QBTEST

K040894 · Qbtech AB · LQD · Jun 22, 2004 · NE

Device Facts

• Record ID: K040894
• Device Name: QBTEST
• Applicant: Qbtech AB
• Product Code: LQD · NE
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Pediatric

Indications for Use

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

Device Story

QbTest is a 15-minute, non-invasive, computer-administered vigilance task; assesses ADHD-related disturbances (inattention, hyperactivity, impulsivity). Input: visual stimuli response via responder button; motion capture via camera tracking reflective marker. Operation: child performs go/not-go task while system records performance and locomotor activity. Output: quantitative measurements of behavior and performance. Used in clinical settings; operated by qualified professionals. Healthcare providers use output to aid clinical assessment of ADHD; provides objective data to support diagnostic process.

Clinical Evidence

No clinical data provided. Bench testing only: camera tested per EN60825-1:1994; system tested per EN 60601-1 (electrical safety) and EN 60601-1-2 (EMC).

Technological Characteristics

Microprocessor-based vigilance task recorder. Components: client PC software, connection box, responder button, camera, reflective marker. Standards: EN60825-1:1994 (laser/optical safety), EN 60601-1 (electrical safety), EN 60601-1-2 (EMC).

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

• OPTAx System (K020800)

Submission Summary (Full Text)

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Ko4o894

JUN 2 2 2004

5:Jk application - QbTest

## 510(k) Summary of safety and effectiveness

| Date: | 03/26/2004 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Qbtech AB<br>Mimergatan 5<br>SE - 417 64 Göteborg<br>Sweden<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Maria Berglund<br>E-mail: [e-mail] |
| Trade Name: | QbTest |
| Classification name: | Recorder, attention task performance |
| Product Code: | LQD |
| Predicate Device: | OPTAx System (K020800) |
| Device Description: | The QbTest is a 15 minute, non invasive test that has been<br>developed to provide precise quantitative assessment of the<br>capacity of children to pay attention to visual stimuli while<br>inhibiting their loco motor activity and controlling their urge to<br>respond impulsively. There are three cardinal disturbances in<br>Attention-Deficit Hyperactivity Disorder (ADHD) impaired<br>attention, hyperactivity and impulsivity. QbTest provides an<br>accurate and reproducible measure of a child's capacity in<br>each of these three domains by utilizing a consistent<br>challenge paradigm coupled with detailed real-time<br>measurements of behavior and performance. The<br>fundamental core of QbTest is a computer-administered<br>go/not-go vigilance response task combined with motion<br>capture. |
| | The system consists of the following components;<br>• Client PC software<br>• Connection box<br>• Responder button<br>• Camera for motion measurement<br>• Reflective marker<br>• USB and serial cable |
| Intended use: | QbTest provides clinicians with objective measurements of<br>hyperactivity, impulsivity, and inattention to aid in the clinical<br>assessment of ADHD. QbTest results should be interpreted<br>only by qualified professionals. |

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QbTest is substantially equivalent to the OPTAx system (K020800). Comparison of It provides the same or similar functions and has a similar design. technological The new characteristics do not affect safety or characteristics to effectiveness. Both the OPTAx system and QbTest are predicate device : indicated to aid in the assessment of ADHD. Both provide objective measurements of impulsivity, inattention and hyperactivity to aid in this process. Both are microprocessorbased vigilance task recorders with motion detection. Performance Testing: The camera is tested in accordance with EN60825-1:1994. The System is tested in accordance with EN 60601-1 "Electrical Equipment, Part 1: General Safety Requirements" and EN 60601-1-2 "Electromedical equipment, EMC

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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 an abstract symbol that resembles three stylized human figures or waves, stacked on top of each other.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Ms. Maria Berglund Quality Assurance ObTech AB Mimergatan 5 417 64 Göteborg Sweden

Re: K040894 Trade/Device Name: QbTest Regulatory Class: Unclassified Product Code: LQD Dated: March 26, 2004 Received: April 29, 2004

Dear Ms. Berglund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be 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 encrosule) to regars as and the Medical Device Amendments, or 10 commerce prox to may 20, 1970, in eccordance with the provisions of the Federal Food, Drug, de rices that have been 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 our may, merelove, mains of the Act include requirements for annual registration, listing of general controlo provider ing 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 If your device is craissimed (tools. Existing major regulations affecting your device can may be subject to suell 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 least of advised that I Drivisan that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any I catal statutes and regations, including, but not limited to: registration and listing (21 Comply with an the 110: 31equirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic form in the qualify by evol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Maria Berglund

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maxioning of substantial equivalence of your device to a legally premarket notification: "The PDA mining sification 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 If you uesn't specific advice for Jour ac 110 %. 4659. Also, please note the regulation entitled, Comaci the Office of Comphanes at (est notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its 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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## Indications for Use

510(k) Number (if known): K040894

Device Name: QbTest

Indications For Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Bigand Neurological Devices

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**510(k) Number** K040894