Test of Variables of Attention (T.O.V.A.) Version 9.0

K170082 · The Tova Company · LQD · May 17, 2017 · NE

Device Facts

• Record ID: K170082
• Device Name: Test of Variables of Attention (T.O.V.A.) Version 9.0
• Applicant: The Tova Company
• Product Code: LQD · NE
• Decision Date: May 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Pediatric

Indications for Use

The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.

Device Story

T.O.V.A. is a computerized continuous performance test (CPT) measuring attention and inhibitory control. Input: patient responses to visual or auditory stimuli recorded via a high-accuracy (±1 ms) microswitch. Operation: patient performs a Go/No-Go task; system records response time, variability, commissions, and omissions. Data is compared against age- and gender-matched normative samples and ADHD-diagnosed populations. Output: immediate, easy-to-read report for clinician use. Used in clinical settings by qualified healthcare professionals to support ADHD assessment. Benefits: provides objective, standardized, culture- and language-free measurements to enhance diagnostic accuracy.

Clinical Evidence

Bench testing only. Verification and validation performed per design controls. System passed electrical safety (IEC 60601-1:2005) and electromagnetic compatibility (IEC 60601-1-2:2014) testing. Software verification confirmed system functionality against requirements. No clinical trial data presented.

Technological Characteristics

System includes T.O.V.A. USB device, microswitch, and software for Mac/Windows. Microcontroller-based architecture. Timing accuracy ±1 ms. Connectivity via USB. Complies with IEC 60601-1:2005 (safety) and IEC 60601-1-2:2014 (EMC).

Indications for Use

Indicated for children and adults to aid in the assessment of attention deficits, including ADHD. No specific contraindications listed.

Predicate Devices

• The Gordon Diagnostic System Model I from Clinical Diagnostics Inc. (K854903)

Submission Summary (Full Text)

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Public Health Service

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

May 17, 2017

The TOVA Company Chris Holder, CEO 2828 SW Corbett Ave. Suite 128 Portland. Oregon 97201

Re: K170082

Trade/Device Name: Test of Variables of Attention (T.O.V.A) version 9.0 Regulatory Class: Unclassified Product Code: LQD Dated: April 12, 2017 Received: April 17, 2017

Dear Chris Holder:

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.

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

# Michael J. Hoffmann -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K170082

Device Name

Test of Variables of Attention (T.O.V.A.) version 9.0

Indications for Use (Describe)

The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficitly disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.

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

| <span style="font-size:12px;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------|
| <span style="font-size:12px;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) SUMMARY

| Date: | 04/12/2017 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | The TOVA Company<br>2828 SW Corbett Ave suite 128<br>Portland, OR 97201 USA<br>Contact Person: Chris Holder<br>Tel [phone]<br>Email: [e-mail] |
| Trade Name: | Test of Variables of Attention (T.O.V.A.) version 9.0 |
| Common name: | Continuous Performance Test (CPT) |
| Product Code: | LQD |
| Classification name: | Recorder, attention task performance |
| Device class: | Unclassified |
| Predicate Device: | The Gordon Diagnostic System Model I from Clinical Diagnostics Inc. (K854903) |
| Device Description: | The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous<br>performance test (CPT) that measures the key components of attention and inhibitory<br>control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of<br>attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children<br>and adults.<br>The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that<br>requires no left/right discrimination or sequencing. Responses to visual or auditory<br>stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The<br>T.O.V.A. calculates response time variability (consistency), response time (speed),<br>commissions (impulsivity), and omissions (focus and vigilance). These calculations are<br>then compared to a large age- and gender-matched normative sample (over 1,700<br>individuals for the visual test, and over 2,500 individuals for the auditory test), as well as<br>to a sample population of individuals independently diagnosed with ADHD. These<br>comparison results are used to create an immediately available, easy-to-read report.<br>The T.O.V.A. system includes: a USB flash drive with software installer for Mac and<br>Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a<br>User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables). |
| Indications for Use: | The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with<br>objective measurements of attention and inhibitory control, which aid in the<br>assessment of attention deficits, including attention-deficit/hyperactivity disorder<br>(ADHD). T.O.V.A. results should only be interpreted by qualified healthcare<br>professionals. |
| Technological<br>Characteristics: | The T.O.V.A. consists of the TO.V.A. USB Device, the T.O.V.A. Microswitch, and a USB<br>flash drive with software for use on a Mac or Windows PC. The T.O.V.A. has been |

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designed and tested to be safe and effective when used by qualified healthcare professionals.

Performance Data: The T.O.V.A. has been verified and validated in accordance with design controls. The T.O.V.A has passed testing for safety and essential performance under IEC 60601-1:2005 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" and electromagnetic compatibility under IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests". In all instances, the T.O.V.A. functioned as intended and the performance observed was as expected.

| Test | Test Method Summary | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2005 “Medical<br>electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential<br>performance” | A third-party test facility (UL,<br>Inc.) tested the T.O.V.A. 9<br>system to IEC 60601-1:2005. | The T.O.V.A. passed the state of the art for<br>electrical safety and functional testing.<br>Although no such testing was done for the<br>GDS, it met the safety and functional testing<br>required for 510(k) clearance in 1989. Thus,<br>the T.O.V.A. is equivalent or better in safety<br>and functionality compared to the GDS. |
| IEC 60601-1-2:2014 “Medical<br>electrical equipment - Part 1-<br>2: General requirements for<br>basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests” | A third-party test facility<br>(Element, Inc.) tested the<br>T.O.V.A. 9 system to IEC<br>60601-1-2:2014. | The T.O.V.A. passed the state of the art for<br>electromagnetic compatibility and<br>electromagnetic immunity testing. Although<br>no such testing was done for the GDS, it met<br>the safety and functional testing required for<br>510(k) in 1989. Thus, the T.O.V.A. is<br>equivalent or better in electrical performance<br>compared to the GDS. |
| T.O.V.A. Verification Testing | The T.O.V.A. system was<br>tested by the TOVA Company<br>as described in “Section 16 –<br>Software”, specifically the<br>“Verification and Validation<br>Summary (“VVS01”)” which<br>includes a detailed matrix of<br>requirements and their<br>corresponding tests. | The T.O.V.A. functioned as intended, passing<br>all major verification tests. Minor issues were<br>found, which are listed in “Section 16 -<br>Software” under Unresolved Anomalies. No<br>equivalent verification tests were listed for<br>the GDS, although it met the verification<br>requirements for a 510(k) in 1989. Thus, the<br>T.O.V.A. is equivalent or even more rigorously<br>verified compared to the GDS. |

#### Substantial Equivalence:

The T.O.V.A. is substantially equivalent to the Gordon Diagnostic System that was cleared under K854903. The T.O.V.A. has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the T.O.V.A. and its predicate devices raise no new issues of safety or effectiveness. A detailed comparison is shown below.

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| | Gordon Diagnostic System (GDS) | Test of Variables of Attention (T.O.V.A.) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K854903 | K170082 |
| FDA CODE | LQD | LQD |
| FDA Class | Unclassified | Unclassified |
| Intended Use | The GDS aids in the diagnosis of<br>attention deficits, especially<br>Attention Deficit Hyperactivity<br>Disorder (ADHD). It provides<br>reliable, objective information<br>about an individual's ability to<br>sustain attention and exert self-<br>control. | The Test of Variables of Attention (T.O.V.A.)<br>provides healthcare professionals with objective<br>measurements of attention and inhibitory<br>control, which aid in the assessment of attention<br>deficits, including attention-deficit/hyperactivity<br>disorder (ADHD). T.O.V.A. results should only be<br>interpreted by qualified healthcare professionals. |
| Normative study | Visual: Ages 4 to 16. | Visual: Ages 4 to 80. |
| range | Auditory: Ages 4 to 16. | Auditory: Ages 6 to 29. |
| | Adults: Labeling says "Published | |
| | norms are also available for adults, | |
| | college students, geriatric | |
| | populations..." | |
| Norming Data | Normative data are based upon<br>protocols of over 1,300 non-<br>hyperactive boys and girls aged 4-<br>16 years. | Normative data are based on 1,714 (visual) and<br>2,680 (auditory) non-ADHD individuals ages 4 to<br>80. |
| Device Description | This device aids in the diagnosis of<br>attention deficits, especially<br>Attention Deficit Hyperactivity<br>Disorder (ADHD). It provides<br>reliable, objective information<br>about an individual's ability to<br>sustain attention and exert self-<br>control. This practical, reliable, and<br>well-researched device enhances<br>the accuracy and relevance of a<br>comprehensive evaluation for<br>attention deficits and<br>impulsiveness. | The Test of Variables of Attention (T.O.V.A.) is an<br>accurate and objective continuous performance<br>test (CPT) that measures the key components of<br>attention and inhibitory control. The T.O.V.A. is<br>used by qualified healthcare professionals in the<br>assessment of attention deficits, including<br>attention-deficit/hyperactivity disorder (ADHD),<br>in children and adults.<br><br>The T.O.V.A. is a culture- and language-free,<br>sufficiently long computerized test that requires<br>no left/right discrimination or sequencing.<br>Responses to visual or auditory stimuli are<br>recorded with a specially designed, highly<br>accurate (±1 ms) microswitch. The T.O.V.A.<br>calculates response time variability (consistency),<br>response time (speed), commissions (impulsivity),<br>and omissions (focus and vigilance). These<br>calculations are then compared to a large age-<br>and gender-matched normative sample (over<br>1,700 individuals for the visual test, and over<br>2,600 individuals for the auditory test), as well as<br>to a sample population of individuals<br>independently diagnosed with ADHD. These<br>comparison results are used to create an<br>immediately available, easy-to-read report |
| | Gordon Diagnostic System (GDS) | Test of Variables of Attention (T.O.V.A.) |
| | | The T.O.V.A. system includes: a USB flash drive<br>with software installer for Mac and Windows PCs,<br>a T.O.V.A. USB device, a T.O.V.A. Microswitch, an<br>Installation Guide, a User's Manual, a Clinical<br>Manual, and accessory cables (USB, VGA, and<br>audio cables). |
| Length of test | 8-9 minutes. | 10.8 to 21.6 minutes. |
| Continuous<br>Performance Test<br>(CPT) | Yes (A-X task). | Yes (Go/No Go task). |
| Visual stimuli | Yes (numeric digits). | Yes (geometric shapes). |
| Auditory stimuli | Yes (sound samples). | Yes (tones). |
| Technology | Real-time, microcontroller-based,<br>portable stand-alone unit. | Real-time, microcontroller-based, portable stand-<br>alone unit, with USB connection to a Mac or<br>Windows PC. |
| Subject response<br>mechanism | Microswitch. | Microswitch. |
| Timing accuracy | Unknown; estimated at ± 10<br>milliseconds. | Accurate timing to ±1 milliseconds. |
| Statistics gathered | Omissions (false negatives),<br>Commissions (false positives), and<br>Response Times (not including<br>variability) | Omissions (false negatives),<br>Commissions (false positives),<br>Response Times (including variability). |
| Report | Printed on thermal printer. | Printed or PDF output. |
| Accessories | Auditory module, printer. | Flash drive and off-the-shelf USB, audio, and<br>video cables. |
| Software | Firmware only, not updateable. | Firmware and software, fully updateable. |
| Platforms | Stand-alone device only. | Windows PCs running Windows 7 - 10.<br>Mac computers running Mac OS X 10.8 - 10.12 |
| Standards with<br>which the Device<br>Complies | No electrical safety or EMC test<br>data listed in 510(k). | IEC 60601-1: 2012 and IEC 60601-1-2:2014 |

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