QB TEST

K133382 · Qbtech AB · LQD · Mar 24, 2014 · NE

Device Facts

• Record ID: K133382
• Device Name: QB TEST
• Applicant: Qbtech AB
• Product Code: LQD · NE
• Decision Date: Mar 24, 2014
• 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 and in the evaluation of treatment interventions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.

Device Story

QbTest is a computer-assisted attention and impulse control task system used in clinical settings to assess ADHD. The system captures patient performance on visual stimuli tasks via a responder button while simultaneously recording physical activity using an infrared camera and a reflective motion marker. The device transforms these inputs into quantitative measurements of hyperactivity, impulsivity, and inattention. Results are generated via a remote server and presented in reports for interpretation by qualified clinicians. By providing objective data, the device aids in the clinical assessment of ADHD and the evaluation of treatment interventions, potentially benefiting patients through more precise monitoring of symptom changes over time.

Clinical Evidence

Evidence based on seven published clinical studies and one registry study (n=115; 42 children, 73 adults). Studies evaluated treatment interventions (stimulants, atomoxetine) using effect sizes (ES) for hyperactivity, inattention, and impulsivity variables. Results showed statistically significant changes from baseline. Registry study compared QbTest to clinical Rating Scales (RS), reporting a PPA of 75% and NPA of 40% for the pooled cohort. Correlations between QbTest and RS were statistically significant but low, indicating the device should complement clinical evaluation.

Technological Characteristics

System includes client software, responder button, infrared camera, and reflective motion marker. Operates via computer-assisted task performance and infrared motion tracking. Tested to EN 60601-1 (electrical safety), EN 60601-1-2 (EMC), and EN 60825-1 (laser/optical safety). Connectivity includes access to a remote server for report generation.

Indications for Use

Indicated for patients with ADHD to provide objective measurements of hyperactivity, impulsivity, and inattention to aid in clinical assessment and evaluation of treatment interventions. For use by qualified professionals only.

Predicate Devices

• QbTest (K122149)

Submission Summary (Full Text)

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

# 510(k) Summary of safety and effectiveness

| Date: | March 24, 2014 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Qbtech AB<br>Kungsgatan 29<br>11156 Stockholm<br>Sweden<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Hans Boström<br>E-mail: [e-mail] |

- Trade Name: QbTest
Classification name: Recorder, attention task performance

- Product Code: LQD
- Predicate Device: QbTest (K122149)

Device Description: QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of 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 Behavior Rating Scale
- · In addition, the user must have access to a remote server that generates test reports

#### Intended use: QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.

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

QbTest is substantially equivalent to QbTest (K122149).

Comparison of technological characteristics to predicate device:

It provides the same functions and has an identical design.

The current version of QbTest can also be used to aid qualified professionals in the evaluation of treatment interventions in patients with ADHD.

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"

## Clinical Performance

Data:

The intended use of QbTest to support qualified professional in the evaluation of treatment interventions in ADHD is not based on one specific prospective study. Instead it is based on collated data from seven published clinical studies where QbTest has been used to evaluate different treatment interventions and one registry study, specifically designed to compare QbTest with clinically validated Rating Scales (RS) in the evaluation of treatment interventions.

Two of the published clinical studies evaluated the responsiveness of the test after single doses of central stimulants (CS) and two other studies focused on the capacity of the test to measure effects over the day for atomoxetine and CS (1-4).

Three of the published studies and the registry study evaluated the Effect Size (ES) of different treatment interventions measured by QbTest. Two of these studies included a placebo control group. In the first placebo-controlled study (5), with the objective to evaluate the effect of atomoxetine by means of QbTest and clinical rating scales, 128 children with ADHD (mean age 9.0) were randomized to treatment with atomoxetine or placebo and followed for 8 weeks. The per-protocol ES (Cohens d; small 0.2, moderate 0.5, and large 0.8) for the principal QbTest hyperactivity variables (Time active, Distance, Area and Microevents) varied between 0, 85 and 1, 49. The corresponding ES for the principle variables measuring inattention (Reaction Time Variation and Omission Errors) were 1.24 and 0.8 respectively and the principle variable measuring impulsivity (Commission Errors) showed an ES of 0,82. All changes from baseline were statistically significant. In the second placebo controlled study (6), 36 medication-naïve children aged 9 - 14 years diagnosed with ADHD were treated with methylphenidate, dexamphetamine and placebo for 3 weeks in a cross-over fashion. Group-level analyses revealed a statistically significant overall treatment effect for stimulant treatment compared to placebo with an ES of 0.62 measured by QbTest (partial eta-square; small 0.01. moderate 0.06 and large 0.14).

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

In a third study (7), QbTest was used to evaluate the effect of 16 and 52 weeks of treatment with methylphenidate in 23 adults. The ES (partial eta-square; small 0.01, moderate 0.06 and large 0.14) for the different QbTest hyperactivity variables (Time active, Distance. Area and Microevents) varied between 0.43 and 0.51. The ES for the variables measuring inattention (Reaction Time Variation and Omission Errors) was 0.51 and 0.46 respectively and the principle variable measuring impulsivity (Commission Errors) showed an ES of 0.28. Repeated measure ANOVAS showed statistically significant changes from baseline for all QbTest variables.

The registry study included consecutive patients. 42 children/adolescents (mean age 11.5) and 73 adults (mean age 35), with QbTest and clinical Rating Scale (RS) data at baseline and after treatment with central stimulants or atomoxetine. Time to follow up varied between 6 davs and 10 weeks. The ES (Cohens d: small 0.2. moderate 0.5, and large 0.8) for the QbTest Total score (QbActivity+ Qblnattention + Qblmpulsivity)/3 and the RS Total score were 1.06 and 0.98 respectively. Changes from baseline were statistically significant for both methods. Time to follow up after treatment initiation was 5-6 weeks (10 weeks for atomoxetine treated patients) in the child/adolescent cohort and 6 to 65 days in the adult cohort. Of the 42 patients included from the child/adolescent cohort, 35 were male and 7 were female. The mean age was 11.5 years (8.5-15.7). Diagnosis was according the DSM-IV criteria and the baseline ADHD symptoms averaged 1.38 (SD = .36) on the ADHD items with a three step Likert scale ranging from "0- Does not apply" to "2-Definitely applies". This represents an at least moderately severity of ADHD. Of the 73 clinical patients included in the analysis from the adult cohort. 32 were women and 41 were men. The mean age was 35 years (18.6-54.1 years). Fifty-eight patients were diagnosed as ADHD combined subtype and 15 patients as ADHD inattentive subtype. The baseline ADHD symptoms in this cohort had an average of 1.95 (SD = .45) on a four step Likert scale ranging from "O- Never or seldom" to "3- Very often". This represents an at least moderately severity of ADHD. Data on ethnicity and social economic status was not collected in the two cohorts since this is not a routine at these clinical centres. The child cohort consisted of a sample of Swedish children assessed for ADHD and the adult cohort consisted of a sample of Dutch adults assessed for ADHD. It can thus be assumed that the majority of the included patients were Caucasians.

| Subjects in each cohort | | |
|-------------------------|-----------|---------|
| Cohort | Frequency | Percent |
| Adult | 73 | 63.5 |
| Child | 42 | 36.5 |
| Total | 115 | 100 |

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

Although the ES in the above studies all show large treatment effects they must be interpreted with caution since two of the studies did not include a concurrent control arm.

In addition to the comparison of ES between QbTest and RS, correlations between QbTest based treatment responses and RS based treatment responses were calculated in the registry study. In several studies where rating scales has been used to evaluate treatment effects, a change of -30% in ADHD RS Total score has been used as a threshold for a meaningful response to treatment. It should however be pointed out that this threshold has nothing to do with the imprecision of rating scales. Rather, this cut-off is based on clinical experience. The same logic can be used for QbTest. Although the imprecision of QbTest has been defined to 0.36 Q-scores, the Qscore of - 0.5 is used as a cut-off that defines a meaningful change from baseline. This cut off is based on clinical experience and psychometric conventions. Consequently, the above clinically based thresholds for a meaningful treatment effect were utilized when the correlation between QbTest and RS was evaluated. The figures and tables below show individual treatment responses, calculated response rates as well as Negative Percent Agreement (NPA) and Positive Percent Agreement (PPA) with Confidence Intervals (CI) for the two methods.

Image /page/3/Figure/2 description: This image is a scatter plot with the x-axis labeled as 'RSpercchange' ranging from -1.00 to 0.25, and the y-axis labeled as 'Qb_Total_Change' ranging from -4.00 to 2.00. The plot is divided into four quadrants by lines at approximately x = -0.25 and y = -0.5. The data points are represented by circles, with different circle types indicating different response categories: 'RS+ Qb-', 'RS- Qb+', 'RS+ Qb+', and 'RS- Qb-'. The legend indicates that the data represents a response where Qb is -0.5 standard deviations and RS is 30%.

Pooled Cohort Analysis:

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

| | RS Total Score | | | |
|-------------------------------|----------------|----------------|-------------|-------|
| | Pooled Cohort | No Improvement | Improvement | Total |
| QbTest Total<br>Score | No Improvement | 23 | 14 | 37 |
| | Improvement | રૂક | 43 | 78 |
| | Total | રક | 57 | 115 |
| NPA = 40 (23/58) Cl: 28 to 53 | | | | |
| PPA = 75 (43/57) | Cl:63 to 85 | | | |

Child Cohort Analysis:

Image /page/4/Figure/2 description: This scatter plot shows the relationship between 'RSpercchange' on the x-axis and 'Qb_Total_Change' on the y-axis. The y-axis ranges from -4.00 to 2.00, while the x-axis ranges from -1.00 to 0.20. The plot contains data points categorized into four groups: 'RS+ Qb-', 'RS- Qb+', 'RS+ Qb+', and 'RS- Qb-', as indicated by the legend, with Qb at -0.5sd and RS at 30%.

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

| | RS Total Score | | | |
|-------------------------------|----------------|----------------|-------------|-------|
| | Child Cohort | No Improvement | Improvement | Total |
| QbTest Total<br>Score | No Improvement | 5 | 3 | 8 |
| | Improvement | 11 | 23 | 34 |
| | Total | 16 | 26 | 42 |
| NPA = 31 (5/16) CI: 14 to 56 | | | | |
| PPA = 88 (23/26) CI: 71 to 96 | | | | |

Adult Cohort Analysis:

Image /page/5/Figure/2 description: This image is a scatter plot with 'RSpercchange' on the x-axis and 'Qb_Total_Change' on the y-axis. The plot is divided into four quadrants by lines at x=0 and y=0. The data points are represented by circles, and there is a legend indicating that the circles represent four different response types: 'RS+ Qb-', 'RS- Qb+', 'RS+ Qb+', and 'RS- Qb-'. The y-axis ranges from -4.00 to 2.00, while the x-axis ranges from -1.00 to 0.25.

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

| | RS Total Score | | | |
|-------------------------------|----------------|----------------|-------------|-------|
| | Adult Cohort | No Improvement | Improvement | Total |
| QbTest Total<br>Score | No Improvement | 18 | 11 | 37 |
| | Improvement | 24 | 20 | 44 |
| | Total | 42 | 31 | 73 |
| NPA = 43 (18/42) CI: 29 to 58 | | | | |
| PPA = 65 (20/31) CI: 47 to 79 | | | | |

The registry study showed statistically significant but low correlations between QbTest and the clinically validated rating scales (RS). Therefore and in the absence of a well-defined gold standard for the evaluation of treatment effects in ADHD, QbTest results should be complemented by a clinical evaluation of the treatment effects to avoid the risk that QbTest results should indicate that a treatment is ineffective when it is clinically effective and that QbTest results should indicate that a treatment is effective when it is clinically ineffective.

## References:

1. Vogt, C., & Williams, T. (2011). Early identification of stimulant treatment responders, partial responders and non-responders using objective measures in children and adolescents with hyperkinetic disorder. Child and Adolescent Mental Health, 16, 144-149. 2. Edebol, H., Helldin, L., Norlander, T. (2013). The Weighed Symptom Scale and Prediction of ADHD in Adults- Objective Measures of Remission and Response to Treatment with Methylphenidate. Clinical Practice & Epidemiology in Mental Health, 9. 171-179.

3. Wehmeier, P.M., Schacht, A., Wolff, C., Otto, W.R., Dittman, R.W., & Banaschewski, T. (2011). Neuropsychological outcomes across the day in children with attention-deficit/hyperactivity disorder treated with atomoxetine: Results from a placebo-controlled study using a computer-based continuous performance test combined with an infrared motion-tracking device. Journal of Child and Adolescent Psychopharmacology, 21, 430-444.

4. Günther, T., Kahraman-Lanzerath, B., Knospe, E.L., Herpertz-Dahlmann, B. & Konrad, K. (2012). Modulation of attentiondeficit/hyperactivity disorder symptoms by short- and long-acting methylphenidate over the course of a day. Journal of Child and Adolescent Psychopharmacology, 22, 1-8.

5. Wehmeier, P.M., Schacht, A., Ulberstad, F., Lehmann, M., Schneider-Fresenius, C., Lehmkuhl, G., Dittman, R.W., & Banaschewski, T. (2012). Does atomoxetine improve executive function, inhibitory control, and hyperactivity? Results from a placebo

{7}------------------------------------------------

controlled trial using quantitative measurement technology. Journal of Clinical Psychopharmacology, 32, 653-660.

6. Ramtvedt, B.E., Røinås, E., Aabech, H.S. & Sundet, K.S. (2013). Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. Journal of Child and Adolescent Psychopharmacology, 23, 1-8.

7. Ginsberg, Y., Hirvikoski, T. & Grann, M. (2012). Long-term functional outcome in adult prison inmates with ADHD receiving OROS-methylphenidate. European Archives of Psychiatry and Clinical Neuroscience, 262, 705-724.

{8}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

1

Public Health Service

Food and Drug Administration 10903 Now Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2014

ObTech AB c/o Hans Boström, MSc., PhD. Medical Director Kungsgatan 29, 7tr S-111 56 Stockholm Sweden

Re: K133382

Trade/Device Name: QbTest Regulation Number: Unclassified Device Classification Name: recorder, attention task performance Regulatory Class: Unclassified Product Code: LQD Dated: March 24, 2014 Received: March 24, 2014

Dear Dr. Boström:

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. Isting 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.

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

{9}------------------------------------------------

Page 2 - Hans Bostrom, MSc., PhD.

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 clectronic 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

. . Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

### K133382

Device Name

QbTest

Indications for Use (Describe)

QbTest provides clinicans with objective measurements of hyperactivity, and inatention to aid in the
clinical assessment of ADHD (Attention Deficit Hyperactivity Disorder) an interentions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.

. ·

Type of Use (Select one or both, as applicable)

8 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)Carlos L. Pena -S

{11}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### 'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'

The burden time for this collection of information is estimated to average 79 hours per response, including the lime to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."