(195 days)
Not Found
No
The device description and performance studies do not mention any AI or ML capabilities. The software application controls basic device parameters and stores treatment history, which are not indicative of AI/ML.
Yes
The device is indicated for the treatment of medical conditions (insomnia, depression, or anxiety) and delivers electrical current to the brain for this purpose.
No
The device is described as a stimulator used for treatment, not for diagnosing conditions. Its function is to deliver electrical current to the brain to treat insomnia, depression, or anxiety, not to identify or analyze these conditions.
No
The device description clearly states that the Cervella Cranial Electrotherapy Stimulator (CES) is a physical device that delivers electrical current through electrodes incorporated into headphones. While it is controlled by a software application, the core medical device is hardware.
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 treatment of insomnia, depression, or anxiety. This is a therapeutic use, not a diagnostic one.
- Device Description: The device delivers electrical current to the brain for treatment. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of samples, reagents, or diagnostic outputs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat a condition through electrical stimulation.
N/A
Intended Use / Indications for Use
Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.
Product codes
JXK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head (Mastoid process)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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:
- 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.
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.
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
§ 882.5800 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.
0
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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
1
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
2
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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3
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 preamendment |
| Class 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 |
4
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:
5
- 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 and
Comments |
|-------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Indications
for Use | Cervella is
indicated for the
treatment of
insomnia,
depression, or
anxiety. | CES Ultra is
indicated for the
treatment of
insomnia,
depression, or
anxiety. | Alpha-Stim CS is
indicated for the
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 | 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) | Alkaline Battery (9V) | Alkaline Battery
(3V) | Cervella battery is
rechargeable |
X. SUMMARY OF SIMILARITIES AND DIFFERENCES
6
INNOVATIVE NEUROLOGICAL DEVICES LLC | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Cervella
| 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 | 7cmx7cmx2cm | 13.5cmx6.4cmx3.3cm | 9.8cmx6.3cmx2cm | Cervella is slightly
smaller |
| 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.