Cumulus Functional Neurophysiology Platform

K221963 · Cumulus Neuroscience Limited · GWQ · Apr 27, 2023 · Neurology

Device Facts

• Record ID: K221963
• Device Name: Cumulus Functional Neurophysiology Platform
• Applicant: Cumulus Neuroscience Limited
• Product Code: GWQ · Neurology
• Decision Date: Apr 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EG signals are time-stamped. The system can be used in the patient's home or a health care facility.

Device Story

Platform acquires EEG signals via 16 Ag/AgCl dry electrodes embedded in a headset; signals are time-stamped and transmitted via Bluetooth to a mobile device running the Cumulus Mobile App. App provides GUI guidance for headset placement and synchronizes data. Healthcare professionals access, download, and review recordings via the Cumulus Medical Device Hub. Used in home or clinical environments to aid in diagnosis. System benefits include increased convenience and ease of deployment compared to traditional lab-based EEG equipment.

Clinical Evidence

No clinical data; bench testing only. Testing included electrical safety, EMC, hardware/software verification and validation, biocompatibility (ISO 10993-1, -5, -10, -18, -23), human factors validation, mechanical durability, and wireless coexistence.

Technological Characteristics

16-channel EEG system using Ag/AgCl dry electrodes. 24-bit ADC, 250/500 Hz sampling rate, >110 dB CMRR, 0.5–50 Hz bandpass. Connectivity via Bluetooth (headset to mobile) and WiFi (mobile to cloud). Powered by Li-Ion battery. Software runs on Android mobile platform. Non-sterile, durable device.

Indications for Use

Indicated for acquisition, display, and storage of EEG signals in adults and adolescents. Used in home or healthcare settings.

Regulatory Classification

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.

Predicate Devices

• NeuralScan System (K192753)

Submission Summary (Full Text)

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April 27, 2023

Cumulus Neuroscience Limited % Patsy Trisler Regulatory Consultant OServe Group, US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K221963

Trade/Device Name: Cumulus Functional Neurophysiology Platform Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: March 24, 2023 Received: March 27, 2023

Dear Patsy Trisler:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Patrick Antkowiak -S

Patrick Antkowiak Acting 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) K221963

Device Name

Cumulus Functional Neurophysiology Platform

Indications for Use (Describe)

The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EG signals are time-stamped.

The system can be used in the patient's home or a health care facility.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(k) Summary – K221963

| I. SUBMITTER | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Cumulus Neuroscience Limited |
| Submitter Address: | Cumulus Neuroscience Limited<br>Concourse Building 3<br>Queens Road<br>Belfast BT3 9DT<br>Northern Ireland, United Kingdom |
| Contact Person: | Caroline Kirwan, Director of Regulatory Affairs and Quality<br>[e-mail] |
| Telephone: | [phone] |
| Date Prepared: | 27 April 2023 |
| II. DEVICE | |
| Trade Name: | Cumulus Functional Neurophysiology Platform |
| Common Name | Electroencephalograph |
| Regulatory Name<br>Classification<br>Product Code | Full-montage standard EEG<br>882.1400<br>GWQ |
| III. PREDICATE DEVICE | |
| Primary Predicate | K192753, NeuralScan System, Medeia, Inc. |
| IV. INDICATIONS FOR USE STATEMENT | |
| The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display,<br>and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of<br>adults and adolescent patients. The EEG signals are time-stamped. The system can be<br>used in the patient's home or a health care facility. | |

## V. DEVICE DESCRIPTION

| Device Identification:<br>Components | The Cumulus Functional Neurophysiology Platform is comprised of the<br>Cumulus Headset which records EEG signals that are time-stamped. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and<br>Technological<br>Characteristics | The Cumulus software application runs on a mobile device running<br>android software. The software has graphical user interface that<br>provides guidance to the user to place the headset correctly. The EEG<br>data is received from the headset via Bluetooth. The data received is<br>synchronised and timestamped between the headset and app. |
| The Cumulus Medical Device Hub provides the user interface for health<br>care professionals to view, download and review data from the<br>recordings. | |
| The Platform components are:<br>• Cumulus EEG Headset with embedded software, which includes:<br>• An adjustable shell into which 16 Ag/AgCl EEG conductive<br>sensors are attached.<br>• A zippered pocket for holding the detachable electronics.<br>• Interface buttons, LEDs, micro USB socket.<br>• Plastic-encased 'Puck' electronics.<br>• Cumulus Mobile device with installed Cumulus Mobile App.<br>• Disposable mastoid sticky sensors<br>• Earphones<br>• Device stand<br>• Headset and mobile device chargers | |
| Patient contacting materials are biocompatible, commercially sourced<br>and are used in the headset without modifications. | |
| The device and accessories are not sterile, nor intended to be<br>sterilized. | |
| VI PERFORMANCE AND SAFETY TESTING | |
| Animal Testing: | This product category does not require animal testing. |
| Clinical Testing: | This product category does not require animal testing. |
| Non-Clinical<br>Testing: | Bench testing was conducted on the following and study reports were<br>submitted in the 510(k):<br>• Electrical safety<br>• Electromagnetic compatibility<br>• Hardware verification<br>• Software verification and validation testing<br>• Biocompatibility verification<br>• Human Factors validation<br>• Mechanical wear and durability of electrodes<br>• Electrochemical characterization<br>• Wireless Coexistence Testing |
| The Cumulus Functional Neurophysiology Platform meets the<br>requirements of the following international standards:<br>• DIN EN ISO 10993-1:2018: Biological Evaluation of Medical<br>Devices, Part 1: Evaluation and testing within a risk management<br>system. | |
| • | ISO 10993-23:2021: Biological evaluation of medical devices - Part<br>23: Tests for irritation |
| • | IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical Electrical<br>Equipment - Part 1: General requirements for basic safety and<br>essential performance. |
| • | IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2:<br>General requirements for basic safety and essential performance –<br>Collateral Standard: Electromagnetic disturbances – Requirements<br>and tests. |
| • | IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11:<br>Requirements for medical electrical equipment and medical<br>electrical systems used in the home healthcare environment. |
| • | IEC 80601-2-26:2019 Medical Electrical Equipment Part 2-26:<br>Particular requirements for the basic safety and essential<br>performance of electroencephalographs. |
| • | ANSI C63.10 2013 American National Standard of Procedures for<br>Compliance Testing of Unlicensed Wireless Devices |
| • | ANSI 63.4 2014 American National Standard for Methods of<br>Measurement of Radio-Noise Emissions from Low-Voltage<br>Electrical and Electronic Equipment in the Range of 9 kHz to 40<br>GHz |
| • | IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medical<br>device software – Software life cycle processes |
| • | ISTA 3A 2018 Packaged-Products for Parcel Delivery System<br>Shipment 70 kg (150 lb) or Less |
| Biocompatibility<br>Testing: | A biocompatibility evaluation was conducted according to ISO 10993-1.<br>It concluded testing was required to assure the intact skin contact<br>components for the prolonged (cumulative) use are biocompatible and<br>non-toxic.<br>Reports presenting the cytotoxicity testing (according to ISO 10993-5)<br>and evaluation of extractable metallic ions and organic compounds<br>(according to ISO 10993-18) of the Ag/AgCl skin contacting sensors<br>were presented in the 510(k). Additional testing for delayed<br>hypersensitivity (according to ISO 10993-10) and intracutaneous<br>reactivity (according to ISO 10993-23) was completed. Testing was<br>conducted by a third party according to Good Laboratory Practices.<br>Results showed the subject device is biocompatible and non-toxic for its<br>intended use. |

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| | NEW DEVICE | PRIMARY PREDICATE | Comparison |
|----------------------------------------------|------------------------------------------------|-------------------|------------|
| VII SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | | | |
| 510(k) # | K221963 | K192753 | N/A |
| DEVICE NAME | Cumulus Functional<br>Neurophysiology Platform | NeuralScan System | |
| MANUFACTURER | Cumulus Neuroscience Ltd | Medeia, Inc. | |
| PRODUCT CODES:<br>PRIMARY | GWQ | OLT, GWJ, GWQ | Same |

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| REGULATORY<br>NAME: | Electroencephalograph | Electroencephalograph | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| CLASSIFICATION:<br>CLASS: | 21 CFR 882.1400<br>II | 21 CFR 882.1400<br>II | |
| INDICATIONS FOR<br>USE | The Cumulus Functional<br>Neurophysiology Platform is<br>intended for the acquisition,<br>display and storage of<br>electroencephalograph (EEG)<br>obtained by placing electrodes on<br>the head of adults and adolescent<br>patients to aid in diagnosis. The<br>EEG signals are time-stamped.<br><br>The system can be used in the<br>patient's home or a health care<br>facility. | The NeuralScan System is<br>intended for the acquisition,<br>display, analysis, and storage, of<br>electrical activity of a patient's<br>brain including<br>electroencephalograph (EEG) and<br>Event-related Potentials (ERP),<br>obtained by placing two or more<br>electrodes on the head to aid in<br>diagnosis. | Same intended<br>use.<br>SE for<br>Indications |
| Rx Only or OTC | Rx Only | Rx Only | Same |
| PRINCIPLE OF<br>OPERATION and<br>SYSTEM<br>COMPONENTS | Used for acquisition of<br>physiological signals using 2 or<br>more channels of EEG from the<br>scalp.<br>It consists of a mobile device with<br>mobile app software, a patient<br>EEG Headset, earphones, and<br>charging cord for EEG Headset<br>and mobile device.<br>The technology provides a means<br>to:<br>• Initiate a study, track user EEG<br>data<br>• Acquire and save signals to<br>memory of the device,<br>• Transmit signal data from<br>device,<br>• Visually inspect acquired<br>signal, | Used for acquisition of<br>physiological signals using 2 or<br>more channels of EEG from the<br>scalp.<br>It consists of an amplifier and<br>software, a laptop computer (base<br>station), a patient EEG cap,<br>response button, ear buds and<br>charging cord.<br>The technology provides a means<br>to:<br>• Initiate a study, track user EEG<br>and ERP data and enter text or<br>questionnaire information<br>• Acquire and save signals to<br>memory of the device,<br>• Transmit signal data from<br>device,<br>• Visually inspect acquired signal,<br>• Manage ERPs. | SE |
| PATIENT<br>POPULATION | Adolescents and adults | All age groups | SE |
| USE<br>ENVIRONMENT | Healthcare and medical facilities,<br>athletic and sports clinics, or<br>outside facilities if led by qualified<br>medical personnel. In addition, it<br>may be used in the home. | Healthcare and medical facilities,<br>athletic and sports clinics, or<br>outside facilities if led by qualified<br>medical personnel | SE |
| BIOCOMPATIBILITY | Per ISO 10993-1 | Per ISO 10993-1 | Same |
| STERILE | No | No | Same |
| SINGLE USE | No | No | Same |
| SHELF LIFE | Durable goods | Durable goods | Same |
| POWER | Li-Ion Battery, with USB cable for<br>charging battery | Li-Ion Battery, with USB cable for<br>charging battery | Same |
| Rx Use or OTC | Rx Use | Rx Use | Same |
| System<br>Components | Patient EEG Headset<br>• Mobile device with mobile<br>app software<br>• Earphones<br>• Web dashboard software<br>• Charging cords for EEG cap<br>• and mobile device | Patient EEG cap<br>• NeuralScan amplifier<br>• Laptop computer<br>• Subject Response button<br>• Ear buds<br>• Charging cord | |
| Interface | Bluetooth (EEG to mobile device)<br>and WiFi (mobile device to cloud) | USB or WiFi to laptop | SE |
| Biopotential signals<br>recorded | Electroencephalography (EEG), | Electroencephalography (EEG),<br>EP/ERP | Same |
| Electroencephalography (EGG) | | | |
| Skin Coupling | Dry electrodes | Custom Electrode Band and Gel | SE |
| Signal recording<br>channels | 16 | Up to 23 | SE |
| EEG input<br>terminals | 16 | Up to 21 | SE |
| Analog to Digital<br>Conversion | 24 bits | 24 bits | Same |
| Sampling Rate | 250 and 500 Hz | 200, 500, 1000 Hz | SE |
| Common Mode<br>Rejection | >110 dB | >110 dB | Same |
| Analysis Software | Embedded and user defined. | Embedded, commercially<br>available, and user defined. | SE |
| Resolution | 24 bits | 24 bits | Same |
| Band Pass | 0.5 – 50 Hz | 0.1 – 50 Hz | SE |
| Noise | 1.6 µVp-p | 2.3 µVp-p | SE |
| Input Voltage range | +/- 200 mV | +/- 400 mV | SE |

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### VIII COMPARISON TO THE PREDICATE DEVICE OF TECHNOLOGICAL CHARACTERISTICS

As shown in the Substantial Equivalence Comparison Table, the intended use, principle of operation and system components, method of contact, user interface, and software design of the Cumulus Functional Neurophysiology Platform compared to the NeuralScan System Primary Predicate are similar.

While the software components of subject device and Predicate are proprietary and thus different, each is evaluated according to FDA's software verification and validation processes. In addition, the specific design of the Cumulus headset is different from the Predicate, however, the recording methodologies used are common in clinical research and typically delivered using lab-suitable technologies (e.g. a PC and computer screen). The Cumulus system uses a mobile device to increase convenience of use and ease of deployment and provides a controlled platform with well-understood technical characteristics.

The differences, in comparison to the Predicate device, raise no new questions of safety and effectiveness.

# VIX CONCLUSION

Based on the comparisons shown in Substantial Equivalence Comparison table, the Cumulus Functional Neurophysiology Platform device is substantially equivalent to the Predicate NeuralScan System. The nonclinical data support the safety of the device system and the hardware and software verification and validation demonstrate that the subject device should perform as intended in the indicated environments.