(266 days)
The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software.
The system includes:
-hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and
-software which is used for the signal acquisition, display, storage, process and measure of biologic signals.
The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers.
The device is intended to be used by physicians, technicians, and other medical professions that are trained in EEG and/or PSG.
The Micromed BRAIN QUICK System is a multi-modal physiological recording system, for use in research institutions, clinics, hospitals, operating rooms, epilepsy monitoring unit environments and/or sleep laboratories. The Micromed BRAIN OUICK System is a modular system which can be configured in different versions; however, the intended use, operating principle and technology remain the same for the different configurations of the Micromed BRAIN QUICK system. The basic unit consists of one or more acquisition amplifiers, a communication interface for transferring data to a PC, a PC with monitor and user interface devices and software for the processing, storage and display of the acquired traces. The power supply is provided through an isolation transformer allowing the connection of several devices to the transformer secondary winding.
The Micromed BRAIN QUICK system acquires EEG signals (bio-potential derived from the brain activity) from third-party commercial electrodes connected to the patient. The Micromed BRAIN QUICK system processes the signal (amplification and filtering), converts it from analogical to digital representation and transmits the result to the software which controls the display of the resulting signal on a monitor, the storage of the signal on a digital storage media (e.g. hard disk or DVD), the analysis for deriving signal measures. The clinical meaning of the displayed trace is determined by the physician only, based upon the signal morphology.
The device is not intended to directly come in contact with any part of the patient body. The device uses and is compatible with EEG commercial electrodes. The device is neither sterile nor sterilizable. It is reusable. The expected lifetime is ten years.
The provided text is related to a 510(k) premarket notification for the Micromed BRAIN QUICK System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing new performance criteria or conducting studies to prove a specific level of diagnostic accuracy against a ground truth.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in terms of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the performance testing described is primarily focused on safety and electrical compatibility to show equivalence.
Specifically, the document states:
- "No specific guidance document on performance is required for EEG/PSG devices."
- "The device capability is equivalent to the features specified for predicate devices."
- "Safety Tests have been performed to verify compliance with IEC 60601-1 and IEC 60601-2-26..."
- "Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed..."
Given this, I cannot construct the table or provide details for the requested study components because the provided text does not describe such a study for the device. The focus is on technical and functional equivalence to already-marketed devices, not on proving a specific clinical performance threshold for a new diagnostic capability.
If you have a document that describes a clinical performance study for an AI/diagnostic device, I would be happy to analyze it against these criteria.
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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2018
Micromed S.p.A % Joseph Ouellette Senior Consultant EAS Consulting Group 1700 Diagonal Road Suite 750 Alexandria, Virginia 22314
Re: K171384
Trade/Device Name: Micromed BRAIN OUICK System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV Dated: January 2, 2018 Received: January 2, 2018
Dear Mr. Ouellette:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171384
Device Name Micromed BRAIN QUICK system
Indications for Use (Describe)
The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software.
The system includes:
-hardware recorders intended to acquire and temporarily store physiological signals for EEG and to transfer the data to separate polysomnographic analysis software, and
-software which is used for the signal acquisition, display, storage, process and measure of biologic signals.
The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers.
The device is intended to be used by physicians, and other medical professions that are trained in EEG and/or PSG.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K171384 510(k) Summary
SUBMITTER
Micromed S.p.A Via Giotto, 2-31021 Mogliano Veneto (TV) Italy
Phone: +39-041-593700 Fax: +39-041-5397011 Email: monica.camillo@micromed.eu
Contact Person Monica Camillo Date Prepared: January 31, 2018
SUBJECT DEVICE
| Trade Name: | Micromed BRAIN QUICK System |
|---|---|
| Common or usual names: | Electroencephalograph |
| Proprietary name: | BRAIN QUICK |
| Classification name: | Electroencephalograph (21 CFR 882.1400) |
| Regulatory Class: | II |
| Product Code: | GWQ, OLV |
PREDICATE DEVICE
The predicate devices used in this submission are:
- K122196 Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition . System-Basic
- . K071782 MICROMED MORPHEUS, MICROMED BRAIN SPY PLUS
DEVICE DESCRIPTION
The Micromed BRAIN QUICK System is a multi-modal physiological recording system, for use in research institutions, clinics, hospitals, operating rooms, epilepsy monitoring unit environments and/or sleep laboratories. The Micromed BRAIN OUICK System is a modular system which can be configured in different versions; however, the intended use, operating principle and technology remain the same for the different configurations of the Micromed BRAIN QUICK system. The basic unit consists of one or more acquisition amplifiers, a communication interface for transferring data to a PC, a PC with monitor and user interface devices and software for the processing, storage and display of the acquired traces. The power supply is provided through an isolation transformer allowing the connection of several devices to the transformer secondary winding.
The Micromed BRAIN QUICK system acquires EEG signals (bio-potential derived from the brain activity) from third-party commercial electrodes connected to the patient. The Micromed BRAIN QUICK system processes the signal (amplification and filtering), converts it from analogical to digital representation and transmits the result to the software which controls the display of the resulting signal on a monitor, the storage of the
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signal on a digital storage media (e.g. hard disk or DVD), the analysis for deriving signal measures. The clinical meaning of the displayed trace is determined by the physician only, based upon the signal morphology.
The device is not intended to directly come in contact with any part of the patient body. The device uses and is compatible with EEG commercial electrodes. The device is neither sterile nor sterilizable. It is reusable. The expected lifetime is ten years.
Intended use, users, environment and indications for use are reported in the intended use section of this 510(k) Summary.
Key Performance Specifications and Characteristics of the Device are reported in the comparison to predicate devices section of this 510(k) Summary.
INTENDED USE
The Micromed BRAIN OUICK System is intended to record, display, store and archive bio-potential signals. It can do this wireless via Class I Bluetooth or via cables.
The Indications for Use statement for the Micromed BRAIN QUICK system is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relevant to the predicate:
-
The Micromed BRAIN QUICK System has overall the same intended use in the same environments as the predicate device.
-
Both the Micromed BRAIN OUICK System and the predicate have the same intended use for the recording, display and storage and archiving of bio-potential signals.
-
The Micromed BRAIN QUICK system IFU has been reworded in order to highlight the presence and functions of the software.
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMed CervelloBasic Bio-Potential SignalAcquisition SystemK122196 | MicromedMorpheus, BrainSpy PlusK071782 | |
|---|---|---|---|
| IntendedUse | The Micromed BRAIN QUICKsystem is intended to record,display, store and archive bio-potential signals. | Acquire, display, store, and archiveelectroencephalographic signals fromthe brain using a full montage arrayand user-specified locations. | Acquire, display, store,and archiveelectroencephalographicsignals from the brainusing a full montagearray (i.e., 16 or moreelectrodes) and userspecified locations. |
| IntendedUseEnvironment | Research institutions, clinics,hospitals, operating rooms,epilepsy evaluation unitenvironments or sleep laboratories. | Not stated | Medical facility,physician's office,laboratory, clinic ornursing home or outsideof a medical facilityunder supervision of amedical professional |
| TargetPatientPopulation | Adult and pediatrics | Not stated | The device will beavailable on all patientpopulations asdetermined by a trainedprofessional |
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMed CervelloBasic Bio-Potential SignalAcquisition SystemK122196 | MicromedMorpheus, BrainSpy PlusK071782 | |
| Indicationsfor Use | The Micromed BRAIN QUICKsystem is intended to acquire andstore physiological signals forEEG and/or polysomnography(PSG) and to transfer data toseparate PSG analysis software.The system includes:-hardware recorders intended toacquire and temporarily storephysiological signals for EEGand/or PSG and to transfer the datato separate polysomnographicanalysis software, and-software which is used for thesignal acquisition, display, storage,process and measure of biologicsignals.The hardware recorders(amplifiers) are BRAIN SPYPLUS, MORPHEUS, SD LTM 32EXPRESS and SD LTM 64EXPRESS. They are intended toacquire the same kind of signalsby using the SystemPlusEVOLUTION software. Therecorder models differ based onthe number of available EEGchannels (16 in the BRAIN SPYPLUS, 24 in the MORPHEUS, 32in SD LTM 32 EXPRESS and 64in SD LTM 64 EXPRESS). Asystem with up to 256 channel canbe obtained by cascading 4 SDLTM 64 EXPRESS amplifiers.The device is intended to be usedby physicians, technicians, andother medical professions that aretrained in EEG and/or PSG. | Up to 64 channels with one Cervellohardware device (Amplifier) and upto 128 channels by cascading 2Cervello devices using the Cervellosoftware. The device is intended toacquire and store physiologicalsignals for EEG and/or PSG, and totransfer the data to separatepolysomnographic analysis software.The devices are intended to be usedby physicians, technicians and othermedical professions that are trainedin EEG and/or PSG.The Cervello Basic System does notmake any judgment of normality orabnormality of the displayed signalsor the results of an analysis. In noway are any of the functionsrepresented as being in and ofthemselves diagnostic. | Acquire and storephysiological signals forEEG and Sleep Studies,and to transfer the datato separatepolysomnographicanalysis software. Thedevices are intended foruse by physicians,technicians, or othermedical professionalsthat are trained in EEGand/ or PSG. |
| Uselimitations | The BRAIN QUICK system doesnot make any judgment ofnormality or abnormality of thedisplayed signals or the result ofan analysis. In no way are any ofthe functions represented as beingin themselves diagnostic.Moreover, the system is not amonitoring system: no physiologicalarms are provided. | The System is not a monitoringsystem. No physiologic alarms areprovided. The acquisition and displayof bio-potential signals is for theinterpretation and use of theclinician. The devices do not makeany judgment of normality orabnormality of the displayed signals. | These devices do notprovide alarms and isnot intended for use asan automated apneamonitor. The devices donot make any judgmentof normality orabnormality of thedisplayed signals. |
| Bio-PotentialSignals | Electroencephalography (EEG),Video EEG, Respiration, Heart | Electroencephalography (EEG)VideoEEG, Respiration, Heart Rate, | Electroencephalography(EEG) |
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMed CervelloBasic Bio-Potential SignalAcquisition SystemK122196 | MicromedMorpheus, BrainSpy PlusK071782 | |
| Recorded | Rate, SPO2 | SPO2 | Electrocardiography(ECG)Respiration, Heart Rate,SPO2 |
| PotentialClinicalApplications | Bio-potential signal acquisition:amplification, recording,digitization, display and storage. | Bio-potential signal amplification,recording, display, digitization,retrieval and display. | The device function isthe acquisition ofbioelectric signals, as istypical for EEGamplifiers and Holterrecorders. |
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
As shown in the following table, the BRAIN QUICK system shares similar technological characteristics with the predicates the main technological characteristics.
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMedCervello Basic Bio-PotentialSignal Acquisition System | Micromed Morpheus,Brain Spy Plus | |
|---|---|---|---|
| K122196 | K071782 | ||
| SystemComponents | Ambulatory and StationaryAmplifiers,Adapter Cables, Signal Processor,Power Supply, (Interface to theuser's Monitor and PC) | Ambulatory and StationaryAmplifiers,Adapter Cables, Signal Processor,Power Supply, (Interface to theuser's Monitor and PersonalComputer) | Ambulatory: AmplifierBasic: Amplifier, AdapterCable,Signal Processor, PowerSupply |
| Accessories | Ambulatory holster, dataacquisition unit mounting pole,video camera mounting pole,equipment cart. | Ambulatory holster, dataacquisition unit mounting pole,equipment cart. | None stated |
| Number ofEEG SignalRecordingChannels | System with SD LTM 64/32EXPRESS: Up to 64 channelswith one device. Up to 256channels by cascading fourdevicesSystem with MORPHEUS/ | 64 channels with one device. 128channels by cascading twodevices. | 24 channels |
| BRAIN SPY PLUS: 24 | |||
| AmplifierInputImpedance | System with SD LTM 64/32EXPRESS: >1012 ΩSystem with MORPHEUS/BRAIN SPY PLUS: >109 Ω (diff) | >109 Ω (diff) | >109 Ω (diff) |
| AmplifierDC SignalRange | System with SD LTM 64/32EXPRESS:1.48 /4.8V (0.46/4.69mV/digit) System withMORPHEUS/BRAIN SPY PLUS: 1V(15μV/digit) | 1V (15μV/digit) | 1V (15μV/digit) |
| AmplifierFrequency | System with SD LTM 64/32 | 0.15 - 220 Hz | 0.15 - 220 Hz |
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMedCervello Basic Bio-PotentialSignal Acquisition SystemK122196 | Micromed Morpheus,Brain Spy PlusK071782 | |
| Response | System with MORPHEUS/BRAIN SPY PLUS: 0.15 – 220Hz | ||
| A/DConversion | System with SD LTM 64/32EXPRESS: 16 bit for EEGchannels, 10 bit for DC channels | 16 bit | 16 bit |
| System with MORPHEUS/BRAIN SPY PLUS: 16 bit | |||
| SamplingRate | 8192 Hz per channel | 8192 Hz per channel | 8192 Hz per channel |
| CMRR | >100dB@50Hz between G1 andall other inputs | >100dB@20Hz between G1 andall other inputs | >100dB@20Hz between G1and all other inputs |
| Noise | System with SD LTM 64/32EXPRESS:<0.5µV r.m.s.@128Hz samplingrateSystem with MORPHEUS:<0.5µV r.m.s. @256Hz samplingrate | <0.5µV r.m.s. @128Hz samplingrate | <0.5µV r.m.s.@256Hzsampling rate |
| PowerSource | Acquisition unit, 2x 1,5V DC AA,alkaline batteries, computer (forsoftware), 120 VAC | Acquisition unit, 2x 1,5V DC AA,alkaline batteries, computer (forsoftware), 120 VAC | 2x 1,5V DC AA, alkalinebatteries |
| Digital andSerial InputChannels | Yes | Yes | Yes |
| Measures | Impedance checkAmplitude | Impedance checkAmplitude | Impedance check |
| Frequency spectrum | Frequency spectrum | N/A | |
| Time interval | Time interval | N/A | |
| Extractionof Spike andFieldPotentials | No | No | N/A |
| Alarms | No | No | No |
| Stimulation | None | None | None |
| Videocamera | Available | Available | Available |
| PatientContact | None - The device interfaces touser supplied bio-potentialelectrodes. | None - The device interfaces touser supplied bio-potentialelectrodes. | None - The device interfacesto user supplied bio-potential electrodes. |
| OperatingSystem | Windows XP, 7, 8.1 | Windows XP, 7, Server 2008 R2,Dual Core 2 GHz Processor | N/A |
| DeviceInput | Keyboard and Mouse | Keyboard and Mouse | N/A |
| Display | Computer Screen &Built-in LCD | Computer Screen | Built-in LCD |
| Micromed BRAIN QUICK(Subject Device) | Blackrock NeuroMedCervello Basic Bio-PotentialSignal Acquisition SystemK122196 | Micromed Morpheus,Brain Spy PlusK071782 | |
| SafetyStandardsCompliance | IEC 60601-1:2005 + /A1:2011 | IEC 60601-1:1998 | IEC 60601-1 (1988)+A1:1991 +A2:1995 (2nd edition) |
| IEC 60601-1-2:2007 | IEC 60601-1-2:2007 | IEC 60601-1-1 2000-12 | |
| IEC 60601-2-26:2012 | IEC 60601-2-26: 2002 | IEC 60601-1-2:2001-09 | |
| IEC 60601-1-4:1996+A1:1999 | |||
| IEC 60601-2-26:2002-11 | |||
| UL 2601-1 | |||
| ETSI EN 301 489-1 | |||
| ETSI EN 301 489-17 | |||
| ETSI EN 300 328-1 |
EXPRESS: 0.15-500 Hz
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Discussion
Comparison with the predicate devices
The Micromed BRAIN QUICK system is a composition system based on devices already on the market in the U.S.A. The BRAIN QUICK system is comprised of one or more amplifiers, software and some accessories needed for supporting (PC, monitor, keyboard, separation transformer) or complementing (cart, video camera) the functions of the devices.
No patient contacting parts are included.
The integration of the amplifier, the software and the supporting accessories devices has already been performed in a similar system sold by Blackrock Neuromed, that is, the predicate device Cervello Basic system.
Similarities
- . The amplifier used in the predicate system is identical to the SD LTM 64 EXPRESS amplifier used in the Micromed BRAIN QUICK system. It is a relabeling of the same device).
- . The MORPHEUS amplifier used in the Micromed BRAIN OUICK system is identical to the amplifier submitted by Micromed under K071782.
- The software used in the Micromed BRAIN QUICK system provides the user with the same functionalities as the software included in the predicate Cervello Basic system.
Differences
- . The Micromed BRAIN OUICK system differs from the Blackrock NeuroMed system in that the two systems use a different cart and a different isolation transformer.
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- . The software used in the Micromed BRAIN QUICK system is an updated version of the one used in the predicate system. The updates to the software version do not impact the safety or effectiveness of the subject device.
PERFORMANCE TESTING
Safety Tests have been performed to verify compliance with IEC 60601-1 and IEC 60601-2-26 to ensure that there are no potential hazards on patients, other persons, or the surroundings, and that basic safety and essential performance for EEG devices have been attained.
Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment.
Immunity tests to IEC 60601-1-2 have been performed to ensure that the EEG equipment has the ability to operate satisfactorily in its electromagnetic environment
No specific guidance document on performance is required for EEG/PSG devices.
The device capability is equivalent to the features specified for predicate devices.
Verification of software was conducted according to Micromed design control procedures: it ensures that the system conforms to all the system design requirements
CONCLUSION
The Micromed BRAIN QUICK System has the same manner of use with basic functions as the predicate device and the Micromed BRAIN OUICK system has a similar requirement for training and expectations of user. The safety requirements and expectations are the same. The systems have comparable performance in terms of data sampling and accuracy. They use identical patient connectors and methodology.
Based on the information provided in this submission, we conclude that the Micromed BRAIN OUICK system is substantially equivalent to the predicate and is safe and effective for its intended use.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).