(129 days)
No
The description focuses on TENS technology and standard electrical stimulation parameters. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is intended for the acute treatment and prophylactic treatment of migraine, which are medical conditions, and it uses electric impulses to achieve these therapeutic effects.
No
Explanation: The device is described as a neurostimulator that delivers electric impulses to treat and prevent pain, not to diagnose a condition. Its intended uses are for the acute and prophylactic treatment of migraine.
No
The device description explicitly lists hardware components such as a "Main Device," "Charging Station," "Electrode Pads," and "USB cable," and performance studies include electrical safety and output waveform testing, indicating it is a physical device with software control.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Migraine TENS Digital Pain Reliever is a neurostimulator that applies electrical impulses to the forehead. It directly interacts with the patient's body to treat and prevent pain.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient.
Therefore, based on the provided information, the Migraine TENS Digital Pain Reliever is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Migraine TENS Digital Pain Reliever LT1103
- 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.
Migraine TENS Digital Pain Reliever LT1103-P
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Product codes
PCC
Device Description
The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.
The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.
The Migraine TENS Digital Pain Reliever consists of the following elements:
- Main Device
- Charging Station
- Electrode Pads
- USB cable
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
- Biocompatibility testing: The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 1099-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". As dictation of contact with the intact skin, the testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the system complies with the IEC 60601-111 and EC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
- Software Verification and Validation Testing: Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device was considered as a "Moderate" level of concern.
- Output waveform Testing: For each program, occilloscope tracing diagrams describing the electrical output was provided to verify the output specifications of the device according to IEC 60601-2-10.
- Electrode impedance and current distribution testing: Electrode impedance and current distribution testing were conducted on the electrode.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 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.
June 17, 2021
Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District Shenzhen, Guangdong China
Re: K210364
Trade/Device Name: Migraine TENS Digital Pain Reliever Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: February 3, 2021 Received: February 8, 2021
Dear Siping Yuan:
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
1
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 (QS) 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,
Patrick Antkowiak 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
2
Indications for Use
510(k) Number (if known)
Device Name Migraine TENS Digital Pain Reliever Model: LT1103, LT1103-P
Indications for Use (Describe)
Migraine TENS Digital Pain Reliever LT1103
- 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.
Migraine TENS Digital Pain Reliever LT1103-P
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
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
as required by section 21 CFR 807.92
Migraine TENS Digital Pain Reliever
| Date of Submission: | 05/28/2021 |
|---|---|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd. |
| Address: | Floor 1-2, No.3 Building, Fanshen Xusheng Industrial |
| Estate Xilixiaobaimang 518108 Nanshan District, | |
| Shenzhen P. R. China | |
| E-mail: | yuansp@dundex.com |
| Tel: | +86(755) 27652471 |
| FAX: | +86(755) 27652674 |
| Contact: | Siping Yuan |
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Proposed Device: 1.
Device Name: Migraine TENS Digital Pain Reliever
Model: LT1103, LT1103-P
Device classification Name: stimulator, nerve, electrical, transcutaneous, for migraine Regulation Description: Transcutaneous electrical nerve stimulator treat to headache. Regulation Medical Specialty: Neurology Neurology Review Panel: Regulation Number: 882.5891 Product Code: PCC Device Class: ll
2. Predicate Device:
| Legally Marketed Device: | Cefaly® Dual |
|---|---|
| 510(k) Number: | K201895 |
| Manufacturer: | CEFALY Technology |
Device Description: 3.
The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.
The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.
The Migraine TENS Digital Pain Reliever consists of the following elements:
- Main Device
- Charging Station
- Electrode Pads
- USB cable
4. Indications for Use:
Migraine TENS Digital Pain Reliever LT1103
- 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.
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Migraine TENS Digital Pain Reliever LT1103-P
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
5. Comparison of Technological Characteristics with the Predicate Device
Both the subject and Predicate Device utilize the application of electrical current through electrodes placed on the forehead. By releasing the low frequency pulse with a particular frequency and reaching the advanced nerve center of cerebral cortex via nervus supraorbitalis, they can stop or postpone the transmission of headache signal to cerebral center.
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Basic technological characteristics, new device vs. Predicate device
| New device | New device | Predicate device | S.E. Discussion | ||
|---|---|---|---|---|---|
| 1 | 510K# | K210364 | K210364 | K201895 | N/A |
| 2 | Device Name and | ||||
| Model | Migraine TENS Digital Pain | ||||
| Reliever | |||||
| Model: LT1103 | Migraine TENS Digital Pain | ||||
| Reliever | |||||
| Model: LT1103-P | Cefaly® Dual | N/A | |||
| 3 | Manufacturer | Shenzhen Dongdixin | |||
| Technology Co., Ltd. | Shenzhen Dongdixin | ||||
| Technology Co., Ltd. | CEFALY Technology | N/A | |||
| 4 | Intended for use | 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. | The prophylactic treatment | ||||
| of episodic migraine in | |||||
| patients 18 years of age or | |||||
| older. | 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 | ||||
| The intended for use of | |||||
| LT1103 is equivalent with | |||||
| predicate device, the | |||||
| intended for use of | |||||
| LT1103-P is covered by | |||||
| the predicate device | |||||
| because LT1103-P | |||||
| contains only one | |||||
| program for prophylactic | |||||
| treatment. | |||||
| 5 | Where used | OTC | OTC | OTC | Equivalent |
| 6 | Power Source | 1 rechargeable LiPo 3.7 V | |||
| battery | 1 rechargeable LiPo 3.7 V | ||||
| battery | 1 rechargeable LiPo 3.7 V | ||||
| battery | Equivalent | ||||
| -Method of Line | |||||
| current isolation | N/A, battery powered | N/A, battery powered | N/A, battery powered | Equivalent | |
| - Patient Leakage | |||||
| Current (μΑ) | |||||
| -Normal condition | |||||
| -Single fault condition | N/A, battery powered | N/A, battery powered | N/A, battery powered | Equivalent | |
| 7 | Channels | 1 | 1 | 1 | Equivalent |
| Synchronous or | |||||
| Alternating? | N/A | N/A | N/A | Equivalent | |
| Method of Channel | |||||
| Isolation | N/A | N/A | N/A | Equivalent | |
| 8 | Constant Current? | Yes | Yes | Yes | Equivalent |
| Constant Voltage? | No | No | No | ||
| 9 | Software/Firmware/M | ||||
| icro processor | |||||
| Control? | Yes | ||||
| 2 fixed programs: | |||||
| -1 fixed program for the | |||||
| treatment of migraine | |||||
| attacks(Program 1) | |||||
| -1 fixed program for | |||||
| prophylactic treatment of | |||||
| migraine attacks(Program 2) | Yes | ||||
| 1 fixed program: | |||||
| -1 fixed program for | |||||
| prophylactic treatment of | |||||
| migraine attacks | Yes | ||||
| 2 fixed programs: | |||||
| -1 fixed program for the | |||||
| acute treatment of | |||||
| migraine attacks(Program |
-1 fixed program for
prophylactic treatment of
migraine attacks(Program
2) | Equivalent, LT1103 is
equivalent with predicate
device.
LT1103-P has only one
program, which is covered
by the predicate device. |
| | Program 1:
Max. output current
Pulse width
Pulse frequency
Session duration | 16 mA
250 $\mu$ s,
fixed 100 Hz,
fixed 60 minutes | N/A | 16 mA
250 $\mu$ s,
fixed 100 Hz,
fixed 60 minutes | Equivalent
The program 1 of LT1103
is equivalent with
predicate device, while
LT1103-P does not have
program 1. |
| | Program 2:
Max. output current
Pulse width
Pulse frequency
Session duration | 16 mA
250 $\mu$ s,
fixed 60 Hz,
fixed 20 minutes | 16 mA
250 $\mu$ s,
fixed 60 Hz,
fixed 20 minutes | 16 mA
250 $\mu$ s,
fixed 60 Hz,
fixed 20 minutes | Equivalent |
| 10 | Timer Range (minutes) | 20 minutes, 60 minutes | 20 minutes | 20 minutes, 60 minutes | Equivalent |
| 11 | Weight (grams.) | 14 | 14 | 12 | Different, but the subject
device has passed the
testing according to the
requirement of
IEC60601-1. |
| 12 | Dimensions (mm)
H*W * L | 41 mm x 41 mm x 13.4mm | 41 mm x 41 mm x 13.4mm | 55 mm x 40 mm x 15mm | |
| 13 | Housing Materials &
Construction | ABS+PC for Main device
ABS for Charging station | ABS+PC for Main device
ABS for Charging station | Plastic ABS | requirement of
IEC60601-1.
The difference does not |
| | | | | | raise any safety or
effectiveness issue. |
| 14 | Waveform | Biphasic | Biphasic | Biphasic | Equivalent |
| 15 | Shape | Rectangular
Full compensated
Symmetrical | Rectangular
Full compensated
Symmetrical | Rectangular
Full compensated
Symmetrical | Equivalent |
| 16 | Max Output Voltage (V) ±20% | | | | |
| 17 | 500Ω | 8 | 8 | 8 | Equivalent |
| 18 | 2kΩ | 32 | 32 | 32 | |
| 19 | 10kΩ | 60 | 60 | 60 | |
| 20 | Max Output Current (mA) ±20% | | | | |
| 21 | 500Ω | 16 | 16 | 16 | Equivalent |
| 22 | 2kΩ | 16 | 16 | 16 | |
| 23 | 10kΩ | 6 | 6 | 6 | |
| 24 | Pulse Width(usec) | 250 µs, fixed | 250 µs, fixed | 250 µs, fixed | Equivalent |
| 25 | Frequency (Hz) | 60 Hz, fixed
100 Hz, fixed | 60 Hz, fixed | 60 Hz, fixed
100 Hz, fixed | Equivalent, the
frequency of LT1103 is
equivalent with
predicate device.
LT1103-P has only one
program, which is
covered by the predicate
device. |
| 26 | Maximum Current
Density
(mA/cm²,500Ω) | 2.37 | 2.37 | 2.37 | Equivalent |
| 27 | Maximum Average
Power Density,
(W/cm²),500Ω | 0.000047 | 0.000017 | 0.000047 | Equivalent, the
Maximum Average
Power Density of LT1103
is equivalent with
predicate device.
IT1103-P has only one |
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| | | | program, which is
covered by the predicate |
|--|--|--|-----------------------------------------------|
| | | | device. |
6. Performance Data:
The following performance data are provided in support of the substantial equivalence determination:
6.1 Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 1099-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". As dictation of contact with the intact skin, the testing included the following tests:
- · Cytotoxicity
- Sensitization
- Irritation
6.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the system complies with the IEC 60601-111 and EC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
6.3 Software Verification and Validation Testing
Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device was considered as a "Moderate" level of concern.
6.4 Output waveform Testing
For each program, occilloscope tracing diagrams describing the electrical output was provided to verify the output specifications of the device according to IEC 60601-2-10.
6.5 Electrode impedance and current distribution testing.
Electrode impedance and current distribution testing were conducted on the electrode.
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7. Conclusions
The intended use and basic technological characteristics of the Migraine TENS Digital Pain Reliever LT1103, LT1103-P are significantly equivalent with those of the Predicate device K201895. Any technological differences do not raise new questions regarding safety and effectiveness.