(141 days)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, and upper and lower extremities due to strain from exercise or normal household and work activities. To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Pain-Aid is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body. The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case. The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device. Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single. These electrodes are manufactured in various shapes to facilitate proper placement on the body.
The provided text from the 510(k) submission for the PDI Works Pain-Aid device (K113037) does not contain a study that proves the device meets specific acceptance criteria.
The submission focuses on establishing substantial equivalence to predicate devices (Endurance Therapeutics Therapeutic Massage Companion, K060846, and Empi Select, K061650) based on intended use and technological characteristics. There is no information about clinical trials, performance studies, or quantitative acceptance criteria for device performance.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily provides the following:
- Device Identification: Transcutaneous Nerve Stimulator, Pain-Aid.
- Intended Use: Temporary relief of pain associated with sore and aching muscles (upper and lower back, upper and lower extremities) due to strain from exercise or normal household/work activities. Also, symptomatic relief and management of chronic, intractable pain and pain due to arthritis.
- Technological Characteristics Comparison Table: This table compares the Pain-Aid to the predicate devices based on intended use, output waveform, technology/control system, patient connection, and safety features. This comparison is used to argue for substantial equivalence, not to demonstrate performance against acceptance criteria in a study.
- Conclusion: The device has the same intended use and similar technological characteristics to the cleared predicate devices, and any minor differences do not impact safety or effectiveness.
In summary, the provided 510(k) simply asserts substantial equivalence to legally marketed devices rather than presenting data from a dedicated performance study with acceptance criteria.
§ 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).