(55 days)
Not Found
No
The description focuses on hardware (LEDs) and basic control (repetition rate) without mentioning any data analysis, pattern recognition, or adaptive algorithms typically associated with AI/ML.
No.
The device is used for diagnostic purposes (photic activation of the EEG during an EEG study and generation of visual evoked potentials), not to treat a condition.
No
The device is a stimulator used during an EEG study; it generates flashes of light and does not diagnose a condition itself.
No
The device description explicitly states it uses a solid-state LED to generate light flashes, which is a hardware component.
Based on the provided information, the Lifelines Photic Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Lifelines Photic Stimulator Function: The device's intended use is for "photic activation of the EEG during an EEG study and in the generation of visual evoked potentials." This involves applying light flashes to a patient directly to stimulate a physiological response (brain activity measured by EEG).
- Lack of Specimen Testing: The description does not mention the device being used to test any biological specimens.
Therefore, the Lifelines Photic Stimulator is a medical device used for in vivo (within the body) stimulation and measurement, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary 807.92(c)
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
ાં 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_________________________________________________________________________________________________________________________________________________________________