ENFANTTM

K043491 · Diopsys, Inc. · GWE · Mar 16, 2005 · Neurology

Device Facts

• Record ID: K043491
• Device Name: ENFANTTM
• Applicant: Diopsys, Inc.
• Product Code: GWE · Neurology
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Enfant system performs non-invasive visual screening in infants and pre-school children; operates in clinics/physician offices. Device presents photopic stimuli (horizontal contrast patterns) on computer monitor; incorporates cartoon visuals and music to maintain pediatric patient attention. System captures EEG signals representing visual evoked potentials (VEP) via electrodes. Software processes signals using spatial filtering and artifact rejection algorithms. Output includes numerical data and graphs representing visual pathway function. Clinicians use output to identify potential visual disorders; facilitates clinical decision-making regarding further ophthalmic examination or treatment. Benefits include objective, non-sedated, non-dilated screening for pediatric populations.

Clinical Evidence

Prospective clinical study of 122 children (aged 6 months to 5 years). Compared Enfant VEP results to standard clinical ophthalmic examination (masked). Primary endpoints: sensitivity 0.973, specificity 0.808, positive predictive value 0.706, negative predictive value 0.984. 94% of subjects completed testing.

Technological Characteristics

Visual evoked potential (VEP) system; photic stimulator; EEG amplifier. Hardware includes computer monitor for stimulus presentation. Software performs signal analysis. Complies with EN 60601-1, IEC 60601-1-2, IEC 60601-2-26, and IEC 60601-2-40 standards. Connectivity: standalone system.

Indications for Use

Indicated for screening infants and pre-school children for visual disorders, including optical or neural abnormalities related to vision, without the need for dilation or sedation.

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

• Maculoscope (Doran/Diagnosys LLC)
• Espion System (K863956)
• VERIS system (K983983)

Reference Devices

• Venus System (K880773)
• RETIscan (K023525)

Submission Summary (Full Text)

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K043491

## Summary of Safety and Effectiveness 510(k) K

1.0 Basic Information

Submitter

Name: Diopsys, Inc. Address: 16 Chapin Road Suite 911 P.O. Box 672 Pine Brook, NJ 07058

#### Contact Person:

Joseph Fontanetta Phone: [phone] 244 0670 Fax: Email: [e-mail]

## Date Prepared: December 14 2004

Device Name: Enfant™M

Classification Name: Electroencephalograph, Evoked Response Classification Name: Electroencephalograph , Evoked Potential (VEP) System Regulatory Class: II Panels: Neurology

Number: 882.1400 Electroencephalograph

Electroencephalograph (EEG) Signal Spectrum Analyzer 882.1420 882.1890 Stimulator, Photic, Evoked Response

Product codes: GWE, GWQ,GWL

## 1.1 Identification of Legally Marked Device

The Enfant™ System is substantially equivalent to the Maculoscope and the Espion System(K863956) both manufactured by Doran (aka Diagnosys LLC) and the VERIS system(K983983) manufactured by Electro-Diagnostic Imaging, Inc. These are hardware and software products. The Enfant™ device is substantially equivalent to the predicate devices with regard to device features and 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. Devices consist of hardware and software to provide a photopic stimulus and EEG capture and analysis of the evoked response. Diopsys purchased the assets of NEUROSCIENTIFIC CORP. Registration number 2434082. The EEG amplifier is an updated version of the amplifier used on the Venus System (K880773). The updates include modification for EMC and obsolete parts.

## 1.2 Device Description

Horizontal Contrast Photopic stimuli are presented to the patient on a computer monitor at various numbers of elements in separately stimulated fields. The fields

Diopsys Inc. 16 Chapin Road Suite 911, P.O. Box 672 Pine Brook, NJ 07058

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are varied in spatial size over a number of cycles. The signals are analyzed by the software using algorithms for spatial filtering and artifact rejection. Data may be presented in number form and on a graph. The device also adds some attention features specifically for children. In particular, a cartoon is presented prior to the VEP pattern. During the Cartoon presentation no data is collected. Age appropriate music is also presented to patient as well. The music is only intended as an attention facilitator.

#### 1.3 Intended Use

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.

| Feature | Enfant | RETIsca<br>n<br>K023525 | Veris<br>K983983 | Doran<br>Maculose<br>ope<br>K863956 | Venus<br>System<br>K880773 |
|------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|------------------|-------------------------------------|-------------------------------|
| Generate photic signals<br>and measure and display<br>the electrical response<br>generated by the visual<br>nervous system | YES | YES | YES | YES | Yes |
| Electrophysiological Test<br>Unit for quantifying the<br>response, measuring a<br>parameter (VEP) related<br>to the response | YES | YES | YES | YES | Yes |
| Intended Populations<br>Patients with suspected<br>ophthalmic conditions | YES | YES | YES | YES | Yes |
| Intended Use | YES | YES | YES | YES | Yes -<br>Research<br>Use Only |
| Environment<br>Hospitals, clinics and<br>physician officies | YES | YES | YES | YES | Yes |
| Physiological Data<br>Collected (VEP) | YES | YES | YES | YES | YES |

#### 1.4 Comparison to Cleared Devices

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## 1.5 Performance Data

The Enfant system has been tested and reviewed to the following i standards listed below.

- EN 60601-1:2003 and CAN/CSA C22.2 No. 601.1 General Requirements 1.5.1 for Safetv.
- 101 Safety.
IEC 60601-1-2 :2001 Collateral Standard: Electromagnetic Compatibility 1.5.2
- IEC 60001-1-2 12001 Conaoleequipment incorporating programmable 1.5.3 electronic system
- IEC 60601-2-26:2002 Particular Requirements for Safety of 1.5.4 Electroencephalographs
- Electrochecphalographs
IEC 60601-2-40:1998 Particular Requirements for Safety -Specifications 1.5.5 for Electromyographs and Evoked Response Equipment.

## 1.6 Clinical performance data and support of effectiveness

1.0 Chilical performance and firmed the effectiveness of the Enfant system in An IND apploved childer stady common children's response to VEP. The study has been accepted for publication by the Journal of American Association for Pediatric accepted for publication by the ocument of the expected to be in the February 2005 issue.

Methods: A new, "child-friendly" visual evoked potential (VEP) system (Enfant™ Methous. A new, "child Thenary" "ise in screening. 122 children, aged 6 months to 5 Diopsys, me., I me Droom in , results in masked fashion to results of standard
years, were tested, comparing test results in masked fashion to results of standard years, were tested, comparing test rostical program analyzed VEP differences between opinnamologio enamine a "pass" or "fail" for each child. For verbal patients, clinical amblyopia was defined as an interocular difference of two or more lines in best corrected amblyopla was defined as an mients, clinical amblyopia was defined by the clinician's vious dout). It is the occlusion or atropine penalization. Preverbal children with decision to treat with occrasion of anyopical eye pathology were also considered clinical positives.

positives.
Results: The test was completed by 94% of the test sample, each child requiring an Results. The test was to complete testing of both eyes. The sensitivity was 0.973, specificity 0.808, positive predictive value 0.706, and the negative predictive value 0.984

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2005

Mr. Joseph Fontanetta President Diopsys, Inc. 16 Chapin Road, Suite 911 P.O. Box 672 Pine Brook, New Jersey 07058

Re: K043491

Trade/Device Name: Enfant™ Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Code: GWE Dated: February 17, 2005 Received: February 18, 2005

Dear Mr. Fontanetta:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard management date of the Medical Device Amendments, or to commerce prior to May 28, 1770, the enactified in accordance with the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) ins. Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FIDA may be found interest announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease be advised that i Dr Brissian that your device complies with other requirements of the Act that I DA has made a cound regulations administered by other Federal agencies. You must of any I cach statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the 11et 51e 31equirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607), adomig (21 OFF Septation (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Joseph Fontanetta

This letter will allow you to begin marketing your device as described in your Section 5 0(k) This letter will allow you to begin marketing your artial equivalence of your device to a legally premarket notification. The FDA midnig of substanted on the some of 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), please
ntiled If you desire specific advice for your device of 10-Also, please note the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note them of contact the Office of Complanee at (216) 217 or (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR the Division of Small "Misbranding by reference to premance notified.org.in the Act from the Division of Small
on of Small information on your responsibilities under the Act from the (900) 638, 10 other general information on your responsion its toll-free number [phone] or 1941)
Manufacturers, International and Consumer Assistance at its for himl Manufacturers, International and Consumer Abolskaree arov/cdrh/industry/support/index.html.

Sincerely yours,

Euch

Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K043491

Device Name: Enfant

Indications For Use: The Enfant is a non-invasive medical device to screen, without Indications For USe: The Entailt is a nori-infants and pe-school children. The system
dilation or sedation, for visual disorders in infants and press may function dilation or sedation, for visual ulsolucis in this in a pro other visual pathway function
uses Visual Evoked potentials to provide information about the visual pathway functi uses Visual Evoked potontials to promise to vision.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Emile Thoms, M

Intsion Sign-Off) Pivision of General, Restorative nd Neurological Devices

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