(211 days)
Cefaly Connected - OTC is indicated for:
-
- Acute treatment of migraine with or without aura in patients 18 years of age or older
-
- Preventative treatment of migraine in patients 18 years of age or older
Cefaly Connected - Rx is indicated for:
- Preventative treatment of migraine in patients 18 years of age or older
-
- Acute treatment of migraine with or without aura in patients 18 years of age or older
-
- Prophylactic treatment of migraine in patients 18 years of age or older
CEFALY Connected - Rx and CEFALY Connected - OTC consists of neurostimulators, Cefaly Electrodes, and mobile application. The neurostimulators are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraines similar to Cefaly® Dual Connected - Rx, and Cefaly® Dual Connected - OTC of K212071. The mobile application, CeCe Miqraine Management App, is a two-way communicatinq, mobile application, installed and run on users' personal mobile devices such as smartphone or tablet. The app is compatible with neurostimulators of CEFALY Connected devices (Rx and OTC). The mobile application communicates with the neurostimulator through Bluetooth and allows users to track the treatments.
The provided text describes a 510(k) premarket notification for a medical device called "CEFALY Connected - OTC" and "CEFALY Connected - Rx." The submission focuses on demonstrating substantial equivalence to a predicate device, the "Cefaly® Dual Series" (K212071). Since this is a 510(k) submission, the primary aim is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove absolute effectiveness against a specific disease. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating equivalence and safety/performance as compared to the predicate, especially regarding changes made to the mobile application.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The core of the submission relies on demonstrating that while there are differences in the mobile application's functionalities, the fundamental medical device functions and underlying technology of the neurostimulator remain equivalent in terms of safety and efficacy to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|
| Technological Equivalence | Similarities: |
| - Device physical status: Both subject and predicate devices have software applications deployed on commercially available smartphones. (Equivalent) | |
| - User authentication: Same account creation and login process. (Equivalent) | |
| - Treatment Logs & Migraine Logs: Record the same patient-reported information. (Equivalent) | |
| - Migraine Report & Graphical Data: Present the same trends, patterns, and data graphs based on user-provided information. (Equivalent) | |
| - Bluetooth protocol: Same for neurostimulator. (Equivalent) | |
| - Power source, charging system, mechanical characteristics (Weight, Dimensions, Channels): Same for the neurostimulator. (Equivalent) | |
| - Waveform characteristics and output specifications (Program 1 - Acute, Program 2 - Prevent): Same for both neurostimulators (Amplitude, Pulse width, Pulse frequency, Session duration, Maximum average current, Maximum average power density, Biphasic, Rectangular, Full compensated, Symmetrical, Net charge per pulse, Max output voltage/current, Pulse duration, Max Phase Charge, Max current density). (Equivalent) | |
| - Audio-visual Indications & Device button functions: Used in the neurostimulators for both devices are the same. (Equivalent) | |
| - Electrode (Dimensions, Gel used, Packaging configuration, Number of electrodes, Electrode storage): Same for both devices. (Equivalent) | |
| Differences & Justification for Equivalence: | |
| - Major App functionalities: Subject device has 2-way communication enabling remote control (start/stop treatment, control intensity) of the neurostimulator via Bluetooth. Predicate only had treatment log, migraine log, and PDF download. Justification: Neurostimulator can operate independently. Mobile app interface is supplementary and can be overridden by neurostimulator controls. Remote control functions are consistent with neurostimulator's existing controls and validated through software system validation and interoperability testing. The "Stop" button in the app functions similarly to physically detaching the device. No new questions of safety or efficacy are raised. | |
| - User Interface: Treatment Session Controls: Subject device allows start/stop treatment sessions, increase/stabilize intensity via app. Predicate had no app treatment session controls. Justification: Controls in subject device app are consistent with neurostimulator, validated through software system validation and interoperability testing. App controls are supplementary and can be overridden by physical device controls. No new questions of safety/efficacy. | |
| - Monitoring Treatment Progress: Both visually monitor progress via app UI and audio-visual indications on hardware. Justification: App acts as an accessory, supplements neurostimulator indications, and device can still indicate progress if app malfunctions. No conflicts or new questions of safety/efficacy. | |
| - Indicators on app interface: Subject device only shows selected treatment type via pop-up at selection; constant display on neurostimulator. Predicate constantly displayed via app. Subject device also has push notifications for active sessions, intensity controls, and preventative treatment reminders. Justification: User is aware of treatment type via neurostimulator visual cues in both cases. Push notifications are supplementary and "non-medical device functions" (reminders), posing no new safety/efficacy questions. | |
| - Option to Log historical preventative treatment data: Subject device allows logging for both Acute and Preventative sessions. Predicate only allowed Acute. Justification: This is a non-medical device function and does not raise new questions of safety and effectiveness. | |
| Software Safety & Performance | Software Verification and Validation, including interoperability testing: Performed to validate control functions and associated features of the mobile app. Reported Performance: Results demonstrate that the user interface is consistent with intended use. Intensity values displayed by app and actual intensity values are almost same (acceptable tolerance limit of -2%). Bluetooth interface does not introduce unacceptable latency. EMF compatibility and wireless safety demonstrated in predicate K212071. |
| Cybersecurity | Threat modeling and penetration testing: Conducted to identify security threats. Reported Performance: Control measures applied and traceability documented in a cybersecurity report. |
| Special Controls Compliance | Addressed & Re-verified in this submission: |
| 1. Software verification, validation, and hazard analysis: Performed (see section 7, Performance Testing - Bench, and Section 11, Conclusion). | |
| 2. Labeling for CeCe Migraine Management App: Includes information on operation and typical sensations. | |
| Addressed in K212071 (Predicate): Biocompatibility, Electromagnetic compatibility, electrical/mechanical/thermal safety, technical parameters characterization, electrode testing, clinical performance data (for neurostimulators), and comprehensive labeling requirements. |
Study Details
The provided document describes studies primarily focused on bench testing and software validation to demonstrate substantial equivalence, rather than a clinical trial proving direct efficacy of the new components.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of patient numbers or a dataset size for evaluating device performance. The testing described is "Software Verification and Validation, including interoperability testing" and "Bench testing." These tests would typically use specific test cases and simulated scenarios rather than a traditional patient test set.
- Data Provenance: Not applicable in the context of patient data. The tests are technical assessments of software functionality and device interoperability.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for software verification and validation, and bench testing, is established by predefined functional requirements, technical specifications, and expected outputs based on engineering principles and regulatory standards. It's not typically established by clinical experts in the same way as an AI diagnostic study.
-
Adjudication method for the test set:
- Not applicable. As the testing pertains to technical performance and software functionality (e.g., whether a button does what it's supposed to, whether Bluetooth communication is stable, whether intensity values are within tolerance), there isn't a "ground truth" established by human experts that requires adjudication.
-
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 done. The device is a "Transcutaneous Electrical Nerve Stimulator to Treat Headache," and the changes concern the mobile application interface. This is not an AI-assisted diagnostic device, nor does it involve "human readers" in a clinical interpretation context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The core neurostimulator device functions independently of the mobile app. The document explicitly states: "The neurostimulator can perform treatment sessions independent of the mobile application." The mobile app provides supplementary control and monitoring functions. So, in a sense, the neurostimulator's standalone performance (without the app) is inherent to its prior clearance (K212071) and acknowledged in this submission. The "algorithm" here refers to the software controlling the neurostimulator and the mobile app's functionalities. The studies performed were on the software (verification, validation, interoperability) and system (bench testing, cybersecurity).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed (software verification, validation, interoperability bench testing) would be the device's technical specifications, design requirements, and regulatory standards. For example, if the app is supposed to display device battery level, the ground truth is the actual battery level measured by the device. If the app sends control commands, the ground truth is whether the device responded correctly and within expected parameters.
- The effectiveness of the core neurostimulator for migraine treatment was established in prior submissions (K212071) through clinical performance data, which would have involved outcomes data related to migraine treatment. However, this submission focuses on the safety and performance of the new software features in the mobile app.
-
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "software" in question refers to the mobile application's control logic and user interface, which are developed through traditional software engineering methods, not statistical learning from large datasets.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
July 18, 2024
CEFALY Technology % Parul Chansoria CEO, Elexes Medical Consulting 30 N Gould St., Ste. R Sheridan, Wyoming 82801
Re: K234029
Trade/Device Name: CEFALY Connected - OTC, CEFALY Connected - Rx Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: June 18, 2024 Received: June 18, 2024
Dear Parul Chansoria:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jitendra V. Virani -S
CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
CEFALY Connected - OTC, CEFALY Connected - Rx
Indications for Use (Describe)
Cefaly Connected - OTC is indicated for:
-
- Acute treatment of migraine with or without aura in patients 18 years of age or older
-
- Preventative treatment of migraine in patients 18 years of age or older
Cefaly Connected - Rx is indicated for:
-
- Acute treatment of migraine with or without aura in patients 18 years of age or older
-
- Prophylactic treatment of migraine in patients 18 years of age or older
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | 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}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for "CEFALY Technology". The word "CEFALY" is in large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font, inside of a rounded rectangle. The logo is in a dark gray color, and the background is white. There is a registered trademark symbol next to the "Y" in "CEFALY".
1. SUBMITTER'S INFORMATION
CEFALY Technology, LIEGE Science Park, Rue Louis Plescia, 34, 4102 Seraing, Belgium
Contact Person
Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: + 408-475-8091 E-mail: parul@elexes.com Summary Prepared: Jul 18, 2024
DEVICE INFORMATION 2.
Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache
Trade Name: CEFALY Connected - OTC, and CEFALY Connected - Rx
Regulation Name: Transcutaneous electrical nerve stimulator to treat headache
Regulation Number: 21 CFR Part 882.5891
Regulatory Class: Class II
Classification Panel: Neurology
Product Code: PCC
3. PREDICATE DEVICE INFORMATION
The Predicate Device is listed in Table 1
Table 1 - Predicate Device
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for CEFALY. The logo is in a gray color. The word "CEFALY" is in large, bold letters, and the word "TECHNOLOGY" is in smaller letters below it, inside of a gray rounded rectangle.
| Predicate Device Name | Manufacturer | Predicate Priority | 510K Number | Regulatory Information |
|---|---|---|---|---|
| Cefaly® Dual Series(Cefaly® DualEnhanced with RFID -Rx, Cefaly® DualEnhanced with RFID -OTC, Cefaly® DualConnected - Rx andCefaly® DualConnected - OTC) | CEFALYTechnology | Primary | K212071 | Regulation Name:Transcutaneouselectrical nervestimulator to treatheadacheRegulationNumber: 21 CFRPart 882.5891Regulatory Class:Class IIClassificationPanel: NeurologyProduct Code:PCC |
The Predicate Device is not subject to recall by the FDA.
For this submission, the subject device has been compared with the Cefaly® Dual Connected - Rx and the Cefaly® Dual Connected - OTC of K212071, to demonstrate substantial equivalence.
DEVICE DESCRIPTION 4.
CEFALY Connected - Rx and CEFALY Connected - OTC consists of neurostimulators, Cefaly Electrodes, and mobile application. The neurostimulators are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraines similar to Cefaly® Dual Connected - Rx, and Cefaly® Dual Connected - OTC of K212071.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray rounded rectangle.
The mobile application, CeCe Miqraine Management App, is a two-way communicatinq, mobile application, installed and run on users' personal mobile devices such as smartphone or tablet. The app is compatible with neurostimulators of CEFALY Connected devices (Rx and OTC). The mobile application communicates with the neurostimulator through Bluetooth and allows users to track the treatments.
This application software allows the users:
- to select a treatment mode (Acute/Prevent)
- to start or stop a treatment session
- to control treatment intensity ●
- to monitor treatment sessions in real-time including time elapsed, the neurostimulator's battery level, Bluetooth connection status
- to log preventative treatment data such as time/date, duration, and treatment intensity
- to maintain (log or record) migraine diary (information), where user can log migraine triggers and symptoms
- to view device status such as the device's battery level, connection state, and user notifications such as the following push notifications
- O reminders scheduled by the user to do a PREVENT treatment, track the treatment session, log a migraine episode
- informs users when the intensity is ramping up and the intensity is o stabilized.
All the above functions are available only to registered users who have successfully paired their neurostimulator.
The above functions are further elaborated below:
-
- Selecting treatment mode
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif font. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif font, set against a gray, rounded rectangle. A registered trademark symbol is located to the right of the letter "Y" in "CEFALY".
510(k) Summ K234029
This feature allows the user to select the preferred treatment mode such as Acute or Preventative.
-
- Starting/Stopping treatment
This feature allows the user to initiate ACUTE or PREVENT treatment sessions alternatively, using the app user interface. Treatment sessions once initiated using the app can run and terminate independently of the app. The app also sends push notifications of treatment activity.
- Starting/Stopping treatment
-
- Controlling treatment intensity
This function allows the user to, as an alternative to the control button on the neurostimulator, increase or stabilize treatment intensity and displays a real-time variation of the intensity level on the app user interface. The treatment control buttons operate exactly the same manner as the control button on the neurostimulator.
- Controlling treatment intensity
-
- Monitoring Treatment session
During a treatment session, users can view the treatment intensity graphically, the time remaining for the treatment session, the battery status of the CEFALY Connected Device paired with the smartphone, and the status of the Bluetooth Connection between the smartphone and the neurostimulator. The mobile application sends push notifications to the smartphone to inform them about active treatment sessions when the app is running in the background.
- Monitoring Treatment session
-
ട്. Logging Treatment information
Users of the mobile application can record information about treatments undergone using both CEFALY Connected devices and other modes such as drugs. This information is used to create data points for visuals on migraine treatment information. -
- Logging Migraine information
Users of the mobile application can record information related to
- Logging Migraine information
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif font. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif font on a gray, rounded rectangle. The registered trademark symbol is next to the Y in CEFALY.
migraines experienced, such as symptoms, maximum pain intensity, migraine triggers, Location of pain, medication or non-drug treatments taken, overall treatment effectiveness, and additional notes about the treatment(s). This information is used to create data points for visuals on trends and patterns in the user's migraine journey.
-
- Generating Insights/Trends
This feature displays the graphical data that includes:
- Generating Insights/Trends
-
The three most common triggers over set time .
-
Intensity of migraine over set time .
-
. Maximum intensity reached during preventative CEFALY sessions over a set time
-
. Migraine frequency over set time
-
The average duration of migraine attacks over a set time
-
Treatment intensities over set time ●
-
. Type of drug and non-drug treatment information logged by the user corresponding to the historical migraine attacks
-
. Average effectiveness based on user-provided ratings each time they log historical migraine attacks
The graphical data is generated based solely on user inputs, i.e., when users fill out the migraine logs and/or the preventative treatment logs.
-
- Export to PDF
This feature allows the following information regarding the health condition (based on user inputs)to be reported:
- Export to PDF
-
. Patient-specific statistics related to existing migraine based on information collected during user registration on the application
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for "CEFALY Technology". The word "CEFALY" is in a larger font size and is placed above the word "TECHNOLOGY". The word "TECHNOLOGY" is inside of a rounded rectangle.
- Trends based on Migraine triggers, location of pain, symptoms, . frequency per day of the week, and intensity based on information collected during user registration on the application.
- . Trends of Acute and Preventative treatments used during migraine attacks
- . Evolution of the symptoms based on Migraine Frequency, Intensity, Average Duration, Acute and preventative Treatments, Average treatment Effectiveness over time
- . Evolution of migraine treatments, triggers, and symptoms, based on categories such as top 3 Acute and Preventative treatments of migraine
Most of the device functions are the same as the device functions cleared in K212071. The changes made include adding more functions to the mobile application. The differences between the mobile application of the Subject Device and the version submitted in K212071 are as follows:
- . The mobile application of the Subject Device has 2-way communication allowing the app to start/stop treatment sessions, and control (increase/stabilize) intensity as an alternative to the control button on the neurostimulator.
- Push notifications to users, suggesting them to undertake . Prevent Treatment as scheduled by them and inform users when the intensity is ramping up and the intensity is stabilized
- Log historical preventative treatment data using the Cefaly . device, namely time, date, duration, and treatment intensity, in addition to the acute treatment data using the Cefaly device
INDICATIONS FOR USE 5.
Cefaly Connected - OTC is indicated for:
-
- Acute treatment of migraine with or without aura in patients 18 years of
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for CEFAYLY. The word "CEFAYLY" is in large, gray, sans-serif letters. Below that, the word "TECHNOLOGY" is in smaller, white, sans-serif letters on a gray rounded rectangle.
age or older
-
- Preventative treatment of migraine in patients 18 years of age or older
Cefaly Connected - Rx is indicated for:
- Preventative treatment of migraine in patients 18 years of age or older
-
- Acute treatment of migraine with or without aura in patients 18 years of age or older
-
- Prophylactic treatment of migraine in patients 18 years of age or older
TECHNOLOGICAL CHARACTERISTICS 6.
| 6.1. Comparison of Technological Characteristics between Subject | ||
|---|---|---|
| and Predicate Devices |
| Comparison for the mobile application component | |||
|---|---|---|---|
| Parameters | Subject Device | Primary Predicate Device:Cefaly® Dual Connected -OTC, and,Cefaly® Dual Connected-Rx | Equivalence |
| Device Physicalstatus | Mobile Application | Mobile Application | Equivalent |
| Major appfunctionalities | Remote treatment session control of hardware through Bluetooth interface Treatment log Migraine log | Treatment log Migraine log PDF Download of trends and patterns | Different |
| Comparison for the mobile application component | |||
| Parameters | Subject Device | Primary Predicate Device:Cefaly® Dual Connected -OTC, and,Cefaly® Dual Connected-Rx | Equivalence |
| PDF Download oftrends and patterns | |||
| User Interface:TreatmentSession Controls | Start/stop treatmentsessions Increase intensity Stabilize intensity | No Treatment session controlsavailable | Different |
| Monitoringtreatmentprogress | Visually Monitor progress oftreatment sessions throughapp user-interface inaddition to the audio-visualindications on the hardware | Visually monitor progress oftreatment sessions throughapp user-interface in additionto the audio-visual indicationson the hardware | Equivalent |
| Treatment Logs | Patient-reported | Patient-reported | Equivalent |
| Migraine logs | Patient-reported | Patient-reported | Equivalent |
| Migraine report | PDF report consisting oftrends and patient-specificstatistics based on user | PDF report consisting of trendsand patient-specific statisticsbased on user reported | Equivalent |
| Comparison for the mobile application component | |||
| Parameters | Subject Device | Primary Predicate Device:Cefaly® Dual Connected -OTC, and,Cefaly® Dual Connected-Rx | Equivalence |
| reported migraineinformation, acute andpreventative treatments,which can be saved andshared with a healthcareprovider | migraine information, acuteand preventative treatments,which can be saved andshared with a healthcareprovider | ||
| Userauthentication | User authentication viaaccount creation and loginprocess | User authentication viaaccount creation and loginprocess | Equivalent |
| Graphical Data | Data graphs displayingnumber of migrainesexperienced, migraine painintensity, location,symptoms, triggers, drug/non-drug treatments,frequency of treatments,distribution of migrainesacross a specified timeframe(months, weeks, etc.),trends in triggers,medications reported, andtreatment intensity of | Data graphs displaying numberof migraines experienced,migraine pain intensity,location, symptoms, triggers,drug/ non-drug treatments,frequency of treatments,distribution of migraines acrossa specified timeframe (months,weeks, etc.), trends in triggers,medications reported, andtreatment intensity of CEFALYtreatment sessions | Equivalent |
| Comparison for the mobile application component | |||
| Parameters | Subject Device | Primary Predicate Device:Cefaly® Dual Connected -OTC, and,Cefaly® Dual Connected-Rx | Equivalence |
| CEFALY treatment sessions | |||
| Indicators onapp interface | Visual (textual indicators inform of pop-ups, banners,push notifications,information display)indicators for:1. On/off status2. Battery charge status interms of remainingcharge3. Bluetooth Connectionstate4. Type of treatmentprogram selected duringinitial selection5. Time remaining for atreatment session to end | Visual (textual indicators in theform of pop-ups, banners,push notifications, informationdisplay) indicators for:1. On/off status2. Battery charge statusin terms of remainingcharge3. Bluetooth Connectionstate4. Type of treatmentprogram selectedthroughout treatmentsession5. Time remaining for atreatment session toend6. When the treatment is | Different |
| Comparison for the mobile application component | |||
| Parameters | Subject Device | Primary Predicate Device:Cefaly® Dual Connected -OTC, and,Cefaly® Dual Connected-Rx | Equivalence |
| 6. Intensity stabilized | in session | ||
| 7. Intensity ramp-up | |||
| 8. Intensity at 10 mA | |||
| 9. Intensity at maximumvalue | |||
| 10. Reminders to do PreventTreatment as scheduledby user | |||
| Option to Loghistoricalpreventativetreatment datausing the CefalyDevice | Available | Unavailable | Different |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, gray, sans-serif font. Below that, the word "TECHNOLOGY" is in a smaller, white, sans-serif font, set against a gray rounded rectangle.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image contains the logo for CEFALY. The logo is in gray and consists of the word "CEFALY" in large, bold letters. Below the word "CEFALY" is the word "TECHNOLOGY" in smaller, white letters on a gray rounded rectangle.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for CEFALY. The logo is in a sans-serif font and is a dark gray color. The word "CEFALY" is on the top line, and the word "TECHNOLOGY" is on the bottom line. The bottom line is inside of a rounded rectangle.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, gray, sans-serif font. Below that, the word "TECHNOLOGY" is in a smaller, white, sans-serif font, set against a gray rounded rectangle.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image contains the logo for "CEFALY TECHNOLOGY". The word "CEFALY" is in a large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font and is set within a gray rounded rectangle. The registered trademark symbol is present to the right of the word "CEFALY".
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
|---|---|---|---|---|
| Parameters | Subject Device | Primary PredicateDevice:Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | Equivalence | |
| Device button functions | Start treatment sessions Increase intensity Stabilize intensity Initiate Bluetooth connection | Start Treatment sessions Increase intensity Stabilize intensity Initiate Bluetooth connection | Equivalent | |
| Bluetooth | Yes | Yes | Equivalent | |
| Charging System | Charging dock,Power adapter andUSB Cable. | Charging dock,Power adapter andUSB Cable. | Equivalent | |
| Power Source | 1 rechargeable LiPo | 1 rechargeable LiPo | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice: | Equivalence | |
| Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | ||||
| 3.7 V battery | 3.7 V battery | |||
| Weight | 25 grams | 25 grams | Equivalent | |
| Dimensions | 66 mm x 47 mm x 17mm | 66 mm x 47 mm x 17 mm | Equivalent | |
| Channels | 1 | 1 | Equivalent | |
| Treatment | 2 programs: | 2 programs: | Equivalent | |
| Programs | • Program 1 - | • Program 1 - | ||
| The acute treatment ofMigraine attacks | The acute treatment ofMigraine attacks | |||
| • Program 2 - | • Program 2 - | |||
| The prevent treatment of | The prevent treatment of | |||
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice:Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | Equivalence | |
| migraine | migraine | |||
| Waveform | Biphasic | Biphasic | Equivalent | |
| Shape | Rectangular | Rectangular | Equivalent | |
| Full compensated | Full compensated | Equivalent | ||
| Symmetrical | Symmetrical | Equivalent | ||
| Net charge (µC)per pulse | 0 | 0 | Equivalent | |
| Maximum outputvoltage (V): | ||||
| At 500 ohms | 8 | 8 | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice: | Equivalence | |
| Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | ||||
| At 2,000 ohms | 32 | 32 | ||
| At 10,000 ohms | 60 | 60 | ||
| Maximum outputcurrent (mA): | ||||
| At 500 ohms | 16 | 16 | Equivalent | |
| At 2,000 ohms | 16 | 16 | Equivalent | |
| At 10,000 ohms | 6 | 6 | Equivalent | |
| Pulse duration(μs) | 505 | 505 | Equivalent | |
| Maximum PhaseCharge (μC) @500 Ohms | 4 | 4 | Equivalent | |
| Type ofimpedancemonitoringsystem | Electrical | Electrical | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice: | Equivalence | |
| Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | ||||
| Maximumcurrent density(mA/cm2, r.m.s.)at 500 ohms | 2.37 | 2.37 | Equivalent | |
| Treatment Programs output specifications - Program 1 | ||||
| Amplitude | 0 - 16 mA | 0 - 16 mA | Equivalent | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | Equivalent | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | Equivalent | |
| Session duration | 60 minutes | 60 minutes | Equivalent | |
| Maximumaverage current(average absolutevalue, mA) at500 ohms | 0.8 | 0.8 | Equivalent | |
| Maximumaverage powerdensity (W/cm2) | 0.000047 | 0.000047 | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice: | Equivalence | |
| Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | ||||
| at 500 ohms | ||||
| Treatment Programs output specifications - Program 2 | ||||
| Amplitude | 0 - 16 mA | 0 - 16 mA | Equivalent | |
| Pulse width | 250 $ μ $ s, fixed | 250 $ μ $ s, fixed | Equivalent | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | Equivalent | |
| Session duration | 20 minutes | 20 minutes | Equivalent | |
| Maximumaverage current(average absolutevalue, mA) at500 ohms | 0.48 | 0.48 | Equivalent | |
| Maximumaverage powerdensity (W/cm2)at 500 ohms | 0.000017 | 0.000017 | Equivalent | |
| Audio-visual Indications | ||||
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary Predicate Device: | Equivalence | |
| Cefaly® Dual Connected - OTC, and,Cefaly® Dual Connected -Rx | ||||
| Audio Indicatorsfor low battery,Type of treatmentprogram selected,Acute andPrevent Program(Low BatteryCharge),Intensity is10mA, Stabilizedintensity, MaximumIntensity reached,IncreaseIntensity (ForExperiencedCEFALY Users),Bluetoothconnection anddisconnectionand electrodedetection | Present | Present | Equivalent | |
| Visual Indicatorsfor low battery, Typeof treatmentprogram selected, | Present | Present | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice: | Equivalence | |
| Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | ||||
| fully chargedbattery, batterycharging,bluetoothconnection anddisconnectionand electrodedetection | ||||
| Electrode | ||||
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent | |
| Electrode Gelused | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent | |
| Packaging configuration | ||||
| Gift Box | Made of cardboard, has amagnetic latch, artwork,and label. | Made of cardboard, has amagnetic latch, artwork, andlabel. | Equivalent | |
| Storage Case | The storage case containsa USB cable, chargingdock, device, usermanual, Instruction guide, | The storage case contains aUSB cable, charging dock,device, user manual,Instruction guide, and | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the PredicateDevice | ||||
| Parameters | Subject Device | Primary PredicateDevice:Cefaly® Dual Connected- OTC, and,Cefaly® Dual Connected-Rx | Equivalence | |
| and resealable bagconsisting of electrodes | resealable bag consisting ofelectrodes | |||
| Number ofelectrodesprovided with thedevice | Three (3) | Three (3) | Equivalent | |
| Electrode storage | Resealable bag | Resealable bag | Equivalent |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray background.
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray background.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image contains the logo for "CEFALY TECHNOLOGY". The word "CEFALY" is in a large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font and is set within a gray rounded rectangle. The registered trademark symbol is present to the right of the word "CEFALY".
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image contains the logo for "CEFALY" in a sans-serif font. Below the word "CEFALY" is the word "TECHNOLOGY" in a smaller, sans-serif font, set against a gray rounded rectangle. The registered trademark symbol is present to the right of the word "CEFALY".
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray rounded rectangle.
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image contains the logo for "CEFALY TECHNOLOGY". The word "CEFALY" is in a large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font and is set within a gray rounded rectangle. The registered trademark symbol is present to the right of the word "CEFALY".
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray background.
{22}------------------------------------------------
Image /page/22/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, bold, gray letters at the top. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray background. The logo is simple and modern.
Substantial Equivalence Discussion 6.2.
Similarities between Subject Device and it's Predicate 6.2.1.
The following technological characteristics are identical between Subject Device and Predicate Devices;
- . Device physical status, as both the Subject Device and Predicate Devices have software applications deployed on commercially available smartphones
- User authentication ●
- Treatment Logs record the same information in case of both Subject and Predicate Devices
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif letters. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif letters on a gray, rounded rectangle.
- Migraine logs record the same information in case of both ● Subject and Predicate devices
- . Migraine report record the same trends and patterns in both the Subject and Predicate Devices
- . Graphical data - Same data graphs based on user-provided information is presented
- Bluetooth protocol is used for ● The same the neurostimulator used with the Subject and in the Predicate Device.
- The power source, the charging system, and mechanical ● characteristics are the same for the neurostimulator in the case of both the Subject and the Predicate Device.
- . Waveform characteristics and output specifications of both ACUTE (Program 1) and PREVENT (Program 2) are the same for both the Subject and the Predicate Device.
- . Audio-visual Indications and Device button functions used in the neurostimulators for both the Subject and Predicate devices, are the same.
- The packaging configuration and patient-contacting . component of the Electrode used with the Subject and Predicate Device are the same.
6.2.2. Differences between Subject Device and it's Predicate
Following are the differences in the technological characteristics of the Subject and Predicate Device:
- . Major App functionalities
The only difference between the Subject and Predicate Device is that the mobile application of the Subject Device has 2-way communication enabling remote control of the
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image contains the logo for "CEFALY". The word "CEFALY" is in large, bold, gray letters. Below "CEFALY" is the word "TECHNOLOGY" in smaller, white letters on a gray background. The logo is simple and modern.
neurostimulator. The mobile application is intended for use as an accessory to the neurostimulator, which is the same for both the Subject Device and the Predicate Device given that:
- Neurostimulator can perform treatment 1. The sessions independent of the mobile application,
-
- Software user interface provided by the mobile application of the Subject Device is supplementary to that of the neurostimulator and can be overridden by the latter.
There are no new questions of safety and efficacy. This is further substantiated by the risk analysis and the Non-clinical Bench Performance testing.
The remaining mobile app functions as cited in the technological comparison of the mobile application component, are identical in the case of the Subject and the Predicate Device, are non-medical ("other") device functions, and as discussed in the device description, do not have any impact on the medical device function (controlling the hardware).
- Treatment Session Controls: ●
The mobile application component in the Subject Device includes different control functions. In the case of the Predicate device, the mobile application component did not include any functionalities to control the neurostimulator.
In the Subject Device, the user controls in the mobile application component (functions related to increasing intensity, starting treatment, and stabilizing treatment) are consistent (function in the same way, i.e., long press
{25}------------------------------------------------
Image /page/25/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is written in large, bold, gray letters. Below the word "CEFALY" is the word "TECHNOLOGY" written in smaller, white letters on a gray rounded rectangle.
for ramp-up, increasing/stabilizing within the first 14 minutes of starting the treatment, etc.) with the technological characteristics of of neurostimulator component, and have been validated through software system validation and interoperability testing.
For the Subject Device, the only additional (device button vs app button) treatment session control provided with the mobile application component is the "Stop" button in the app. This button allows the user to prematurely terminate an active treatment session that is initiated from the app. In the case of Predicate Device, the user had the only option to manually detach the device from the electrode for premature interruption of an active session initiated from the device. However, the manual detachment and the "Stop" button have the same function, that is, prematurely terminate the treatment. Thus, no new questions of safety or efficacy are raised.
Furthermore, given that the control functions provided with the mobile application and the neurostimulator component of the Subject Device are independent of each other and the user can override the app controls using the neurostimulator controls, it makes the app controls only supplementary, thus not raising different questions of safety or efficacy.
- Monitoring treatment Progress
Given that the mobile app is intended to be used as an accessory that supplements, in this case, the userinterface of the neurostimulator, and does not override the audio-visual indicators provided by the neurostimulator, there are no conflicts regarding the indications for the treatment progress for the user, during an active treatment session. The user can use indicators
{26}------------------------------------------------
Image /page/26/Picture/0 description: The image shows the logo for CEFALY. The logo is in a sans-serif font and is a dark gray color. The word "CEFALY" is on the top line, and the word "TECHNOLOGY" is on the bottom line. The bottom line is inside of a gray rounded rectangle.
from either or both the neurostimulator and mobile application to review the treatment progress. Furthermore, given that the neurostimulator can still indicate (due to independent functioning, i.e., not needing the app to be active throughout a treatment session) treatment progress in the event of the app malfunctioning, there are no new questions of safety or efficacy.
-
Types of indicators on app interface ●
The differences between the Subject and Predicate Devices are in terms of -
- Type of indications provided for informing the user about the type of treatment program selected or activated - In the Subject Device, the mobile app allows the user to select the type of treatment session. The selection made through a pop-up thus informs the user about the Acute or Preventative session, as the user taps the app button textually displaying the name of the session. However, once the selection through the mobile app is made, the type of session selected is indicated only by the visual indication on the neurostimulator. The mobile app in the case of Predicate Device, however, constantly displays the name of the treatment session in addition to the visual indicator on the neurostimulator, throughout the session's duration.
Given that the user is made aware of the type of treatment selected throughout the session, by the same visual indication on the neurostimulator in the case of both Subject and Predicate devices, there are no new safety or efficacy questions due to the use of the mobile app as an accessory.
- Type of indications provided for informing the user about the type of treatment program selected or activated - In the Subject Device, the mobile app allows the user to select the type of treatment session. The selection made through a pop-up thus informs the user about the Acute or Preventative session, as the user taps the app button textually displaying the name of the session. However, once the selection through the mobile app is made, the type of session selected is indicated only by the visual indication on the neurostimulator. The mobile app in the case of Predicate Device, however, constantly displays the name of the treatment session in addition to the visual indicator on the neurostimulator, throughout the session's duration.
{27}------------------------------------------------
Image /page/27/Picture/0 description: The image shows the logo for "CEFALY Technology". The word "CEFALY" is in large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font inside of a rounded rectangle. The logo is a dark gray color and the background is white. There is a registered trademark symbol next to the "Y" in "CEFALY".
-
- Indications to inform active session In the case of mobile application of the subject device there are no indications for an active session. However, there are push notifications to inform the user in case the app is running in the background for a predefined amount of time, which while acting as a supplementary indication, also ensures that there are no safety hazards as a result of the user becoming dependent on the mobile app user interface in a home environment. There are similar push notifications for the Intensity related controls as discussed in the device description.
-
- Reminder to perform prevent session The mobile application of the Subject Device includes a reminder functionality for Preventative sessions. The user can set reminders for themselves to perform preventative treatment sessions, which is displayed by the app, accordingly as a reminder to the user. The application does not analyze user provided information to suggest the reminders. As this functionality is based on the user's inputs and is a non-medical device function, there are no new questions of safety and effectiveness.
- Option to log historical preventative treatment data using ● the Cefaly device
The mobile application of the subject device allows the user to log historical data for treatment using Cefaly device, for both Acute and Preventative sessions. The Predicate Device allowed logging only Acute treatment sessions performed using the Cefaly device. This is a non-medical device function, and thus does not raise any questions of safety and effectiveness.
{28}------------------------------------------------
Image /page/28/Picture/0 description: The image contains the logo for CEFAYLY. The word CEFAYLY is in large, bold, gray letters. Below that, the word TECHNOLOGY is in smaller, white, bold letters on a gray rounded rectangle.
PERFORMANCE TESTING - BENCH 7.
Software Verification and Validation, including interoperability testing, was performed per the Software Test Plan to validate the control functions and associated features of the mobile app. Results of the testing were recorded in a test report, which demonstrates that the user interface provided by the application is consistent with the intended use of the device cleared under K212071.
Bench testing was performed to evaluate interoperability. The testing demonstrated that the intensity values displayed by the app and the actual intensity values are almost the same with an acceptable tolerance limit (-2%). It also demonstrates that the Bluetooth interface does not introduce unacceptable latency between the device and the mobile application. The Electromagnetic compatibility of CEFALY Connected and the safety of the wireless functions were demonstrated in K212071.
Threat modeling and penetration testing were done to identify security threats. Control measures were applied accordingly and traceability between the measures and the identified security threats was documented in a cybersecurity report.
8. PERFORMANCE TESTING -ANIMAL
No animal studies have been conducted for the Subject Device.
9. PERFORMANCE TESTING - CLINICAL
No clinical studies have been conducted for the Subject Device.
{29}------------------------------------------------
Image /page/29/Picture/0 description: The image contains the logo for "CEFALY". The word "CEFALY" is in large, gray, sans-serif font. Below "CEFALY" is a gray rounded rectangle with the word "TECHNOLOGY" in white, sans-serif font. To the right of the word "CEFALY" is a small registered trademark symbol.
0(k) Summ K234029
10. COMPLIANCE WITH SPECIAL CONTROLS
Cefaly Technology complies with all applicable special controls for 21 CFR Part 882.5891.
The following special controls are directly addressed and re-verified in this submission:
-
- Appropriate software verification, validation, and hazard analysis must be performed - See section 7, Performance Testing - Bench and section 11, Conclusion.
-
- Labeling for CeCe Migraine Management App includes the following:
- a. Information on how the device operates and the typical sensations experienced during treatment - The relevant information has been included in the labeling.
The following special controls were addressed in K212071:
-
- The patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety
-
- The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system must be fully characterized.
-
- Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted.
-
- Appropriate software verification, validation, and hazard analysis must be performed.
{30}------------------------------------------------
Image /page/30/Picture/0 description: The image shows the logo for "CEFALY Technology". The word "CEFALY" is in a large, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font below it. The logo is a dark gray color. The logo is simple and modern.
0(k) Summ K234029
-
- Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population.
-
- Labeling for the neurostimulators (See K212071) includes the following:
- a. Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
- b. Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery
- c. Appropriate precautions such as the long-term effects of chronic use of the device are unknown.
- d. A summary of the expected risks and benefits of using the device.
- e. A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
- f. Information on how the device operates and the typical sensations experienced during treatment
- g. Information on how the device operates and the typical sensations experienced during treatment
- h. A detailed summary of the device's technical parameters.
- i. An expiration date/shelf life for the electrodes and the number of times they can be reused.
- i. Disposal instructions - For all the aforementioned (a through i) labeling requirements, appropriate information, and instructions have been provided in the labeling of the Subject Device.
{31}------------------------------------------------
Image /page/31/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif font. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif font, set against a gray, rounded rectangle. A registered trademark symbol is located to the right of the letter "Y" in "CEFALY".
CONCLUSION 11.
The Subject Device is believed to be substantially equivalent to the Predicate Device based on the results of risk assessment, software validation, and interoperability tests. The risk assessment evaluates the hazards associated with the medical device, non-medical device functions, interoperability, and cybersecurity. The risk assessment also demonstrates that the non-medical device ("other") functions of the mobile application do not affect the safety and efficacy of the medical device functions associated with the Subject Device.
The software validation evaluates the intended functioning of the user interface associated with treatment controls in the mobile app and demonstrates that the controlling functions of the mobile app are the same as the physical controls provided by the neurostimulator, and are safe and effective. Bench testing and software validation, together validate the Bluetooth Interface functioning and substantiate that the treatment controls using the mobile app are not affected by the interface. The existing wireless coexistence results demonstrate that there are no new hazards arising from the use of the Subject Device in a home environment.
The results of these evaluations demonstrate that new questions of safety and efficacy are not raised due to the technological differences between the Subject and Predicate Devices, resulting in the Subject Device being substantially equivalent to the Predicate Device.
§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
(a)
Identification. A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted.
(5) Appropriate software verification, validation, and hazard analysis must be performed.
(6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population.
(7) Labeling must include the following:
(i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
(ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery.
(iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown.
(iv) A summary of the expected risks and benefits of using the device.
(v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
(vi) Information on how the device operates and the typical sensations experienced during treatment.
(vii) A detailed summary of the device technical parameters.
(viii) An expiration date/shelf life for the electrodes and the number of times they can be reused.
(ix) Disposal instructions.