QBTES

K122149 · Qbtech AB · LQD · Oct 17, 2012 · NE

Device Facts

• Record ID: K122149
• Device Name: QBTES
• Applicant: Qbtech AB
• Product Code: LQD · NE
• Decision Date: Oct 17, 2012
• 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 non-invasive, computer-assisted system for quantitative assessment of attention, impulsivity, and hyperactivity. Input data includes visual stimuli response (via responder button) and motion tracking (via infrared camera and reflective marker). The system measures performance on a vigilance task while simultaneously recording physical activity. Output consists of objective measurements of hyperactivity, impulsivity, and inattention, which are processed via a remote server to generate clinical reports. Used in clinical settings by healthcare professionals to assist in ADHD assessment. The device provides reproducible data to support clinical decision-making and patient evaluation.

Clinical Evidence

Clinical evidence includes a normative database of 1307 individuals (ages 6-60) with balanced age/gender distribution. Four published studies evaluated clinical validity for the intended population. Two test-retest studies demonstrated reliability. Bench testing confirmed compliance with EN60825-1 (laser safety) and EN60601-1/EN60601-1-2 (electrical safety and EMC).

Technological Characteristics

Microprocessor-based vigilance task recorder. Components: infrared camera, reflective motion marker, responder button, client software. Connectivity: requires access to a remote server for report generation. Standards: EN60825-1 (laser safety), EN60601-1 (electrical safety), EN60601-1-2 (EMC).

Indications for Use

Indicated for use as an aid in the clinical assessment of ADHD in patients (including adolescents and adults). Results must be interpreted by qualified healthcare professionals.

Predicate Devices

• QbTest (K040894)
• Gordon Diagnostic System (K854903)

Submission Summary (Full Text)

{0}------------------------------------------------

K122149

# 510(k) Summary

| Date: | 17 July |
|-------|---------|
|-------|---------|

OCT 1 7 2012

Qbtech AB 510(k) Submitter:

- Kungsgatan 29 11156 Stockholm Sweden Tel: [phone] Fax: +46 8 Contact person: Hans Boström E-mail: hans bostrom@qbtech se
2012

Trade Name: QbTest

Classification name: Recorder, attention task performance

LQD Product Code:

QbTest (K040894) and Gordon Diagnostic System (K854903) Predicate Device:

| Descripti<br>on | Gordon<br>Diagnostic<br>System (K854903) | QbTest (K040894) | QbTest v3.5 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Gordon<br>Diagnostic System<br>(GDS) aids in the<br>diagnosis of<br>attention deficits,<br>especially Attention<br>Deficit Hyperactivity<br>Disorder (ADHD). It<br>provides reliable,<br>objective<br>information about<br>an individual's | QbTest (K040894)<br>provides clinicians with<br>objective measurements of<br>hyperactivity, impulsivity,<br>and inattention to aid in the<br>clinical assessment of<br>ADHD. QbTest results<br>should be interpreted only<br>by qualified professionals. | QbTest v3.5 provides<br>clinicians with objective<br>measurements of<br>hyperactivity, impulsivity,<br>and inattention to aid in the<br>clinical assessment of<br>ADHD. QbTest results<br>should be interpreted only<br>by qualified professionals. |

{1}------------------------------------------------

| ability to sustain | |
|---------------------|--|
| attention and exert | |
| self-control. | |
| | |

Device Description: QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of an individual'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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements.

The system consists of the following components:

- · Client software
- · Responder button (also referred to as responder unit)
- · Infrared camera
- · Reflective motion marker
- · User manual
- Technical manual
- Stimulus card
- · Camera stand
- · Measuring tape
- · QbTest Behaviour Rating Scale

· In addition, the user must have access to a remote server that generates test reports

Indications for Use: QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only.

Intended 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.

Comparison of

QbTest is substantially equivalent to the original QbTest

{2}------------------------------------------------

| technological<br>characteristics to<br>predicate device: | (K040894).<br>It provides the same or similar functions and has a similar<br>design. Both the current version of QbTest and the<br>original version of QbTest (K040894) are indicated to aid<br>in the assessment of ADHD. Both provide objective<br>measurements of impulsivity, inattention and hyperactivity<br>to aid in this process. Both are microprocessor-based<br>vigilance task recorders with motion detection.<br><br>The current version of QbTest can also be used in<br>adolescents and adults as Gordon Diagnostic System<br>(K854903). |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | The camera is tested in accordance with EN60825-1:1994. The System<br>is tested in accordance with EN 60601-1 "Electrical Equipment, Part 1:<br>General Safety Requirements" and EN 60601-1-2 "Electromedical<br>equipment, EMC" |
| Clinical Testing: | Normative tests have been gathered from several different cohorts<br>resulting in a normative database of 1307 individuals between 6 and 60<br>years with an even age and gender distribution. The characteristics of<br>this norm database and the methods to generate age and gender<br>specific comparisons are described in the technical manual. There are<br>four published studies which have evaluated the clinical validity of the<br>QbTest for its intended use population. In addition, two test-retest<br>studies have been completed to demonstrate the reliability of the<br>QbTest. |
| Conclusions: | QbTest v3.5 is substantially equivalent to the original QbTest<br>(K040894). It provides the same or similar functions and has a similar<br>design. Both the original QbTest (K040894) and QbTest v3.5 are<br>indicated to aid in the assessment of ADHD. Both provide objective<br>measurements of impulsivity, inattention and hyperactivity to aid in this<br>process. Both are microprocessor-based vigilance task recorders with<br>motion detection. |

QbTest v3.5 can be used also in adolescents and adults as can the Gordon Diagnostic System (K854903).

{3}------------------------------------------------

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified above.

.

:

{4}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

OCT 17 2012

Qbtech AB % Mr. Hans Bostrom Medical Director Kungsgatan 29 11156 Stockholm Sweden

Re: K122149

> Trade/Device Name: QbTest v3.5 Regulation Number: Unclassified Regulation Name: Recorder, Attention Task Performance Regulatory Class: Class II Product Code: · LQD Dated: July 17, 2012 Received: July 19, 2012

Dear Mr. Bostrom:

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. 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 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.

{5}------------------------------------------------

### Page 2 - Mr. Hans Bostrom

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); medical device reporting (reporting of medical 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/CDRH/CDRHOffices/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.

Debra Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# STATEMENT FOR INDICATIONS FOR USE

510 (k) Number (if known):

K122149

Device Name:

QbTest

Indications for Use:

QbTest provides clinicians with objective measurements of hyperactivity, 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 GFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K122149