(127 days)
Not Found
No
The description focuses on standard statistical comparisons to normative and clinical samples, not on adaptive learning or complex pattern recognition characteristic of AI/ML.
No.
The device is used for assessment and measurement of attention deficits, which aids in diagnosis, but it does not provide therapy or treatment.
Yes
The device provides objective measurements of attention and inhibitory control to aid in the assessment of attention deficits, including ADHD, which directly supports a diagnostic process by a healthcare professional.
No
The device description explicitly states that the T.O.V.A. system includes hardware components such as a T.O.V.A. USB device and a T.O.V.A. Microswitch, in addition to the software.
Based on the provided information, the Test of Variables of Attention (T.O.V.A.) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- T.O.V.A. Function: The T.O.V.A. is a computerized behavioral test that measures attention and inhibitory control through responses to visual or auditory stimuli. It does not involve the analysis of biological samples.
- Intended Use: The intended use is to provide objective measurements that aid in the assessment of attention deficits, including ADHD. This is a behavioral assessment, not a diagnostic test based on biological markers.
Therefore, the T.O.V.A. falls under the category of a medical device used for behavioral assessment, not an In Vitro Diagnostic.
N/A
Intended Use / 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-deficitly disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.
Product codes
LQD
Device Description
The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults.
The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report.
The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults.
Normative study range: Visual: Ages 4 to 80. Auditory: Ages 6 to 29.
Intended User / Care Setting
qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Normative data are based on 1,714 (visual) and 2,680 (auditory) non-ADHD individuals ages 4 to 80.
Description of the test set, sample size, data source, and annotation protocol
A sample population of individuals independently diagnosed with ADHD is used for comparison.
Summary of Performance Studies
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: IEC 60601-1:2005 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"
Test Method Summary: A third-party test facility (UL, Inc.) tested the T.O.V.A. 9 system to IEC 60601-1:2005.
Results: The T.O.V.A. passed the state of the art for electrical safety and functional testing. Although no such testing was done for the GDS, it met the safety and functional testing required for 510(k) clearance in 1989. Thus, the T.O.V.A. is equivalent or better in safety and functionality compared to the GDS.
Test: 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"
Test Method Summary: A third-party test facility (Element, Inc.) tested the T.O.V.A. 9 system to IEC 60601-1-2:2014.
Results: The T.O.V.A. passed the state of the art for electromagnetic compatibility and electromagnetic immunity testing. Although no such testing was done for the GDS, it met the safety and functional testing required for 510(k) in 1989. Thus, the T.O.V.A. is equivalent or better in electrical performance compared to the GDS.
Test: T.O.V.A. Verification Testing
Test Method Summary: The T.O.V.A. system was tested by the TOVA Company as described in "Section 16 – Software", specifically the "Verification and Validation Summary ("VVS01")" which includes a detailed matrix of requirements and their corresponding tests.
Results: The T.O.V.A. functioned as intended, passing all major verification tests. Minor issues were found, which are listed in "Section 16 - Software" under Unresolved Anomalies. No equivalent verification tests were listed for the GDS, although it met the verification requirements for a 510(k) in 1989. Thus, the T.O.V.A. is equivalent or even more rigorously verified compared to the GDS.
Key Metrics
Omissions (false negatives), Commissions (false positives), Response Times (including variability).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three faces in profile, one behind the other. The faces are connected by a single line that forms the nose and forehead of each face.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for "The TOVA Company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the text "the TOVA company", with "the" above "TOVA" and "company" below "TOVA".
510(k) SUMMARY
| Date: | 04/12/2017 |
|---|---|
| 510(k) Submitter: | The TOVA Company |
| 2828 SW Corbett Ave suite 128 | |
| Portland, OR 97201 USA | |
| Contact Person: Chris Holder | |
| Tel 360-661-2899 | |
| Email: chris@thetovacompany.com | |
| 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 |
| performance test (CPT) that measures the key components of attention and inhibitory | |
| control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of | |
| attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children | |
| and adults. | |
| The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that | |
| requires no left/right discrimination or sequencing. Responses to visual or auditory | |
| stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The | |
| T.O.V.A. calculates response time variability (consistency), response time (speed), | |
| commissions (impulsivity), and omissions (focus and vigilance). These calculations are | |
| then compared to a large age- and gender-matched normative sample (over 1,700 | |
| individuals for the visual test, and over 2,500 individuals for the auditory test), as well as | |
| to a sample population of individuals independently diagnosed with ADHD. These | |
| comparison results are used to create an immediately available, easy-to-read report. | |
| The T.O.V.A. system includes: a USB flash drive with software installer for Mac and | |
| Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a | |
| 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 |
| 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. | |
| Technological | |
| Characteristics: | The T.O.V.A. consists of the TO.V.A. USB Device, the T.O.V.A. Microswitch, and a USB |
| flash drive with software for use on a Mac or Windows PC. The T.O.V.A. has been |
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Image /page/4/Picture/0 description: The image shows the logo for "The TOVA Company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the word "the" in a smaller font, and the word "TOVA" in a larger, bold, blue font. Below the word "TOVA" is the word "company" in a smaller, gray font.
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 | ||
| electrical equipment - Part 1: | ||
| General requirements for | ||
| basic safety and essential | ||
| performance” | A third-party test facility (UL, | |
| Inc.) tested the T.O.V.A. 9 | ||
| system to IEC 60601-1:2005. | The T.O.V.A. passed the state of the art for | |
| electrical safety and functional testing. | ||
| Although no such testing was done for the | ||
| GDS, it met the safety and functional testing | ||
| required for 510(k) clearance in 1989. Thus, | ||
| the T.O.V.A. is equivalent or better in safety | ||
| and functionality compared to the GDS. | ||
| 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” | A third-party test facility | |
| (Element, Inc.) tested the | ||
| T.O.V.A. 9 system to IEC | ||
| 60601-1-2:2014. | The T.O.V.A. passed the state of the art for | |
| electromagnetic compatibility and | ||
| electromagnetic immunity testing. Although | ||
| no such testing was done for the GDS, it met | ||
| the safety and functional testing required for | ||
| 510(k) in 1989. Thus, the T.O.V.A. is | ||
| equivalent or better in electrical performance | ||
| compared to the GDS. | ||
| T.O.V.A. Verification Testing | The T.O.V.A. system was | |
| tested by the TOVA Company | ||
| as described in “Section 16 – | ||
| Software”, specifically the | ||
| “Verification and Validation | ||
| Summary (“VVS01”)” which | ||
| includes a detailed matrix of | ||
| requirements and their | ||
| corresponding tests. | The T.O.V.A. functioned as intended, passing | |
| all major verification tests. Minor issues were | ||
| found, which are listed in “Section 16 - | ||
| Software” under Unresolved Anomalies. No | ||
| equivalent verification tests were listed for | ||
| the GDS, although it met the verification | ||
| requirements for a 510(k) in 1989. Thus, the | ||
| T.O.V.A. is equivalent or even more rigorously | ||
| 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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Image /page/5/Picture/1 description: The image is a logo for "the TOVA company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the text "the TOVA company", with "the" above "TOVA" and "company" below "TOVA". The text is in blue.
| 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 | |
| attention deficits, especially | ||
| Attention Deficit Hyperactivity | ||
| Disorder (ADHD). It provides | ||
| reliable, objective information | ||
| about an individual's ability to | ||
| sustain attention and exert self- | ||
| control. | 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. | ||
| 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 | |
| protocols of over 1,300 non- | ||
| hyperactive boys and girls aged 4- | ||
| 16 years. | Normative data are based on 1,714 (visual) and | |
| 2,680 (auditory) non-ADHD individuals ages 4 to |
-
|
| Device Description | This device aids in the diagnosis of
attention deficits, especially
Attention Deficit Hyperactivity
Disorder (ADHD). It provides
reliable, objective information
about an individual's ability to
sustain attention and exert self-
control. This practical, reliable, and
well-researched device enhances
the accuracy and relevance of a
comprehensive evaluation for
attention deficits and
impulsiveness. | The Test of Variables of Attention (T.O.V.A.) is an
accurate and objective continuous performance
test (CPT) that measures the key components of
attention and inhibitory control. The T.O.V.A. is
used by qualified healthcare professionals in the
assessment of attention deficits, including
attention-deficit/hyperactivity disorder (ADHD),
in children and adults.
The T.O.V.A. is a culture- and language-free,
sufficiently long computerized test that requires
no left/right discrimination or sequencing.
Responses to visual or auditory stimuli are
recorded with a specially designed, highly
accurate (±1 ms) microswitch. The T.O.V.A.
calculates response time variability (consistency),
response time (speed), commissions (impulsivity),
and omissions (focus and vigilance). These
calculations are then compared to a large age-
and gender-matched normative sample (over
1,700 individuals for the visual test, and over
2,600 individuals for the auditory test), as well as
to a sample population of individuals
independently diagnosed with ADHD. These
comparison results are used to create an
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
with software installer for Mac and Windows PCs,
a T.O.V.A. USB device, a T.O.V.A. Microswitch, an
Installation Guide, a User's Manual, a Clinical
Manual, and accessory cables (USB, VGA, and
audio cables). |
| Length of test | 8-9 minutes. | 10.8 to 21.6 minutes. |
| Continuous
Performance Test
(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,
portable stand-alone unit. | Real-time, microcontroller-based, portable stand-
alone unit, with USB connection to a Mac or
Windows PC. |
| Subject response
mechanism | Microswitch. | Microswitch. |
| Timing accuracy | Unknown; estimated at ± 10
milliseconds. | Accurate timing to ±1 milliseconds. |
| Statistics gathered | Omissions (false negatives),
Commissions (false positives), and
Response Times (not including
variability) | Omissions (false negatives),
Commissions (false positives),
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
video cables. |
| Software | Firmware only, not updateable. | Firmware and software, fully updateable. |
| Platforms | Stand-alone device only. | Windows PCs running Windows 7 - 10.
Mac computers running Mac OS X 10.8 - 10.12 |
| Standards with
which the Device
Complies | No electrical safety or EMC test
data listed in 510(k). | IEC 60601-1: 2012 and IEC 60601-1-2:2014 |
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Image /page/6/Picture/1 description: The image shows the logo for "The TOVA Company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the word "TOVA" in large, blue letters, with the word "the" above it in smaller letters. Below the word "TOVA" is the word "company" in smaller letters.