(90 days)
No
The summary describes a photic stimulation system for EEG studies, which is controlled by the EEG system software for setting parameters. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as an accessory for diagnostic purposes (evaluating brain activity during EEG studies), not for treatment.
No
The device is an accessory used in combination with an EEG system to induce photic activation, which helps in evaluating brain activity anomalies. It does not diagnose.
No
The device description explicitly states that the "LED PHOTIC IC POWER is an integral part of the LED PHOTIC System," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the LED PHOTIC System is used for photic activation of the brain during EEG studies. It directly interacts with the patient's brain activity, not with a sample taken from the patient.
- The device is an accessory to an EEG system. EEG systems measure electrical activity in the brain, which is an in vivo measurement, not an in vitro one.
- The device description focuses on stimulating the brain. This is a direct interaction with the living body, not a test performed on a sample outside the body.
Therefore, the LED PHOTIC System is a medical device used for in vivo diagnostic procedures (specifically, as an accessory to an EEG for brain activity evaluation), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GWE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.
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
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 substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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 Veneto
Treviso, ITALY 31021 |
-------------------- | ------------------------------------------------------ |
---|
Submission Correspondent:
| | On behalf of Micromed S.p.A., the following consultant is assigned the responsibility of
submission correspondence: |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| | Marina Ruotolo, Regulatory Affairs
Via Giotto 2
Mogliano Veneto
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 | |||
Characteristics | |||
Intended 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 | The Lifelines | ||
Photic | |||
Stimulator is | |||
indicated for | |||
photic activation | |||
of the EEG | |||
during an | Proposed IFU | ||
contains | |||
additional | |||
information, | |||
but IFU intent | |||
remains the | |||
same. |
4
K211974 Page 2 of 2
| | 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. | EEG study and in
the generation
of visual evoked
potentials. | |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|
| Light output | Max 1.9 kLux at 10 cm/Max
1.1 kLux at 20 cm/Max 0.7
kLux at 30 cm | 13 kLux at 1 ft. | Predicate
device has
lower Lux at
similar
distance. |
| Flash rate | 0-60Hz | 1-60Hz | Similar |
| Power supply | 120Vpower (wall outlet)
access required. | Can be powered
via USB on host
PC or power
supply. | Similar |
| Software | Computer controlled
(not included) | Computer
controlled
(software
included) | Predicate
device has
software
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.