TENS device-HeadaTerm 2 (Model: YF-HT2)

K230782 · Wat Medical Technology, Inc. · PCC · Feb 26, 2024 · Neurology

Device Facts

• Record ID: K230782
• Device Name: TENS device-HeadaTerm 2 (Model: YF-HT2)
• Applicant: Wat Medical Technology, Inc.
• Product Code: PCC · Neurology
• Decision Date: Feb 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Device Story

TENS device-HeadaTerm 2 is a transcutaneous electrical nerve stimulator for migraine prophylaxis. Device adheres to patient's forehead via conductive paste; delivers electrical impulses to supraorbital and supratrochlear nerves. User-controlled intensity via 9 gear options; electronic feedback mechanism adjusts impulses for personalized comfort. Intended for OTC home use by patients 18+; operated by patient. Device provides drug-free treatment; alleviates migraine pain through nerve stimulation. Benefits include non-pharmacological migraine management.

Clinical Evidence

No clinical efficacy data provided. Usability study conducted with 24 participants to validate OTC use; all subjects successfully completed tasks including equipment wearing, power-off, intensity adjustment, charging, and storage.

Technological Characteristics

Class II TENS device. Materials: conductive paste interface. Energy: 3.7V 60mAh lithium battery. Waveform: AC symmetric square wave. Pulse width: 250µs; Frequency: 60Hz. Output: 9 intensity gears. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, IEC 60601-1-2. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-23.

Indications for Use

Indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the Food Drug & Cosmetic Act, the Transcutaneous Electrical Nerve Stimulator to Treat Headache is subject to the following special controls:

Predicate Devices

• TENS device-HeadaTerm, eEspresso (K172450)
• Cefaly® Dual (K201895)

Submission Summary (Full Text)

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February 26, 2024

WAT Medical Technology Inc. Joe Xu Manager Room703-711, No.2 North Taoyuan Road Ningbo, Zhejiang 315600 P. R. China

Re: K230782

Trade/Device Name: TENS device-HeadaTerm 2 (Model: YF-HT2) Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator to Treat Headache Regulatory Class: Class II Product Code: PCC Dated: January 24, 2024 Received: January 25, 2024

Dear Joe Xu:

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).

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaorui Tang

for: CDR Jitendra Virani, MS 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

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### Indications for Use

510(k) Number (if known) K230782

Device Name TENS device-HeadaTerm 2

Indications for Use (Describe)

The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic 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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### 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

### Prepared Date: February 26, 2024

### 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | WAT Medical Technology Inc. |
|-----------------|-----------------------------------------------------------------------------------|
| Address: | Room703-711, No.2 North Taoyuan Road, 315600, Ningbo,<br>Zhejiang Province, P.R.C |
| Contact person: | Joe Xu |
| E-mail: | [e-mail] |
| Tel: | [phone] |

### 2. Device Identification

| Trade/Device Name: | TENS device-HeadaTerm 2 |
|--------------------|--------------------------------------------------------------|
| Models: | YF-HT2 |
| Common name: | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Regulation Number: | 21 CFR 882.5891 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator to treat headache |
| Regulation Class: | Class II |
| Panel: | Neurology |
| Product Code: | PCC |

### 3. Predicate Device

| Primary predicate device: | | | |
|---------------------------|--------------------------------------------------------------|--|--|
| 510(K) number: | K172450 | | |
| Device Name: | TENS device-HeadaTerm, eEspresso | | |
| Manufacturer: | WAT Medical Technology Inc. | | |
| Common name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | | |
| Regulation Number: | 21 CFR 882.5891 | | |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator to treat headache | | |
| Regulation Class: | Class II | | |
| Panel: | Neurology | | |
| Product Code: | PCC | | |

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Image /page/4/Picture/0 description: The image shows the logo for WAT Med. The logo consists of the letters "WT" in green and blue, followed by the words "WAT Med" in blue. The letters are bold and sans-serif. The logo is simple and modern.

Secondary predicate device:

| 510(K) number: | K201895 |
|--------------------|--------------------------------------------------------------|
| Device Name: | Cefaly® Dual |
| Manufacturer: | CEFALY Technology |
| Common name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Regulation Number: | 21 CFR 882.5891 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator to treat headache |
| Regulation Class: | Class II |
| Panel: | Neurology |
| Product Code: | PCC |

### 4. Device Description

TENS device-HeadaTerm 2 offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device- HeadaTerm 2 enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.

The device could adhere to patient's forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.

### 5. Indication for use

The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

### 6. Technological Characteristics Comparison

Compared to the primary predicate device and secondary predicate device, the subject device has the same intended use, similar product design, and similar performance as the primary predicate device, the main differences between TENS device-HeadaTerm 2 and device TENS device-HeadaTerm is appearance, external form, battery, and TENS device-HeadaTerm 2 is intended for OTC, compared to secondary predicate device "Cefaly® Dual", Cefaly® Dual also changed from prescription to OTC use. The summarized comparison is listed in the following table: 510(k) Summary - 2 of 7

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| SE<br>Comparisons | Subject Device | Primary Predicate<br>Device<br>K172450 | Secondary<br>predicate device<br>K201895 | Similarities/<br>Differences | |
|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------|
| Device name,<br>Model | TENS device-<br>HeadaTerm 2<br>Model: YF-HT2 | TENS device-<br>HeadaTerm<br>Model: YF-HT-W1 | Cefaly® Dual | N/A | |
| Manufacturer | WAT Medical Technology<br>Inc. | WAT Medical Technology<br>Inc. | CEFALY Technology | N/A | |
| Classification | Class II | Class II | Class II | Same | |
| Product code | PCC | PCC | PCC | PCC | |
| Indication for use | The TENS device-<br>HeadaTerm 2 is<br>indicated for the<br>prophylactic treatment of<br>episodic migraine in<br>patients 18 years of age<br>or older. | The TENS device-<br>HeadaTerm is indicated<br>for the prophylactic<br>treatment of episodic<br>migraine in patients 18<br>years of age or older. | The indications for<br>use of the Cefaly®<br>Dual for an over-<br>the-counter use are:<br>-The acute<br>treatment of<br>migraine with or<br>without aura in<br>patients18 years of<br>age or older.<br>-The prophylactic<br>treatment of<br>episodic migraine in<br>patients 18years of<br>age or older. | Note No.1 | |
| RX/OTC | OTC | RX | OTC | Note No.2 | |
| Power source | 3.7V DC 60mAh lithium<br>battery | One 3V lithium coin cells | 1 rechargeable LiPo<br>3.7 V battery | Note No.3 | |
| Follow Current | Yes | Yes | Not specific | Same | |
| Voltage Overload<br>Detection | Yes | Yes | Not specific | Same | |
| Adjustable<br>Intensity | ON/OFF button on front<br>of device is used to<br>control the startup and<br>shutdown<br>The "+" and "-" touch key<br>at the top and bottom of<br>the control part, which | ON/OFF button on front<br>of device.<br>The device is equipped<br>with the intensity<br>adjustment function, and<br>users can select the<br>most suitable gears. The | Not specific | Note No.4 | |
| Channel | | 1 | 1 | 1 | Same |
| Operat<br>ion<br>Tips | Start | Yes | Yes | Not specific | Same |
| | Low<br>Battery | No | No | Not specific | Same |
| | Work | Yes | Yes | Not specific | Same |
| Time Set | | No-Manually Adjust | No-Manually Adjust | Not specific | Same |
| Automatic<br>overload trip<br>voltage level | | Yes | Yes | Not specific | Same |
| Constant Current | | No | No | Not specific | Same |
| Patient override<br>control method | | ON/OFF button on front<br>of device is used to<br>control the startup and<br>shutdown<br>The "+" and "-" touch key<br>at the top and bottom of<br>the control part, which<br>can be used to adjust<br>the stimulation intensity<br>gear. | On/Off and gear adjust<br>button on front of device.<br>The device is equipped<br>with the intensity<br>adjustment function, and<br>users can select the<br>most suitable gears. The<br>intensity of device keeps<br>going up after the device<br>is started. After it rises to<br>the suitable intensity,<br>you can make a short<br>press on the control<br>button to lock the current<br>intensity after the buzzer<br>rings once and the<br>indicator lamp flickers<br>once intermittently. | Not specific | Note No.4 |
| | | can be used to adjust<br>the stimulation intensity<br>gear. | intensity of device keeps<br>going up after the device<br>is started. After it rises to<br>the suitable intensity,<br>you can make a short<br>press on the control<br>button to lock the current<br>intensity after the buzzer<br>rings once and the<br>indicator lamp flickers<br>once intermittently. | | |
| | Electrical connection | Electrical connection | | | |
| Waveform | AC Symmetric Square<br>Wave | AC Symmetric Square<br>Wave | Biphasic | Same as the<br>primary<br>predicate | |
| Pulse width | 250 us ( $ \u00b1 $ 20) | 250 us ( $ \u00b1 $ 20) | 250 us | Same | |
| Frequency (Hz) | 60Hz ( $ \u00b1 $ 1) | 60Hz ( $ \u00b1 $ 1) | 60Hz | Same | |
| Maximum output<br>voltage (V):<br>@500 ohms | 8V( $ \u00b1 $ 0.5%) | 8V( $ \u00b1 $ 0.5%) | Not specific | Same | |
| Maximum output<br>voltage (V):<br>@2000 ohms | 32V( $ \u00b1 $ 0.5%) | 32V( $ \u00b1 $ 0.5%) | Not specific | Same | |
| Maximum output<br>voltage (V):<br>@10000 ohms | 60V( $ \u00b1 $ 3V) | 60V( $ \u00b1 $ 3V) | Not specific | Same | |
| Maximum output<br>current (mA):<br>@500 ohms | 16mA( $ \u00b1 $ 0.5%) | 16mA( $ \u00b1 $ 0.5%) | 16mA | Same | |
| Maximum output<br>current (mA):<br>@2000 ohms | 16mA ( $ \u00b1 $ 0.5%) | 16mA ( $ \u00b1 $ 0.5%) | 16mA | Same | |
| Maximum output<br>current (mA):<br>@10000 ohms | 6mA ( $ \u00b1 $ 0.5%) | 6mA ( $ \u00b1 $ 0.5%) | 6mA | Same | |
| Maximum phase<br>charge (µC)<br>@500 $ \u03a9 $ | 3.95 | 3.95 | Not specific | Same | |
| Maximum<br>Current Density,<br>(mA/cm², r.m.s.)<br>@500 $ \u03a9 $ | 2.35 | 2.35 | 2.37 | Same | |
| Maximum<br>Average Power<br>Density, (W/cm $ \u00b2 $ )<br>@500 $ \u03a9 $ | 0.000017 | 0.000017 | 0.000047 | Same | |
| Maximum<br>Average Current<br>(average<br>absolute value,<br>mA) @500Ω | 0.48 | 0.48 | Not specific | Same | |
| Net Charge (µC)<br>per pulse | 0 | 0 | 0 | Same | |

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## WAT Med

- Note No. 1 The indication for use of subject device is same as that of primary predicate device. The secondary predicate device Cefaly® Dual has two indications, one for each fixed Programs: Program 1 for acute treatment of migraine, and Program 2 for prophylactic treatment of episodic migraine, the indication for use of subject device is same as Program 2, prophylactic treatment of migraine.
- Note No. 2 Cefaly® Dual was also changed from prescription to over-the-counter (OTC) use based on their device and Human Factor Validation testing, we conducted usability study among 24 participants, which demonstrated that subject device is appropriate for OTC use by the intended patient population.
- Note No. 3 The battery is different, we have performed testing on battery according to IEC 62133-2, the difference between two batteries will not affect the safety and effectiveness of the product compared to the predicate devices.
- Note No. 4 The two products have the same core part. TENS device-HeadaTerm 2 provide 9 gears of simulation intensity, the predicate device provides only one simulation intensity, the max output voltage and current, waveform, pulse width, frequency and power density of TENS device-HeadaTerm 2 is same to that of predicate device, so the difference will not affect the safety and effectiveness of the product compared to the predicate devices.

All the differences don't affect the safety and effectiveness compared to the predicate devices which is concluded after all the required testing, so no new safety and effectiveness issues relating to the system come into conclusion.

### 7. Performance Data

### Clinical test:

Clinical testing is not required.

### Non-clinical data

The subject device performed:

### Safety and Performance:

IEC 60601-1:2005+A12:2012 Medical electrical equipment -Part 1: General requirements for

basic safety and essential performance

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IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-2-10:2012+A1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

### EMC:

IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests

### Biocompatibility:

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization

ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation Software verification:

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Usability verification:

A total of 24 participants took part in usability study, 15 participants were assigned to group A as they successfully selected themselves as intended users. 5 participants were assigned to group B as they incorrectly selected themselves as intended users but were ruled out as an intended users by the study team and the HCP. 4 participants were assigned to group C as they identified themselves as unintended users but were deemed as intended users by study team and the HCP. All 24 subjects completed the following tasks correctly: equipment wearing, power-off, intensity adjustment, changing, storage, which prove that subject device can be used correctly by different users, and it is appropriate for the OTC use.

### 8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the primary predicate device (K172450) and the secondary predicate device (K201895) in terms of the safety and effectiveness.