(580 days)
The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off. The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
The provided text is a 510(k) Summary for the "Smart Neck Stimulator" (K200558). This document primarily focuses on demonstrating substantial equivalence to predicate devices based on device description, intended use, and conformance to electrical safety, EMC, and biocompatibility standards through bench testing.
Therefore, the information required to answer questions regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), training set details, and ground truth establishment is not available in this document. The document details the physical and electrical safety characteristics rather than performance in a clinical, diagnostic, or AI-assisted scenario.
The document's "Test Summary" and "Comparison to Predicate Device and Conclusion" sections refer to safety and performance by lab bench testing and adherence to standards, not clinical or AI-based performance studies.
Here's what can be extracted from the document:
- Device Name: Smart Neck Stimulator (Model: 4098 (RED))
- Product Code: NUH
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Intended Use/Indications for Use: The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
- Type of Use: Over-The-Counter Use
- Predicate Devices:
- Tests Performed (Bench Testing for Safety and Performance):
- IEC 60601-1 (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-2-10 (Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators)
- IEC 60601-1-11 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 62133-2 (Secondary Cells And Batteries - Safety Requirements for Lithium Systems)
- IEC 62366-1 (Medical Devices - Application Of Usability Engineering To Medical Devices)
- ISO 10993-5 (Biological evaluation of medical devices - Tests for In Vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
Regarding the specific questions posed:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Implicitly, the acceptance criteria are compliance with the referenced IEC/ISO standards (e.g., electrical safety limits, biocompatibility standards, EMC limits) and demonstration that the device's technical specifications are comparable to or within acceptable limits relative to predicate devices, and would not raise new safety or effectiveness concerns.
- Reported Device Performance: The document lists the device's specifications (e.g., output voltage, current, pulse duration, frequency, heating temperature, dimensions, weight) and states that bench tests were performed and results "complied with the test requests" and "meet the safety standards." However, it does not provide specific numerical performance results against an acceptance criterion in a tabular format beyond listing the device's characteristics and noting compliance.
Example (Structured as requested, but data is qualitative in the document):
| Acceptance Criteria Category | Specific Criteria (Implicitly from Standards & Predicate Comparison) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 62133-2 standards, and comparable to predicate devices for parameters like patient leakage current, average current through electrodes. | "results complied with the test requests" and "meet the safety standards IEC 60601-1 and IEC 60601-1-11." Specific values are provided for comparison to predicates (e.g., Patient Leakage Current NC, Average current through electrodes |
§ 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).