LIFELINES PHOTIC STIMULATOR

K101691 · Lifelines , Ltd. · GWE · Aug 10, 2010 · Neurology

Device Facts

• Record ID: K101691
• Device Name: LIFELINES PHOTIC STIMULATOR
• Applicant: Lifelines , Ltd.
• Product Code: GWE · Neurology
• Decision Date: Aug 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.

Device Story

Lifelines Photic Stimulator generates short-duration white light flashes via solid-state LED. Device operates at repetition rates between 1 and 60Hz; controlled by host PC via TTL, USB, or serial interface. Used in clinical settings by healthcare professionals to perform photic activation during EEG studies or to generate visual evoked potentials. Output consists of light flashes; device provides 100mV isolated pulse output. Benefits include standardized visual stimulation for diagnostic neurophysiology. Device is mounted on an arm for positioning during patient testing.

Clinical Evidence

Bench testing only. Compliance with safety standards including IEC 60601-1 (Medical Electrical safety), IEC 60601-2 (EMC compliance), and ISO 15004-2 (Light Hazard Protection) was demonstrated.

Technological Characteristics

Solid-state LED light source; 700lm typical luminous flux; 1-10ms flash duration; 1-60Hz flash rate. Interfaces: TTL, USB, Serial. Power: 5-15V DC. Physical: 5" diameter x 5" long, 12 oz. Safety standards: EN/IEC 60601-1, EN/IEC 60601-1-2, UL60601-1, CAN/CSA-C22.2 No.601-1-M90, ISO 15004-2.

Indications for Use

Indicated for photic activation of the EEG during EEG studies and generation of visual evoked potentials in patients undergoing neurophysiological examinations.

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

• BE Plus / AURA-LTM64 Amplifier (K053606)

Submission Summary (Full Text)

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# 510(k) Summary 807.92(c)

K101691

## SPONSOR

Company Name:

Lifelines Ltd.

AUG 1 0 2010

Company Address

7 Clarendon Court Over Wallop, near Stockbridge Hampshire SO20 8HU United Kingdom

Telephone: Fax:

Stephen Walters

Contact Person:

Stephen Walter's

44.1264.782226 44.1264.782088

Summary Preparation Date: June 14, 2010

#### DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

Lifelines Photic Stimulator Photic Stimulator Stimulator, Photic, Evoked Response 882.1890 GWE Class II

#### PREDICATE DEVICE

Legally Marketed Equivalent Device

Company EB Neuro, S.P.A.

Product BE Plus / AURA-LTM64 Amplifier 510(k) # K053606

#### DEVICE DESCRIPTION

The Photic Stimulator is a device for generating short-duration flashes of white light by means of a solid-state LED (light emitting diode). The flashes are controlled from a host PC and typically occur over a repetition rate of between 1 and 60Hz.

#### DEVICE INDICATIONS FOR USE

The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.

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| Manufacturer | Lifelines Ltd. | EB Neuro, S.P.A. |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Photic Stimulator | Model BE Plus / AURA-- |
| | | LTM64 |
| K Number | K093153 | K053606 |
| Intended Use | The Lifelines Photic<br>Stimulator is indicated for<br>photic activation of the<br>EEG during an EEG study | The BE Plus / AURA-LTM64<br>Amplifier is intended to be<br>used by or under the direction<br>of a physician for acquisition<br>of EEG, polygraphy and |
| | and in the generation of<br>visual evoked potentials. | polysomnography signals and<br>transmission of these signals<br>to a PC during recording of<br>neurophysiology<br>examinations. |
| Mode of Operation | Arm mounted Photic<br>stimulator generates flashes of<br>white light by means light<br>emitting diode (LED). | Arm mounted photic<br>stimulator generates flashes of<br>white light by means light<br>emitting diode (LED). |
| Specifications | | |
| Light source | Single hi-intensity LED and<br>associated optics | 96 LEDs |
| Luminous Flux | 700lm typical, 900 lm max<br>13,000 lux at 1 foot | 144.0 lumens (minimum)<br>182.4 lumens (typical)<br>230.4 lumens (maximum) |
| Duration | 1-10ms duration fixed or auto<br>duty cycle, 100ms max | 5 ms |
| Interfaces | | 5-pin TRIAD male connector;<br>Power supply, controlling<br>signal (trigger) |
| Flash Rate | 1-60Hz or single (manual)<br>flash | Up to 60 per second,<br>externally controlled |
| Input | TTL, USB, Serial | TTL level |
| Outputs | 100mV isolated pulse | TTL level |
| Power | 5 - 15V DC | 12 VDC (±5%) |
| Compatibility | For use with Trackit system,<br>NicoletOne system or any<br>other compatible system<br>providing interface to USB,<br>TTL or serial control signals | For use with Grass Comet or<br>AURA Base Station |
| Physical size | 5" diameter x 5" long | Flash lamp:<br>8.25" W x 2.5" H x 2" D<br>Weight 7.1 ozs. |
| | Weight 12 ozs. | Adapter Box:<br>3.25" W x 1.75" H x 0.75" D<br>Weight 1.8 ozs. |

# 12.1 Predicate Product Comparison Chart

ﺎﺭﻱ

图

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| Flash Lamp Holder Specifications | | |
|----------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Weight | Base & Mast: 24.2 lbs.<br>Arm: 1.7 lbs | Base & Mast: 24.2 lbs<br>Arm: 1.6 lbs |
| Mast Height | 39" | 34.5" |
| Base Diameter | 26" | 24" |
| Arm Length | 34" | 34" |
| Safety Testing | EN/IEC 60601-1<br>EN/IEC 60601-1-2<br>UL60601-1<br>CAN/CSA-C22.2 No.601-1-<br>M90 | EN 60601-1,<br>EN 60601-1-2<br>IEC 60825-1:1993+ A1: 1997<br>+ A2:2001 |

## SAFETY and EFFECTIVENESS

The Lifelines Photic Stimulator was compliant to the safety standards. IEC 60601-1 Medical Electrical safety IEC 60601-2 EMC compliance ISO 15004-2 Light Hazard Protection

## CONCLUSION

Lifelines Photic Stimulator is similar to the predicate device in

- intended use, . .
- technological characteristics .
- design. .

The Lifelines Photic Stimulator is substantially equivalent to the predicate device and introduces no new questions concerning safety and efficacy.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Lifelines Ltd. c/o Mr. E.J. Smith Regulatory Consultant Smith Associates 1468 Harwell Ave. Crofton, MD 21114

AUG 1 0 2010

Re: K101691

Trade/Device Name: Lifelines Photic Stimulator Regulation Number: 21 CFR 882,1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: June 14, 2010 Received: June 16, 2010

Dear Mr. Mr. Smith:

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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Orug 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 1 ( 1 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandinia 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.

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Page 2 - Mr. E.J. Smith

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 (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.

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 vours.

R. R. im of

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

K101691

ાં છે.

510(k) Number (if known): الملك 9 1

AUG 1 0 2010

Device Name: Photic Stimulator

Indications for Use:

The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.

#### (Check appropriate designation below)

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

DOWSHER RISTEN

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________