DIOPSYS NOVA VEP VISION TESTING SYSTEM

K101763 · Diopsys, Inc. · GWE · May 9, 2011 · Neurology

Device Facts

• Record ID: K101763
• Device Name: DIOPSYS NOVA VEP VISION TESTING SYSTEM
• Applicant: Diopsys, Inc.
• Product Code: GWE · Neurology
• Decision Date: May 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device generates photic stimuli (checkerboard, gratings, flash) on calibrated monitor; records EEG signals representing visual evoked potentials (VEP). Software performs spatial/temporal filtering and artifact rejection on EEG data; presents results in numerical/graphical form. Includes attention-grabbing features (pictures/music) for children/inattentive adults. Used in hospitals, clinics, and physician offices by physicians or trained technicians. Output assists clinicians in identifying visual system structural and neural abnormalities; aids in clinical decision-making regarding visual function.

Clinical Evidence

Bench testing only. Evidence includes software verification and validation (UI, installation, signal testing, configuration, calibration), and system-level bench testing of the EEG amplifier and LCD monitor. Safety testing performed per IEC 60601-1, 60601-1-2, 60601-1-4, 60601-2-26, and 60601-2-40.

Technological Characteristics

Electrophysiological device; 110V power source. Hardware includes EEG amplifier and calibrated computer monitor. Stimuli: checkerboard, horizontal/vertical/sinusoidal gratings, flash, monochromatic/color pattern onset. Connectivity: synchronized data collection module. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40.

Indications for Use

Indicated for infants, children, and adults to provide information about visual system structural and neural abnormalities via VEP signal analysis. Used by physicians and trained medical technicians in hospitals, clinics, and physician offices.

Regulatory Classification

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.

Predicate Devices

• Diopsys Enfant® Pediatric VEP Vision Testing System (K043491)
• VeriSci Corporation Neucodia System (K081591)

Submission Summary (Full Text)

{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: [phone] Fax: [phone]

#### 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<br>K043491 | Neucodia<br>K081591 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The NOVA is an<br>electrophysiological<br>device<br>that generates photic<br>stimuli, and records,<br>processes and analyzes<br>the resultant visual<br>evoked<br>potential (VEP) signals to<br>provide information about<br>visual system structural<br>and neural<br>abnormalities. | The Enfant is a non<br>invasive medical device to<br>screen without dilation or<br>sedation, for visual disorders<br>in infants and pre school<br>children. The system uses<br>visual evoked potentials to<br>provide information about the<br>visual pathway function and<br>about optical or neural<br>abnormalities related to vision. | The Neucodia system is<br>an electrophysiological<br>device that generates<br>photic stimuli, and<br>records, processes and<br>analyzes the resultant<br>visual evoked potential<br>(VEP) signals for the<br>study of central visual<br>functions. |
| Target<br>Population | Infants, pre-school<br>children, children and<br>adults | Infants and pre-school children | Normal observers,<br>individuals at-risk for<br>visual pathway<br>dysfunction or with<br>confirmed ophthalmic<br>disorders |
| Where used | Hospitals, Clinics and<br>physician offices | Hospitals, Clinics and<br>physician offices | Hospitals, clinics,<br>physicians' offices and<br>research laboratories |
| Intended<br>Users | Physicians and trained<br>medical technicians | Physicians and trained<br>medical technicians | Vision researchers,<br>neurologists, eye-care<br>professionals, and trained<br>medical technicians |
| Energy Used | 110V | 110V | 110V |
| Design | Synchronized Data<br>Collection (external<br>module), Transient VEP | Synchronized Data Collection,<br>(internal module), Steady<br>State VEP | Synchronized Data<br>Collection, Steady State<br>and Transient VEP |
| Electrical<br>safety<br>Standards<br>met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-2-26<br>IEC 60601-2-40 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-2-26<br>IEC 60601-2-40 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-2-26<br>ISO 15004-2 |
| Data<br>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 [phone] or [phone] 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

{5}------------------------------------------------

## 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? | | | X |
| Neonate/Newborn | (Birth to 28 days) | | X |
| Infant | (29 days - < 2 years old) | X | |
| Child | (2 years - < 12 years old) | X | |
| Adolescent | (12 years - < 18 years old) | X | |
| Transitional Adolescent A¹ | (18 years - < 21 years old) | | X |
| Transitional Adolescent B² | (18 years - < 21 years old) | X | |

Compared to adults > 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