LED PHOTIC System

K211974 · Micromed S.P.A. · GWE · Sep 23, 2021 · Neurology

Device Facts

• Record ID: K211974
• Device Name: LED PHOTIC System
• Applicant: Micromed S.P.A.
• Product Code: GWE · Neurology
• Decision Date: Sep 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

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.

Device Story

The LED PHOTIC System is an accessory for EEG systems used to perform intermittent photic stimulation (IPS) on patients. It consists of a light stimulation unit and a dedicated power supply (LED PHOTIC IC POWER). The device is operated by physicians or neurophysiopathology technicians in professional clinical settings. Parameters for the stimulation are managed by the host EEG system software. The device delivers controlled light flashes (0-60Hz) to the patient; the resulting brain activity is recorded by the EEG system. Clinicians use the output to identify brain anomalies triggered by visual stimulation. The device is intended to assist in the diagnostic evaluation of neurological conditions.

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1 (electrical safety), IEC 60601-1-6 (usability), IEC 60601-2 (EMC compliance), and IEC 62471 (photobiological safety). No clinical data was provided.

Technological Characteristics

Photic stimulator accessory; light output max 1.9 kLux at 10 cm; flash rate 0-60Hz; powered via 120V wall outlet; computer-controlled via host EEG system software. Compliant with IEC 60601-1, IEC 60601-1-6, IEC 60601-2, and IEC 62471.

Indications for Use

Indicated for photic activation of the brain during EEG studies to evaluate brain activity anomalies via intermittent photic stimulation. For use by qualified physicians or neurophysiopathology technicians in professional clinical environments.

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

• Lifelines Photic Stimulator (K101691)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <span style="text-decoration: underline;"></span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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 Veneto<br>Treviso, ITALY 31021 |
|--------------------|------------------------------------------------------|
|--------------------|------------------------------------------------------|

## Submission Correspondent:

| | On behalf of Micromed S.p.A., the following consultant is assigned the responsibility of<br>submission correspondence: |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| | Marina Ruotolo, Regulatory Affairs<br>Via Giotto 2<br>Mogliano Veneto<br>Treviso, 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 Device<br>Characteristics | | | |
| Intended Use | LED PHOTIC System is an<br>accessory indicated for photic<br>activation of brain during the<br>electroencephalographic<br>(EEG) studies. It always has to<br>be used in combination with<br>an EEG system, in order to | The Lifelines<br>Photic<br>Stimulator is<br>indicated for<br>photic activation<br>of the EEG<br>during an | Proposed IFU<br>contains<br>additional<br>information,<br>but IFU intent<br>remains the<br>same. |

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K211974 Page 2 of 2

| | evaluate particular anomalies<br>of the brain activity due to the<br>intermittent photic<br>stimulation. The product must<br>be used only by qualified<br>personnel (physicians or<br>technicians of<br>neurophysiopathology) for the<br>execution of EEG exams in a<br>professional environment. | EEG study and in<br>the generation<br>of visual evoked<br>potentials. | |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|
| Light output | Max 1.9 kLux at 10 cm/Max<br>1.1 kLux at 20 cm/Max 0.7<br>kLux at 30 cm | 13 kLux at 1 ft. | Predicate<br>device has<br>lower Lux at<br>similar<br>distance. |
| Flash rate | 0-60Hz | 1-60Hz | Similar |
| Power supply | 120Vpower (wall outlet)<br>access required. | Can be powered<br>via USB on host<br>PC or power<br>supply. | Similar |
| Software | Computer controlled<br>(not included) | Computer<br>controlled<br>(software<br>included) | Predicate<br>device has<br>software<br>capabilities. |

## 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.