(320 days)
No
The description mentions "software algorithm for spatial/temporal filtering and artifact rejection" and "analysis by the software algorithm," which are standard signal processing techniques, not necessarily indicative of AI/ML. There is no mention of AI, ML, deep learning, training data, or any other terms commonly associated with AI/ML in the provided text.
No.
The device's stated intended use is to provide information about visual system abnormalities by recording and analyzing VEP signals, not to treat or cure a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides information about the visual system structural and neural abnormalities," which is a diagnostic purpose.
No
The device description explicitly states that the "NOVA system is identical to that of the Enfant, ® which was cleared under K043491" from a hardware standpoint. It also mentions hardware components like a calibrated computer monitor, EEG Amplifier, and LCD. While the software is a key difference from the predicate, the device itself is a system that includes hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- NOVA's function: The NOVA device works by applying a stimulus (photic) to the patient and recording the body's electrical response (VEP signals). It does not analyze samples taken from the body. It interacts directly with the patient's visual system.
Therefore, based on the provided description, the NOVA device falls under the category of a physiological measurement device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NOVA is an electrophysiological device that generates photic stimuli, and records, processes, and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.
Product codes
GWE
Device Description
Checkerboard, Horizontal grating, Vertical grating, Sinusoidal grating, Flash, monochromatic pattern onset or color pattern onset Contrast Photic stimuli are presented to the patient on a calibrated computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The fields are also phase reversed at different temporal frequencies. The signals are analyzed by the software algorithm for spatial/temporal filtering and artifact rejection. Data may be presented in numerical and graphical form. The device also utilizes attention grabbing features specifically for children or non attentive adults. In particular, a picture is presented prior to the onset of the VEP pattern stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.
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
Adults
Infant (29 days -
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).
0
510(k) Summary
October 14, 2010
MAY - 9 2011
Device Description
Trade Name: Diopsys™ NOVA VEP Vision Testing System VEP vision testing system Common Name: Classification Name: Evoked response photic stimulator Regulation Number: 882.1890 Product Code: GWE Regulatory Class: II
Contact Information
Joseph Fontanetta President/CEO Diopsys, Inc. 16 Chapin Road, Suite 911 Pine Brook, NJ 07058 Tel: (973) 244-0622 Fax: (973) 244-0670
Identification of Legally Marketed Predicate Devices
The Diopsys NOVA VEP Vision Testing System (NOVA), is substantially equivalent to the Diopsys Enfant® Pediatric VEP Vision Testing System (K043491) and the VeriSci Corporation Neucodia System (K081591). The NOVA device is substantially equivalent to the predicate devices with regard to device features, designs, operational procedure, data acquisition conditions, specifications, as well as intended use. All devices are visual evoked response test systems with similar operating requirements that are based on standard clinical procedures. These devices consist of hardware and software to provide photic stimulus and EEG capture and analysis of the evoked response. All the devices are intended to be used by trained medical professionals for the study of visual functions.
Device Description
Checkerboard, Horizontal grating, Vertical grating, Sinusoidal grating, Flash, monochromatic pattern onset or color pattern onset Contrast Photic stimuli are presented to the patient on a calibrated computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The fields are also phase reversed at different temporal frequencies. The signals are analyzed by the software algorithm for spatial/temporal filtering and artifact rejection. Data may be presented in numerical and graphical form. The device also utilizes attention grabbing features specifically for children or non attentive adults. In particular, a picture is presented prior to the onset of the VEP pattern
1
stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.
Indications for Use
र :
The NOVA is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.
| Parameter | Diopsys NOVA | Enfant
K043491 | Neucodia
K081591 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The NOVA is an
electrophysiological
device
that generates photic
stimuli, and records,
processes and analyzes
the resultant visual
evoked
potential (VEP) signals to
provide information about
visual system structural
and neural
abnormalities. | The Enfant is a non
invasive medical device to
screen without dilation or
sedation, for visual disorders
in infants and pre school
children. The system uses
visual evoked potentials to
provide information about the
visual pathway function and
about optical or neural
abnormalities related to vision. | The Neucodia system is
an electrophysiological
device that generates
photic stimuli, and
records, processes and
analyzes the resultant
visual evoked potential
(VEP) signals for the
study of central visual
functions. |
| Target
Population | Infants, pre-school
children, children and
adults | Infants and pre-school children | Normal observers,
individuals at-risk for
visual pathway
dysfunction or with
confirmed ophthalmic
disorders |
| Where used | Hospitals, Clinics and
physician offices | Hospitals, Clinics and
physician offices | Hospitals, clinics,
physicians' offices and
research laboratories |
| Intended
Users | Physicians and trained
medical technicians | Physicians and trained
medical technicians | Vision researchers,
neurologists, eye-care
professionals, and trained
medical technicians |
| Energy Used | 110V | 110V | 110V |
| Design | Synchronized Data
Collection (external
module), Transient VEP | Synchronized Data Collection,
(internal module), Steady
State VEP | Synchronized Data
Collection, Steady State
and Transient VEP |
| Electrical
safety
Standards
met | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-2-26
IEC 60601-2-40 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-2-26
IEC 60601-2-40 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-2-26
ISO 15004-2 |
| Data
Collected | EEG signals | EEG signals | EEG signals |
Comparison to Cleared Devices
2
Performance Data
Software: Verification and Validation
- 1 ). User Interface User interface operates as expected.
- 2). Software Installation Process Software installs as expected.
- 3). Signal Test Procedure VEP recordings are displayed as expected.
- 4). System Configuration Software configures hardware components as expected.
- 5). Calibration Test Verifies VEP stimulus parameters meet specification.
- 6), Comparison of EEG Response Verifies VEP recording compared to known recording.
Safety Testing: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40
System Testing: Bench testing for the system, EEG Amplifier and LCD.
Conclusion
The NOVA is substantially equivalent to the predicate Enfant and Neucodia based on safety and efficacy testing.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medgra, LLC c/o Mr. Richard Hettenbach President 44 Countrywood Drive Morris Plains, NJ 07950
MAY - 9 2011
Re: K101763
Trade/Device Name: Diopsys™ NOVA VEP Vision Testing System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: October 14, 2010 Received: October 18, 2010
Dear Mr. Hettenbach:
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.
4
Page 2 - Mr. Richard Hettenbach
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melvin R. Feldstein, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
510(k) Number (if known): K101763
Diopsys™ NOVA VEP Vision Testing System Device Name:
The NOVA is an electrophysiological device that generates Indications For Use: photic stimuli, and records, processes, and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.
Intended Use Population | Yes | No | |
---|---|---|---|
Adults | X | ||
All pediatric patients age 21 years old, this group receives special considerations (e.g., different device design or testing, different protocol procedures, etc.) |
2 No special considerations compared to adults > 21 years old
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101763