(296 days)
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 EEG signals are time-stamped.
The system can be used in the patient's home or a health care facility.
The Cumulus Functional Neurophysiology Platform is comprised of the Cumulus Headset which records EEG signals that are time-stamped.
The Cumulus software application runs on a mobile device running android software. The software has graphical user interface that provides guidance to the user to place the headset correctly. The EEG data is received from the headset via Bluetooth. The data received is synchronised and timestamped between the headset and app.
The Cumulus Medical Device Hub provides the user interface for health care professionals to view, download and review data from the recordings.
The Platform components are:
• Cumulus EEG Headset with embedded software, which includes:
• An adjustable shell into which 16 Ag/AgCl EEG conductive sensors are attached.
• A zippered pocket for holding the detachable electronics.
• Interface buttons, LEDs, micro USB socket.
• Plastic-encased 'Puck' electronics.
• Cumulus Mobile device with installed Cumulus Mobile App.
• Disposable mastoid sticky sensors
• Earphones
• Device stand
• Headset and mobile device chargers
Patient contacting materials are biocompatible, commercially sourced and are used in the headset without modifications.
The device and accessories are not sterile, nor intended to be sterilized.
The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display, and storage of electroencephalograph (EEG) signals obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient's home or a healthcare facility.
Here's a breakdown of the acceptance criteria and the study information:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list acceptance criteria in a quantitative format for the functional performance of the EEG acquisition. Instead, it demonstrates substantial equivalence to a predicate device (NeuralScan System, K192753) based on a comparison of technological characteristics. The "reported device performance" is derived from these comparisons.
| Characteristic | Cumulus Functional Neurophysiology Platform Performance | Predicate Device (NeuralScan System) Performance | Comparison Outcome |
|---|---|---|---|
| Intended Use | Acquisition, display, storage of EEG from adults/adolescents to aid diagnosis. Time-stamped. Use in home or healthcare. | Acquisition, display, analysis, storage of EEG and ERP from patients to aid diagnosis. | Same intended use |
| Rx Only or OTC | Rx Only | Rx Only | Same |
| Patient Population | Adolescents and adults | All age groups | SE (Substantially Equivalent) |
| Use Environment | Healthcare/medical facilities, athletic/sports clinics, or outside facilities with qualified medical personnel. Also in home. | Healthcare/medical facilities, athletic/sports clinics, or outside facilities with qualified medical personnel. | SE |
| Biocompatibility | Per ISO 10993-1, confirmed by testing | 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, USB charging | Li-Ion Battery, USB charging | Same |
| System Components | Patient EEG Headset, mobile device with app, earphones, web dashboard, charging cords | Patient EEG cap, NeuralScan amplifier, laptop, subject response button, ear buds, charging cord | Varies, but deemed SE |
| Interface | Bluetooth (EEG to mobile), WiFi (mobile to cloud) | USB or WiFi to laptop | SE |
| Biopotential signals recorded | Electroencephalography (EEG) | Electroencephalography (EEG), EP/ERP | Same |
| Skin Coupling | Dry electrodes | Custom Electrode Band and Gel | SE |
| Signal recording channels | 16 | Up to 23 | SE |
| EEG input terminals | 16 | Up to 21 | SE |
| Analog to Digital Conversion | 24 bits | 24 bits | Same |
| Sampling Rate | 250 and 500 Hz | 200, 500, 1000 Hz | SE |
| Common Mode Rejection | >110 dB | >110 dB | Same |
| Analysis Software | Embedded and user defined | Embedded, commercially 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 |
Note: "SE" in the "Comparison Outcome" column refers to "Substantially Equivalent," meaning the differences do not raise new questions of safety or effectiveness when compared to the predicate device.
2. Sample size used for the test set and the data provenance
The document states that clinical testing was not required for this product category. Therefore, no "test set" in the context of a clinical performance study for diagnosing conditions using the EEG recordings is described or referenced. The assessment is based on non-clinical bench testing and comparison to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical efficacy study or diagnostic accuracy study with a "test set" was conducted or required, there were no experts used to establish ground truth in this context.
4. Adjudication method for the test set
Not applicable, as no clinical test set for diagnostic performance was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or mentioned. This device is an EEG acquisition and display platform, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was reported. The device's primary function is data acquisition and display, which serves as input for human interpretation.
7. The type of ground truth used
Not applicable for clinical efficacy, as the submission focuses on hardware and software performance for signal acquisition and display (substantial equivalence). For the non-clinical bench testing (electrical safety, EMC, hardware/software verification, biocompatibility, human factors, etc.), the "ground truth" would be established by the specifications of the relevant international standards (e.g., IEC 60601 series, ISO 10993 series).
8. The sample size for the training set
Not applicable. This device is an EEG acquisition and display system; it does not involve AI/ML algorithms that require a "training set" for diagnostic performance.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{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
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
{2}------------------------------------------------
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary – K221963
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Cumulus Neuroscience Limited |
| Submitter Address: | Cumulus Neuroscience LimitedConcourse Building 3Queens RoadBelfast BT3 9DTNorthern Ireland, United Kingdom |
| Contact Person: | Caroline Kirwan, Director of Regulatory Affairs and Qualitycaroline.kirwan@cumulusneuro.com |
| Telephone: | +44 (0)28 9264 6600 |
| Date Prepared: | 27 April 2023 |
| II. DEVICE | |
| Trade Name: | Cumulus Functional Neurophysiology Platform |
| Common Name | Electroencephalograph |
| Regulatory NameClassificationProduct Code | Full-montage standard EEG882.1400GWQ |
| 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,and storage of electroencephalograph (EEG) obtained by placing electrodes on the head ofadults and adolescent patients. The EEG signals are time-stamped. The system can beused in the patient's home or a health care facility. |
V. DEVICE DESCRIPTION
| Device Identification:Components | The Cumulus Functional Neurophysiology Platform is comprised of theCumulus Headset which records EEG signals that are time-stamped. |
|---|---|
| andTechnologicalCharacteristics | The Cumulus software application runs on a mobile device runningandroid software. The software has graphical user interface thatprovides guidance to the user to place the headset correctly. The EEGdata is received from the headset via Bluetooth. The data received issynchronised and timestamped between the headset and app. |
| The Cumulus Medical Device Hub provides the user interface for healthcare professionals to view, download and review data from therecordings. | |
| The Platform components are:• Cumulus EEG Headset with embedded software, which includes:• An adjustable shell into which 16 Ag/AgCl EEG conductivesensors are attached.• A zippered pocket for holding the detachable electronics.• Interface buttons, LEDs, micro USB socket.• Plastic-encased 'Puck' electronics.• Cumulus Mobile device with installed Cumulus Mobile App.• Disposable mastoid sticky sensors• Earphones• Device stand• Headset and mobile device chargers | |
| Patient contacting materials are biocompatible, commercially sourcedand are used in the headset without modifications. | |
| The device and accessories are not sterile, nor intended to besterilized. | |
| 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-ClinicalTesting: | Bench testing was conducted on the following and study reports weresubmitted in the 510(k):• Electrical safety• Electromagnetic compatibility• Hardware verification• Software verification and validation testing• Biocompatibility verification• Human Factors validation• Mechanical wear and durability of electrodes• Electrochemical characterization• Wireless Coexistence Testing |
| The Cumulus Functional Neurophysiology Platform meets therequirements of the following international standards:• DIN EN ISO 10993-1:2018: Biological Evaluation of MedicalDevices, Part 1: Evaluation and testing within a risk managementsystem. | |
| • | ISO 10993-23:2021: Biological evaluation of medical devices - Part23: Tests for irritation |
| • | IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical ElectricalEquipment - Part 1: General requirements for basic safety andessential performance. |
| • | IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2:General requirements for basic safety and essential performance –Collateral Standard: Electromagnetic disturbances – Requirementsand tests. |
| • | IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11:Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment. |
| • | IEC 80601-2-26:2019 Medical Electrical Equipment Part 2-26:Particular requirements for the basic safety and essentialperformance of electroencephalographs. |
| • | ANSI C63.10 2013 American National Standard of Procedures forCompliance Testing of Unlicensed Wireless Devices |
| • | ANSI 63.4 2014 American National Standard for Methods ofMeasurement of Radio-Noise Emissions from Low-VoltageElectrical and Electronic Equipment in the Range of 9 kHz to 40GHz |
| • | IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medicaldevice software – Software life cycle processes |
| • | ISTA 3A 2018 Packaged-Products for Parcel Delivery SystemShipment 70 kg (150 lb) or Less |
| BiocompatibilityTesting: | A biocompatibility evaluation was conducted according to ISO 10993-1.It concluded testing was required to assure the intact skin contactcomponents for the prolonged (cumulative) use are biocompatible andnon-toxic.Reports presenting the cytotoxicity testing (according to ISO 10993-5)and evaluation of extractable metallic ions and organic compounds(according to ISO 10993-18) of the Ag/AgCl skin contacting sensorswere presented in the 510(k). Additional testing for delayedhypersensitivity (according to ISO 10993-10) and intracutaneousreactivity (according to ISO 10993-23) was completed. Testing wasconducted by a third party according to Good Laboratory Practices.Results showed the subject device is biocompatible and non-toxic for itsintended use. |
{4}------------------------------------------------
{5}------------------------------------------------
| NEW DEVICE | PRIMARY PREDICATE | Comparison | |
|---|---|---|---|
| VII SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | |||
| 510(k) # | K221963 | K192753 | N/A |
| DEVICE NAME | Cumulus FunctionalNeurophysiology Platform | NeuralScan System | |
| MANUFACTURER | Cumulus Neuroscience Ltd | Medeia, Inc. | |
| PRODUCT CODES:PRIMARY | GWQ | OLT, GWJ, GWQ | Same |
{6}------------------------------------------------
| REGULATORYNAME: | Electroencephalograph | Electroencephalograph | |
|---|---|---|---|
| CLASSIFICATION:CLASS: | 21 CFR 882.1400II | 21 CFR 882.1400II | |
| INDICATIONS FORUSE | The Cumulus FunctionalNeurophysiology Platform isintended for the acquisition,display and storage ofelectroencephalograph (EEG)obtained by placing electrodes onthe head of adults and adolescentpatients to aid in diagnosis. TheEEG signals are time-stamped.The system can be used in thepatient's home or a health carefacility. | The NeuralScan System isintended for the acquisition,display, analysis, and storage, ofelectrical activity of a patient'sbrain includingelectroencephalograph (EEG) andEvent-related Potentials (ERP),obtained by placing two or moreelectrodes on the head to aid indiagnosis. | Same intendeduse.SE forIndications |
| Rx Only or OTC | Rx Only | Rx Only | Same |
| PRINCIPLE OFOPERATION andSYSTEMCOMPONENTS | Used for acquisition ofphysiological signals using 2 ormore channels of EEG from thescalp.It consists of a mobile device withmobile app software, a patientEEG Headset, earphones, andcharging cord for EEG Headsetand mobile device.The technology provides a meansto:• Initiate a study, track user EEGdata• Acquire and save signals tomemory of the device,• Transmit signal data fromdevice,• Visually inspect acquiredsignal, | Used for acquisition ofphysiological signals using 2 ormore channels of EEG from thescalp.It consists of an amplifier andsoftware, a laptop computer (basestation), a patient EEG cap,response button, ear buds andcharging cord.The technology provides a meansto:• Initiate a study, track user EEGand ERP data and enter text orquestionnaire information• Acquire and save signals tomemory of the device,• Transmit signal data fromdevice,• Visually inspect acquired signal,• Manage ERPs. | SE |
| PATIENTPOPULATION | Adolescents and adults | All age groups | SE |
| USEENVIRONMENT | Healthcare and medical facilities,athletic and sports clinics, oroutside facilities if led by qualifiedmedical personnel. In addition, itmay be used in the home. | Healthcare and medical facilities,athletic and sports clinics, oroutside facilities if led by qualifiedmedical 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 forcharging battery | Li-Ion Battery, with USB cable forcharging battery | Same |
| Rx Use or OTC | Rx Use | Rx Use | Same |
| SystemComponents | Patient EEG Headset• Mobile device with mobileapp software• Earphones• Web dashboard software• Charging cords for EEG cap• and mobile device | Patient EEG cap• NeuralScan amplifier• Laptop computer• Subject Response button• Ear buds• Charging cord | |
| Interface | Bluetooth (EEG to mobile device)and WiFi (mobile device to cloud) | USB or WiFi to laptop | SE |
| Biopotential signalsrecorded | Electroencephalography (EEG), | Electroencephalography (EEG),EP/ERP | Same |
| Electroencephalography (EGG) | |||
| Skin Coupling | Dry electrodes | Custom Electrode Band and Gel | SE |
| Signal recordingchannels | 16 | Up to 23 | SE |
| EEG inputterminals | 16 | Up to 21 | SE |
| Analog to DigitalConversion | 24 bits | 24 bits | Same |
| Sampling Rate | 250 and 500 Hz | 200, 500, 1000 Hz | SE |
| Common ModeRejection | >110 dB | >110 dB | Same |
| Analysis Software | Embedded and user defined. | Embedded, commerciallyavailable, 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 |
{7}------------------------------------------------
{8}------------------------------------------------
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.
§ 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).