(142 days)
The device is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, 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.
The ThermaCare® Quick Therapy TENS device is a wireless, two channels wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient use of the dedicated APP (iOS or Android) or remote control. Reusable, self-adhesive pads allow for discreet and convenient placement on multiple pain locations on the body. The ThermaCare® Quick Therapy TENS contains 23 TENS programs. It is designed to be used at home, by adults of all genders.
The ThermaCare® Quick Therapy TENS device contains one main TENS unit which is rechargeable and one remote control which is powered by 2 AAA batteries. The pads with attached TENS unit can then be applied to intact skin at the desired location for pain relief. Control of the ThermaCare® Quick Therapy TENS device is completed through the available TENS APP (iOS or Android)or remote control. The communication is done via Bluetooth Low Energy.
The device will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the App, setting and controlling therapy programs, and troubleshooting. The ThermaCare® Quick Therapy TENS consists of the following elements:
• Main device: generates the TENS pulses; connects to the electrode; controlled by APP on smart phone and remote control.
• Electrodes: Self-adhesive re-usable hydrogel electrodes connects to the device.
• APP on mobile device: The APP controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the mobile device and the main device.
• Remote control: The remote controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the remote control and the main device.
· Adapter (optional): for charging the battery unit via a micro-USB socket which connected with the adapter, and insert the adapter to the supply mains.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ThermaCare® Quick Therapy TENS (Model: TC001):
Based on the provided FDA 510(k) Summary, this document primarily focuses on establishing substantial equivalence to a predicate device (Wireless Pain Relieve Device, Model LT5018C, K173462), rather than detailing acceptance criteria for a novel device and studies proving it meets those criteria in a clinical performance sense.
The document primarily relies on bench testing and compliance with recognized standards to demonstrate the safety and effectiveness of the new device relative to the predicate. There is no evidence of a clinical study with human subjects to evaluate the device's performance against specific acceptance criteria for pain relief.
Therefore, many of the requested sections (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance) are not applicable or cannot be answered from the provided text, as these typically relate to clinical performance studies.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it demonstrates compliance with safety and technical standards, and shows the technical specifications and outputs are comparable to a legally marketed predicate device.
Here's a summary of the technical specifications and their comparison to the predicate device, which implicitly serve as a form of "acceptance" for substantial equivalence:
| Characteristic | Acceptance Criteria (Predicate / Standard Compliance) | Reported Device Performance (TC001) |
|---|---|---|
| Intended Use | TENS for various pain relief (Predicate's TENS mode) | TENS for various pain relief |
| Power Source | DC 3.7V Li-ion (main), 2xAAA (remote) | DC 3.7V Li-ion (main), 2xAAA (remote) |
| Patient Leakage Current | 0uA (DC), 2.0uA (AC) (Predicate) | 0uA (DC), 29uA max (AC) (Tested to IEC 60601-1) |
| Avg DC current (no pulses) | 0 (Predicate) | 0 |
| Output Modes | 2 (TENS/EMS) (Predicate) | 1 (TENS) |
| Output Channels | N/A (Predicate, implied single) | Alternating (Two channels, tested to IEC 60601-2-10) |
| Channel Isolation | N/A (Predicate) | By Electrical Circuit and Software (Tested to IEC 60601-1) |
| Regulated Current/Voltage | Current control (Predicate) | Current control |
| Software/Firmware Control | Yes (Predicate) | Yes |
| Automatic Overload Trip | Yes (Predicate) | Yes |
| Automatic No Load Trip | Yes (Predicate) | Yes |
| Automatic Shut off | Yes (Predicate) | Yes |
| User Override Control | Yes (Predicate) | Yes (Device, remote, APP controls) |
| On/Off Status Indicator | Yes (Predicate) | Yes |
| Low Battery Indicator | Yes (Predicate) | Yes |
| Voltage/Current Level Indicator | Yes (Predicate) | Yes |
| Timer Range | 30 minutes (Predicate) | 5-30 minutes (Tested to IEC 60601-2-10) |
| Weight | 36g (main), 65g (remote) (Predicate) | 32g (main), 55g (remote, without batteries) (Tested to IEC 60601-1) |
| Dimensions (HWL) | 360x59x11.5mm (main), 115x53x25mm (remote) (Predicate) | 80.5x45x13.5mm (main), 127x48.6x24.4mm (remote) (Tested to IEC 60601-1) |
| Housing Materials | ABS (Predicate) | ABS |
| Compliance 21 CFR 898 | Yes (Predicate) | Yes |
| Compliance Voluntary Standards | IEC 60601-1, -1-2, -2-10, -1-11; ISO 10993-1, -5, -10 (Predicate) | IEC 60601-1, -1-2, -2-10, -1-11; ISO 10993-1, -5, -10 |
| Waveform | Biphasic (Predicate) | Biphasic |
| Shape | Rectangular (Predicate) | Rectangular |
| Max Output Voltage (V) @ 500Ω | 31 (Predicate) | 30.4 (Tested to IEC 60601-2-10) |
| Max Output Voltage (V) @ 2kΩ | 66 (Predicate) | 70 (Tested to IEC 60601-2-10) |
| Max Output Voltage (V) @ 10kΩ | 66 (Predicate) | 70 (Tested to IEC 60601-2-10) |
| Max Output Current (mA) @ 500Ω | 62 (Predicate) | 60.8 (Tested to IEC 60601-2-10) |
| Max Output Current (mA) @ 2kΩ | 33 (Predicate) | 35 (Tested to IEC 60601-2-10) |
| Max Output Current (mA) @ 10kΩ | 6.6 (Predicate) | 7 (Tested to IEC 60601-2-10) |
| Pulse Duration (µsec) | 150-250 (Predicate) | 100-200 (Tested to IEC 60601-2-10) |
| Frequency (Hz) | 2-100 (Predicate) | 2-100 |
| Max Phase Charge (uC) @ 500Ω | 31 (Predicate) | 24.32 (Tested to IEC 60601-2-10) |
| Max Current Density @ 500Ω | 0.48mA/cm² (Predicate) | 0.295mA/cm² (Tested to IEC 60601-2-10) |
| Max Avg Current (mA) @ 500Ω | 1.2 (Predicate) | 1.22 (Tested to IEC 60601-2-10) |
| Max Avg Power Density (mW/cm²) @ 500Ω | 2.88 (Predicate) | 1.8 (Tested to IEC 60601-2-10) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "testing" referred to in this document is primarily bench testing and compliance with international standards (biocompatibility, electrical safety, EMC, software V&V, output waveform testing), not a clinical study on human subjects.
- Data Provenance: Not applicable for clinical performance data. The device manufacturer is Shenzhen Dongdixin Technology Co., Ltd. in Shenzhen, China (as seen in the correspondent's address). The testing was likely conducted in laboratories adhering to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical ground truth was established by human experts for this submission type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication was performed.
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 Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic system involving human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is electrotherapy equipment, not an algorithm. Its performance specifications were tested in a standalone manner (bench testing).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the international performance and safety standards (e.g., IEC 60601 series, ISO 10993 series) and the specifications of a legally marketed predicate device. The studies performed (biocompatibility, electrical safety, EMC, software V&V, output waveform) aimed to prove that the new device adheres to these standards and has comparable technical characteristics to the predicate.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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).