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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the SPARK Scan device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics. The device is an electroencephalograph (EEG) intended to acquire, display, and store brain electrical activity to aid in diagnosis.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the SPARK Scan's ability to "aid in diagnosis." Instead, the "Performance Testing Summary" section indicates:

Non-Clinical Testing:
- Software verification and validation testing
- Cybersecurity Risk Analysis and Testing
- Human Factors Use Related Risk Analysis
Biocompatibility: Not applicable (no patient contact).
Electrical Safety and Electromagnetic Compatibility: Not applicable (no hardware).
Animal Testing: Not required.
Clinical Testing: Not required.

The comparison table between the subject device (SPARK Scan) and the predicate device (Mitsar-EEG) highlights technological characteristics rather than performance metrics against acceptance criteria.

Feature	Acceptance Criteria (Implied from Predicate Comparison)	Reported Device Performance (SPARK Scan)
Intended Use	Acquire, display, store brain electrical activity to aid in diagnosis.	Acquire, display, store brain electrical activity to aid in diagnosis. (Identical to predicate)
Intended User	Medical Staff	Medical Staff (Identical to predicate)
Target Population	Adults	Adults (Identical to predicate)
Use Environment	Healthcare Facilities	Healthcare Facilities (Identical to predicate)
Signal Acquisition	Yes, EEG	Yes, EEG (Identical to predicate)
Number of Recording Channels	Up to 21 (Predicate)	Up to 32 (Similar to predicate, subject device has more)
Impedance Test	Yes	Yes (Identical to predicate)
Sampling Rate	500Hz	500Hz (Identical to predicate)
Interface	PC	PC (Identical to predicate)
Software V&V	Successful completion of V&V testing.	Completed software verification and validation testing.
Cybersecurity	Successful completion of risk analysis and testing.	Completed Cybersecurity Risk Analysis and Testing.
Human Factors	Successful completion of use-related risk analysis.	Completed Human Factors Use Related Risk Analysis.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Clinical testing is not required to support substantial equivalence." This implies there was no clinical test set of patient data used for performance claims. The "test set" for the reported performance appears to be related to software verification and validation, cybersecurity, and human factors, which are not described using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical testing on patient data with diagnostic outcomes was performed or required, there is no mention of experts establishing a ground truth for a test set in the context of diagnostic aid. The ground truth for software testing would be defined by specifications and requirements, not expert interpretation of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described because no clinical test set requiring expert consensus for ground truth 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 study was conducted or is mentioned. The device is described as software for acquiring, displaying, and storing EEG data, not as an AI-assisted diagnostic tool that aids human readers in interpretation. Clinical testing was deemed "not required to support substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The SPARK Scan is described as an SaMD (Software as a Medical Device) product comprising Edge Software and a Data Storage and Communication Platform, compatible with third-party EEG hardware. Its function is to acquire, display, and store EEG data. It is not presented as an "algorithm only" device that provides a diagnostic output in a standalone capacity without human interpretation. It aids in diagnosis by providing raw EEG data, requiring "Medical Staff" (Intended User) for interpretation. Clinical testing was not required for its clearance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical testing conducted (software V&V, cybersecurity, human factors), the ground truth would be defined by engineering specifications, security protocols, and human factors engineering principles, respectively. No medical ground truth (e.g., expert consensus on diagnosis, pathology, or outcomes data) was used or required for this submission.

8. The sample size for the training set

The document does not mention a training set for machine learning or AI algorithms, as the device's function is described as data acquisition, display, and storage, not as an AI diagnostic tool. Therefore, sample size for a training set is not applicable or provided.

9. How the ground truth for the training set was established

Not applicable, as no training set for machine learning or AI is mentioned.

Summary

{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)

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

Device Trade Name:	SPARK Scan
Manufacturer:	SPARK Neuro Inc.212 W. 18th Street #17ANew York, NY 10011 USA
Contact:	John DoucetVice President, Neurology Regulatory AffairsMCRA, LLC803 7th Street NWWashington, DC 20001Office: 202.552.5835Jdoucet@mcra.com
Prepared by:	MCRA, LLC803 7th St NWWashington, DC 20001Office: 202.552.5800
Date Prepared:Regulation:Class:Product Code:Classification Name:Common Name:Primary Predicate:	May 18, 202321 CFR 882.1400IIGWQFull-Montage Standard ElectroencephalographElectroencephalographK143233 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 an SaMD product that consists of the Edge Software and Data Storage and Communication Platform.

{4}------------------------------------------------

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
RegulationNumber	21 CFR 882.1400	21 CFR 882.1400	Identical
Product Codes	GWQ	GWQ	Identical
Indications forUse Statement	The SPARK Scan isintended to acquire,display, and store theelectrical activity of apatient's brain obtainedby placing two or moreelectrodes on the head toaid in diagnosis.	The Mitsar-EEG isintended to acquire,display, and store theelectrical activity of apatient's brain obtainedby placing two or moreelectrodes on the head toaid in diagnosis.	Identical
Intended User	Medical Staff	Medical Staff	Identical
Target Population	Adults	Adults	Identical
Use Environment	Healthcare Facilities	Healthcare Facilities	Identical
SystemComponents	Edge SoftwareData Storage andCommunication PlatformOff-The-Shelf EEGAmplifier (K172312)Off-The-Shelf EEG Cap(K110223)	EEG AmplifierUSB-CableUSB-DongleEEG Studio Software	Similar.The subjectand thepredicatedevices eachcomprisecomponentsthat allow forits properfunctionality.
Acquires signals	Yes, EEG	Yes, EEG	Identical

Comparison to the Predicate Device:

{5}------------------------------------------------

Number of SignalsRecordingChannelsCompatibility	up to 32	up to 21	Similar.Subject deviceis similar tothe number ofrecordingchannels ofthe predicatedevice.
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.

Regulation Number and Section

§ 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).