(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.
§ 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.