← Product Code [GWE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE) · K101691 # LIFELINES PHOTIC STIMULATOR (K101691) _Lifelines , Ltd. · GWE · Aug 10, 2010 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K101691 ## Device Facts - **Applicant:** Lifelines , Ltd. - **Product Code:** [GWE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE.md) - **Decision Date:** Aug 10, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1890 - **Device Class:** Class 2 - **Review Panel:** Neurology ## 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. ## 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. ## Regulatory 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](/device/K053606.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 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. {1}------------------------------------------------ | 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
Stimulator is indicated for
photic activation of the
EEG during an EEG study | The BE Plus / AURA-LTM64
Amplifier is intended to be
used by or under the direction
of a physician for acquisition
of EEG, polygraphy and | | | and in the generation of
visual evoked potentials. | polysomnography signals and
transmission of these signals
to a PC during recording of
neurophysiology
examinations. | | Mode of Operation | Arm mounted Photic
stimulator generates flashes of
white light by means light
emitting diode (LED). | Arm mounted photic
stimulator generates flashes of
white light by means light
emitting diode (LED). | | Specifications | | | | Light source | Single hi-intensity LED and
associated optics | 96 LEDs | | Luminous Flux | 700lm typical, 900 lm max
13,000 lux at 1 foot | 144.0 lumens (minimum)
182.4 lumens (typical)
230.4 lumens (maximum) | | Duration | 1-10ms duration fixed or auto
duty cycle, 100ms max | 5 ms | | Interfaces | | 5-pin TRIAD male connector;
Power supply, controlling
signal (trigger) | | Flash Rate | 1-60Hz or single (manual)
flash | Up to 60 per second,
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,
NicoletOne system or any
other compatible system
providing interface to USB,
TTL or serial control signals | For use with Grass Comet or
AURA Base Station | | Physical size | 5" diameter x 5" long | Flash lamp:
8.25" W x 2.5" H x 2" D
Weight 7.1 ozs. | | | Weight 12 ozs. | Adapter Box:
3.25" W x 1.75" H x 0.75" D
Weight 1.8 ozs. | # 12.1 Predicate Product Comparison Chart ﺎﺭﻱ 图 {2}------------------------------------------------ | Flash Lamp Holder Specifications | | | |----------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------| | Weight | Base & Mast: 24.2 lbs.
Arm: 1.7 lbs | Base & Mast: 24.2 lbs
Arm: 1.6 lbs | | Mast Height | 39" | 34.5" | | Base Diameter | 26" | 24" | | Arm Length | 34" | 34" | | Safety Testing | EN/IEC 60601-1
EN/IEC 60601-1-2
UL60601-1
CAN/CSA-C22.2 No.601-1-
M90 | EN 60601-1,
EN 60601-1-2
IEC 60825-1:1993+ A1: 1997
+ 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. {3}------------------------------------------------ # 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. {4}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 {5}------------------------------------------------ # 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_________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K101691](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K101691) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com