OPTAX SYSTEM

K020800 · Optax Systems, Inc. · LQD · Jun 10, 2002 · NE

Device Facts

• Record ID: K020800
• Device Name: OPTAX SYSTEM
• Applicant: Optax Systems, Inc.
• Product Code: LQD · NE
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Pediatric

Indications for Use

The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.

Device Story

OPTAx is a 15-minute, office-based, non-invasive system for assessing ADHD symptoms in children. It utilizes a computer-administered GO/NO-GO vigilance response task to measure inattention and impulsivity, while a motion analysis camera tracks locomotor activity to measure hyperactivity. The system consists of an iMac computer, pre-installed software, a motion analysis camera, and a secure server for data analysis. The clinician initiates the test; the system records behavioral performance and physical movement. Data is processed to provide quantitative metrics of the three core ADHD domains. Clinicians use these objective reports to support clinical assessment and decision-making. The device benefits patients by providing reproducible, quantitative data to assist in the diagnostic process.

Clinical Evidence

Clinical testing was performed on the OPTAx System to validate its performance in measuring hyperactivity, impulsivity, and inattention. Specific metrics and study results are not detailed in the provided summary.

Technological Characteristics

Microprocessor-based vigilance task recorder. Components include an iMac computer, peripherals, and a motion analysis camera. Camera safety tested to EN 60825-1-1994. System utilizes a GO/NO-GO vigilance task paradigm. Data processing occurs via software on a secure server.

Indications for Use

Indicated for children to aid in the clinical assessment of ADHD by providing objective measurements of hyperactivity, impulsivity, and inattention.

Predicate Devices

• Gordon Diagnostic System (K854903)

Submission Summary (Full Text)

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JUN 1 0 2002

Kozogoo

# OPTAx Systems Inc. 510K Summary of Safety and Effectiveness June 6, 2002

Sponsor Name OPTAx Systems Inc. 20 Mall Rd. Suite 210 Burlington, MA 01803

#### 2. Device Name

1.

Proprietary Name: OPTAx System Common/Usual Name: RECORDER, ATTENTION TASK PERFORMANCE

Identification of Predicate or Legally Marketed Device 3.

Gordon Diagnostic System cleared under K854903.

### Device Description 4.

OPTAx (Optical Tracking and Attention test) is a 15 minutenon-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm, coupled with detailed real-time measurements of behavior and performance. The fundamental core of OPTAx is a computer-administered GO/NO-GO vigilance response task.

The OPTAx System consists of the following components:

- . IMac computer and peripherals (printer and adapters)
- Pre-installed OPTAx software program ●
- . Motion analysis camera and peripherals
- Data analysis software on the OPTAx secure server .

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#### રું. Intended Use

The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.

#### Comparison of Technological Characteristics 6.

Both the Gordon and OPTAx Systems are indicated to aid in the diagnosis and assessment of ADHD. Both provide objective measurements of impulsivity and inattention to aid in this process; OPTAx also provides objective measurements of hyperactivity.

Both are microprocessor-based vigilance task recorders.

## Performance Testing

Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System.

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JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OPTAx Systems, INC. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, MA 01748

Re: K020800 Trade/Device Name: OPTAx System Regulatory Class: Unclassified Product Code: LQD Dated: March 8, 2002 Received: March 12, 2002

Dear Ms. Iampietro:

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 - Ms. Debbie Iampietro

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

s. Stephen Rhodes

elia 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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K020800 – Additional Information .

K020800 510(k) Number (if known):

Device Name: OPTAx System

Indications For Use:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">X</div> | OR | Over-The-Counter Use |
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(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K020800 |
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