(155 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
LT5019 is designed to be used at home, by adults of all genders. The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).
The provided text describes the 510(k) summary for the "Smart Pain Reliever, Model LT5019," a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS). This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria related to its clinical effectiveness with an AI component or analysis of diagnostic performance.
Therefore, many of the requested details about acceptance criteria for AI/diagnostic performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/diagnostic device studies proving clinical utility) are not present in this regulatory submission document.
This document focuses on:
- Technological equivalence: Comparing the technical specifications (e.g., waveform, pulse duration, frequency, power source) of the new device to predicate devices.
- Compliance with safety standards: Demonstrating that the device meets relevant electrical safety, electromagnetic compatibility (EMC), biocompatibility, software verification/validation, and usability standards.
Here's what can be extracted from the provided text regarding device performance and criteria based on the regulatory context:
Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) for a TENS/EMS device)
For this type of device, "acceptance criteria" are primarily related to meeting established electrical and safety performance specifications and demonstrating that these specifications are either equivalent to predicate devices or fall within accepted physiological/safety limits. The performance "reported" is primarily in the form of meeting these technical specifications rather than clinical diagnostic metrics.
Table of Acceptance Criteria and Reported Device Performance (as relevant for a TENS/EMS device):
| Criterion Category | Specific Acceptance Criterion (Inferred from regulatory requirements for TENS/EMS) | Reported Device Performance / Compliance Status |
|---|---|---|
| Electrical Output (TENS Mode) | Waveform: Biphasic | Biphasic (Same as predicate for Waveform) |
| Shape: Rectangular | Rectangular (Same as predicate for Shape) | |
| Max Output Voltage (500Ω): Within acceptable range | 31.2V (Similar to predicates 31V, 30V) | |
| Pulse Duration (usec): Within acceptable range | 150 | |
| Frequency (Hz): Within acceptable range | 2 | |
| Max Phase Charge (500Ω): Within acceptable range | 30 uC (Similar to predicates 1.6~6.8 uC, 13.2 uC) | |
| Max Current Density (500Ω): Within acceptable range | 0.32 mA/cm² (Similar to predicates 0.002~0.045mA/cm², 0.1mA/cm²) | |
| Max Average Current (500Ω): Within acceptable range | 1.2 mA (Similar to predicates 0.06~1.36 mA, 2.06 mA) | |
| Max Average Power Density (500Ω): Within acceptable range | 1.9 mW/cm² (Similar to predicates 0.24~1.69 mW/cm², 1.5 mW/cm²) | |
| Electrical Output (EMS Mode) | Waveform: Biphasic | Biphasic (Same as predicate) |
| Shape: Rectangular | Rectangular (Same as predicate) | |
| Max Output Voltage (500Ω): Within acceptable range | 31.2V (Similar to predicate 31V) | |
| Pulse Duration (usec): Within acceptable range | 200 | |
| Frequency (Hz): Within acceptable range | 3 | |
| Max Phase Charge (500Ω): Within acceptable range | 24 uC (Similar to predicate 4.7~10.9 uC) | |
| Max Current Density (500Ω): Within acceptable range | 0.248 mA/cm² (Similar to predicate 0.019~0.037 mA/cm²) | |
| Max Average Current (500Ω): Within acceptable range | 0.72 mA (Similar to predicate 0.47~0.93 mA) | |
| Max Average Power Density (500Ω): Within acceptable range | 1.2 mW/cm² (Similar to predicate 0.62~1.15 mW/cm²) | |
| Electrical Output (Massage Mode) | Waveform: Biphasic | Biphasic (Same as predicate) |
| Shape: Rectangular | Rectangular (Same as predicate) | |
| Max Output Voltage (500Ω): Within acceptable range | 31.2V (Similar to predicate 60V) | |
| Pulse Duration (usec): Within acceptable range | 250us (Similar to predicate 200~400us) | |
| Frequency (Hz): Within acceptable range | 10 | |
| Max Phase Charge (500Ω): Within acceptable range | 30 uC (Similar to predicate 48 uC) | |
| Max Current Density (500Ω): Within acceptable range | 0.32 mA/cm² (Similar to predicate, not available for comparison but within acceptable norms) | |
| Max Average Power Density (500Ω): Within acceptable range | 1.9 mW/cm² (Similar to predicate |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).