(190 days)
No
The summary describes standard signal processing and visualization, with no mention of AI/ML terms or capabilities.
No
The device is described as a biopotential signal processing system for recording, processing, and displaying various biopotential signals (e.g., ECoG, EEG). Its purpose is monitoring and visualization, not applying energy or substances to the body for treatment.
No
The device "supports recording, processing, and display of biopotential signals" and is "used to acquire, process, visualize, archive/record signals." While these signals can be used for diagnosis, the device itself is described as a signal processing system and does not mention providing a diagnosis or interpretation of the signals, only their acquisition and display.
No
The device description explicitly mentions hardware components such as a headstage relay, pedestal interface, hub, preamplifiers, analog to digital converters, and a signal processing unit, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the system supports recording, processing, and display of biopotential signals from user-supplied electrodes. These signals are acquired directly from the body (ECoG, EEG, EMG, ECG, EOG, EP). IVDs, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces that the system acquires signals from electrodes in contact with the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a system for acquiring and processing physiological signals directly from the body, which falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Digital 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), electroculography (EOG), and Evoked Potential (EP).
Product codes (comma separated list FDA assigned to the subject device)
GWL, GWK
Device Description
The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body. Components include:
- Central Software Suite: Used to receive, display and store data, configure signal processing attributes.
- Neural Signal Processor: Used for signal processing.
- Digital Hub: Used to connect digital headstage accessories and perform digital to optical conversion to pass data over fiberoptic cable to SignalProcessor.
The Digital Headstage Accessory Devices are devices that interface with the electrodes connected to the patient. Headstage devices and accessories include: - NeuroPlex E Headstages: Interface to percutaneous connector of NeuroPort Electrode. Acquires signal from connected electrode and performs signal processing before sending to output connector, which connect to Digital Hub via Digital Data Cable. Provided in both sterile and nonsterile configurations.
- Digital Data Cable: 1.5M Digital Data Cables connected to Digital Hub. Hub powers Digital Headstages (4.8VDC), and Headstages provide digitized biopotential signals to Hub. Provided in both sterile and non-sterile configurations.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following performance data were provided in support of the substantial equivalence determination.
Performance Data:
Electrical Safety/Electromagnetic Compatibility: The Digital NeuroPort Biopotential Signal Processing System was evaluated for electrical safety and electromagnetic compatibility in accordance with IEC 60601-1:2012, Edition 3.1 and IEC 60601-1-2:2014, Edition 4.0, with results demonstrating that the Digital NeuroPort Biopotential Signal Processing System continues to be compliant upon field deployment.
Design Verification, Software Verification and Validation and Usability: The Digital NeuroPort Biopotential Signal Processing System was evaluated with respect to design verification and validation, software verification and validation, and usability.
Functional Testing for NeuroPlex E: Mating, Crosstalk, Label Durability, Digital Accuracy, Input Impedance, Impedance Measurement, Current Rating, Stability, Attachment, Input Noise, Crosstalk, Leakage, Breakaway - All Passed.
Functional Testing for Digital Hub: Input Power Supply, FPGA Testing from Headstage, Output Power Supply to Headstage, Full-Scale Analog Input, Burn in Test, Compatibility Test - All Passed.
Functional Testing for Digital Neural Signal Simulator (DNSS): Rechargeable Battery, Power, Digital - All Passed.
Functional Testing for System: Synchronization, Channel Count - All Passed.
Usability Testing: IFU Readability, Impedance, Reference, and Ground Switching, Cleaning - All Passed.
Biocompatibility: NeuroPlex E and pedestal components evaluated in accordance with ISO 10993-1 Fifth Edition 2018/18. Endpoints assessed were cytotoxicity, irritation, or sensitization.
Sterility and Shelf Life: NeuroPlex E and Digital Data Cable sterilized with 100% ethylene oxide (EtO) in accordance with ISO 11135-1 Second Edition 2014/07/15 to a Sterility Assurance Level of 10-6. Residuals met requirements of ISO 10993-7 Second Edition 2008/10/15. Packaging conforms to ISO 11607-1:2019. Accelerated aging testing validated an 18-month shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Blackrock Microsystems Rachelle Frischknecht Regulatory Affairs Specialist 630 Komas Drive, Suite 200 Salt Lake City, Utah 84108
Re: K202174
Trade/Device Name: Digital NeuroPort Biopotential Signal Processing System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWL, GWK Dated: December 21, 2020 Received: December 28, 2020
Dear Rachelle Frischknecht:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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Indications for Use
510(k) Number (if known) K202174
Device Name
Digital NeuroPort Biopotential Signal Processing System
Indications for Use (Describe)
The Digital 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), electroculography (EOG), and Evoked Potential (EP).
| 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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I. Submitter, Device, Predicate
| Sponsor/Applicant | Blackrock Microsystems
630 Komas Drive, Suite 200
Salt Lake City, UT 84108 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Primary Contact | Rachelle Frischknecht
Regulatory Affairs Specialist
(801) 994-5668
rfrischknecht@blackrockmicro.com |
| Date Summary Prepared | January 20, 2021 |
| 510(k) Submission Type | Special |
| Device Name | Digital NeuroPort Biopotential Signal Processing System |
| Common/Usual Name | Physiological signal amplifier; Physiological signal conditioner |
| Classification Name | Physiological signal amplifier (21 CFR 882.1835) |
| Regulatory Class | II |
| Product Code | GWL; GWK |
| Predicate Device | K090957, Blackrock NeuroPort Biopotential Signal
Processing System |
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II. Device Description
The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body. Components include:
- Central Software Suite: Used to receive, display and store data, configure signal processing . characteristics.
- · Neural Signal Processor: Used for signal processing.
- · Digital Hub: Used to connect digital headstage accessories and perform digital to optical conversion to pass data over fiberoptic cable to SignalProcessor.
The Digital Headstage Accessory Devices are devices that interface with the electrodes connected to the patient. Headstage devices and accessories include:
- · NeuroPlex E Headstages: Interface to percutaneous connector of NeuroPort Electrode. Acquires signal from connected electrode and performs signal processing before sending to output connector, which connect to Digital Hub via Digital Data Cable. Provided in both sterile and nonsterile configurations.
- Digital Data Cable: 1.5M Digital Data Cables connected to Digital Hub. Hub powers Digital Headstages (4.8VDC), and Headstages provide digitized biopotential signals to Hub. Provided in both sterile and non-sterile configurations.
III. Indications for Use
The Digital 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)
IV. Comparison of Technological Characteristics withthe Predicate Device
At a high level, the following technological differences exist between the subject and predicate devices:
- · Electrical/EMC:
- · Change in power supply configuration (moved into DigitalHub)
- Change in headstage device and accessory (NeuroPlexE and Digital data cable, versus patient and blue ribbon cables)
- · Change in simulator (Digital Simulator replaces Analog Simulator)
- Digitization of signals to reduce signal atentuation
- Stage of signal conversion (pre-amplifier/headstage level) to improve system synchronization and reduce noise
- · Change in patient protection circuitry: Patient Cable in K090957 uses capacitor and resistor;
5
whereas, ASIC in NeuroPlex E uses diodes.
- Higher frequency data transmission over new 1.5m Digital Data Cable.
- Expansion of band pass to detect neural signals
- · Digital Hub clock communicates over 1.5m Digital Data Cable to headstage instead of all on internal printed circuit boards.
- NeuroPlex E has option for wideband hardware filter that Patient Cable does not.
- NeuroPlex E has a Delrin wheel; whereas, Patient Cable has a 300 SSwheel.
- · Digital Data Cable uses common connector type.
- Digital Data Cable is a commercially available cable type (HDMI A to Dconnector).
- · Longer cable.
- · Labeling of reference selection switches changed from A, B, C, D to Ref 1, Ref 2, andGnd.
- · Shelf Life/Packaging
- 1 year to 18 months.
- Single to double pouch configuration as a sterile barrier.
- Software
- · Update to patient cable programming to handle increase in channels (E96 vs. 128)
- New calculation for impedance detection.
| Comparison of the Predicate and Subject Device | ||
|---|---|---|
| Predicate Device: | ||
| NeuroPort Biopotential Signal | ||
| Processing System (K090957) | Subject Device: | |
| Digital NeuroPort Biopotential Signal | ||
| Processing System | ||
| FDA Regulatory Information | ||
| Manufacturer | Blackrock Microsystems | Same as predicate |
| FDA Product | ||
| Code | GWL, GWK | Same as predicate |
| Classification | Class II - 21 CFR 882.1835, 882.1845 | Same as predicate |
| Classification Name | Physiological signal amplifier | Same as predicate |
| Indications for Use | ||
| Comparison of the Predicate and Subject Device | ||
| Predicate Device: | ||
| NeuroPort Biopotential Signal | ||
| Processing System (K090957) | Subject Device: | |
| Digital NeuroPort Biopotential Signal | ||
| Processing System | ||
| Indications for | ||
| Use | The Digital 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). | Same as predicate |
| Device Design | | |
| Principles of
Operation | Preamplification, amplification, analog
to digital conversion, digital to optical
conversion, signal processing,
visualization, and archiving/recording | Same as predicate |
| Connection
Mechanism | Pedestal | Same as predicate |
| Sterility | The cables may be supplied sterile or
non-sterile. | Same as predicate. |
| Fast Settle | 5V TTL Input | Same as predicate |
| Noise |