LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

Device Description

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation.

The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

AI/ML Overview

The provided text describes the regulatory clearance for a medical device called "LED PHOTIC System" and its comparison to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification summary for a Class II medical device, which is an accessory for EEG studies to provide photic stimulation. The performance testing mentioned focuses on safety standards (electrical safety, usability, EMC compliance, photobiological safety), not on accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: The document only lists safety standard compliance, not performance criteria for diagnostic accuracy or similar AI/ML metrics.
Sample size used for the test set and the data provenance: No such testing is described for diagnostic performance. The safety tests would have their own sample sizes (e.g., number of units tested) but these are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.
Adjudication method for the test set: Not applicable.
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, as the device is a photic stimulator, not an AI/ML diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (no AI/ML algorithm mentioned).
How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section only states:

The LED PHOTIC System was tested and found compliant to the following safety standards:
- IEC 60601-1:2005+A1:2012: Medical Electrical safety
- IEC 60601-1-6:2010+A1:2013: Usability
- IEC 60601-2:2014: EMC Compliance
- IEC 62471:2006: Photobiological Safety

This submission is about establishing substantial equivalence to a predicate device (Lifelines Photic Stimulator K101691) primarily based on shared intended use, similar operational principles, and compliance with general medical device safety standards. It is not an evaluation of an AI-driven system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

September 23, 2021

Micromed S.p.A. Marina Ruotolo Regulatory Affairs Via Giotto 2 Mogliano Veneto, Treviso 31021 Italy

Re: K211974

Trade/Device Name: LED PHOTIC System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: June 21, 2021 Received: June 25, 2021

Dear Marina Ruotolo:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211974

Device Name LED PHOTIC System

Indications for Use (Describe)

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K211974 Page 1 of 2

Traditional 510(k) Summary

Summary Date: 21 June 2021

Applicant Name: Micromed S.p.A.

Applicant Address:	Via Giotto 2 Mogliano VenetoTreviso, ITALY 31021
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Submission Correspondent:

	On behalf of Micromed S.p.A., the following consultant is assigned the responsibility ofsubmission correspondence:
	Marina Ruotolo, Regulatory AffairsVia Giotto 2Mogliano VenetoTreviso, ITALY 31021
Trade Name:	LED PHOTICSystem
Common Name:	Photic Simulator
Classification Name:	21 CFR 882.1890, GWE-Evoked Response Photic Stimulator
Device Class:	Class II
Predicate Device:	Lifelines Photic Stimulator (K101691), Lifelines Ltd.

Device Description: LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation.

The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

Indications for Use: LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or neurophysiopathology) for the execution of EEG exams in a professional environment.

Comparison with Predicate Device:

Device & Predicate Device(s):	K211974	K101691	Comments
General DeviceCharacteristics
Intended Use	LED PHOTIC System is anaccessory indicated for photicactivation of brain during theelectroencephalographic(EEG) studies. It always has tobe used in combination withan EEG system, in order to	The LifelinesPhoticStimulator isindicated forphotic activationof the EEGduring an	Proposed IFUcontainsadditionalinformation,but IFU intentremains thesame.

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K211974 Page 2 of 2

	evaluate particular anomaliesof the brain activity due to theintermittent photicstimulation. The product mustbe used only by qualifiedpersonnel (physicians ortechnicians ofneurophysiopathology) for theexecution of EEG exams in aprofessional environment.	EEG study and inthe generationof visual evokedpotentials.
Light output	Max 1.9 kLux at 10 cm/Max1.1 kLux at 20 cm/Max 0.7kLux at 30 cm	13 kLux at 1 ft.	Predicatedevice haslower Lux atsimilardistance.
Flash rate	0-60Hz	1-60Hz	Similar
Power supply	120Vpower (wall outlet)access required.	Can be poweredvia USB on hostPC or powersupply.	Similar
Software	Computer controlled(not included)	Computercontrolled(softwareincluded)	Predicatedevice hassoftwarecapabilities.

Performance Testing:

The LED PHOTIC System was tested and found compliant to the following safety standards:

. IEC 60601-1:2005+A1:2012: Medical Electrical safety
. IEC 60601-1-6:2010+ A1:2013: Usability
. IEC 60601-2:2014: EMC Compliance
. IEC 62471:2006: PhotobiologicalSafety

Conclusion: Based on performance testing and comparison to predicate performance, the LED PHOTIC system demonstrates substantialequivalence.

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).