(266 days)
Not Found
No
The summary describes a system for acquiring, storing, and displaying physiological signals (EEG/PSG). It mentions signal processing (amplification, filtering, analog-to-digital conversion) and analysis for deriving signal measures, but explicitly states that the clinical meaning is determined by the physician based on signal morphology. There is no mention of AI, ML, or any automated interpretation or classification of the signals using such technologies. The focus is on data acquisition and display for physician review.
No
The device is described as a system for acquiring, storing, and analyzing physiological signals for EEG and/or polysomnography. Its function is to process and display biological signals for diagnostic purposes, not to treat a medical condition.
Yes
The device acquires physiological signals for EEG and/or polysomnography, processes and stores them, and transfers data for analysis. The intended use explicitly states it is for acquiring and storing physiological signals, which are then used by trained medical professionals to determine clinical meaning. While it doesn't automatically provide a diagnosis, it provides the essential data required for a diagnosis to be made.
No
The device description explicitly states that the system includes both hardware recorders (amplifiers) and software. It describes the hardware components and their function in acquiring and transmitting physiological signals.
Based on the provided text, the Micromed BRAIN QUICK system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Micromed BRAIN QUICK System Function: The description clearly states that the system acquires and stores physiological signals (EEG and PSG) directly from the patient's body using electrodes. It processes and displays these signals.
- No Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient.
The device is a physiological signal acquisition and processing system used for monitoring brain activity and sleep patterns, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
GWQ, OLV
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 QUICK 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain activity
Indicated Patient Age Range
Adult and pediatrics
Intended User / Care Setting
physicians, technicians, and other medical professions that are trained in EEG and/or PSG.
Research institutions, clinics, hospitals, operating rooms, epilepsy evaluation unit environments or sleep laboratories.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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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3
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
4
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 Cervello
Basic Bio-Potential Signal
Acquisition System
K122196 | Micromed
Morpheus, Brain
Spy Plus
K071782 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The Micromed BRAIN QUICK
system is intended to record,
display, store and archive bio-
potential signals. | Acquire, display, store, and archive
electroencephalographic signals from
the brain using a full montage array
and user-specified locations. | Acquire, display, store,
and archive
electroencephalographic
signals from the brain
using a full montage
array (i.e., 16 or more
electrodes) and user
specified locations. |
| Intended
Use
Environment | Research institutions, clinics,
hospitals, operating rooms,
epilepsy evaluation unit
environments or sleep laboratories. | Not stated | Medical facility,
physician's office,
laboratory, clinic or
nursing home or outside
of a medical facility
under supervision of a
medical professional |
| Target
Patient
Population | Adult and pediatrics | Not stated | The device will be
available on all patient
populations as
determined by a trained
professional |
| | Micromed BRAIN QUICK
(Subject Device) | Blackrock NeuroMed Cervello
Basic Bio-Potential Signal
Acquisition System
K122196 | Micromed
Morpheus, Brain
Spy Plus
K071782 |
| Indications
for Use | 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. | Up to 64 channels with one Cervello
hardware device (Amplifier) and up
to 128 channels by cascading 2
Cervello devices using the Cervello
software. The device is intended to
acquire and store physiological
signals for EEG and/or PSG, and to
transfer the data to separate
polysomnographic analysis software.
The devices are intended to be used
by physicians, technicians and other
medical professions that are trained
in EEG and/or PSG.
The Cervello Basic System does not
make any judgment of normality or
abnormality of the displayed signals
or the results of an analysis. In no
way are any of the functions
represented as being in and of
themselves diagnostic. | Acquire and store
physiological signals for
EEG and Sleep Studies,
and to transfer the data
to separate
polysomnographic
analysis software. The
devices are intended for
use by physicians,
technicians, or other
medical professionals
that are trained in EEG
and/ or PSG. |
| Use
limitations | The BRAIN QUICK system does
not make any judgment of
normality or abnormality of the
displayed signals or the result of
an analysis. In no way are any of
the functions represented as being
in themselves diagnostic.
Moreover, the system is not a
monitoring system: no physiologic
alarms are provided. | The System is not a monitoring
system. No physiologic alarms are
provided. The acquisition and display
of bio-potential signals is for the
interpretation and use of the
clinician. The devices do not make
any judgment of normality or
abnormality of the displayed signals. | These devices do not
provide alarms and is
not intended for use as
an automated apnea
monitor. The devices do
not make any judgment
of normality or
abnormality of the
displayed signals. |
| Bio-
Potential
Signals | Electroencephalography (EEG),
Video EEG, Respiration, Heart | Electroencephalography (EEG)
VideoEEG, Respiration, Heart Rate, | Electroencephalography
(EEG) |
| | Micromed BRAIN QUICK
(Subject Device) | Blackrock NeuroMed Cervello
Basic Bio-Potential Signal
Acquisition System
K122196 | Micromed
Morpheus, Brain
Spy Plus
K071782 |
| Recorded | Rate, SPO2 | SPO2 | Electrocardiography
(ECG)
Respiration, Heart Rate,
SPO2 |
| Potential
Clinical
Applications | Bio-potential signal acquisition:
amplification, recording,
digitization, display and storage. | Bio-potential signal amplification,
recording, display, digitization,
retrieval and display. | The device function is
the acquisition of
bioelectric signals, as is
typical for EEG
amplifiers and Holter
recorders. |
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6
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 NeuroMed
Cervello Basic Bio-Potential
Signal Acquisition System | Micromed Morpheus,
Brain Spy Plus |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | | K122196 | K071782 |
| System
Components | Ambulatory and Stationary
Amplifiers,
Adapter Cables, Signal Processor,
Power Supply, (Interface to the
user's Monitor and PC) | Ambulatory and Stationary
Amplifiers,
Adapter Cables, Signal Processor,
Power Supply, (Interface to the
user's Monitor and Personal
Computer) | Ambulatory: Amplifier
Basic: Amplifier, Adapter
Cable,
Signal Processor, Power
Supply |
| Accessories | Ambulatory holster, data
acquisition unit mounting pole,
video camera mounting pole,
equipment cart. | Ambulatory holster, data
acquisition unit mounting pole,
equipment cart. | None stated |
| Number of
EEG Signal
Recording
Channels | System with SD LTM 64/32
EXPRESS: Up to 64 channels
with one device. Up to 256
channels by cascading four
devices
System with MORPHEUS/ | 64 channels with one device. 128
channels by cascading two
devices. | 24 channels |
| | BRAIN SPY PLUS: 24 | | |
| Amplifier
Input
Impedance | System with SD LTM 64/32
EXPRESS: >1012 Ω
System with MORPHEUS/
BRAIN SPY PLUS: >109 Ω (diff) | >109 Ω (diff) | >109 Ω (diff) |
| Amplifier
DC Signal
Range | System with SD LTM 64/32
EXPRESS:
1.48 /4.8V (0.46/4.69
mV/digit) System with
MORPHEUS/
BRAIN SPY PLUS: 1V
(15μV/digit) | 1V (15μV/digit) | 1V (15μV/digit) |
| Amplifier
Frequency | System with SD LTM 64/32 | 0.15 - 220 Hz | 0.15 - 220 Hz |
| | Micromed BRAIN QUICK
(Subject Device) | Blackrock NeuroMed
Cervello Basic Bio-Potential
Signal Acquisition System
K122196 | Micromed Morpheus,
Brain Spy Plus
K071782 |
| Response | System with MORPHEUS/
BRAIN SPY PLUS: 0.15 – 220
Hz | | |
| A/D
Conversion | System with SD LTM 64/32
EXPRESS: 16 bit for EEG
channels, 10 bit for DC channels | 16 bit | 16 bit |
| | System with MORPHEUS/
BRAIN SPY PLUS: 16 bit | | |
| Sampling
Rate | 8192 Hz per channel | 8192 Hz per channel | 8192 Hz per channel |
| CMRR | >100dB@50Hz between G1 and
all other inputs | >100dB@20Hz between G1 and
all other inputs | >100dB@20Hz between G1
and all other inputs |
| Noise | System with SD LTM 64/32
EXPRESS: