(395 days)
Not Found
No
The description mentions an "electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user," but this does not necessarily imply AI/ML. It could be a simple feedback loop based on user input or pre-programmed parameters. There is no mention of AI, ML, or related terms, nor any description of training or test data sets which are typical for AI/ML-based devices.
Yes.
The device is indicated for the "prophylactic treatment of episodic migraine" and uses electrical stimulation to "treat and prevent migraine headaches," which directly addresses a medical condition.
No
The device is indicated for the prophylactic treatment and prevention of migraine headaches by stimulating nerves, not for diagnosing them.
No
The device description explicitly mentions hardware components such as electrodes, conductive paste, and a host key, and the performance studies include testing for electrical safety, electromagnetic safety, and biocompatibility, all of which are related to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- HeadaTerm Function: The HeadaTerm device works by applying electrical stimulation to nerves on the forehead. It directly interacts with the patient's body to treat a condition (migraine). It does not analyze any biological samples taken from the patient.
The description clearly indicates that the device is a therapeutic device that delivers electrical impulses to the body for treatment, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
PCC
Device Description
TENS device-HeadaTerm 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 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 patients 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, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
supraorbital nerve and supratrochlear nerve (on the forehead)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: Not Applicable
Non-Clinical Testing: Electrical Safety, Electromagnetic Safety, Performance of nerve and muscle stimulators, Performance of Device for Home Use, Biocompatibility: Cytotoxicity, Biocompatibility: Irritation, Biocompatibility: Sensitization.
All tests come back with "Pass" results which demonstrating the same safety and effectiveness with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5891 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.
0
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September 13, 2018
WAT Medical Technology Inc. % Rodney Zhang CTO WAT Medical Technology Inc. Room703-711, No.2 North Taoyuan Road Ningbo, 315600 China
Re: K172450
Trade/Device Name: TENS device-HeadaTerm, eEspresso Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: August 1, 2017 Received: August 14, 2017
Dear Rodney Zhang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Timothy A. Marjenin -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172450
Device Name
TENS device-HeadaTerm, eEspresso
Indications for Use (Describe)
The TENS device-HeadaTerm 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 1
SUMMARY OF SAFETY AND EFFECTIVENESS
SECTION 1 - 1 of 7
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
09/11/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | WAT Medical Technology Inc. |
|---|---|
| Company Address: | Room703-711, No.2 North Taoyuan Road, 315600, |
| Ningbo, Zhejiang Province, P.R.C | |
| Contact Person: | Dr. Rodney Zhang |
| Phone: | 86-574-6506-0811 |
| Email: | 13500799711@139.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | TENS device-HeadaTerm, eEspresso |
|---|---|
| Common Name: | Transcutaneous electrical nerve stimulator to treat headache |
| Model No. | YF-HT-W1. |
| Product Code: | PCC |
| Regulation Number: | 21 CFR 882.5891 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Predicate I | |
|---|---|
| Manufacturer: | STX-Med SPRL |
| Trade Name: | Cefaly |
| Product Code: | PCC |
| Classification Name: | Transcutaneous electrical nerve stimulator to treat |
| headache | |
| Regulation Number: | 21 CFR 882.5891 |
| Classification: | Class II |
| FDA 510 (k) #: | K122566 (Primary), K160237 |
5. Description of the Device [21 CFR 807.92(a)(4)]
TENS device-HeadaTerm 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 enables an electronic feedback mechanism to adjust the electrical
SECTION 1 - 2 of 7
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impulses to the specific requirements of the individual user for personalized efficacy and comfort.
The device could adhere to patients 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, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.
6. Previous Device Names and Company:
Previous Device Name:
Other names appears in various test reports including but not limit to Biocompatibility reports, electrical safety, EMC are recorded as HeadaTerm-wet, HeadaTerm-wet(shell), HeadaTerm-wet device for preventing and treating primary headache, these names are the previous names being used for proposed products. Previous Company:
The company appears in various test reports is WAT Medical Technology (Ningbo) Co., Ltd, which is the same company as the current WAT Medical Technology Inc.
7. Indications for Use [21 CFR 807.92(a)(5)]
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
8. Technological Characteristic [21 CFR 807.92(a)(6)]
By releasing the low frequency pulse with a particular frequency and reaching the advanced nerve center of cerebral cortex via nervus supraorbitalis, they can adjust all signals causing headache which come from the biological and physical channels, so as to stop or postpone the transmission of headache signal to cerebral center.
| Clinical Testing | Not Applicable |
|---|---|
| Non-Clinical Testing | Electrical Safety |
| Electromagnetic Safety | |
| Performance of nerve and muscle stimulators | |
| Performance of Device for Home Use |
9. Clinical Testing and Non-Clinical Testing
SECTION 1 - 3 of 7
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| Biocompatibility: Cytotoxicity | |
|---|---|
| Biocompatibility: Irritation | |
| Biocompatibility: Sensitization |
The non-clinical testing conducted are listed above, and all tests come back with "Pass" results which demonstrating the same safety and effectiveness with the predicate device.
10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Product Name | TENS device-HeadaTerm | CEFALY | |
| Product Code | PCC | PCC | |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | |
| Classification | Class II | Class II | |
| Intended Use | The TENS device-HeadaTerm is | ||
| indicated for the prophylactic | |||
| treatment of episodic migraine in | |||
| patients 18 years of age or older. | The Cefaly® device is indicated for | ||
| the prophylactic treatment of | |||
| episodic migraine in patients 18 | |||
| years of age or older. | |||
| 510 (k) Number | N/A | K160237, K122566 | |
| Device Feature | |||
| Device Name | TENS device-HeadaTerm | CEFALY | |
| Power Source | One 3V lithium coin cells | One lithium battery | |
| Follow Current | Yes | Yes | |
| Voltage Overload | |||
| Detection | Yes | Yes | |
| Adjustable Intensity | ON/OFF button on front | ||
| of device | ON/OFF button on front | ||
| of device | |||
| Channel | 1 | 1 | |
| Start | Yes | Yes | |
| Operatio | |||
| n Tips | Low | ||
| Battery | No | Yes | |
| Work | Yes | Yes | |
| Software-controlled | No | Yes | |
| Time Set | No - Manually Adjust | No - Manually Adjust | |
| Constant Current | No | No | |
| Automatic overload | |||
| trip voltage level | Yes | Yes | |
| Patient override | |||
| control method | On/Off button on front of device | On/Off button on front of device | |
| Indicator displays | Unit functioning | ||
| Electrical connection | Unit functioning | ||
| Low battery | |||
| Electrical connection | |||
| Timer Setting | Yes | Yes | |
| Weight | 11g | 30g | |
| Dimensions | 127x35x12mm | 160 x 170 x 40 mm | |
| Waveform | AC Symmetric Square | ||
| Wave | AC Symmetric Square | ||
| Wave | |||
| Phase Duration | |||
| (µsec) | 250us(±20) | 250us(±0.5%) | |
| Phase Interval | 10us(±0.5%) | 10us(±0.5%) | |
| Pulse Period | 500us(±0.5%) | 505us(±0.5%) | |
| Frequency (Hz) | 60Hz(±1) | 60Hz(±0.5%) | |
| Net Charge (µC) per | |||
| pulse | 0 | 0 | |
| Maximum output | |||
| voltage (V): | 8.00V(±0.5%) | 8.00V(±0.5%) | |
| @500 ohms | |||
| Maximum output | |||
| voltage (V): | |||
| @2000 ohms | 32V(±0.5%) | 32V(±0.5%) | |
| Maximum output | |||
| voltage (V): | |||
| @10000 ohms | 60V(±3) | 60V(±0.5%) | |
| Maximum output | |||
| current (mA): | |||
| @500 ohms | 16mA(±0.5%) | 16mA(±0.5%) | |
| Maximum output | |||
| current (mA): | |||
| @2000 ohms | 16mA(±0.5%) | 16mA(±0.5%) | |
| Maximum output | |||
| current (mA): | |||
| @10000 ohms | 6mA(±0.5%) | 6mA(±0.5%) | |
| Maximum phase | |||
| charge (μC) @500Ω | 3.95 | 4 | |
| Maximum Current | |||
| Density, (mA/cm2, | |||
| r.m.s.) @500Ω | 2.35 | 2.37 | |
| Maximum Average | |||
| Power Density, | |||
| (W/cm2) @500Ω | 0.000017 | 0.000017 | |
| Maximum Average | |||
| Current (average | |||
| absolute value, mA) | |||
| @500Ω | 0.48 | 0.48 | |
| IEC60601-1 | Yes | Yes | |
| IEC60601-1-2 | Yes | Yes | |
| IEC60601-2-10 | Yes | Yes | |
| IEC 60601-1-11 | Yes | No |
SECTION 1 - 4 of 7
7
W. WAT Med
SECTION 1 - 5 of 7
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SECTION 1 - 6 of 7
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11. Conclusion [21 CFR 807.92(b)(3)]
TENS device-HeadaTerm are substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.