(303 days)
Not Found
No
The summary describes a system for recording, processing, and displaying biopotential signals (EEG/PSG). It explicitly states the device "does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition." The processing described is standard signal processing and analysis, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, or related terms.
No.
The device is intended for recording, processing, and displaying biopotential signals (EEG and PSG) for diagnostic purposes, not for therapeutic intervention. The description explicitly states it "does not provide to the user any diagnostic conclusion about the patient's condition," reinforcing its role as a data acquisition and display tool rather than a treatment device.
No
The device is described as a system for recording, processing, and displaying biopotential signals (EEG and PSG). The "Intended Use / Indications for Use" section explicitly states: "The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition." This indicates it's a data acquisition and display tool, not a diagnostic one.
No
The device description explicitly states that the system comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch, and the software. This indicates the presence of significant hardware components beyond just software.
Based on the provided text, the Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Neuron-Spectrum-AM system records, processes, and displays biopotential signals (EEG and PSG) directly from the patient's body using electrodes. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as a "digital neurophysiological system for recording, processing, and displaying biopotential signals." This aligns with in vivo (within the living body) measurement, not in vitro (in glass/outside the living body) analysis.
Therefore, the Neuron-Spectrum-AM system is a neurophysiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, and 1 direct current channel.
The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
Product codes (comma separated list FDA assigned to the subject device)
OLT, OLV, GWQ
Device Description
The Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (Subject device) is an ambulatory wireless digital neurophysiological device capable of recording, processing, and displaying electroencephalography (EEG), video EEG, long-term monitoring (LTM), and polysomnography (PSG) biopotential signals.
The NS-AM device comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch and the Neuron-Spectrum.NET desktop application software. The Neuron-Spectrum.NET Software application was cleared in the Predicate's 510(k) submission (K133995).
The Subject device supports up to 21 EEG channels, 4 wide-band polygraphic channels, 1 breath channel, and 1 direct current channel for a total of 27 analog input channels.
The Electronic Unit acquires, records and transmits biopotential signals such electroencephalography (EEG) and polysomnography (PSG). The built-in 2.4GHz Wi-Fi radio allows real-time transfer of the collected biopotential signals to the computer running the Neuron-Spectrum.NET software. The biopotential signals are also recorded onto a removable SD memory card as back up for later post analysis.
The Electronic Unit includes a front panel ON/OFF power button, a light sensor and a User Interface (UI). The UI consist of a liquid crystal display and three menu navigation buttons. Figure 4 shows the UI main functions. The Electronic Unit can be powered by replaceable internal AA batteries or by the External Rechargeable Battery Bank.
The Electronic Unit and the External Rechargeable Battery Bank reside side-by-side inside the Carrying Pouch. The pouch is strapped and worn over the patient clothing while in use.
The Neuron-Spectrum.NET software is a computer application that receives, records, processes, and displays the biopotential signals collected by the electronic unit on the PC display. The main operations provided by the Neuron-Spectrum.NET software are:
- EEG Acquisition
- EEG Review, Editing, Storing, Exporting.
- EEG Analysis
- Creation of Exam Reports
- Program Setup
The electronic unit measures (141 H x 96 W x 36 D) mm and weighs about 270 grams. The External Rechargeable Battery Bank unit measures (165 H x 106 W x 25 D) mm and weighs about 570 grams. The combined weight for the electronic unit, the battery adaptor and the External Rechargeable Battery Bank is approximately 880 grams.
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
all ages and sexes.
Intended User / Care Setting
in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories. The device can also be used as a home use device under supervision of qualified personnel.
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)
A program of non-clinical design verification and validation testing, and evaluation was conducted that included:
- Biocompatibility Evaluation
- Safety, Performance and Bench Testing including EMC .
- . Software Verification and Validation Testing
The biocompatibility conclusions summary for all patient-contacting materials of the Subject Device indicated they are Biocompatible.
The safety and performance testing results for Electrical Safety, EMC, Wireless Coexistence, RFID Immunity and bench testing concluded that the Subject device meets and complies with the safety and performance of the applicable standards and bench testing requirements.
The software verification and validation results concluded that the Subject device meets and complies with the applicable software requirements specifications.
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.
Not Found
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
§ 882.1400 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
November 30, 2022
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neurosoft Ltd. % Vicki Chester Manager, Regulatory Affairs and Quality Assurance CortiCare, Inc. 5950 La Place Court. Ste. 160 Carlsbad, California 92008
Re: K220254
Trade/Device Name: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OLV, GWQ Dated: March 4, 2022 Received: March 4, 2022
Dear Vicki Chester:
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
1
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 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 mediation-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,
Patrick Antkowiak -S
for 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) K220254
Device Name
Neuron-Spectrum-AM System with Neuron-Spectrum.NET
Indications for Use (Describe)
The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, and 1 direct current channel.
The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
| 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements established by 21 CFR 807.92.
1. Submitter Information Submitter: Neurosoft Ltd. Address: 5, Voronin str. 153032, Ivanovo Russia Federation Michael Durdin Contact Person: Chief Development Officer Phone: +7 (4932) 24-04-34 Fax: +7 (4932) 24-04-35 Date Prepared: November 29, 2022 2. Subject Device Common Name: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software Trade Name: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software Regulation: 21 CFR 882.1400 Classification Name: Electroencephalograph Product Codes: OLT (primary), OLV (secondary), GWQ FDA Panel: 84 - Neurology Class: II 3. Predicate Device 510(k) Number: K133995 Manufacturer: Neurosoft Ltd. Trade Name: Neuron-Spectrum-4/P with Neuron-Spectrum.NET Regulation: 21 CFR 882.1400 Classification Name: Electroencephalograph Product Code: OLT, OLV, GWQ FDA Panel: 84 - Neurology Class: II
4
4. Device Description
The Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (Subject device) is an ambulatory wireless digital neurophysiological device capable of recording, processing, and displaying electroencephalography (EEG), video EEG, long-term monitoring (LTM), and polysomnography (PSG) biopotential signals.
As listed in Table 1, The NS-AM device comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch and the Neuron-Spectrum.NET desktop application software. The Neuron-Spectrum.NET Software application was cleared in the Predicate's 510(k) submission (K133995).
The Subject device supports up to 21 EEG channels, 4 wide-band polygraphic channels, 1 breath channel, and 1 direct current channel for a total of 27 analog input channels.
The Electronic Unit acquires, records and transmits biopotential signals such electroencephalography (EEG) and polysomnography (PSG). The built-in 2.4GHz Wi-Fi radio allows real-time transfer of the collected biopotential signals to the computer running the Neuron-Spectrum.NET software. The biopotential signals are also recorded onto a removable SD memory card as back up for later post analysis.
The Electronic Unit includes a front panel ON/OFF power button, a light sensor and a User Interface (UI). The UI consist of a liquid crystal display and three menu navigation buttons. Figure 4 shows the UI main functions. The Electronic Unit can be powered by replaceable internal AA batteries or by the External Rechargeable Battery Bank.
The Electronic Unit and the External Rechargeable Battery Bank reside side-by-side inside the Carrying Pouch. The pouch is strapped and worn over the patient clothing while in use.
The Neuron-Spectrum.NET software is a computer application that receives, records, processes, and displays the biopotential signals collected by the electronic unit on the PC display. The main operations provided by the Neuron-Spectrum.NET software are:
- EEG Acquisition
- · EEG Review, Editing, Storing, Exporting.
- EEG Analysis
- Creation of Exam Reports
- · Program Setup
The electronic unit measures (141 H x 96 W x 36 D) mm and weighs about 270 grams. The External Rechargeable Battery Bank unit measures (165 H x 106 W x 25 D) mm and weighs about 570 grams. The combined weight for the electronic unit, the battery adaptor and the External Rechargeable Battery Bank is approximately 880 grams.
| Table 1: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software Components | ||||
|---|---|---|---|---|
| # | Description | Note |
|---|---|---|
| 1 | Electronic Unit (2.4GHz Wi-Fi Radio / 32MB SD Mem Card) | Main Data Collection |
| Device | ||
| 2 | Battery Adaptor (Electromechanical Interface to External Battery) | Component |
| 3 | External Rechargeable Battery Bank (w/ Power Supply Adaptor) | Component |
| 4 | Neuron-Spectrum.NET Software Application | Application |
5
5. Intended Use/Indications for Use
5.1. Neuron-Spectrum-AM system Intended Use
The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system intended for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, 1 breath channel, and 1 direct current channel.
The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
5.2. Explanation of Differences
The Intended Use of the Neuron-Spectrum-AM system is nearly identical to that of the Predicate device. The (3) key differences between the Intended Use of the Neuron-Spectrum-AM system and the Intended Use of the Predicate device are:
- The Neuron-Spectrum-AM Electronic Unit is portable and communicates with the PC a. running the Neuron-Spectrum.NET software via a wireless link versus a USB link in the Predicate device;
- The Neuron-Spectrum-AM system can also be used in a Home Healthcare environment under b. supervision of qualified personnel; and
- C. There are minor differences in the number of channels that can be monitored.
The use of wireless communications versus USB has the same operation and functionality as the Predicate device between the Electronic Unit and the computer running the NS.NET software. Technology for wireless communications and Cybersecurity are implemented in the Neuron-Spectrum-AM system to ensure correctness and security of the wireless data transmission.
The use of the Neuron-Spectrum-AM system in a Home Healthcare environment is under the supervision of qualified healthcare monitoring personnel, the same as in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories for the Neuron-Spectrum-AM system and the Predicate device. The Neuron-Spectrum-AM system conforms with International Standard IEC 60601-1-11 for medical electrical systems used in the home healthcare environment.
The minor differences in the number of channels that can be monitored are not critical to the intended diagnostic use of the device. Moreover, this number of channels allows recording the highquality EEG that complies with the American Clinical Neurophysiology Society Guidelines (https://journals.lww.com/clinicalneurophys/Fulltext/2016/08000/American Clinical Neurophysiolo gy Society.3.aspx).
Overall, these differences are not critical to the intended diagnostic use of the device, and do not affect the safety and effectiveness of the device when used as labeled.
Neurosoft Ltd.
6
6. Comparison of Technological Characteristics to Predicate
Table 2 provides a comparison of the technological characteristics between the Subject device and the Predicate device.
Subject Device: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
Predicate Device: Neuron-Spectrum- 4/P with Neuron- Spectrum.NET Software (K133995)
Table 2: Comparison of Technological Characteristics
| Characteristic | Subject Device | Predicate Device | Same /
Different |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Biopotential Signals
Recorded | Electroencephalography (EEG) Electrocardiography (ECG) Electrooculography (EOG) Video EEG, PSG Respiration | Electroencephalography (EEG) Electrocardiography (ECG) Electrooculography (EOG) Video EEG, PSG Respiration Evoked potential (EP) | Similar |
| Number of Signal
Recording Channels | Up to 21 EEG channels 1 Breath channel 1 Direct current channel | Up to 21 EEG channels 1 Breath channel 2 Direct current channels | Same |
| Analog Input
Channels (per unit) | 27 | 28 | Different |
| Sampling rate | 100, 200, 500, 1000, 2000, 5000 Hz | 100, 200, 500, 1000, 2000, 5000 Hz | Same |
| Electronic Unit
Power Source | Battery Power | Computer USB Port Power | Different |
| Application Software | Neuron-Spectrum.NET
Software | Neuron-Spectrum.NET
Software | Same |
| Video Camera Support | Available | Available | Same |
| Alarms | None | None | Same |
| Digital Resolution | 32/64 bits | 32/64 bits | Same |
| Input noise EEG (rms
value) | Within 0.5-200 Hz not
more than 2 µV (not more
than 0.3 µV) | Within 0.5-200 Hz not
more than 2 µV (not more
than 0.3 µV) | Same |
| Input impedance EEG | Not less than 400 MΩ | Not less than 400 MΩ | Same |
| Characteristic | Subject Device | Predicate Device | Same /
Different |
| Low Pass Filter | • -12dB/octave
• 5-200 Hz (step 0.1 Hz) | • 5-200 Hz (step 0.1 Hz) | Same |
| High Pass Filter | • -12dB/octave
• 0.05–10 Hz (step 0.01 Hz) | • 0.05-10 Hz (step 0.01 Hz) | Same |
| Connection to Patient | • By means of EEG, ECG, EOG, PSG electrodes and sensors (respiratory sensors, snoring sensor, body position sensor-cup electrodes) | • By means of EEG, ECG, EOG, PSG electrodes and sensors (respiratory sensors, snoring sensor, body position sensor-cup electrodes) | Same |
| Acquired and displayed events: | | | |
| - EEG | • Yes | • Yes | Same |
| - ECG | • Yes | • Yes | Same |
| - EOG | • Yes | • Yes | Same |
| - EP | • No | • Yes | Different |
| - Body Position | • Yes | • Yes | Same |
| - Chest Movements | • Yes | • Yes | Same |
| - CPAP | • Yes | • Yes | Same |
| - Air Flow | • Yes | • Yes | Same |
| - Nasal Flow Pressure | • Yes | • Yes | Same |
| - Abdominal
Movements | • Yes | • Yes | Same |
| - Snoring | • Yes | • Yes | Same |
| Safety Standard
Compliance | • IEC 60601-1
• IEC 60601-1-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-2-26
• IEC 60601-2-40
• IEC 62304
• IEC 60601-1-11 | • IEC 60601-1
• IEC 60601-1-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-2-26
• IEC 62304 | Same |
| Characteristic | Subject Device | Predicate Device | Same /
Different |
| Trigger input
(synchronization to
external events) | • Yes | • Yes | Same |
| Trigger output
(synchronization for
external devices) | • Yes | • Yes | Same |
| Electronic Unit
communications to -
Computer Interface | • Wireless communication
using a 2.4GHz Wi-Fi
Radio | • Wired communication
using a USB Cable | Different |
| Size (H/W/D) mm | • Electronic Unit:
141H x 96W x 36D
• External Rechargeable
Battery Bank:
165H x 106W x 25D | • Electronic Unit:
140x200x45 mm | Similar |
| Weight (g) | • Electronic Unit: 270g
• Electronic Unit plus the
Battery Adaptor plus the
External Rechargeable
Battery Bank: 880 g | • Electronic Unit: Not more
than 900g
(Floor Stand not included) | Similar |
| CMRR | • Not less than 100 dB | • Not less than 100 dB | Same |
| Noise | •