Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noise-cancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.

AI/ML Overview

This submission lacks specific acceptance criteria and detailed study results to demonstrate device performance against those criteria. The provided document is a 510(k) summary, which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined performance acceptance criteria through clinical studies.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of clinical or technical performance metrics (e.g., specific reduction in anxiety scores, minimum current output accuracy, etc.) and then report the device performance against those criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared design, operating principles, and compliance with general safety and performance standards.

The table presented in the "IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE" and "X. SUMMARY OF SIMILARITIES AND DIFFERENCES" sections compares the Cervella device's characteristics to its predicate devices, CES Ultra and Alpha-Stim CS. This comparison serves as the de facto "performance data" that the manufacturer presented for substantial equivalence, rather than a direct measurement against pre-defined acceptance criteria for a new clinical claim.

Property	Cervella (Reported Performance)	Predicate 1 (CES Ultra)	Predicate 2 (Alpha-Stim CS)	Differences and Comments
Indications for Use	Treatment of insomnia, depression, or anxiety.	Treatment of insomnia, depression, or anxiety.	Treatment of insomnia, depression, or anxiety.	None
Waveform	Symmetrical Biphasic Square Wave	Symmetrical Biphasic Square Wave	Symmetrical Biphasic Square Wave	None
Current Intensity Range	0µA – 500µA adjustable in 50µA increments	0µA — 1500µA continually adjustable	0µA — 500µA adjustable in 50µA increments	Same range as Alpha-Stim, narrower range than CES Ultra
Pulse Width Range	5ms - 1s (varies depending on frequency selection)	2ms	250ms - 1s	Pulse width varies depending on frequency selection
Number of electrodes	Two	Two	Two	None
Electrode Placement	Head (Mastoid process)	Head (Mastoid process or Earlobes)	Head (Earlobes)	Same placement as CES Ultra
Power Source	Li-ion Battery (3.7V) (rechargeable)	Alkaline Battery (9V)	Alkaline Battery (3V)	Cervella battery is rechargeable
Frequency selections	0.5Hz, 1.5Hz, 100Hz	100Hz	0.5Hz, 1.5Hz, 100Hz	Same frequency selection as Alpha-Stim CS
Treatment Range	10 min – 60 min in 10 min intervals	30 min, 60min, or continuous	10, 20, 60 minutes or continuous	Same min-max range as Alpha-Stim
Unit Controls	Via Bluetooth-enabled smart device featuring Cervella app	Built into the device	Built into the device	Wireless operation
Treatment history logging	Automatic	Not available	Not Available	New feature
Ability for patient to use audio and noise cancelling feature of headset during treatment	Optional via dedicated separate Bluetooth connection	Not available	Not Available	New feature
Dimensions and weight	7cm x 7cm x 2cm	13.5cm x 6.4cm x 3.3cm	9.8cm x 6.3cm x 2cm	Cervella is slightly smaller
Enclosure	Plastic	Plastic	Plastic	None

2. Sample size used for the test set and data provenance:

The document (a 510(k) summary) does not describe a clinical "test set" in the context of typical AI/ML performance evaluation (e.g., a cohort of patients whose data is used to validate an algorithm's diagnostic or therapeutic efficacy).

The performance data cited are primarily bench testing against electrical safety and performance standards for medical devices (ES60601-1:2005, IEC 60601-1-2, IEC 60601-2-10, IEC 62133). These tests do not involve patient data or clinical outcomes. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective data in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for diagnostic or therapeutic accuracy. The ground truth for electrical safety and performance standards is defined by the standards themselves, not by expert consensus on clinical data.

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

Not applicable, as there was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The Cervella device is a Cranial Electrotherapy Stimulator (CES), a standalone therapeutic device, not an AI-assisted diagnostic or interpretive tool that would typically be evaluated in an MRMC study with human readers. The document does not describe any such study.

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

The device itself is a standalone therapeutic device. Its core function – delivering electrical stimulation – is algorithm-driven in terms of current intensity, frequency, and duration programming, but it's not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The performance data provided is mainly about its physical and electrical characteristics conforming to standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy.

7. The type of ground truth used:

For the evaluation described, the "ground truth" was compliance with mandatory and voluntary medical device safety and performance standards (e.g., IEC 60601 series). These standards define the expected electrical output, safety features, and battery performance. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the purpose of this 510(k) submission, as it focuses on substantial equivalence of physical and electrical parameters.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the typical sense to learn patterns or make predictions. Its operation is based on predefined electrical parameters.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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March 7, 2019

Innovative Neurological Devices LLC Bart Waclawik President 13295 Illinois Street, Suite 312 Carmel, Indiana 46032

Re: K182311

Trade/Device Name: Cervella Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial Electrotherapy Stimulator Regulatory Class: Class III Product Code: JXK Dated: February 1, 2019 Received: February 4, 2019

Dear Bart Waclawik:

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/cdrl/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Pamela D. Scott Digitally signed by Pamela D.
Scott Scott Scott Scott -s Date: 2019.03.07 22:01:53 -5 -05'00 for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183211

Device Name Cervella

Indications for Use (Describe)

Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92(c), 510(k) summary is provided.

l. DATE PREPARED: March 5, 2019

II. SUBMITTER

INNOVATIVE NEUROLOGICAL DEVICES LLC 13295 Illinois St, Suite 312 Carmel, IN 46032 (855) 413-3300 Phone: Contact Person: Bart Waclawik

III. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Bart Waclawik President | CEO INNOVATIVE NEUROLOGICAL DEVICES LLC Phone: (855) 413-3300 e-mail: regulatory@cervella.us

IV. DEVICE

Brand Name of Device:	Cervella™
Common or Usual Name:	Cranial Electrotherapy Stimulator (CES)
Classification Name:	Stimulator, Cranial, Electrotherapy, a preamendmentClass III device per 21 CFR §882.5800
Regulatory Class:	III
Product Code:	JXK

V. PREDICATE DEVICES

Device Trade Name:	CES Ultra™
Device Company:	Neuro-Fitness, LLC
510(k) Numbers:	K062284
Device Trade Name:	Alpha-Stim CS
Device Company:	Electromedical Products Inc.
510(k) Numbers:	K903014

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VI. DEVICE DESCRIPTION

Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noisecancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.

INDICATIONS FOR USE VII.

Cervella is indicated for the treatment of insomnia, depression, or anxiety.

SUBSTANTIAL EQUIVALENCE VIII.

The Cervella CES is substantially equivalent with respect to indications for use, stimulation parameters (i.e. current levels, frequencies, pulse width and amplitude), and electrode placement to predicate devices CES Ultra cleared by K062284 and Alpha-Stim CS cleared by K903014.

IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE

The Cervella device has the same intended use and operating principles, with similar design features, and functional and performance characteristics as the previously-cleared devices. Cervella is designed to comply with relevant federal and international safety and performance standards.

Cervella has undergone standard engineering bench testing to confirm conformance to design specifications as well as independent laboratory testing to insure conformance with applicable mandatory and voluntary medical device safety standards as follows:

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ES60601-1:2005/(R)2012 and A1:2012 ●
IEC 60601-1-2 Edition 4.0 2014-02
IEC 60601-2-10 Edition 2.1 2016-04
IEC 62133 Edition 2.0 2012-1.

Conformance to mandatory and voluntary standards, combined with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.

Property	Cervella	CES Ultra	Alpha-Stim CS	Differences andComments
Indicationsfor Use	Cervella isindicated for thetreatment ofinsomnia,depression, oranxiety.	CES Ultra isindicated for thetreatment ofinsomnia,depression, oranxiety.	Alpha-Stim CS isindicated for thetreatment ofinsomnia,depression, oranxiety.	None
Waveform	SymmetricalBiphasicSquare Wave	Symmetrical BiphasicSquare Wave	SymmetricalBiphasic SquareWave	None
CurrentIntensityRange	0µA – 500µAadjustable in50µAincrements	0µA — 1500µAcontinually adjustable	0µA — 500µAadjustable in 50μAincrements	Same range asAlpha-Stim,narrower rangethan CES Ultra
Pulse WidthRange	5ms - 1s	2ms	250ms - 1s	Pulse width variesdepending onfrequencyselection
Number ofelectrodes	Two	Two	Two	None
ElectrodePlacement	Head (Mastoidprocess)	Head (Mastoidprocess or Earlobes)	Head (Earlobes)	Same placementas CES Ultra
PowerSource	Li-ion Battery(3.7V)	Alkaline Battery (9V)	Alkaline Battery(3V)	Cervella battery isrechargeable

X. SUMMARY OF SIMILARITIES AND DIFFERENCES

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INNOVATIVE NEUROLOGICAL DEVICES LLC | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Cervella

Frequencyselections	0.5Hz, 1.5Hz,100Hz	100Hz	0.5Hz, 1.5Hz, 100Hz	Same frequencyselection asAlpha-Stim CS
TreatmentRange	10 min – 60 minin 10 minintervals	30 min, 60min, orcontinuous	10, 20, 60 minutesor continuous	Same min-maxrange as Alpha-Stim
UnitControls	Via Bluetooth-enabled smartdevice featuringCervella app	Built into the device	Built into the device	Wirelessoperation
Treatmenthistorylogging	Automatic	Not available	Not Available	New feature
Ability forpatient touse audioand noisecancellingfeature ofheadsetduringtreatment	Optional viadedicatedseparateBluetoothconnection	Not available	Not Available	New feature
Dimensionsand weight	7cmx7cmx2cm	13.5cmx6.4cmx3.3cm	9.8cmx6.3cmx2cm	Cervella is slightlysmaller
Enclosure	Plastic	Plastic	Plastic	None

XI. CONCLUSIONS

Cervella CES is substantially equivalent to the listed predicate device without raising any new issues of safety or effectiveness. The new device has the same intended use and operating principles, with similar features, and functional and performance characteristics as the predicates. The device was designed to comply with relevant federal and international safety and performance standards and has been tested to ensure conformity with all applicable medical device safety standards.

Regulation Number and Section

§ 882.5800 Cranial electrotherapy stimulator.

(a)
Identification. A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.(b)
Classification. (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment;
(B) A warning that patients should be monitored by their physician for signs of worsening;
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur;
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur;
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device;
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.