Gateway Circle<br>Kettering, OH 45440 | | | | |
| Submitter's Telephone: | 937-434-5455 | | | | |
| Contact Name: | Frank Scarpino, PhD | | | | |
| Date Summary was<br>Prepared: | December 10, 2006 | | | | |
| Trade or Proprietary Name: | balanceback™ Mobile Intuitive VNG System | | | | |
| Common or Usual Name: | Mobile VNG | | | | |
| Classification Name: | Nystagmograph (21 CFR 882.1460), product code GWN,<br>Class II | | | | |
| Predicate Devices: | <table><tr><th>Device Name</th><th>510(k) Number</th></tr><tr><td>balanceback™ Intuitive VNG System</td><td>K042529</td></tr></table> | Device Name | 510(k) Number | balanceback™ Intuitive VNG System | K042529 |
| Device Name | 510(k) Number | | | | |
| balanceback™ Intuitive VNG System | K042529 | | | | |

#### Indications for Use:

The balanceback " Mobile iVNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

## Description of the Device and Summary of the Technological Characteristics:

Eye movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system.

Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed.

The patient under examination wears the iVNG goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion

Fall Prevention Technologies, LLC

Page E-1

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#### balanceback™ Mobile VNG 510 (k) Submission

Doc ID: BBQMS_M00100 ISO13485 4.2, 5.0,

picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations.

The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eve movements for the attending clinician. The Mobile iVNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test.

Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and Mobile iVNG software record the patient's eve movements while he/she follows the stimulus.

### Substantial Equivalence:

The balanceback "10 Mobile iVNG device is substantially equivalent to the balanceback TM iVNG Workstation System (Desktop Configuration). This device supports the recording. viewing, and analyzing of horizontal and vertical eve movements to assist in the identification of balance disorders in human subjects. This device uses near identical technology, including the same goggles mounted with video cameras and software handling all the same tests (such as: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, and optokinetic examinations). These devices use the same sampling rate and similar illumination wavelengths. The primary differences are the configuration (from desktop to laptop) and the controls of the control box (additional video management hardware).

### Testing:

Various tests of the hardware and software are being performed to verify system specifications. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements. As part of this verification, a certified body shall conduct tests to determine the conformance of the device to the recognized standards shown below. The device will not be marketed or sold until it has been certified to pass these tests.

- · ANSI Z-136.1 (2000)
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995)
- · IEC 60601-1-1 (2000)
- · IEC 60601-1-2 (2001)
- · UL 60601-1 (2003)

#### 7.3

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fall Prevention Technologies, LLC % Intertek Testing Services Mr. Neil E. Devine, Jr. 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAR 3 0 2007

Re: K070729

Trade/Device Name: balanceback™ Mobile Intuitive VNG System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: February 14, 2007 Received: March 15, 2007

Dear Mr. Devine:

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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 -- Mr. Neil E. Devine, Jr.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark A. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# D Indications for Use Statement

## Indications for Use

Ko 70729

510(k) Number (if known):

Device Name:

balanceback TM Mobile Intuitive VNG System

Indications for Use:

The balanceback ™ Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

Prescription Use Yes AND/OR Over-The-Counter-Use No (Part 21 CFR 801 Subpart (Part 21 CFR 801 Subpart D) C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence o Evaluation (ODE) sion Sign-(Division Sign-on)
Division of General, Restorative, and Neurological Dev Fall Prevention Technologies, LLC 510(k) Number Page D-1