(52 days)
No
The document describes a system for recording, processing, and displaying biopotential signals. It explicitly states that the acquisition and display are for clinician interpretation and use, and there are no mentions of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for recording and display of biopotential signals for interpretation by a clinician, not for providing therapy or treatment.
No
The device records and displays biopotential signals for interpretation by a clinician, but it is explicitly stated that "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." It facilitates data collection for diagnosis by a clinician rather than making a diagnosis itself.
No
The device description explicitly states that the system "when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals." This indicates the system includes hardware components (or relies on specific hardware components) for signal acquisition, not just software processing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Blackrock NeuroPort Biopotential Signal Processing System records, processes, and displays biopotential signals (electrical signals from the body) from electrodes placed on or in the body. This is an in vivo (within the living body) measurement, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use describes recording and displaying signals from electrodes, not analyzing samples taken from the body.
- Device Description: The description reinforces that it records signals from electrodes connected to the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures typically associated with IVDs.
Therefore, the Blackrock NeuroPort Biopotential Signal Processing System is a device for measuring electrical activity within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).
Product codes
GWL, GWK
Device Description
The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include:
- Electrooculography (EOG),
- Electrocorticography (ECoG),
- electroencephalography (EEG),
- electromyography (EMG),
- electroencephalography (ECG) and
- evoked potential (EP).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
research institution, clinic, hospital, operating room and epilepsy evaluation environments
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
Software documentation, system testing and standards compliance were provided to support the substantial equivalence, safety and effectiveness of the System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for Blackrock Microsystems. The logo is a stylized figure eight with the company name below it. The figure eight is black and white, and the company name is in a sans-serif font.
510(k) Summary
Device Name: Blackrock NeuroPort Biopotential Signal Processing System
510(k) Sponsor: I2S Micro Implantable Systems, LLC, d/b/a Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108
510(k) Contact: Chris DeCaria Director of Product Development Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108
Summary Date: May 15, 2009
Trade Name: Blackrock NeuroPort Biopotential Signal Processing System
Common Name: Bio-potential Signal Acquisition System
Classification Name: CFR 882.1835 Physiologic Signal Amplifier, Product Code: GWL CFR 882.1845 Physiological Signal Conditioners, Product Code: GWK
Predicate Devices:
510{k) Number: K042626
Trade Name: NeuroPort™ Neural Signal Processing (NSP) System
510(k) Number: K060803 Trade Name: g.USBamp
510(k) Number: K040113 Trade Name: Sandman SD20 Amplifier
1.0 Description of Device
The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include:
-
- Electrooculography (EOG),
- Electrocorticography (ECoG), 2.
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- electroencephalography (EEG), 3.
-
- electromyography (EMG),
- న్న electroencephalography (ECG) and
- evoked potential (EP). 6.
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.
1.2 Clinical Application
The System is used in research institution, clinic, hospital, operating room and epilepsy evaluation environments to acquire (record) bio-potential signals from user supplied electrodes or the NeuroPort Array. All of these electrodes require a high input impedance amplifier to acquire and display the bio-potential signal from the human body the electrodes contact.
2.0 Intended use of Device
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).
3.0 Technological Characteristics
The only hardware modifications to the predicated NeuroPort System are:
-
- The addition of interface cables to support connection of user supplied electrodes to the amplifier. These interface cables are verified by the continuity of the single pathway, commercial electrode input connector to the amplifier output connector.
-
- A passive signal splitter box allows the user supplied electrodes to connect to the System Amplifier and the user's own equipment. This passive box will be verified by continuity of the signal pathways between the user supplied electrode input connector and the two signal connector outputs (System Amplifier output connector and User defined equipment connector).
- Sync to an external EEG instrument, such as the X-CEL TEK device is addressed in 3. the software testing, see Section 6.0.
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- The syncing of two Systems to be capable of recording up to 256 input channels is supported in the software testing, see Section 6.
3.1 Comparison to Predicates
| Feature | System
Under Review | Predicate
NeuroPort
Instrument
(K060523) | Predicate
g.USBamp
(K060803) | Predicate
Sandman SD20
Amplifier
(K0040113) | Comments |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use,
Indications
for Use | The Blackrock NeuroPort
Biopotential Signal
Processing System
supports recording,
processing and display of
biopotential signals from
user supplied electrodes.
Biopotential signals
include, but are not limited
to: Electrocorticography
(ECOG),
electroencephalography
(EEG), electromyography
(EMG),
electrocardiography
(ECG), electrooculography
(EOG) and Evoked
Potential (EP). | The intended use of
the Cyberkinetics
Neurotechnology
Systems, Inc.
NeuroPort Neural
Signal Processor
System is for
temporary ( 100 Megohm | Unknown | Same as
predicate
NeuroPort
Instrument. |
| A/D
Conversion | 16 Bit | 16 Bit | 24 Bit | 16 Bit | Equivalent |
| Sampling
Rate | Up to 30,000 Hz | Up to 30,000 Hz | Up to 38,400 Hz | Up to 32,000 Hz | Equivalent |
| CMRR | > 90 dB | > 90 dB | > 100 dB | > 100 dB | Equivalent |
·
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| Feature | System
Under Review | Predicate
NeuroPort
Instrument
(K060523) | Predicate
g.USBamp
(K060803) | Predicate
Sandman SD20
Amplifier
(K0040113) | Comments |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analysis
Software | Embedded, commercially
available and user
defined.
Examples:
Persyst Insight™
NeuroPlex™
Matlab™
Spike 2™
and others. | Embedded,
commercially
available and user
defined.
Examples:
Persyst Insight™
NeuroPlex™
Matlab™
Spike 2™
and others. | Embedded and
commercially
available.
Examples:
Matlab™
and others. | Embedded and
commercially
available | Equivalent
The
physician/clinician
may apply their
own analysis
software as a
research tool or
other
commercially
available
software
supporting
analysis. |
| Power | 110 VAC | 110 VAC | USB Port | Unknown | Safety of the
power source is
verified by
standards
compliance. |
| Alarms | No | No | No | Unknown | Same |
| Safety
Standards
Compliance | IEC 60601-1:1998
IEC 60601-1-2:2001
IEC 60601-2-26 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-26 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-26 | IEC 60601-1
IEC 60601-1-2 | Same |
4.0 Data Summary
Software documentation, system testing and standards compliance were provided to support the substantial equivalence, safety and effectiveness of the System.
5.0 Conclusions
The modifications to the Predicate NeuroPort System to create the Blackrock NeuroPort Biopotential Signal Processing System were evaluated and raise no new questions of safety or effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines forming the wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I2S Micro Implantable Systems, LLC c/o Gary Syring, Principal Consultant Quality & Regulatory Associates, Inc. 800 Levanger Lane Stoughton, WI 53589
MAY 2 8 2009
Re: K090957
Trade/Device Name: Blackrock NeuroPort Biopotential Signal Processing System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiologic Signal Amplifier Regulatory Class: II Product code: GWL (and GWK) Dated: April 2, 2009
Received: April 6, 2009
Dear Mr. Syring:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Malvina B. Eglehnus, mD.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
690957
Indications for Use
510(k) Number (if known):
Device Name: Blackrock NeuroPort Biopotential Signal Processing System
Indications for Use:
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E.K. Rhm
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090957
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