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The Deepwave Percutaneous Neuromodulation Pain Therapy System is comprised of a percutaneous electrode array and the Deepwave Neuromodulation Pain Therapy Device. The Deepwave Percutaneous Neuromodulation Pain Therapy System is indicated for:

• Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain;
• Symptomatic relief of post-traumatic pain;
• Symptomatic relief of post-operative pain.

Biowave Corporation's Deepwave Percutaneous Neuromodulation Pain Therapy System is essentially identical to Biowave's Deepwave Neuromodulation Pain Therapy Device cleared under K052289 except that the proposed device includes a percutaneous electrode array instead of standard surface electrodes.

The percutaneous electrode array (PEA) is a sterile, single-use microneedle patch which facilitates the delivery of electrical signals through the skin into tissue. The size of the PEA patch is 2.5 inches in diameter. In the center of the patch is a 1.5 inch diameter array of 1014 microneedles made from medical grade 316L stainless steel which are 736 microns (0.736 millimeters) in length. When placed onto the skin the PEA feels like sandpaper or Velcro to the touch. The Feed Pad is a standard electrode that is 2" x 4" or 5" x 8" in size. The Deepwave Percutaneous Neuromodulation device sends a signal from the Feed Pad through the body to the PEA.

The Deepwave Percutaneous Neuromodulation Pain Therapy Device is a batterypowered device intended to provide clinicians with the ability to prescribe PENS 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 microneedle patch called a Percutaneous Electrode Array ("PEA") placed directly over the source of the pain (the treatment site).

The provided 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics. This document is a premarket notification for substantial equivalence, which primarily focuses on comparing a new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective.

Therefore, many of the requested details are not applicable or not present in this type of submission.

Not Applicable/Not Provided based on the 510(k) Summary:

1. Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria established for the new device.
2. Sample size for the test set and data provenance: No new clinical test set data is presented. The submission relies on the established safety and effectiveness of predicate devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for diagnostic imaging devices to assess the impact of AI on human reader performance, which doesn't directly apply to a pain therapy system.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This device is a physical therapy system, not an AI algorithm operating independently.
7. Type of ground truth used: Not applicable, as no new clinical study data requiring ground truth is presented.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's approach to demonstrating substantial equivalence:

The applicant, Biowave Corporation, establishes substantial equivalence for the Deepwave Percutaneous Neuromodulation Pain Therapy System (K061166) by comparing it to two predicate devices:

• Vertis NeuroScience Inc., Percutaneous Neuromodulation Control Unit and Accessories (K022241)
• Biowave Corporation's Deepwave Neuromodulation Pain Therapy Device (K052289)

The basis for substantial equivalence is primarily focused on:

• Identical Indications for Use: All three devices (proposed and predicates) are indicated for "symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain" and "symptomatic relief of post-operative pain."
• Similar Design and Function:
  • The proposed device and the Vertis predicate are both Percutaneous Electrical Nerve Stimulation (PENS) devices using percutaneous electrodes.
  • The Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) is a Transcutaneous Electrical Nerve Stimulation (TENS) device using standard surface electrodes, and the new device is described as "essentially identical" to it, with the key difference being the use of a percutaneous electrode array instead of surface electrodes.
  • The percutaneous electrode array (PEA) in the proposed device is highlighted as penetrating less depth than the Vertis PEA, implying no increased safety risk.
  • Both the proposed device and the Vertis PENS device use a biphasic waveform and a beat frequency in the range of 100-200 Hz.
  • Both are software-driven PENS units designed for pain reduction.
• Similarity in Basic Unit Characteristics and Output Specifications: This is stated to be similar according to FDA guidance for Powered Muscle Stimulator 510(k)s.

In essence, the submission asserts that because the new device's indications, fundamental technology (electrical neuromodulation), and key technical specifications (waveform, frequency) are similar to already cleared devices, and its unique component (microneedle PEA) is designed in a way that doesn't introduce new safety or effectiveness concerns (e.g., less penetration than a predicate PEA), it is substantially equivalent and thus, as safe and effective.

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