BiowaveHOME Neuromodulation Pain Therapy Device

• K Number: K152437
• Device Name: BiowaveHOME Neuromodulation Pain Therapy Device
• Manufacturer: BIOWAVE CORPORATION
• Date Cleared: 2015-09-25 ( 29 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Special
• Panel: NE
• Reference & Predicate Devices: K053389 , K072123

Intended Use

The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for:

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

Device Description

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain. Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:

• . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
• . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
• . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
• . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
  The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.

AI/ML Overview

This is a 510(k) premarket notification for the BiowaveHOME Neuromodulation Pain Therapy System. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria as you would typically find in a PMA or De Novo submission.

Therefore, the provided document does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the way you would expect for a novel device.

Here's why and what information can be extracted:

• No new performance study: The document explicitly states that this is a "Special 510(k)" and that the "purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewave Neuromodulation Pain Therapy Device (K072123)." It emphasizes that the modified BiowaveHOME device "has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123." This means Biowave Corporation is leveraging the prior clearance of the predicate device (K072123) and argues that the modifications are minor and do not significantly alter the device's fundamental safety or effectiveness.
• Basis for Substantial Equivalence: The submission focuses on comparing the BiowaveHOME with its predicate (Homewave Neuromodulation Pain Therapy Device, K072123) and other related predicate devices (Deepwave (BiowavePRO), K053389; Deepwave Percutaneous (BiowavePENS), K053389) on design, function, intended use, and indications. The argument is that since the modified device is so similar to an already cleared device, it is "substantially equivalent" and does not require new efficacy studies.

Therefore, many of your requested items about a performance study, acceptance criteria, sample sizes, experts, ground truth, and MRMC studies, are not applicable or not present in this type of submission.

However, I can provide the available information:

• Device Name: BiowaveHOME Neuromodulation Pain Therapy System
• Product Code: GZJ (Transcutaneous electrical nerve stimulator for pain relief)
• Indications for Use:
  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
  • Symptomatic relief of acute pain
  • Symptomatic relief of post-operative pain

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable/Not provided. This submission does not define new acceptance criteria for a clinical performance study because it's based on substantial equivalence to a predicate device. Performance is assumed to be equivalent to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. No new clinical "test set" was used for performance validation in this 510(k) submission.

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/Not provided. No independent expert review of a test set for ground truth was conducted for this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. No test set adjudication method is mentioned as no new clinical study was conducted.

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/Not provided. This device is a pain therapy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not provided. This is a hardware neuromodulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable/Not provided. No new ground truth assessment for clinical performance was performed for this 510(k). The "ground truth" for its effectiveness is implicitly tied to the prior clearance of its predicate device, based on the studies that supported that predicate.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable/Not provided. As above, no training set is relevant here.

In summary, this document is an FDA 510(k) clearance letter and its associated summary for a device that is essentially a modified version of an already cleared device. It relies on demonstrating substantial equivalence rather than presenting new clinical study data with specific acceptance criteria.

Regulation Number and Section

§ 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).