(341 days)
The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
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.
The provided text describes the regulatory clearance of a medical device (TENS device-HeadaTerm 2) and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document primarily focuses on:
- Regulatory Clearance: FDA 510(k) clearance for the TENS device-HeadaTerm 2 (K230782).
- Device Description: What the device is and how it works.
- Indication for Use: Prophylactic treatment of episodic migraine in patients 18 years or older, for Over-The-Counter (OTC) use.
- Predicate Devices: Comparison to TENS device-HeadaTerm (K172450) and Cefaly® Dual (K201895).
- Technological Characteristics Comparison: A table detailing similarities and differences with predicate devices.
- Performance Data (Non-clinical): Lists standards the device was tested against (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) for safety, EMC, and biocompatibility.
- Usability Verification: A brief mention of a usability study.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document confirms the device passed tests according to various standards but does not list specific numerical acceptance criteria (e.g., a minimum sensitivity or specificity) or the resulting performance values for these criteria.
- Sample size used for the test set and the data provenance: Only a usability study is mentioned with a sample size of 24 participants. No test set for measuring specific performance metrics (like efficacy in migraine treatment) is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a performance test set with ground truth is not described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document explicitly states "Clinical testing is not required."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical TENS device, not an AI algorithm.
- The type of ground truth used: Not applicable as no such performance study is described.
- The sample size for the training set: Not applicable as no AI/machine learning algorithm training is mentioned.
- How the ground truth for the training set was established: Not applicable.
The only "study" mentioned with concrete numbers is a usability study:
- Sample size: 24 participants.
- Goal: To prove the device is appropriate for OTC use.
- Outcome: All 24 subjects completed specified tasks correctly (equipment wearing, power-off, intensity adjustment, changing, storage). This implicitly serves as an "acceptance criterion" for usability in an OTC setting, and the reported performance (all 24 subjects successful) meets it.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location, likely China. It's a prospective study.
- Ground Truth: Established by observing correct completion of tasks by the participants and assessment by a "study team and the HCP" (Healthcare Professional), implying expert observation and judgment on task completion.
In summary, the provided document is a regulatory clearance letter and a 510(k) summary, not a detailed clinical or performance study report with specific acceptance criteria beyond adherence to recognized medical device standards and a basic usability verification.
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Image /page/0/Picture/0 description: The image shows 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 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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,Zhejiang Province, P.R.C |
| Contact person: | Joe Xu |
| E-mail: | joexu@watmedical.com |
| Tel: | +86-574-88132850 |
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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| SEComparisons | Subject Device | Primary PredicateDeviceK172450 | Secondarypredicate deviceK201895 | Similarities/Differences | |
|---|---|---|---|---|---|
| Device name,Model | TENS device-HeadaTerm 2Model: YF-HT2 | TENS device-HeadaTermModel: YF-HT-W1 | Cefaly® Dual | N/A | |
| Manufacturer | WAT Medical TechnologyInc. | WAT Medical TechnologyInc. | CEFALY Technology | N/A | |
| Classification | Class II | Class II | Class II | Same | |
| Product code | PCC | PCC | PCC | PCC | |
| Indication for use | The TENS device-HeadaTerm 2 isindicated for theprophylactic treatment ofepisodic migraine inpatients 18 years of ageor older. | The TENS device-HeadaTerm is indicatedfor the prophylactictreatment of episodicmigraine in patients 18years of age or older. | The indications foruse of the Cefaly®Dual for an over-the-counter use are:-The acutetreatment ofmigraine with orwithout aura inpatients18 years ofage or older.-The prophylactictreatment ofepisodic migraine inpatients 18years ofage or older. | Note No.1 | |
| RX/OTC | OTC | RX | OTC | Note No.2 | |
| Power source | 3.7V DC 60mAh lithiumbattery | One 3V lithium coin cells | 1 rechargeable LiPo3.7 V battery | Note No.3 | |
| Follow Current | Yes | Yes | Not specific | Same | |
| Voltage OverloadDetection | Yes | Yes | Not specific | Same | |
| AdjustableIntensity | ON/OFF button on frontof device is used tocontrol the startup andshutdownThe "+" and "-" touch keyat the top and bottom ofthe control part, which | ON/OFF button on frontof device.The device is equippedwith the intensityadjustment function, andusers can select themost suitable gears. The | Not specific | Note No.4 | |
| Channel | 1 | 1 | 1 | Same | |
| OperationTips | Start | Yes | Yes | Not specific | Same |
| LowBattery | No | No | Not specific | Same | |
| Work | Yes | Yes | Not specific | Same | |
| Time Set | No-Manually Adjust | No-Manually Adjust | Not specific | Same | |
| Automaticoverload tripvoltage level | Yes | Yes | Not specific | Same | |
| Constant Current | No | No | Not specific | Same | |
| Patient overridecontrol method | ON/OFF button on frontof device is used tocontrol the startup andshutdownThe "+" and "-" touch keyat the top and bottom ofthe control part, whichcan be used to adjustthe stimulation intensitygear. | On/Off and gear adjustbutton on front of device.The device is equippedwith the intensityadjustment function, andusers can select themost suitable gears. Theintensity of device keepsgoing up after the deviceis started. After it rises tothe suitable intensity,you can make a shortpress on the controlbutton to lock the currentintensity after the buzzerrings once and theindicator lamp flickersonce intermittently. | Not specific | Note No.4 | |
| can be used to adjustthe stimulation intensitygear. | intensity of device keepsgoing up after the deviceis started. After it rises tothe suitable intensity,you can make a shortpress on the controlbutton to lock the currentintensity after the buzzerrings once and theindicator lamp flickersonce intermittently. | ||||
| Electrical connection | Electrical connection | ||||
| Waveform | AC Symmetric SquareWave | AC Symmetric SquareWave | Biphasic | Same as theprimarypredicate | |
| Pulse width | 250 us ( $ \u00b1 $ 20) | 250 us ( $ \u00b1 $ 20) | 250 us | Same | |
| Frequency (Hz) | 60Hz ( $ \u00b1 $ 1) | 60Hz ( $ \u00b1 $ 1) | 60Hz | Same | |
| Maximum outputvoltage (V):@500 ohms | 8V( $ \u00b1 $ 0.5%) | 8V( $ \u00b1 $ 0.5%) | Not specific | Same | |
| Maximum outputvoltage (V):@2000 ohms | 32V( $ \u00b1 $ 0.5%) | 32V( $ \u00b1 $ 0.5%) | Not specific | Same | |
| Maximum outputvoltage (V):@10000 ohms | 60V( $ \u00b1 $ 3V) | 60V( $ \u00b1 $ 3V) | Not specific | Same | |
| Maximum outputcurrent (mA):@500 ohms | 16mA( $ \u00b1 $ 0.5%) | 16mA( $ \u00b1 $ 0.5%) | 16mA | Same | |
| Maximum outputcurrent (mA):@2000 ohms | 16mA ( $ \u00b1 $ 0.5%) | 16mA ( $ \u00b1 $ 0.5%) | 16mA | Same | |
| Maximum outputcurrent (mA):@10000 ohms | 6mA ( $ \u00b1 $ 0.5%) | 6mA ( $ \u00b1 $ 0.5%) | 6mA | Same | |
| Maximum phasecharge (µC)@500 $ \u03a9 $ | 3.95 | 3.95 | Not specific | Same | |
| MaximumCurrent Density,(mA/cm², r.m.s.)@500 $ \u03a9 $ | 2.35 | 2.35 | 2.37 | Same | |
| MaximumAverage PowerDensity, (W/cm $ \u00b2 $ )@500 $ \u03a9 $ | 0.000017 | 0.000017 | 0.000047 | Same | |
| MaximumAverage Current(averageabsolute value,mA) @500Ω | 0.48 | 0.48 | Not specific | Same | |
| Net Charge (µC)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.
§ 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.