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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:

• 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.

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The BioWaveGO Neuromodulation Pain Therapy Device is indicated 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 Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.

The provided text describes the BioWaveGO Neuromodulation Pain Therapy Device, its indications for use, and a comparison with predicate devices to establish substantial equivalence for FDA clearance. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on regulatory clearance through substantial equivalence, which compares a new device to existing legally marketed predicate devices, rather than an independent performance study with defined acceptance criteria and statistical analysis.

Therefore, the requested information cannot be fully extracted from the provided text. I will detail what can be inferred or is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum pain reduction, specific accuracy metrics). Instead, it focuses on functional and electrical safety compliance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The "Performance Testing Summary" outlines a list of tests conducted, but it does not specify the sample size of devices tested or any patient data provenance. The clearance is based on comparison to predicates and engineering/safety testing, not clinical performance data in patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document describes technical performance testing and safety evaluations, not a study that would require expert-established ground truth related to clinical outcomes or image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical or interpretive "ground truth" establishment by experts is mentioned, an adjudication method is not applicable to the described engineering and safety tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in this document. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic tool.

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

This concept is not applicable to the BioWaveGO device. It is a physical medical device providing electrical stimulation, not an algorithm, and it is intended for human use, either over-the-counter or with a prescription (for its predicate).

7. The Type of Ground Truth Used

The "ground truth" for the tests described appears to be based on engineering specifications, safety standards, and functional requirements of the device. For example, ensuring the session timer is operational only during active treatment means verifying the device's software behaves according to its design specification under various conditions. There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth for the technical tests performed.

8. The Sample Size for the Training Set

This information is not provided. Since this is a hardware device cleared based on substantial equivalence and engineering tests, rather than an AI/ML algorithm or a device requiring a clinical efficacy trial with a training set, this concept is not applicable in the context described.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no mention of a training set for an algorithm or a device requiring such.

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