(30 days)
The BioWaveGO Rx is indicated for prescription use for:
· Symptomatic relief of chronic, intractable pain
· Symptomatic relief of acute pain
· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain
The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME. The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.
This FDA 510(k) summary for the BioWaveGO Rx device does not contain a typical acceptance criteria table and performance study results. Instead, it focuses on demonstrating substantial equivalence to a predicate device (BioWaveGO, K180943) through a comparison of specifications.
The document explicitly states: "No additional testing was required for this Special 510(k)." This indicates that a new performance study with acceptance criteria was not conducted for the BioWaveGO Rx as part of this submission because it is deemed substantially equivalent in performance to its predicate. The substantial equivalence is based on the device being identical in design and indications to the predicate, with the only change being its availability for prescription use rather than over-the-counter.
Therefore, many of the requested elements for a performance study are not applicable or cannot be extracted from this document, as a specific new performance study wasn't part of this 510(k) submission.
Despite the lack of a dedicated performance study for this specific submission, I can present the information that is available and explain the context:
1. Acceptance Criteria and Reported Device Performance
As no new performance study was conducted, there are no specific acceptance criteria or reported device performance results from a new study presented in this document. The "performance" assessment is by comparison to the predicate device, asserting that its performance is equivalent due to identical design and function. The acceptance criteria, in this context, would be that the BioWaveGO Rx device demonstrates substantial equivalence to its predicate across all specified characteristics.
The table below summarizes the comparison points that implicitly serve as "performance" metrics for substantial equivalence:
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (BioWaveGO Rx) | Outcome |
|---|---|---|---|
| Indications for Use | - Symptomatic relief of chronic, intractable pain |
- Symptomatic relief of acute pain
- As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | - Symptomatic relief of chronic, intractable pain
- Symptomatic relief of acute pain
- As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | Identical |
| Connectivity | Bluetooth Capable: Yes
Smartphone Interface: Yes | Bluetooth Capable: Yes
Smartphone Interface: Yes | Identical |
| Regulatory Classification (Use) | Prescription (similar to BioWaveHOME reference device) / Over-the-Counter (BioWaveGO predicate) | Prescription | Similar (Aligns with reference, differentiates from predicate, but justified by professional oversight) |
| Power Source | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | Identical (to BioWaveGO predicate) |
| Line Current Isolation | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | Identical |
| Number of Output Modes/Channels | One / One | One / One | Identical |
| Output Regulation | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/Microprocessor Control | Yes | Yes | Identical |
| Safety Features | Automatic Overload Trip: Yes (software)
Automatic No-Load Trip: Yes (software)
Automatic Shut Off: Yes
Patient Override Control: Yes
Many safety interlocks | Automatic Overload Trip: Yes (software)
Automatic No-Load Trip: Yes (software)
Automatic Shut Off: Yes
Patient Override Control: Yes
Many safety interlocks | Identical |
| Indicator Display | On/Off Status: Yes
Low Battery: Yes
Voltage/Current Level: Yes (% of full scale) | On/Off Status: Yes
Low Battery: Yes
Voltage/Current Level: Yes (% of full scale) | Identical |
| Timer Range | 30 minutes | 30 minutes | Identical |
| Compliance with Standards| Voluntary Standards: Yes
21 CFR 898: Yes | Voluntary Standards: Yes
21 CFR 898: Yes | Identical |
| Physical Dimensions | Weight: 6 ounces
Dimensions: 3.0" x 4.0" x 1.0" | Weight: 6 ounces
Dimensions: 3.0" x 4.0" x 1.0" | Identical (to BioWaveGO predicate) |
| Housing Materials | ABS via conventional injection molding | ABS via conventional injection molding | Identical |
| Waveform/Shape | Biphasic / Sum of 2 sine waves | Biphasic / Sum of 2 sine waves | Identical |
| Maximum Output Voltage | 80V p-p @ 500 Ω (20 V AC RMS) (BioWaveGO predicate) | 80V p-p @ 500 Ω (20 V AC RMS) | Identical (to BioWaveGO predicate) |
| Maximum Output Current | 160mA p-p @ 500 Ω (40mA RMS) (BioWaveGO predicate) | 160mA p-p @ 500 Ω (40mA RMS) | Identical (to BioWaveGO predicate) |
| Pulse Width | Continuous modulation | Continuous modulation | Identical |
| Frequency (Hz) | 4062 Hz + 3940 Hz (BioWaveGO predicate) | 4062 Hz + 3940 Hz | Equivalence based on frequency difference (to BioWaveHOME) |
| Beat Frequency (Hz) | 122 Hz | 122 Hz | Identical |
| Net Charge (mC per pulse) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | Identical |
| Maximum Current Density | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
2. Sample size used for the test set and the data provenance
Not applicable. As stated, "No additional testing was required for this Special 510(k)." The evidence for substantial equivalence relies on the existing clearance of the predicate device (BioWaveGO, K180943) and a reference device (BioWaveHOME, K152437), not a new clinical or performance test set for the BioWaveGO Rx.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new human-read test set was established. This submission is a comparison of technical specifications against previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was part of this submission.
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. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic imaging device or a device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical neuromodulation device, not an algorithm, and its performance is inherent to its electrical stimulation characteristics, not a standalone algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the BioWaveGO Rx, the "ground truth" for its substantial equivalence claim is the demonstrated safety and efficacy of its predicate device (BioWaveGO, K180943), which previously underwent its own regulatory clearance process. The current submission's "ground truth" is that the new device largely mirrors the predicate's technical and performance characteristics.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
§ 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).