(90 days)
QbTest from Qbtech AB (K133382)
No
The description focuses on standard statistical comparisons to normative data and a sample population, not on adaptive learning or predictive modeling characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The "Intended Use / Indications for Use" and "Device Description" sections state that the device is for assessment and evaluation of treatment, not for providing treatment itself.
Yes
The device is intended to aid in the assessment and evaluation of attention deficits, including ADHD, by providing objective measurements through a continuous performance test, which is a diagnostic function.
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) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- T.O.V.A.'s 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 examination of any biological specimens from the human body.
- Intended Use: The intended use is to provide objective measurements of attention and inhibitory control to aid in the assessment and evaluation of treatment for attention deficits. This is a behavioral assessment, not a diagnostic test performed on biological samples.
Therefore, the T.O.V.A. falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
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. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
Product codes
LOD
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. In addition, the visual T.O.V.A. is used to evaluate treatment for attention deficits, including ADHD.
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
Visual: Ages 4 to 80.
Auditory: Ages 6 to 29.
Intended User / Care Setting
Qualified professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Testing for safety and essential performance for electrical and electromagnetic capability is identical to the T.O.V.A. cleared under K170082.
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 QbTest, it met the safety and functional testing required for 510(k) clearance in 2014. Thus, the T.O.V.A. has equivalent safety and functionality testing to the QbTest.
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 QbTest, it met the safety and functional testing required for a traditional 510(k) premarket notification in 1989. Thus, the T.O.V.A. has equivalent electrical performance to the QbTest.
T.O.V.A. Verification Testing
Test Method Summary: The T.O.V.A. system was fully tested (verified) by the TOVA Company.
Results: The T.O.V.A. functioned as intended, passing all major verification tests, and was FDA cleared under K170082. Since the QbTest was cleared under K133382, T.O.V.A. and QbTest meet equivalent verification testing requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
QbTest from Qbtech AB (K133382)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2018
The TOVA Company Chris Holder, CEO 2828 SW Corbett Ave, Suite 128 Portland. Oregon 97201
Re: K173915
Trade/Device Name: Test of Variables of Attention (T.O.V.A.) version 9.0 Regulatory Class: Unclassified Product Code: LOD Dated: December 20, 2017 Received: December 22, 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 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.
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
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MichaelJ. Hoffmann -S
Carlos L. Peña, PhD, MS for 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) K173915
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. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified 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 word "the" in a smaller font, and below that is the word "TOVA" in a larger, bold, blue font. Below "TOVA" is the word "company" in a smaller font.
510(k) SUMMARY
| Date: | March 19th, 2018 |
|---|---|
| 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: | |
| Common name: | |
| Product Code: | |
| Classification name: | |
| Device class: | Test of Variables of Attention (T.O.V.A.) version 9.0 |
| Continuous Performance Test (CPT) | |
| LQD | |
| Recorder, attention task performance | |
| Unclassified | |
| Predicate Device: | QbTest from Qbtech AB (K133382) |
| 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. In addition, the visual T.O.V.A. is used to evaluate treatment for attention | |
| deficits, including ADHD. | |
| 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. The visual T.O.V.A. aids in | |
| the assessment of, and evaluation of treatment for, attention deficits, including | |
| attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the | |
| assessment of attention deficits, including ADHD. T.O.V.A. results should only be | |
| interpreted by qualified professionals. |
4
Image /page/4/Picture/0 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" in a smaller font above "TOVA", and "company" in a smaller font below "TOVA".
| 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 | |
| designed and tested to be safe and effective when used by qualified 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. Testing for safety and essential performance | |
| for electrical and electromagnetic capability is identical to the T.O.V.A. cleared under | |
| K170082. |
| 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 | ||
| QbTest, it met the safety and functional | ||
| testing required for 510(k) clearance in 2014. | ||
| Thus, the T.O.V.A. has equivalent safety and | ||
| functionality testing to the QbTest. | ||
| 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 QbTest, it | ||
| met the safety and functional testing | ||
| required for a traditional 510(k) premarket | ||
| notification in 1989. Thus, the T.O.V.A. has | ||
| equivalent electrical performance to the | ||
| QbTest. | ||
| T.O.V.A. Verification Testing | The T.O.V.A. system was fully | |
| tested (verified) by the TOVA | ||
| Company. | The T.O.V.A. functioned as intended, passing | |
| all major verification tests, and was FDA | ||
| cleared under K170082. Since the QbTest was | ||
| cleared under K133382, T.O.V.A. and QbTest | ||
| meet equivalent verification testing | ||
| requirements. |
Substantial
Equivalence:
The T.O.V.A. is substantially equivalent to the QbTest that was cleared under submission number K133382. The T.O.V.A. has similar intended use 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 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" in a smaller font above "TOVA" and "company" in a smaller font below "TOVA".
| QbTest | Test of Variables of Attention (T.O.V.A.) | |
|---|---|---|
| 510(k) Number | K133382 | K170082 |
| FDA CODE | LQD | LQD |
| FDA Class | Unclassified | Unclassified |
| 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. | The Test of Variables of Attention (T.O.V.A.) | |
| provides healthcare professionals with objective | ||
| measurements of attention and inhibitory | ||
| control. The visual T.O.V.A. aids in the | ||
| assessment of, and evaluation of treatment for, | ||
| attention deficits, including attention- | ||
| deficit/hyperactivity disorder (ADHD). The | ||
| auditory T.O.V.A. aids in the assessment of | ||
| attention deficits, including ADHD. T.O.V.A. | ||
| results should only be interpreted by qualified | ||
| professionals. | ||
| Normative study | ||
| range | Visual: Ages 6 to 60 | Visual: Ages 4 to 80. |
| Auditory: Ages 6 to 29. | ||
| Norming Data | Normative data are based on 1,307 | |
| individuals ages 6 to 60. | Normative data are based on 1,714 (visual) and | |
| 2,680 (auditory) individuals ages 4 to 80. | ||
| Device Description | ||
| (510k Summary) | 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 | 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. In addition, the visual | ||
| T.O.V.A. is used to evaluate treatment for | ||
| attention deficits, including ADHD. |
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 |
| | QbTest | Test of Variables of Attention (T.O.V.A.) |
| | Responder button (also referred to as responder unit)Infrared cameraReflective motion markerUser manualTechnical manualStimulus cardCamera standMeasuring tapeQbTest Behavior Rating ScaleIn addition, the user must have access to a remote server that generates test reports | 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 | 15 to 20 minutes. | 10.8 to 21.6 minutes. |
| Continuous
Performance Test
(CPT) | Yes (Go/No Go task). | Yes (Go/No Go task). |
| Visual stimuli | Yes (geometric shapes). | Yes (geometric shapes). |
| Auditory stimuli | None | Yes (tones). |
| Technology | Software on a Windows PC with a
"response unit" microswitch and
infra-red camera and reflector
headband. | Real-time, microcontroller-based, portable stand-
alone unit, with USB connection to a Mac or
Windows PC. |
| Subject response
mechanism | "Response Unit" (microswitch). | T.O.V.A. Microswitch. |
| Timing accuracy | Unknown. | Accurate to $\pm$ 1 milliseconds. |
| Statistics gathered | Omissions (false negatives),
Commissions (false positives),
Response Times,
Response Time Variability,
Anticipatory Responses,
Multiple Responses,
Head motion. | Omissions (false negatives),
Commissions (false positives),
Response Times,
Response Time Variability,
Anticipatory Responses,
Multiple Responses. |
| Report | 1-page graphical report | 6-page graphical report |
| Accessories | Client software, responder unit,
Infrared camera, Reflective motion
marker, Stimulus card, Camera
stand, Measuring tape, QbTest
Behavior Rating Scale | T.O.V.A. USB Device, T.O.V.A. Microswitch, USB
flash drive, and off-the-shelf USB, audio, and
video cables. |
| Software | Software, updateability unknown. | Firmware and software, fully updateable. |
| Platforms | Windows PCs running Windows 7 – 10. | Windows PCs running Windows 7 – 10.
Mac computers running Mac OS X 10.8 – 10.12 |
| Standards with
which the Device
Complies | IEC 60601-1: 2012 and IEC 60601-1-
2:2014 | IEC 60601-1: 2012 and IEC 60601-1-2:2014 |
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Image /page/6/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 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 font.