(296 days)
Not Found
No
The summary describes a system for acquiring, displaying, and storing EEG data, with no mention of AI or ML for analysis or interpretation.
No
The device is intended for the acquisition, display, and storage of EEG signals for diagnostic purposes, not for providing therapy or treatment.
No
The device is intended for the acquisition, display, and storage of EEG signals. While EEG data can be used for diagnostic purposes by a healthcare professional, the device itself is not stated to perform any diagnostic interpretations or analyses of the collected data. It serves as a data acquisition and management platform.
No
The device description explicitly lists hardware components such as the Cumulus EEG Headset, disposable mastoid sticky sensors, earphones, device stand, and chargers, in addition to the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the acquisition, display, and storage of electroencephalograph (EEG) signals. This is a physiological measurement of electrical activity in the brain.
- Device Description: The device is a platform for recording EEG data using electrodes placed on the head. It involves hardware (headset, electronics) and software for data acquisition and display.
- Lack of In Vitro Component: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device directly measures a physiological signal in vivo (within the body).
The device is clearly focused on capturing and presenting physiological data from the patient's body, which falls under the category of a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
GWQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head
Indicated Patient Age Range
adults and adolescent patients
Intended User / Care Setting
The system can be used in the patient's home or a health care facility.
Healthcare and medical facilities, athletic and sports clinics, or outside facilities if led by qualified medical personnel. In addition, it may be used in the home.
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)
Bench testing was conducted on the following and study reports were submitted 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K192753, NeuralScan System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K221963
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Cumulus Neuroscience Limited |
| Submitter Address: | Cumulus Neuroscience Limited |
| Concourse Building 3 | |
| Queens Road | |
| Belfast BT3 9DT | |
| Northern Ireland, United Kingdom | |
| Contact Person: | Caroline Kirwan, Director of Regulatory Affairs and Quality |
| caroline.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 Name | |
| Classification | |
| Product Code | Full-montage standard EEG |
| 882.1400 | |
| 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, | |
| 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. |
V. DEVICE DESCRIPTION
| Device Identification:
Components | The Cumulus Functional Neurophysiology Platform is comprised of the
Cumulus Headset which records EEG signals that are time-stamped. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and
Technological
Characteristics | 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. | |
| 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
Testing: | Bench testing was conducted on the following and study reports were
submitted 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 the
requirements of the following international standards:
• DIN EN ISO 10993-1:2018: Biological Evaluation of Medical
Devices, Part 1: Evaluation and testing within a risk management
system. | |
| • | ISO 10993-23:2021: Biological evaluation of medical devices - Part
23: Tests for irritation |
| • | IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical Electrical
Equipment - Part 1: General requirements for basic safety and
essential performance. |
| • | IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2:
General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements
and tests. |
| • | IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11:
Requirements for medical electrical equipment and medical
electrical 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 essential
performance of electroencephalographs. |
| • | ANSI C63.10 2013 American National Standard of Procedures for
Compliance Testing of Unlicensed Wireless Devices |
| • | ANSI 63.4 2014 American National Standard for Methods of
Measurement of Radio-Noise Emissions from Low-Voltage
Electrical and Electronic Equipment in the Range of 9 kHz to 40
GHz |
| • | IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medical
device software – Software life cycle processes |
| • | ISTA 3A 2018 Packaged-Products for Parcel Delivery System
Shipment 70 kg (150 lb) or Less |
| Biocompatibility
Testing: | A biocompatibility evaluation was conducted according to ISO 10993-1.
It concluded testing was required to assure the intact skin contact
components for the prolonged (cumulative) use are biocompatible and
non-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 sensors
were presented in the 510(k). Additional testing for delayed
hypersensitivity (according to ISO 10993-10) and intracutaneous
reactivity (according to ISO 10993-23) was completed. Testing was
conducted by a third party according to Good Laboratory Practices.
Results showed the subject device is biocompatible and non-toxic for its
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 | ||
| Neurophysiology Platform | NeuralScan System | ||
| MANUFACTURER | Cumulus Neuroscience Ltd | Medeia, Inc. | |
| PRODUCT CODES: | |||
| PRIMARY | GWQ | OLT, GWJ, GWQ | Same |
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| REGULATORY
| NAME: | Electroencephalograph | Electroencephalograph | |
|---|---|---|---|
| CLASSIFICATION: | |||
| CLASS: | 21 CFR 882.1400 | ||
| II | 21 CFR 882.1400 | ||
| II | |||
| INDICATIONS FOR | |||
| 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 to aid in diagnosis. The | |||
| EEG signals are time-stamped. |
The system can be used in the
patient's home or a health care
facility. | The NeuralScan System is
intended for the acquisition,
display, analysis, and storage, of
electrical activity of a patient's
brain including
electroencephalograph (EEG) and
Event-related Potentials (ERP),
obtained by placing two or more
electrodes on the head to aid in
diagnosis. | Same intended
use.
SE for
Indications |
| Rx Only or OTC | Rx Only | Rx Only | Same |
| PRINCIPLE OF
OPERATION and
SYSTEM
COMPONENTS | Used for acquisition of
physiological signals using 2 or
more channels of EEG from the
scalp.
It consists of a mobile device with
mobile app software, a patient
EEG Headset, earphones, and
charging cord for EEG Headset
and mobile device.
The technology provides a means
to:
• Initiate a study, track user EEG
data
• Acquire and save signals to
memory of the device,
• Transmit signal data from
device,
• Visually inspect acquired
signal, | Used for acquisition of
physiological signals using 2 or
more channels of EEG from the
scalp.
It consists of an amplifier and
software, a laptop computer (base
station), a patient EEG cap,
response button, ear buds and
charging cord.
The technology provides a means
to:
• Initiate a study, track user EEG
and ERP data and enter text or
questionnaire information
• Acquire and save signals to
memory of the device,
• Transmit signal data from
device,
• Visually inspect acquired signal,
• Manage ERPs. | SE |
| PATIENT
POPULATION | Adolescents and adults | All age groups | SE |
| USE
ENVIRONMENT | Healthcare and medical facilities,
athletic and sports clinics, or
outside facilities if led by qualified
medical personnel. In addition, it
may be used in the home. | Healthcare and medical facilities,
athletic and sports clinics, or
outside facilities if led by qualified
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
charging battery | Li-Ion Battery, with USB cable for
charging battery | Same |
| Rx Use or OTC | Rx Use | Rx Use | Same |
| System
Components | Patient EEG Headset
• Mobile device with mobile
app 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 signals
recorded | Electroencephalography (EEG), | Electroencephalography (EEG),
EP/ERP | Same |
| Electroencephalography (EGG) | | | |
| 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 |
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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.