(90 days)
Not Found
No
The description focuses on a computer-administered vigilance task and motion analysis, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML mentions.
No
The device aids in the clinical assessment and diagnosis of ADHD by providing objective measurements; it does not treat or provide therapy.
Yes
The device is described as providing "objective measurements" to "aid in the clinical assessment of ADHD," which is a diagnostic purpose.
No
The device description explicitly lists hardware components beyond a standard computer, specifically a "Motion analysis camera and peripherals," which are integral to the device's function of real-time behavioral measurement.
Based on the provided information, the OPTAx System is not an IVD (In Vitro Diagnostic).
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.
- OPTAx Function: The OPTAx System is described as a non-invasive, office-based test that uses a motion analysis camera and a computer-administered task to measure behavioral responses (hyperactivity, impulsivity, and inattention). It does not analyze biological samples from the patient.
- Input Modality: The input modality is a "Motion analysis camera," which captures physical movement, not biological samples.
Therefore, the OPTAx System falls outside the scope of an In Vitro Diagnostic device. It is a behavioral assessment tool.
N/A
Intended Use / Indications for Use
The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
LQD
Device Description
OPTAx (Optical Tracking and Attention test) is a 15 minute non-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child'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 OPTAx is a computer-administered GO/NO-GO vigilance response task.
The OPTAx System consists of the following components:
- . IMac computer and peripherals (printer and adapters)
- Pre-installed OPTAx software program ●
- . Motion analysis camera and peripherals
- Data analysis software on the OPTAx secure server .
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
Not Found
Intended User / Care Setting
clinicians, office-based
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)
Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Gordon Diagnostic System cleared under K854903.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
JUN 1 0 2002
Kozogoo
OPTAx Systems Inc. 510K Summary of Safety and Effectiveness June 6, 2002
Sponsor Name OPTAx Systems Inc. 20 Mall Rd. Suite 210 Burlington, MA 01803
2. Device Name
Proprietary Name: OPTAx System Common/Usual Name: RECORDER, ATTENTION TASK PERFORMANCE
Identification of Predicate or Legally Marketed Device 3.
Gordon Diagnostic System cleared under K854903.
Device Description 4.
OPTAx (Optical Tracking and Attention test) is a 15 minutenon-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child'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 OPTAx is a computer-administered GO/NO-GO vigilance response task.
The OPTAx System consists of the following components:
- . IMac computer and peripherals (printer and adapters)
- Pre-installed OPTAx software program ●
- . Motion analysis camera and peripherals
- Data analysis software on the OPTAx secure server .
1
રું. Intended Use
The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
Comparison of Technological Characteristics 6.
Both the Gordon and OPTAx Systems are indicated to aid in the diagnosis and assessment of ADHD. Both provide objective measurements of impulsivity and inattention to aid in this process; OPTAx also provides objective measurements of hyperactivity.
Both are microprocessor-based vigilance task recorders.
Performance Testing
Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JUN 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OPTAx Systems, INC. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, MA 01748
Re: K020800 Trade/Device Name: OPTAx System Regulatory Class: Unclassified Product Code: LQD Dated: March 8, 2002 Received: March 12, 2002
Dear Ms. Iampietro:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Debbie Iampietro
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
s. Stephen Rhodes
elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K020800 – Additional Information .
K020800 510(k) Number (if known):
Device Name: OPTAx System
Indications For Use:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | ----------------------------------------- | ---- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K020800 |
|---|---|
| --------------- | --------- |