(91 days)
Not Found
No
The summary describes a system for acquiring, displaying, and storing EEG data. It mentions software for user interface, hardware interaction, data management, storage, and communication. There is no mention of AI, ML, or any algorithms that would interpret or analyze the EEG data using such technologies. The performance studies listed are focused on software verification, validation, cybersecurity, and human factors, not on the performance of an AI/ML algorithm.
No
The device is used for acquiring, displaying, and storing EEG data to aid in diagnosis, not for treating any condition.
Yes
The intended use statement explicitly states that the device is intended to "aid in diagnosis" by acquiring, displaying, and storing electrical activity of a patient's brain.
No
The device description explicitly mentions an "EEG hardware interface" and compatibility with an "FDA-cleared EEG hardware system," indicating it relies on external hardware for data acquisition. While it includes software components (Edge Software and Cloud Software), it is not solely software.
Based on the provided information, the SPARK Scan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SPARK Scan acquires electrical activity directly from the patient's brain by placing electrodes on the head. It does not analyze samples like blood, urine, or tissue.
- The intended use is to acquire, display, and store electrical activity of the brain to aid in diagnosis. This is consistent with the function of an electroencephalogram (EEG) device, which measures electrical activity in the brain.
- The device description explicitly states it is for the acquisition, display, and storage of electroencephalogram (EEG) data.
IVD devices typically involve laboratory testing of biological samples to provide information about a patient's health status. The SPARK Scan is a device that interacts directly with the patient's body to collect physiological data.
N/A
Intended Use / Indications for Use
The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The SPARK Scan is intended for the acquisition, display, and storage of electroencephalogram (EEG) data. The SPARK Scan is intended to be used by EEG technicians, or appropriately trained Nurses and Medical Assistants practicing in any medical setting where EEG data collection may be required.
The SPARK Scan is an SaMD product that consists of the Edge Software and Data Storage and Communication Platform.
The Edge software runs locally on the user's device and consists of a User interface and the EEG hardware interface, including the electroconductive gel (K1117). The User Interface is a desktop application that (a) manages interaction with the EEG hardware interface, (b) facilitates set up and recording of EEG data, and (c) provides limited access to review of patient records according to the user's permissions.
The Data Storage and Communication Platform (Cloud Software): The Cloud software runs on a server managed by SPARK Neuro and contains no user interface. The Cloud Software is responsible only for managing (a) authorization and authentication of users and (b) storage, validation, and access to all data collected on the system.
The SPARK Scan is compatible with three 3rd-party accessory devices: an FDA-cleared EEG hardware system, a standard off-the-shelf-laptop, and FDA-cleared EEG Recording Viewing Platforms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
Adults
Intended User / Care Setting
EEG technicians, or appropriately trained Nurses and Medical Assistants practicing in any medical setting where EEG data collection may be required.
Healthcare Facilities
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)
Non-Clinical Testing
- . Software verification and validation testing
- Cybersecurity Risk Analysis and Testing ●
- Human Factors Use Related Risk Analysis ●
Biocompatibility
The subject device does not come into direct or indirect contact with the patient. This is not applicable.
Electrical Safety and Electromagnetic Compatibility
The subject device does not contain hardware. This is not applicable.
Animal Testing
Animal testing is not required to support substantial equivalence.
Clinical Testing
Clinical testing is not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K143233 Mitsar-EEG
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
August 18, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SPARK Neuro Inc. % John Doucet Vice President, Neurology Regulatory Affairs MCRA. LLC 803 7th Street NW Washington, DC 20001
Re: K231457
Trade/Device Name: SPARK Scan Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO Dated: May 18, 2023 Received: May 19, 2023
Dear John Doucet:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S
for
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) TBD
Device Name SPARK Scan
Indications for Use (Describe)
The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Device Trade Name: | SPARK Scan | ||
|---|---|---|---|
| Manufacturer: | SPARK Neuro Inc. | ||
| 212 W. 18th Street #17A | |||
| New York, NY 10011 USA | |||
| Contact: | John Doucet | ||
| Vice President, Neurology Regulatory Affairs | |||
| MCRA, LLC | |||
| 803 7th Street NW | |||
| Washington, DC 20001 | |||
| Office: 202.552.5835 | |||
| Jdoucet@mcra.com | |||
| Prepared by: | MCRA, LLC | ||
| 803 7th St NW | |||
| Washington, DC 20001 | |||
| Office: 202.552.5800 | |||
| Date Prepared: | |||
| Regulation: | |||
| Class: | |||
| Product Code: | |||
| Classification Name: | |||
| Common Name: | |||
| Primary Predicate: | May 18, 2023 | ||
| 21 CFR 882.1400 | |||
| II | |||
| GWQ | |||
| Full-Montage Standard Electroencephalograph | |||
| Electroencephalograph | |||
| K143233 Mitsar-EEG |
Indications For Use:
The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.
Device Description:
The SPARK Scan is intended for the acquisition, display, and storage of electroencephalogram (EEG) data. The SPARK Scan is intended to be used by EEG technicians, or appropriately trained Nurses and Medical Assistants practicing in any medical setting where EEG data collection may be required.
The SPARK Scan is an SaMD product that consists of the Edge Software and Data Storage and Communication Platform.
4
The Edge software runs locally on the user's device and consists of a User interface and the EEG hardware interface, including the electroconductive gel (K1117). The User Interface is a desktop application that (a) manages interaction with the EEG hardware interface, (b) facilitates set up and recording of EEG data, and (c) provides limited access to review of patient records according to the user's permissions.
The Data Storage and Communication Platform (Cloud Software): The Cloud software runs on a server managed by SPARK Neuro and contains no user interface. The Cloud Software is responsible only for managing (a) authorization and authentication of users and (b) storage, validation, and access to all data collected on the system.
The SPARK Scan is compatible with three 3rd-party accessory devices: an FDA-cleared EEG hardware system, a standard off-the-shelf-laptop, and FDA-cleared EEG Recording Viewing Platforms.
| Subject Device | Primary Predicate | Comparison | |
|---|---|---|---|
| Trade Name | SPARK Scan | Mitsar-EEG | N/A |
| Company | SPARK Neuro | Mitsar Co., LTD | N/A |
| K Number | K23xxxx | K143233 | N/A |
| Regulation | |||
| Number | 21 CFR 882.1400 | 21 CFR 882.1400 | Identical |
| Product Codes | GWQ | GWQ | Identical |
| Indications for | |||
| Use Statement | The SPARK Scan is | ||
| intended to acquire, | |||
| display, and store the | |||
| electrical activity of a | |||
| patient's brain obtained | |||
| by placing two or more | |||
| electrodes on the head to | |||
| aid in diagnosis. | The Mitsar-EEG is | ||
| intended to acquire, | |||
| display, and store the | |||
| electrical activity of a | |||
| patient's brain obtained | |||
| by placing two or more | |||
| electrodes on the head to | |||
| aid in diagnosis. | Identical | ||
| Intended User | Medical Staff | Medical Staff | Identical |
| Target Population | Adults | Adults | Identical |
| Use Environment | Healthcare Facilities | Healthcare Facilities | Identical |
| System | |||
| Components | Edge Software | ||
| Data Storage and | |||
| Communication Platform | |||
| Off-The-Shelf EEG | |||
| Amplifier (K172312) | |||
| Off-The-Shelf EEG Cap | |||
| (K110223) | EEG Amplifier | ||
| USB-Cable | |||
| USB-Dongle | |||
| EEG Studio Software | Similar. | ||
| The subject | |||
| and the | |||
| predicate | |||
| devices each | |||
| comprise | |||
| components | |||
| that allow for | |||
| its proper | |||
| functionality. | |||
| Acquires signals | Yes, EEG | Yes, EEG | Identical |
Comparison to the Predicate Device:
5
| Number of Signals
Recording
Channels
Compatibility | up to 32 | up to 21 | Similar.
Subject device
is similar to
the number of
recording
channels of
the predicate
device. |
|-------------------------------------------------------------|----------|----------|----------------------------------------------------------------------------------------------------------------------|
| Impedance Test | Yes | Yes | Identical |
| Sampling Rate | 500Hz | 500Hz | Identical. |
| Interface | PC | PC | Identical |
Performance Testing Summary:
Non-Clinical Testing
- . Software verification and validation testing
- Cybersecurity Risk Analysis and Testing ●
- Human Factors Use Related Risk Analysis ●
Biocompatibility
The subject device does not come into direct or indirect contact with the patient. This is not applicable.
Electrical Safety and Electromagnetic Compatibility
The subject device does not contain hardware. This is not applicable.
Animal Testing
Animal testing is not required to support substantial equivalence.
Clinical Testing
Clinical testing is not required to support substantial equivalence.
Conclusion: The subject device and the predicate device have the same intended use and have similar technological characteristics. The data included in this submission demonstrate substantial equivalence to the predicate device listed above. SPARK Scan is substantially equivalent to the predicate device.