(112 days)
The Deepwave Neuromodulation Pain Therapy Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
- Symptomatic relief of post-traumatic acute pain .
- Symptomatic relief of post-operative pain .
The Biowave Corporation Neuromodulation Pain Therapy Device is a battery-powered device intended to provide clinicians with the flexibility to prescribe powered muscle stimulation and TENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller electrode pad ("Pain Site Pad") placed directly over the source of the pain (the treatment site).
The provided text for K052289, "Deepwave Neuromodulation Pain Therapy Device," is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts used for ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details about a standalone (algorithm only) performance study.
- How ground truth was established for either test or training sets.
Instead, the submission focuses on comparing the proposed device's indications for use, design, and function to a predicate device to establish substantial equivalence. The key information provided is:
1. Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in a table. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or substantially equivalent indications for use and similar technological characteristics.
- Reported Device Performance: No specific performance metrics or clinical study results with numerical values are reported to demonstrate efficacy against pre-defined acceptance criteria. The claim of performance is implicitly that it performs equivalently to the predicate device for pain relief.
2. Sample Size and Data Provenance for Test Set: Not applicable. The document does not describe a clinical study with a test set in the conventional sense of a diagnostic or predictive device.
3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not mentioned as such. The basis for efficacy is the established use of similar technology in the predicate device for pain relief.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable.
6. Standalone Performance Study: Not mentioned or applicable.
7. Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy studies. The "ground truth" for the device's intended use (symptomatic relief of pain) is based on the therapeutic effect of electrical stimulation, which is a well-established mechanism for pain management. The submission relies on the established safety and efficacy of the predicate device.
8. Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How Ground Truth for the Training Set Was Established: Not applicable.
Summary of Device Comparison (Basis for Substantial Equivalence):
The document states that the Deepwave Neuromodulation Pain Therapy Device's indications for use are identical to those of the predicate device (Chattanooga Group Forte Model CPS 200 Stimulator Device, K982828).
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Identical Indications:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
- Symptomatic relief of post-traumatic acute pain.
- Symptomatic relief of post-operative pain.
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Similar Design and Function: Both devices offer a biphasic waveform, sine waves, and a beat frequency in the range of 100-200 Hz. Both are software-driven TENS units that provide a treatment program for pain reduction.
Conclusion: The submission concludes that the Biowave Deepwave Device is substantially equivalent to the predicate devices for the specified indications based on the identical indications for use and similar technological characteristics. This type of 510(k) submission primarily relies on comparisons to legally marketed devices, rather than new extensive clinical trials, to demonstrate safety and effectiveness.
§ 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).