(529 days)
Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are 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 Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are 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
The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.). The devices are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.
The provided text is a 510(k) premarket notification for the Cefaly Dual Series devices. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence. Crucially, this document does not contain information about a study that proves the device meets specific acceptance criteria in the format typically used for demonstrating the performance of a novel AI/ML-based medical device.
The document states:
- "No animal testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
- "No clinical testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
This indicates that the submission relies on demonstrating substantial equivalence to existing devices through bench testing and comparison of technological characteristics, rather than new clinical performance data to prove efficacy. The changes made to the device (e.g., Bluetooth, RFID, audio/visual indicators, charging system, weight, dimensions, electrode thickness, packaging) are assessed against safety and electrical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and adhesion performance.
Therefore, I cannot provide the requested information for a study proving acceptance criteria for an AI/ML device because:
- No acceptance criteria for an AI/ML device are listed. The document pertains to a Transcutaneous Electrical Nerve Stimulator, not a device incorporating AI/ML for diagnostic or therapeutic decision-making.
- No study proving device performance against such criteria is presented. The "Performance Testing - Bench" section (Table 5.7.1) lists general electrical and EMC safety standards, and adhesion testing for electrodes, but not performance metrics related to migraine treatment outcomes that would typically be evaluated in a clinical trial.
Without a study described as such in the provided text, I cannot fill in the requested table or additional details. The information provided heavily focuses on hardware changes and their compliance with general safety standards, and substantiates that the functionality of the device (e.g., electrical stimulation parameters) remains equivalent to the cleared predicate devices, thus not requiring new clinical evidence of effectiveness for migraine treatment.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2022
CEFALY Technology % Parul Chansoria CEO and Founder Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, Wyoming 82801
Re: K212071
Trade/Device Name: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual 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: January 6, 2022 Received: January 10, 2022
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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, MS MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212071
Device Name
Cefaly Dual Series (Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx)
Indications for Use (Describe) Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:
- Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Preventative treatment of migraine in patients 18 years of age or older
Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are 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)
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Image /page/3/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. A small registration mark is present to the right of the letter "Y".
5.1. 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: December 12, 2022
5.2. Device Information
- 5.2.1. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected OTC Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation Number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
- 5.2.2. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected Rx Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
CEFALY Technology K212071
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- 5.2.3. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - OTC Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
- 5.2.4. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - Rs Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
5.3. Predicate Device Information
The following Predicate Devices are used:
| Company | Product | 510(k)Number | Subject Device |
|---|---|---|---|
| CEFALYTechnology | Cefaly® Dual | K173006 | • Cefaly® DualConnected Rx,• Cefaly® DualEnhanced withRFID Rx |
| CEFALYTechnology | Cefaly® Dual | K201895 | • Cefaly® DualConnectedOTC,• Cefaly® Dual |
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| Enhanced withRFID OTC | |||
|---|---|---|---|
| -- | -- | -- | --------------------------- |
The Predicate Devices stated above are not subject to recall by the FDA.
5.4. Device Description
Cefaly® Dual Series by CEFALY Technology consists of Cefaly® Dual Enhanced with RFID - R., Cefaly® Dual Enhanced with RFID - OTC. Cefaly® Dual Connected - R. and Cefaly® Dual Connected - OTC. The Cefaly® Dual Series of devices are identical to the Predicate Devices Cefaly® Dual - Rx (K173006) and Cefaly® Dual - OTC (K201895).
The submission includes CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected which are indicated for Ry, are identical to the Predicate Devices CEFALY® Dual - Rx (K173006) and CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected, which are indicated for OTC, are identical to the Predicate Devices CEFALY® Dual - OTC (K201895). Additionally, all the devices in the CEFALY® Dual Series are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.
The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.).
ર.ડ. Indications for Use
Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID -OTC are 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
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Cefaly Dual Connected – Rx and Cefaly Dual Enhanced With RFID – Rx are 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
5.6. Technological Characteristics
5.6.1. Comparison of the Technological Characteristics between Subject Device and Predicate Device
| Parameters | Subject Device:Cefaly® DualConnected - OTC | PredicateDevice:Cefaly® Dual | Equivalence | |
|---|---|---|---|---|
| Manufacturer | CEFALYTechnology | CEFALYTechnology | ||
| Device Name | CEFALY® DualConnected | CEFALY® Dual | - | |
| 510(k) Number | - | K201895 | - | |
| Product code | PCC | PCC | Equivalent | |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent | |
| Classification: | II | II | Equivalent | |
| Indications forUse | The indications foruse of CEFALY®Dual Connected foran over-the-counteruse are: | The indicationsfor CEFALY®Dual for anover-the-counteruse are: | Equivalent | |
| • Acute treatmentof migraine withor without aurain patients 18years of age orolder• Preventativetreatment ofmigraine inpatients 18years of age orolder | • The acutetreatment ofmigraine withor without aurain patients 18years of age orolder• The prophylactictreatment ofepisodicmigraine inpatients 18years of age orolder | |||
| MobileApplication | Yes | No | Different | |
| Bluetooth | Yes | No | Different | |
| RFID forelectrodedetection | Yes | No | Different | |
| Charging System | Charging dock,Power adapter andUSB Cable. | Power adapterand USB Cable | Different | |
| Power Source | 1 rechargeable LiPo3.7 V battery | 1 rechargeableLiPo 3.7 Vbattery | Equivalent | |
| Electrode MetalPlate (RFID tag)Thickness | 1 mm | 0.4 mm | Different | |
| Weight | 25 grams | 12 grams | Different | |
| Dimensions | 66 mm x 47 mm x 17 mm | 55 mm x 40 mm x15 mm | Different | |
| Channels | 1 | 1 | Equivalent | |
| TreatmentPrograms | 2 programs:Program 1 - The acute treatment of migraine attacks Program 2 - The prevent treatment of migraine | 2 programs:Program 1 - The acute treatment of migraine attacks Program 2 - The prophylactic treatment of episodic migraine | Equivalent | |
| 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 | |
| At 2,000 ohms | 32 | 32 | Equivalent | |
| At 10,000 ohms | 60 | 60 | Equivalent | |
| 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 | |
| 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 | ||
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | ||
| Session duration | 60 minutes | 60 minutes | ||
| Maximumaverage current(average absolutevalue, mA) at500 ohms | 0.8 | 0.8 | Equivalent | |
| Maximumaverage powerdensity (W/cm²)at 500 ohms | 0.000047 | 0.000047 | Equivalent | |
| Treatment Programs output specifications - Program 2 | ||||
| Amplitude | 0 - 16 mA | 0 - 16 mA | ||
| Pulse width | 250 µs, fixed | 250 µs, fixed | Equivalent | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | ||
| Session duration | 20 minutes | 20 minutes | ||
| 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 | ||||
| Audio Indicatorsfor low battery,Acute andPrevent Program(Low BatteryCharge),Intensity is10mA, IncreaseIntensity (ForExperiencedCEFALY Users),Bluetoothconnection anddisconnectionand electrodedetection | Present | Absent | Different | |
| Visual Indicatorsfor low battery,bluetoothconnection anddisconnectionand electrodedetection | Present | Absent | Different | |
| Electrode | ||||
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent | |
| RFID tag | Present | Not Present | Different | |
| Electrode Metalplate | 1 mm | 0.4 mm | Different | |
| (tinplate)thickness | ||||
| Electrode Gelused | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent | |
| Packaging configuration | Gift Box | Made of cardboard,has a magnetic latch,artwork, and label. | A white boxmade ofcardboard, nomagnetic latchand no artwork.The white boxslides inside asleeve that hasartwork andlabel. | Different |
| Storage Case | The storage casecontains a USBcable, chargingdock, device, usermanual, Instructionguide, andresealable bagconsisting ofelectrodes | The storage casecontains a USB,charging adapter,and electrodeinside.The device is on acardboard sheeton top of thestorage case. Usermanual(s) arebelow the case. | Different | |
| Number ofelectrodesprovided with thedevice | Three (3) | One (1) | Different | |
| Electrode storage | Resealable bag | Non- resealablebag | Different |
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CEFALY Technology K212071
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CEFALY Technology K212071
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5.6.1.1. Similarities between Subject Device and Predicate Device
- · The intended use is the same for the Subject and the Predicate Devices and both devices are meant for over-the-counter use.
- Treatment Programs Waveform characteristics and output . specifications are same for both the Subject and Predicate Device.
- The Channels are the same for both the Subject and . Predicate Devices.
- Maximum output voltage is the same for both Subject and . Predicate Devices.
- Maximum output current is the same for both Subject and . Predicate Devices.
- The Power source (Battery) is the same for both Subject . and Predicate Devices.
- . The Pulse duration, Maximum phase charge and Type of impedance monitoring system is the same for both Subject and Predicate devices.
- . The dimensions and patient contacting material used in the electrode is same for both Subject and Predicate devices.
Differences between Subject Device and Predicate Device 5.6.1.2.
- The usage of Mobile application and Bluetooth in Subject . Device is different from Predicate Device.
- The RFID tag is added to electrode for Subject Device for ● electrode detection and, electrode metal plate thickness in
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Subject Device (1mm) is different from Predicate Device (0.4mm).
- The weight and dimensions of the Subject device is ● different from Predicate Device.
- The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
- The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
- The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.
5.6.2. Comparison of the Technological Characteristics between Subject Device and Predicate Device
| Parameters | Subject Device:Cefaly® DualConnected - Rx | Predicate Device:Cefaly® Dual | Equivalence |
|---|---|---|---|
| Manufacturer | CEFALYTechnology | CEFALYTechnology | |
| Device Name | CEFALY® DualConnected | CEFALY® Dual | - |
CEFALY Technology K212071
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| 510(k) Number | - | K173006 | - |
|---|---|---|---|
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications for Use | The indications for use of CEFALY® Dual Connected for an Rx are:• 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 | The indications for CEFALY® Dual for an Rx use are:• The acute treatment of migraine with or without aura in patients 18 years of age or older• The prophylactic treatment of episodic migraine in patients 18 years of age or older | Equivalent |
| Mobile Application | Yes | No | Different |
| Bluetooth | Yes | No | Different |
| RFID for electrode detection | Yes | No | Different |
| Charging System | Charging dock,Power adapter andUSB Cable. | Power adapter andUSB Cable | Different |
| Power Source | 1 rechargeable LiPo3.7 V battery | 1 rechargeableLiPo 3.7 V battery | Equivalent |
| Electrode metalplate (RFID tag)thickness | 1 mm | 0.4 mm | Different |
| Weight | 25 grams | 12 grams | Different |
| Dimensions | 66 mm x 47 mm x 17mm | 55 mm x 40 mm x15 mm | Different |
| Channels | 1 | 1 | Equivalent |
| TreatmentPrograms | 2 programs:Program 1 - The acute treatment of migraine attacksProgram 2 - The prevent treatment of migraine | 2 programs:Program 1 - The acute treatment of migraine attacksProgram 2 - The prophylactic treatment of episodic migraine | Equivalent |
| 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 output voltage (V): | |||
| At 500 ohms | 8 | 8 | Equivalent |
| At 2,000 ohms | 32 | 32 | |
| At 10,000 ohms | 60 | 60 | |
| Maximum output current (mA): | |||
| At 500 ohms | 16 | 16 | Equivalent |
| At 2,000 ohms | 16 | 16 | |
| At 10,000 ohms | 6 | 6 | |
| Pulse duration (μs) | 505 | 505 | Equivalent |
| Maximum Phase Charge (µC) @ 500 Ohms | 4 | 4 | Equivalent |
| Type of impedance monitoring system | Electrical | Electrical | Equivalent |
| Maximum currentdensity (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 | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | |
| Session duration | 60 minutes | 60 minutes | |
| Maximumaverage current(average absolutevalue, mA) at 500ohms | 0.8 | 0.8 | Equivalent |
| Maximumaverage powerdensity (W/cm²)at 500 ohms | 0.000047 | 0.000047 | Equivalent |
| Treatment Programs output specifications - Program 2 | |||
| Amplitude | 0 - 16 mA | 0 - 16 mA | Equivalent |
| Pulse width | 250 µs, fixed | 250 µs, fixed | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | |
| Session duration | 20 minutes | 20 minutes | |
| Maximumaverage current(average absolute | 0.48 | 0.48 | Equivalent |
| value, mA) at 500 ohms | |||
| Maximum average power density (W/cm²) at 500 ohms | 0.000017 | 0.000017 | Equivalent |
| Audio-visual Indications | |||
| Audio Indicators for low battery, Acute and Prevent Program (Low Battery Charge), Intensity is 10mA, Increase Intensity (For Experienced CEFALY Users), Bluetooth connection and disconnection and electrode detection | Present | Absent | Different |
| Visual Indicators for low battery, bluetooth connection and disconnection and electrode detection | Present | Absent | Different |
| Electrode | |||
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent |
| RFID tag | Present | Not Present | Different |
| Electrode Metalplate (tinplate)thickness | 1 mm | 0.4 mm | Different |
| Electrode Gelused | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent |
| Packaging Configuration | |||
| Gift Box | Made of cardboard,has a magnetic latch,artwork, and label. | A white box madeof cardboard, nomagnetic latch andno artwork. Thewhite box slidesinside a sleeve thathas artwork andlabel. | Different |
| Storage Case | The storage casecontains a USBcable, chargingdock, device, usermanual, Instructionguide, and resealablebag consisting ofelectrodes | The storage casecontains a USB,charging adapter,and electrodeinside.The device is on acardboard sheet ontop of the storagecase. Usermanual(s) arebelow the case. | Different |
| Number ofelectrodesprovided with thedevice | Three (3) | One (1) | Different |
| Electrode storage | Resealable bag | Non- resealable | Different |
| bag |
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CEFALY Technology K212071
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Similarities between Subject Device and Predicate Device 5.6.2.1.
- The intended use is the same for the Subject and the . Predicate Devices and both devices are meant for Prescription use.
- Treatment Programs Waveform characteristics and output ● specifications are same for both the Subject and Predicate Device.
- The Channels are the same for both the Subject and . Predicate Devices.
- . Maximum output voltage is the same for both Subject and Predicate Devices.
- Maximum output current is the same for both Subject and . Predicate Devices.
- The Power source (Battery) is the same for both Subject . and Predicate Devices.
- The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
- . The dimensions and patient contacting material used in the electrode is same for both Subject and Predicate devices.
5.6.2.2. Differences between Subject Device and Predicate Device
- The usage of Mobile application and Bluetooth in Subject Device is different from Predicate Device.
- The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in
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Subject Device (1mm) is different from Predicate Device (0.4mm).
- The weight and dimensions of the Subject device is ● different from Predicate Device.
- The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
- The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
- The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.
5.6.3. Comparison of the Technological Characteristics between Subject Device and Predicate Device
| Parameters | Subject Device:Cefaly® DualEnhanced with RFID- OTC | Predicate Device:Cefaly® Dual | Equivalence |
|---|---|---|---|
| Manufacturer | CEFALY Technology | CEFALYTechnology | |
| Device Name | CEFALY® DualEnhanced with RFID | CEFALY® Dual | - |
| 510(k) Number | - | K201895 | - |
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications forUse | The indications foruse of CEFALY® DualEnhanced with RFIDfor anover-the-counter useare:Acute treatment ofmigraine withor without aurain patients 18years of age orolder Preventativetreatment ofmigraine inpatients 18years of age orolder | The indicationsfor CEFALY®Dual for anover-the-counteruse are:The acutetreatment ofmigraine with orwithout aura inpatients 18 yearsof age or older Theprophylactictreatment ofepisodicmigraine inpatients 18 yearsof age or older | Equivalent |
| MobileApplication | No | No | Equivalent |
| Bluetooth | No | No | Equivalent |
| RFID forelectrodedetection | Yes | No | Different |
| ChargingSystem | Charging dock, Poweradapter and USBCable | Power adapter andUSB Cable | Different |
| Power Source | 1 rechargeable LiPo3.7 V battery | 1 rechargeableLiPo 3.7 V battery | Equivalent |
| Electrode MetalPlate Thickness | 1 mm | 0.4 mm | Different |
| Weight | 25 grams | 12 grams | Different |
| Dimensions | 66 mm x 47 mm x 17mm | 55 mm x 40 mm x15 mm | Different |
| Channels | 1 | 1 | Equivalent |
| TreatmentPrograms | 2 programs:Program 1 - The acute treatment of migraine attacksProgram 2 - The prevent treatment of migraine | 2 programs:Program 1 - The acute treatment of migraine attacksProgram 2 - The prophylactic treatment of episodic migraine | Equivalent |
| Waveform | Biphasic | Biphasic | Equivalent |
| Shape | Rectangular | Rectangular | Equivalent |
| Full compensated | Full compensated | Equivalent | |
| Symmetrical | Symmetrical | Equivalent | |
| Net charge(µC) per pulse | 0 | 0 | |
| Maximumoutput voltage(V): | |||
| At 500 ohms8 | 8 | Equivalent | |
| At 2,000 ohms32 | 32 | ||
| At 10,000 ohms60 | 60 | ||
| Maximumoutput current(mA): | |||
| At 500 ohms16 | 16 | Equivalent | |
| At 2,000 ohms16 | 16 | ||
| At 10,000 ohms6 | 6 | ||
| Pulse duration(μs) | 505 | 505 | Equivalent |
| MaximumPhase Charge(µC) @ 500Ohms | 4 | 4 | Equivalent |
| Type ofimpedancemonitoringsystem | Electrical | Electrical | Equivalent |
| Maximumcurrent density(mA/cm²,r.m.s.) at 500ohms | 2.37 | 2.37 | Equivalent |
| Treatment Programs output specifications - Program 1 | |||
| AmplitudePulse widthPulse frequencySessionduration | 0 - 16 mA250 µs, fixed100 Hz, fixed60 minutes | 0 - 16 mA250 µs, fixed100 Hz, fixed60 minutes | Equivalent |
| Maximumaverage current(averageabsolute value,mA) at 500ohms | 0.8 | 0.8 | Equivalent |
| Maximumaverage powerdensity(W/cm²) at 500ohms | 0.000047 | 0.000047 | Equivalent |
| AmplitudePulse widthPulse frequencySessionduration | 0 - 16 mA250 µs, fixed60 Hz, fixed20 minutes | 0 - 16 mA250 µs, fixed60 Hz, fixed20 minutes | Equivalent |
| Maximumaverage current(averageabsolute value,mA) at 500ohms | 0.48 | 0.48 | Equivalent |
| Maximumaverage powerdensity(W/cm²) at 500ohms | 0.000017 | 0.000017 | Equivalent |
| Audio-visual Indications | |||
| AudioIndicators forlow battery,Acute andPreventProgram (LowBatteryCharge),Intensity is10mA, IncreaseIntensity (ForExperiencedCEFALYUsers) and | Present | Absent | Different |
| electrodedetection | |||
| VisualIndicators forlow battery andelectrodedetection | Present | Absent | Different |
| Electrode | |||
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent |
| RFID tag | Present | Not Present | Different |
| Electrode Metalplate (tinplate)thickness | 1 mm | 0.4 mm | Different |
| Electrode Gelused | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent |
| Packaging Configuration | |||
| Gift Box | Made of cardboard,has a magnetic latch,artwork, and label. | A white box madeof cardboard, nomagnetic latch andno artwork. Thewhite box slidesinside a sleeve thathas artwork andlabel. | Different |
| Storage Case | The storage casecontains a USB cable,charging dock, device,user manual,Instruction guide, andresealable bagconsisting of | The storage casecontains a USB,charging adapter,and electrodeinside.The device is on a | Different |
| electrodes | cardboard sheet ontop of the storagecase. Usermanual(s) arebelow the case. | ||
| Number ofelectrodesprovided withthe device | Three (3) | One (1) | Different |
| Electrodestorage | Resealable bag | Non- resealablebag | Different |
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CEFALY Technology K212071
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Image /page/29/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and has a small trademark symbol after the "Y".
Similarities between Subject Device and Predicate Device 5.6.3.1.
- The intended use is the same for the Subject and Predicate Devices and both devices are meant for over-the-counter use.
- Treatment Programs Waveform characteristics and output . specifications are same for both the Subject and Predicate Devices.
- . The Channels are the same for both Subject and Predicate Devices.
- Maximum output voltage is the same for both Subject and . Predicate Devices.
- Maximum output current is the same for both Subject and . Predicate Devices.
- The Power source (Battery) is the same for both Subject . and Predicate Devices.
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- The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
- The dimensions and patient contacting material used in the . electrode is same for both Subject and Predicate devices.
Differences between Subject Device and Predicate Device 5.6.3.2.
- The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in Subject Device (1mm) is different from Predicate Device (0.4mm).
- The weight and dimensions of the Subject device is ● different from Predicate Device.
- The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
- The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
- The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.
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5.6.4. Comparison of the Technological Characteristics between Subject Device and Predicate Device
| Parameters | Subject Device:Cefaly® DualEnhanced withRFID - Rₓ | Predicate Device:Cefaly® Dual | Equivalence |
|---|---|---|---|
| Manufacturer | CEFALYTechnology | CEFALYTechnology | |
| Device Name | CEFALY® DualEnhanced with RFID | CEFALY® Dual | - |
| 510(k) Number | - | K173006 | - |
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications forUse | The indications foruse of CEFALY®Dual Enhanced withRFID for an Rₓ useare: | The indications forCEFALY® Dual foran Rₓ use are:• The acutetreatment ofmigraine with orwithout aura inpatients 18 yearsof age or older• The prophylactictreatment ofepisodic migraine | Equivalent |
| 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 | in patients 18 years of age or older | ||
| Mobile Application | No | No | Equivalent |
| Bluetooth | No | No | Equivalent |
| RFID for electrode detection | Yes | No | Different |
| Charging System | Charging dock, USB Cable. | Power adapter and USB Cable | Different |
| Power Source | 1 rechargeable LiPo 3.7 V battery | 1 rechargeable LiPo 3.7 V battery | Equivalent |
| Electrode Metal Plate (RFID tag) Thickness | 1 mm | 0.4 mm | Different |
| Weight | 25 grams | 12 grams | Different |
| Dimensions | 66 mm x 47 mm x 17 mm | 55 mm x 40 mm x 15 mm | Different |
| Channels | 1 | 1 | Equivalent |
| TreatmentPrograms | 2 programs:Program 1 - The acute treatment of migraine attacks Program 2 - The prevent treatment of migraine | 2 programs:Program 1 - The acute treatment of migraine attacks Program 2 - The prophylactic treatment of episodic migraine | Equivalent |
| Waveform | Biphasic | Biphasic | Equivalent |
| Shape | RectangularFull compensatedSymmetrical | RectangularFull compensatedSymmetrical | Equivalent |
| Net charge (μC)per pulse | 0 | 0 | Equivalent |
| Maximumoutput voltage | 8 | Equivalent | |
| (V):At 500 ohmsAt 2,000 ohmsAt 10,000 ohms | 8 | 32 | |
| Maximumoutput current(mA):At 500 ohms | 16 | 16 | Equivalent |
| At 2,000 ohmsAt 10,000 ohms | 16 | 166 | |
| Pulse duration(μς) | 505 | 505 | Equivalent |
| MaximumPhase Charge(μC) @ 500Ohms | 4 | 4 | Equivalent |
| Type ofimpedancemonitoringsystem | Electrical | Electrical | Equivalent |
| Maximumcurrent density(mA/cm²,r.m.s.) at 500ohms | 2.37 | 2.37 | Equivalent |
| Treatment Programs output specifications - Program 1 | |||
| Amplitude | 0 - 16 mA | 0 - 16 mA | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | Equivalent |
| Session duration | 60 minutes | 60 minutes | |
| Maximum average current(average absolute value,mA) at 500 ohms | 0.8 | 0.8 | Equivalent |
| Maximum average powerdensity (W/cm²)at 500 ohms | 0.000047 | 0.000047 | Equivalent |
| Treatment Programs output specifications - Program 2 | |||
| Amplitude | 0 - 16 mA | 0 - 16 mA | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | Equivalent |
| Session duration | 20 minutes | 20 minutes | |
| Maximum average current(average absolute value,mA) at 500 ohms | 0.48 | 0.48 | Equivalent |
| Maximumaverage powerdensity (W/cm²)at 500 ohms | 0.000017 | 0.000017 | Equivalent |
| Audio-visual Indications | |||
| AudioIndicators forlow battery,Acute andPreventProgram (LowBatteryCharge),Intensity is10mA, IncreaseIntensity (ForExperiencedCEFALYUsers) andelectrodedetection | Present | Absent | Different |
| VisualIndicators forlow battery andelectrodedetection | Present | Absent | Different |
| Electrode | |||
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent |
| RFID tag | Present | Not Present | Different |
| Electrode Metalplate (tinplate)thickness | 1 mm | 0.4 mm | Different |
| Electrode Gelused | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent |
| Packaging Configuration | |||
| Gift Box | Made of cardboard,has a magnetic latch,artwork, and label. | A white box madeof cardboard, nomagnetic latch andno artwork. Thewhite box slidesinside a sleeve thathas artwork andlabel. | Different |
| Storage Case | The storage casecontains a USBcable, chargingdock, device, usermanual, Instructionguide, and resealablebag consisting ofelectrodes | The storage casecontains a USB,charging adapter,and electrode inside.The device is on acardboard sheet ontop of the storagecase. Usermanual(s) are belowthe case. | Different |
| Number ofelectrodesprovided withthe device | Three (3) | One (1) | Different |
| Electrodestorage | Resealable bag | Non- resealable bag | Different |
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Similarities between Subject Device and Predicate Device 5.6.4.1.
- The intended use is the same for the Subject and the . Predicate Devices and both devices are meant for Prescription use.
- . Treatment Programs - Waveform characteristics and output specifications are same for both the Subject and Predicate Device.
- The Channels are the same for both the Subject and ● Predicate Devices.
- Maximum output voltage is the same for both Subject and . Predicate Devices.
- Maximum output current is the same for both Subject and . Predicate Devices.
- The Power source (Battery) is the same for both Subject . and Predicate Devices.
- The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
- The dimensions and patient contacting material used in the ● electrode is same for both Subject and Predicate devices.
Differences between Subject Device and Predicate Device 5.6.4.2.
- The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in Subject Device (1mm) is different from Predicate Device (0.4mm).
- The weight and dimensions of the Subject device is ● different from Predicate Device.
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- The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
- The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
- The packaging configuration of Subject and Predicate . devices are different. However, it does not raise new questions about safety and efficacy.
5.7. PERFORMANCE TESTING - BENCH
The following bench performance testing was carried out for the devices in the Cefaly® Dual series to evaluate the safety and efficacy of the devices due to the changes made over the Predicate Device:
| Table 5.7.1 : List of Tests Performed - Cefaly® Dual Series | ||
|---|---|---|
| Testing Type | Test Description | Test Result |
| Electrical Safety andElectromagneticCompatibilityTesting | IEC 60601-1:2005+AMD 1 Edition 3.1, 2012-08 IEC 60601-1-2Edition 4.0 | Electrical safety andEMC evaluation wereperformed on the Cefaly®Dual Series according tofollowingFDA-recognized andother internationalstandards. |
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| 2014-02- IEC 60601-1-11 Edition 2.0 2015-01- IEC 60601-2-10 Edition 2.1 2016-04 | |
|---|---|
| -- | ----------------------------------------------------------------------------------------- |
Adhesion testing was carried out to evaluate the adhesion performance of the Cefaly electrodes when used with the Subject Devices. The test results demonstrated that the electrodes function as intended when used and replaced in accordance with the IFU, and that there are no new or different questions related to safety and efficacy of the Subject Device.
5.8. PERFORMANCE TESTING -ANIMAL
No animal testing was required to justify the differences with the corresponding Predicate Devices.
PERFORMANCE TESTING - CLINICAL 5.9.
No clinical testing was required to justify the differences with the corresponding Predicate Devices.
5.10. COMPLIANCE WITH SPECIAL CONTROLS
Cefaly Technology complies with all applicable special controls for 21 CFR 882.5891. The special controls and corresponding compliance are listed below:
-
- The patient-contacting components of the device must be demonstrated to be biocompatible - The material and manufacturing methods remain the same to that of the Predicate Devices, therefore the biocompatibility continues to be met as per K201895.
-
- Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety - Electrical safety and Electromagnetic compatibility testing for Cefaly® Dual Series was
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conducted in compliance with IEC 60601-1 and IEC 60601-1-2 standards and the results were found to be satisfactory.
-
- 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 (uC) 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 - The Cefaly® Dual Series devices have an electrical impedance monitoring system. Characterization of all the required technical parameters of the device was provided, and verification and validation tests were performed in accordance with IEC 60601-2-10 for Cefaly® Dual Series devices.
- Electrical performance, adhesive integrity, shelf life, reusability, and 4. current distribution testing of the electrodes must be conducted - Electrical performance, adhesive integrity, reusability, and current distribution testing was conducted for Cefaly® Dual Series and the results were found to be satisfactory. Nothing that affects the shelf life of the Cefaly® Dual Series was changed, and the shelf life continues to be the same as that of the Predicate Devices.
-
- Appropriate software verification, validation, and hazard analysis must be performed - Device Hazard Analysis and Software V&V were conducted for Cefaly® Dual Series and the results were found to be satisfactory.
-
- Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population -Indications for use, intended patient population, and technological characteristics of the Subject Device remain unchanged as compared to the Predicate Devices. The differences between the Subject and the Predicate Devices do not have an impact on the clinical performance and it continues to be the same as that of the Predicate Devices.
-
- Labeling for Cefaly® Dual Series devices includes the following:
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- Appropriate contraindications such as not for use in subjects with a. 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
- Appropriate precautions such as the long-term effects of chronic C. use of the device are unknown.
- d. A summary of the expected risks and benefits of using the device.
- A summary of the clinical performance data, including information e. 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
- A detailed summary of the device technical parameters . g.
- h. An expiration date/shelf life for the electrodes and the number of times they can be reused.
-
- 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.
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CONCLUSION 5.11.
Cefaly® Dual Series is substantially equivalent to the Predicate Device Cefaly® Dual in terms of technological characteristics, system operating range and indications for use. CEFALY Technology has concluded that the performance data obtained by evaluation of the Subject Device to the international standards demonstrate the safety and effectiveness of the Subject Device and justify substantial equivalence with the corresponding Predicate Devices.
CEFALY Technology K212071
§ 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.