(129 days)
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.
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
This document is a 510(k) summary for the Migraine TENS Digital Pain Reliever. It describes the device and compares it to a predicate device (Cefaly® Dual) to demonstrate substantial equivalence.
Based on the provided text, here's what can be extracted regarding acceptance criteria and the study proving the device meets them:
This device is a TENS unit for migraine relief, not an AI/imaging diagnostic device. Therefore, many of the requested criteria (like ground truth, expert consensus, MRMC studies, effect size of human improvement with AI, standalone AI performance, training set details) are not applicable to this type of medical device submission.
The acceptance criteria here pertain to safety and performance equivalence with a legally marketed predicate device, rather than diagnostic accuracy or human-AI reader performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal "acceptance criteria" table in the typical sense for AI/diagnostic devices. Instead, it demonstrates equivalence by comparing the technical specifications of the new device (Migraine TENS Digital Pain Reliever LT1103, LT1103-P) against the predicate device (Cefaly® Dual, K201895).
The "S.E. Discussion" column in the table below effectively serves as the "reported device performance" against the implicitly accepted predicate's performance.
| Criterion (Comparison Point) | Acceptance Criteria (Implicit: Equivalence to Predicate) | Reported Device Performance (S.E. Discussion) |
|---|---|---|
| Intended Use | Equivalent to predicate device. | LT1103 is equivalent with predicate device. LT1103-P is covered by the predicate device (as it contains only one program for prophylactic treatment). |
| Where Used | OTC | Equivalent |
| Power Source | Rechargeable LiPo 3.7 V battery, N/A for line current isolation, patient leakage current info. | Equivalent |
| Channels | 1; N/A for synchronous/alternating and channel isolation. | Equivalent |
| Constant Current? | Yes | Yes (Equivalent) |
| Constant Voltage? | No | No |
| Software/Firmware/Microprocessor Control? | Yes, 2 fixed programs (acute and prophylactic) for LT1103. Yes, 1 fixed program (prophylactic) for LT1103-P. | LT1103 is equivalent with predicate device. LT1103-P has only one program, which is covered by the predicate device. |
| Program 1 (Acute Treatment) Specifications (Max. output current, Pulse width, Pulse frequency, Session duration) | 16 mA, 250 µs, 100 Hz, 60 minutes | The program 1 of LT1103 is equivalent with predicate device, while LT1103-P does not have program 1. |
| Program 2 (Prophylactic Treatment) Specifications (Max. output current, Pulse width, Pulse frequency, Session duration) | 16 mA, 250 µs, 60 Hz, 20 minutes | Equivalent |
| Timer Range (minutes) | 20 minutes, 60 minutes | Equivalent |
| Weight (grams.) | Comparable to predicate (12g for predicate) | Different (14g for new device), but passed testing according to IEC60601-1. |
| Dimensions (mm) HWL | Comparable to predicate (55mm x 40mm x 15mm for predicate) | 41 mm x 41 mm x 13.4mm |
| Housing Materials & Construction | Functionally equivalent, no new safety/effectiveness issues. | ABS+PC for Main device, ABS for Charging station. Difference does not raise any safety or effectiveness issue. |
| Waveform | Biphasic | Equivalent |
| Shape | Rectangular, Full compensated, Symmetrical | Equivalent |
| Max Output Voltage (V) ±20% @ 500Ω, 2kΩ, 10kΩ | 8V, 32V, 60V, respectively | Equivalent for 500Ω (8V). 32V for 2kΩ, 60V for 10kΩ (Implied equivalent as it's not explicitly stated as different). |
| Max Output Current (mA) ±20% @ 500Ω, 2kΩ, 10kΩ | 16mA, 16mA, 6mA, respectively | Equivalent for 500Ω (16mA). 16mA for 2kΩ, 6mA for 10kΩ (Implied equivalent as it's not explicitly stated as different). |
| Pulse Width(usec) | 250 µs, fixed | Equivalent |
| Frequency (Hz) | 60 Hz, fixed; 100 Hz, fixed | The frequency of LT1103 is equivalent with predicate device. LT1103-P has only one program, which is covered by the predicate device. |
| Maximum Current Density (mA/cm², 500Ω) | 2.37 | Equivalent |
| Maximum Average Power Density (W/cm²), 500Ω | 0.000047 for Program 1 / LT1103; 0.000017 for Program 2 / LT1103-P | Equivalent. The Maximum Average Power Density of LT1103 is equivalent with predicate device. IT1103-P has only one program, which is covered by the predicate device. |
| Biocompatibility | Meet ISO 10993-1 for intact skin contact. | Testing included Cytotoxicity, Sensitization, Irritation. |
| Electrical Safety and EMC | Comply with IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2. | Testing conducted, complies with standards. |
| Software Verification and Validation | Conducted as recommended by FDA guidance for "Moderate" level of concern. | Testing conducted. |
| Output Waveform Testing | Verify output specifications per IEC 60601-2-10. | Oscilloscope tracing diagrams provided. |
| Electrode Impedance and Current Distribution Testing | N/A (implicit: sufficient to support safe and effective operation). | Testing conducted on electrode. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a TENS device, not an AI/imaging device that would use a test set of patient images or data in that context. The "testing" here refers to engineering and safety performance testing.
- Test Set Sample Size: Not applicable.
- Data Provenance: Not applicable. The "data" comes from engineering tests, not patient studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Safety and performance are established through objective engineering tests against international standards and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no concept of "adjudication" in the context of engineering and safety testing for a TENS device in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a treatment device, not a diagnostic AI device. Human "readers" are not involved in its primary function, nor is AI assistance relevant to its therapeutic mechanism.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable in the AI/diagnostic sense. The reference standard or "ground truth" for this submission are:
- International safety and performance standards (e.g., ISO 10993-1, IEC 60601 series).
- The established safe and effective performance of the predicate device (K201895 Cefaly® Dual).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
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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 IndustrialEstate 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 andModel | Migraine TENS Digital PainRelieverModel: LT1103 | Migraine TENS Digital PainRelieverModel: LT1103-P | Cefaly® Dual | N/A |
| 3 | Manufacturer | Shenzhen DongdixinTechnology Co., Ltd. | Shenzhen DongdixinTechnology Co., Ltd. | CEFALY Technology | N/A |
| 4 | Intended for use | The acute treatment ofmigraine with or withoutaura in patients 18 years ofage or older.The prophylactic treatmentof episodic migraine inpatients 18 years of age orolder. | The prophylactic treatmentof episodic migraine inpatients 18 years of age orolder. | The acute treatment ofmigraine with or withoutaura in patients 18 yearsof age or older.The prophylactictreatment of episodicmigraine in patients 18years of age or older. | EquivalentThe intended for use ofLT1103 is equivalent withpredicate device, theintended for use ofLT1103-P is covered bythe predicate devicebecause LT1103-Pcontains only oneprogram for prophylactictreatment. |
| 5 | Where used | OTC | OTC | OTC | Equivalent |
| 6 | Power Source | 1 rechargeable LiPo 3.7 Vbattery | 1 rechargeable LiPo 3.7 Vbattery | 1 rechargeable LiPo 3.7 Vbattery | Equivalent |
| -Method of Linecurrent isolation | N/A, battery powered | N/A, battery powered | N/A, battery powered | Equivalent | |
| - Patient LeakageCurrent (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 orAlternating? | N/A | N/A | N/A | Equivalent | |
| Method of ChannelIsolation | N/A | N/A | N/A | Equivalent | |
| 8 | Constant Current? | Yes | Yes | Yes | Equivalent |
| Constant Voltage? | No | No | No | ||
| 9 | Software/Firmware/Micro processorControl? | Yes2 fixed programs:-1 fixed program for thetreatment of migraineattacks(Program 1)-1 fixed program forprophylactic treatment ofmigraine attacks(Program 2) | Yes1 fixed program:-1 fixed program forprophylactic treatment ofmigraine attacks | Yes2 fixed programs:-1 fixed program for theacute treatment ofmigraine attacks(Program1)-1 fixed program forprophylactic treatment ofmigraine attacks(Program2) | Equivalent, LT1103 isequivalent with predicatedevice.LT1103-P has only oneprogram, which is coveredby the predicate device. |
| Program 1:Max. output currentPulse widthPulse frequencySession duration | 16 mA250 $\mu$ s,fixed 100 Hz,fixed 60 minutes | N/A | 16 mA250 $\mu$ s,fixed 100 Hz,fixed 60 minutes | EquivalentThe program 1 of LT1103is equivalent withpredicate device, whileLT1103-P does not haveprogram 1. | |
| Program 2:Max. output currentPulse widthPulse frequencySession duration | 16 mA250 $\mu$ s,fixed 60 Hz,fixed 20 minutes | 16 mA250 $\mu$ s,fixed 60 Hz,fixed 20 minutes | 16 mA250 $\mu$ 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 subjectdevice has passed thetesting according to therequirement ofIEC60601-1. |
| 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 deviceABS for Charging station | ABS+PC for Main deviceABS for Charging station | Plastic ABS | requirement ofIEC60601-1.The difference does not |
| raise any safety oreffectiveness issue. | |||||
| 14 | Waveform | Biphasic | Biphasic | Biphasic | Equivalent |
| 15 | Shape | RectangularFull compensatedSymmetrical | RectangularFull compensatedSymmetrical | RectangularFull compensatedSymmetrical | 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, fixed100 Hz, fixed | 60 Hz, fixed | 60 Hz, fixed100 Hz, fixed | Equivalent, thefrequency of LT1103 isequivalent withpredicate device.LT1103-P has only oneprogram, which iscovered by the predicatedevice. |
| 26 | Maximum CurrentDensity(mA/cm²,500Ω) | 2.37 | 2.37 | 2.37 | Equivalent |
| 27 | Maximum AveragePower Density,(W/cm²),500Ω | 0.000047 | 0.000017 | 0.000047 | Equivalent, theMaximum AveragePower Density of LT1103is equivalent withpredicate device.IT1103-P has only one |
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| program, which iscovered 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.
§ 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.