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.

AI/ML Overview

This document is a 510(k) summary for the Lifelines Photic Stimulator, which is a medical device for generating flashes of white light used in EEG studies and for generating visual evoked potentials.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EB Neuro, S.P.A. Model BE Plus / AURA-LTM64 Amplifier) based on intended use, technological characteristics, and design.

Therefore, many of the requested sections about acceptance criteria, study details, and performance metrics cannot be directly extracted from this document as they are not present. This type of submission relies on the established safety and effectiveness of a predicate device rather than presenting new clinical performance data.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a clinical outcome. Instead, the acceptance criteria for the 510(k) submission are based on demonstrating substantial equivalence to a predicate device. This involves matching or demonstrating comparable characteristics in:

Acceptance Criteria Category	Lifelines Photic Stimulator (Reported Device Performance)	Predicate Device (EB Neuro, S.P.A. Model BE Plus / AURA-LTM64)
Intended Use	Photic activation of EEG during EEG study and generation of visual evoked potentials.	Acquisition of EEG, polygraphy, and polysomnography signals and transmission to a PC during neurophysiology examinations. (Note: Predicate's stated use is broader but encompasses photic stimulation functionality)
Technological Characteristics
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
Flash Rate	1-60Hz or single (manual) flash	Up to 60 per second, externally controlled
Interfaces	TTL, USB, Serial	5-pin TRIAD male connector; Power supply, controlling signal (trigger); 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 (Stimulator)	5" diameter x 5" long; Weight 12 ozs.	Flash lamp: 8.25" W x 2.5" H x 2" D (Weight 7.1 ozs.); Adapter Box: 3.25" W x 1.75" H x 0.75" D (Weight 1.8 ozs.)
Design	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)).
Safety Testing	EN/IEC 60601-1, EN/IEC 60601-1-2, UL60601-1, CAN/CSA-C22.2 No.601-1-M90, IEC 60825-1:1993+ A1: 1997 + A2:2001 (implied via predicate comparison)	EN 60601-1, EN 60601-1-2, ISO 15004-2 (Light Hazard Protection)

Study Description:
The "study" presented here is a comparison to a legally marketed predicate device (EB Neuro, S.P.A. Model BE Plus / AURA-LTM64 Amplifier, K053606) to demonstrate substantial equivalence, rather than a clinical trial or performance study on humans or specialized test sets. The report asserts that the Lifelines Photic Stimulator is similar to the predicate device in intended use, technological characteristics, and design. The FDA's letter confirms substantial equivalence based on this comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study that involved a "test set" of patient data in the conventional sense. The "test" here was a comparison of device specifications and safety standards against a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for clinical performance was not established as there was no patient-based clinical study. The "ground truth" for the submission was the regulatory safety and performance standards met by the predicate device and the new device's adherence to relevant safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a photic stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is hardware and does not involve an algorithm for standalone performance evaluation in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, as well as adherence to relevant international and national safety standards (e.g., EN/IEC 60601-1, IEC 60825-1) for medical electrical equipment and light hazard protection.

8. The sample size for the training set

Not applicable. This device submission does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. This device submission does not involve machine learning or a "training set."

Summary

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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

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 PhoticStimulator is indicated forphotic activation of theEEG during an EEG study	The BE Plus / AURA-LTM64Amplifier is intended to beused by or under the directionof a physician for acquisitionof EEG, polygraphy and
	and in the generation ofvisual evoked potentials.	polysomnography signals andtransmission of these signalsto a PC during recording ofneurophysiologyexaminations.
Mode of Operation	Arm mounted Photicstimulator generates flashes ofwhite light by means lightemitting diode (LED).	Arm mounted photicstimulator generates flashes ofwhite light by means lightemitting diode (LED).
Specifications
Light source	Single hi-intensity LED andassociated optics	96 LEDs
Luminous Flux	700lm typical, 900 lm max13,000 lux at 1 foot	144.0 lumens (minimum)182.4 lumens (typical)230.4 lumens (maximum)
Duration	1-10ms duration fixed or autoduty cycle, 100ms max	5 ms
Interfaces		5-pin TRIAD male connector;Power supply, controllingsignal (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 anyother compatible systemproviding interface to USB,TTL or serial control signals	For use with Grass Comet orAURA Base Station
Physical size	5" diameter x 5" long	Flash lamp:8.25" W x 2.5" H x 2" DWeight 7.1 ozs.
	Weight 12 ozs.	Adapter Box:3.25" W x 1.75" H x 0.75" DWeight 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.Arm: 1.7 lbs	Base & Mast: 24.2 lbsArm: 1.6 lbs
Mast Height	39"	34.5"
Base Diameter	26"	24"
Arm Length	34"	34"
Safety Testing	EN/IEC 60601-1EN/IEC 60601-1-2UL60601-1CAN/CSA-C22.2 No.601-1-M90	EN 60601-1,EN 60601-1-2IEC 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.

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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 (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

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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_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).