BALANCEBACK VNG SYSTEM

K042529 · Fall Prevention Technologies, LLC · GWN · Oct 6, 2004 · Neurology

Device Facts

• Record ID: K042529
• Device Name: BALANCEBACK VNG SYSTEM
• Applicant: Fall Prevention Technologies, LLC
• Product Code: GWN · Neurology
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG 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

BalanceBack VNG system records/analyzes eye movements to assist in identifying balance disorders; used by physicians/clinicians in clinical settings. System includes goggles with IR light sources and IR cameras; projector for visual stimuli. IR cameras capture continuous grayscale video of eyes; video digitized/processed by computer software. Software tracks/records/analyzes eye movements during battery of tests: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, high-frequency head shake. System calculates/reports parameters for each test; results combined with clinical info by physician to assess balance sensors/processing system. Benefits include objective documentation of eye movement patterns to aid clinical diagnosis.

Clinical Evidence

Bench testing only. Verification procedures with pass/fail criteria performed to ensure system specifications met. Device certified for conformance to ANSI Z-136.1 (2000), IEC 60601-1 (2004), IEC 60601-1-1 (2000), IEC 60601-1-2 (2001), and UL 60601-1 (2003). No clinical data provided.

Technological Characteristics

System includes goggles with IR light sources and IR cameras, digital computer, and projector. Sensing principle: IR video-oculography. Connectivity: workstation-based. Standards: ANSI Z-136.1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1. Software performs signal processing, tracking, and analysis of eye movement parameters.

Indications for Use

Indicated for human subjects with suspected balance disorders. Intended for use by trained physicians or clinicians in clinical settings. No specific age or gender restrictions stated.

Regulatory Classification

Identification

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

Predicate Devices

• Eye Dynamics, Inc. House Infrared/Video Electronystagmographic (ENG) System (K925111)
• Sensomotoric Instruments, Inc. 2d Vog - Video-Oculography System (K972243)

Submission Summary (Full Text)

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OCT 6 - 2004

#### 510(k) Summary E

| Submitter's Name: | Fall Prevention Technologies, LLC | | |
|-------------------------------|-----------------------------------------------------------------------------------|---------------|--|
| Submitter's Address: | 2300 NW Corporate Blvd. Suite 141 | | |
| | Boca Raton, FL 33431 | | |
| Submitter's Telephone: | 561-995-8883 | | |
| Contact Name: | Keith Kravitz | | |
| Date Summary was<br>Prepared: | August 10, 2004 | | |
| Trade or Proprietary Name: | BalanceBack VNG System | | |
| Common or Usual Name: | VNG | | |
| Classification Name: | Nystagmograph (21 CFR 882.1460), product code GWN,<br>Class II | | |
| Predicate Devices: | Device Name | 510(k) Number | |
| | Eye Dynamics, Inc. House<br>Infrared/Video Electronystagmographic<br>(ENG) System | K925111 | |
| | Sensomotoric Instruments, Inc. 2d Vog<br>- Video-Oculography System | K972243 | |

### Indications for Use:

The BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG 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:

Eve 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 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

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high-frequency 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.

K042529

The patient under examination wears the VNG goggles. The 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 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 eye movements for the attending clinician. The VNG 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 VNG software, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and VNG software record the patient's eye movements while he/she follows the stimulus.

### Substantial Equivalence:

The BalanceBack VNG device is substantially equivalent to the Eye Dynamics, Inc. House Video/Video Electronystagmographic (ENG) System and the Sensomotoric Instruments, Inc. 2d Vog - Video-Oculography System. All three devices support the recording, viewing, and analyzing of horizontal and vertical eye movements to assist in the identification of balance disorders in human subjects. These devices use similar technology, including workstation, computer monitor, masks mounted with video cameras, and software, for performing caloric, positional, Hallpike, gaze, saccades, smooth pursuit, and optokinetic examinations. All three devices use the same sampling rate and similar illumination wavelengths.

### 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 60601-1-1 (2000) | • UL 60601-1 (2003) |
|-----------------------|------------------------|---------------------|
| IEC 60601-1 (2004) | • IEC 60601-1-2 (2001) | |

- · IEC 60601-1 (2004) · IEC 60601-1-2 (2001)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

Fall Prevention Technologies, LLC c/o Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K042529

Trade/Device Name: BalanceBack VNG System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: September 16, 2004 Received: September 17, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be devermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives of 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 r ou may a 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 may or bain 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 r reade o a reade 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. Daniel W. Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin maneting of substantial equivalence of your device to a legally premarket notification. The PDF Intellig of castion 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 11 you desire spocific acrive 2017 904 276-0115. Also, please note the regulation entitled, Coliner the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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

Ver/ 3 - 4/24/96

Applicant: Fall Prevention Technologies, LLC

510(k) Number (if known): _____

Device Name: BalanceBack VNG System

Indications For Use:

The BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG is intended for use only n support of residentlying on an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

er the Counter Use

Miriam C. Provost

(Division Division of General, Restorative, and Neurological Devices

510(k) Number_

Prescription Use
per 21 CFR 801.109