(303 days)
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.
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.
The provided FDA 510(k) summary (K220254) for the Neurosoft Ltd. Neuron-Spectrum-AM with Neuron-Spectrum.NET Software describes the device and its claimed substantial equivalence to a predicate device (K133995). Given the information, here's a breakdown of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "sensitivity must be > X%") for the device's diagnostic performance, nor does it report specific performance metrics like sensitivity, specificity, accuracy, etc., for the device's clinical efficacy.
Instead, the acceptance criteria are implicitly met through demonstrating substantial equivalence to a predicate device by showing that it "is as safe, as effective, and performs as well as or better than the Neuron-Spectrum-4/P with Neuron-Spectrum.NET Predicate device".
The "reported device performance" is focused on passing various non-clinical engineering and software tests to demonstrate this substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Device Safety & Effectiveness (Overall) | "The documentation and test results provided... demonstrate that the Neuron-Spectrum-AM with Neuron-Spectrum.NET Software device is as safe, as effective, and performs as well as or better than the Neuron-Spectrum-4/P with Neuron-Spectrum.NET Predicate device." |
| Biocompatibility | All patient-contacting materials (Housing, External Rechargeable Battery Bank, Carrying Pouch) were found to be Biocompatible. |
| Electrical Safety | Passed and complies with applicable standards (e.g., IEC 60601-1, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-11). |
| Electromagnetic Compatibility (EMC) | Passed and complies with applicable standards (e.g., IEC 60601-1-2). |
| Wireless Coexistence & RFID Immunity | Passed these tests, ensuring proper functioning in environments with other wireless devices. |
| Bench Testing (Signal acquisition quality compared to predicate) | The summary states that "bench testing concluded that the Subject device meets and complies with the ... bench testing requirements." While specific metrics are not explicitly stated as acceptance criteria, the comparison table implicitly indicates that they were found to be similar or equivalent to the predicate for critical parameters: - Input noise EEG: Within 0.5-200 Hz not more than 2 µV (not more than 0.3 µV) - Input impedance EEG: Not less than 400 MΩ - CMRR: Not less than 100 dB - Noise: <= 1 µVrms - Bandwidth: in range from 0.5 up to 60 Hz from -10 up to +5% - Input signal Range: 1-12000 µV - Notch Filter: Not less than 40 dB - Sampling rate: 100-5000 Hz - Digital Resolution: 16 Bit ADC |
| Software Verification & Validation | "The software verification and validation results concluded that the Subject device meets and complies with the applicable software requirements specifications." (Complies with IEC 62304) |
| Functional Equivalence (with justified differences) | The device performs the same core functions (recording, processing, displaying biopotential signals like EEG/PSG) as the predicate. Differences in communication (wireless vs. USB), power source (battery vs. USB), user interface (on-device LCD vs. PC), data storage (SD card + HDD vs. HDD only), and home use are addressed and deemed not to affect safety/effectiveness. The lack of EP recording is noted as not essential per ACNS guidelines. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states under "8.2. Clinical Testing": "The substantial equivalence for the Subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed."
This means there was no test set of patient data used for clinical performance evaluation. The data provenance is therefore not applicable as no clinical data was used in the assessment for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was performed and no test set of patient data was used, this information is not applicable.
4. Adjudication Method for the Test Set
As no clinical testing was performed, an adjudication method for a test set is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study was done, as explicitly stated that "no clinical testing was performed." Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable. The device does not include an AI diagnostic component for interpretation; it is a signal acquisition and processing system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone performance study was done for an algorithm's diagnostic capability, as the device's function is to record, process, and display biopotential signals (EEG/PSG), not to provide automated diagnostic conclusions or interpretations. The device "does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition."
7. The Type of Ground Truth Used
Given that no clinical testing was performed, there was no clinical ground truth (expert consensus, pathology, outcomes data, etc.) established for the purpose of demonstrating clinical performance. The "ground truth" for the engineering performance tests would be defined by the known specifications of the test equipment and the expected outputs under controlled conditions.
8. The Sample Size for the Training Set
Since this is a medical device for recording and processing biopotential signals and not a machine learning/AI diagnostic algorithm that requires training on patient data for clinical interpretation, there is no training set in the context of typical AI algorithm development. The device's "training" refers to its engineering design and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
As there is no training set as typically understood for an AI algorithm, this information is not applicable. The "ground truth" for the device's development lies in engineering specifications, regulatory standards, and the functional performance of the predicate device.
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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
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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
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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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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
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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 CollectionDevice |
| 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 |
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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.
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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 SignalsRecorded | 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 SignalRecording 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 InputChannels (per unit) | 27 | 28 | Different |
| Sampling rate | 100, 200, 500, 1000, 2000, 5000 Hz | 100, 200, 500, 1000, 2000, 5000 Hz | Same |
| Electronic UnitPower Source | Battery Power | Computer USB Port Power | Different |
| Application Software | Neuron-Spectrum.NETSoftware | Neuron-Spectrum.NETSoftware | Same |
| Video Camera Support | Available | Available | Same |
| Alarms | None | None | Same |
| Digital Resolution | 32/64 bits | 32/64 bits | Same |
| Input noise EEG (rmsvalue) | Within 0.5-200 Hz notmore than 2 µV (not morethan 0.3 µV) | Within 0.5-200 Hz notmore than 2 µV (not morethan 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 |
| - AbdominalMovements | • Yes | • Yes | Same |
| - Snoring | • Yes | • Yes | Same |
| Safety StandardCompliance | • 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 toexternal events) | • Yes | • Yes | Same |
| Trigger output(synchronization forexternal devices) | • Yes | • Yes | Same |
| Electronic Unitcommunications to -Computer Interface | • Wireless communicationusing a 2.4GHz Wi-FiRadio | • Wired communicationusing a USB Cable | Different |
| Size (H/W/D) mm | • Electronic Unit:141H x 96W x 36D• External RechargeableBattery Bank:165H x 106W x 25D | • Electronic Unit:140x200x45 mm | Similar |
| Weight (g) | • Electronic Unit: 270g• Electronic Unit plus theBattery Adaptor plus theExternal RechargeableBattery Bank: 880 g | • Electronic Unit: Not morethan 900g(Floor Stand not included) | Similar |
| CMRR | • Not less than 100 dB | • Not less than 100 dB | Same |
| Noise | • <=1 $\mu$ Vrms | • <=1 $\mu$ Vrms | Same |
| Notch Filter | • 50/60 Hz Selectable | • 50/60 Hz Selectable | Same |
| A/D Conversion | • 16 Bit ADC | • 16 Bit ADC | Same |
| Sampling Rate | • 100 - 5000 Hz | • 100 - 5000 Hz | Same |
| Analysis Time | • 1s - 30s | • 1s - 30s | Same |
| Signal Delay(pre/post) | • 0 - 10 | • 0 - 10 | Same |
| Video Recording | • Yes | • Yes | Same |
| Bandwidth | • in range from 0.5 up to 60 Hzfrom -10 up to +5% | • in range from 0.5 up to 60 Hzfrom -10 up to +5% | Same |
| Input signal Range | 1-12000 $\mu$ V | 1-12000 $\mu$ V | Same |
| Max sampling rate | • 5000 Hz | • 5000 Hz | Same |
| Max storage rate | • 5000 Hz | • 5000 Hz | Same |
| Characteristic | Subject Device | Predicate Device | Same /Different |
| Notch Filter | • Not less than 40 dB | • Not less than 40 dB | Same |
| DC Inputs | • Yes | • Yes | Same |
| EOG | • Yes | • Yes | Same |
| EOG Channels | • Yes | • Yes | Same |
| Pressure transducer | • Yes | • Yes | Same |
| Effort(chest/abdominal) | • Yes | • Yes | Same |
| Snore | • Yes | • Yes | Same |
| Flow (Thermal) | • Yes | • Yes | Same |
| Pulse Oximetry | • Yes | • Yes | Same |
| Electronic Unit UserInterface | • Yes• Front panel LCD,• Navigation Keys | • No• Requires connection to acomputer | Different |
| Data Storage | • Removable SD memory cardand/or computer HDD | • Computer HDD only | Different |
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7. Summary of Technological Differences
7.1. Home Use
The Subject device can be used in professional healthcare facilities as well as in a home healthcare environment. However, the setup and startup of the device in home healthcare environment will be performed and monitored by trained personnel.
7.2. Electronic Unit Power Source
The Subject is a battery-powered device. The device is powered using the included External Rechargeable Battery Bank which is charged using an external power supply independent of the instrument and outside of the patient environment. External Rechargeable Battery Bank power gives the Subject device ambulatory capabilities. The Predicate device requires to be tethered to a computer USB port for power and data transfer. This difference does not affect the safety and effectiveness of the Subject device when compared to the Predicate device.
7.3. Electronic Unit Communications to Computer Interface
The Subject device uses a radio link utilizing a 2.4GHz Wi-Fi Radio Module for communications between the Electronic Unit and a computer running the NS.NET software, as compared to the Predicate which uses a USB cable link.
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7.4. Electronic Unit User Interface
The Subject device Electronic Unit includes a monochrome liquid crystal display and three navigation buttons that allows the instrument to be setup to operate without being connected to a PC. The Predicate device requires a cable connection to a PC for power and setup.
7.5. Data Storage
The Subject device instrument includes industry standard Secure Digital (SD) non-volatile memory technology which allows the device to collect data directly to a removable SD memory card. When used in conjunction with a PC in the Wi-Fi network, the Subject device can simultaneously record and send biopotential data to the removable SD memory card and to the computer connected to the Wi-Fi network.
7.6. EP Recording
The Neuron-Spectrum-AM does not support the recording of EP as this technique is not obligatory to fulfill in accordance with ACNS recommendations on EEG studies.
8. Performance Data Summary
8.1. Summary of Non-Clinical Testing Performed
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
8.2. Clinical Testing
The substantial equivalence for the Subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed.
8.3. Conclusions from Biocompatibility Evaluation
A biocompatibility conclusions summary for the all patient-contacting materials of the Subject Device is presented in Table 3.
| Item | Material(Type) | Where Used | Biocompatibility |
|---|---|---|---|
| Housing(Electronic Unit) | ABS/PVC | • Resides inside Carrying Pouch• No direct or indirect tissue contact | Biocompatible |
| Housing(Ext. RechargeableBattery Bank) | PVC | • Resides inside Carrying Pouch• No direct or indirect tissue contact | Biocompatible |
| Carrying Pouch | SyntheticLeatherFabric | • Worn Over patient clothing• No direct or indirect tissue contact• Occasional Transient contact with handsand arms | Biocompatible |
Table 3: Subject Device Materials Biocompatibility Evaluation
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8.4. Conclusions from Safety, Performance and Bench Testing
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.
8.5. Conclusions from Software Verification and Validation
The software verification and validation results concluded that the Subject device meets and complies with the applicable software requirements specifications.
9. Overall Conclusion
The documentation and test results provided in this submission of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the Neuron-Spectrum-AM with Neuron-Spectrum.NET Software device is as safe, as effective, and performs as well as or better than the Neuron-Spectrum-4/P with Neuron-Spectrum.NET Predicate device.
§ 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).