BioWaveGO

K180943 · Biowave Corporation · GZJ · Aug 17, 2018 · Neurology

Device Facts

• Record ID: K180943
• Device Name: BioWaveGO
• Applicant: Biowave Corporation
• Product Code: GZJ · Neurology
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Battery-powered transcutaneous electrical nerve stimulator (TENS) for pain relief; delivers high-frequency alternating current sinusoidal signals via electrodes to skin. Device operates via smartphone app interface; Bluetooth-enabled. User-controlled intensity; software monitors session timer, electrode/cable connectivity, and load impedance. Safety interlocks prevent operation during charging or in over-temperature conditions. Hardware watchdog timers ensure system reset. Output is regulated voltage; biphasic waveform. Used by patients in home or clinical settings for symptomatic pain management. Output affects nerve signaling to provide relief; benefits include non-invasive, portable pain management.

Clinical Evidence

Bench testing only. Evaluations included operational mode verification, battery charging safety, load impedance detection, cable/electrode recognition, over-temperature protection, hardware watchdog timer functionality, and electrical safety testing.

Technological Characteristics

Battery-powered (3.2V 1100mAh LiFePO4); ABS housing; biphasic sinusoidal waveform; regulated voltage output; Bluetooth connectivity for smartphone interface; software-based safety interlocks (overload, no-load, automatic shut-off).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic, intractable pain, acute pain, or as adjunctive treatment for post-surgical and post-traumatic acute pain.

Regulatory Classification

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.

Predicate Devices

• BioWaveHOME (K152437)

Reference Devices

• Quell (K152954)
• LL TENS 160A (K152374)
• LL TENS 160B (K152374)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date August 17, 2018. The text is in a simple, sans-serif font and is horizontally aligned. The date is written out in full, with the month, day, and year clearly visible.

Biowave Corporation % Dave Mcgurl Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K180943

Trade/Device Name: BioWaveGO Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, GZJ Dated: July 11, 2018 Received: July 11, 2018

Dear Dave McGurl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carlos L. Pena -S) A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K180943

Device Name BioWaveGo

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

# K180943

| Device Trade Name: | BioWaveGO System |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851 |
| Contact: | Bradford Siff<br>Founder & President<br>BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by: | Mr. Dave McGurl<br>Director, Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>Office: 202.552.5797<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | April 26th, 2018 |
| Classifications: | 21 CFR §882.5890, Transcutaneous electrical nerve stimulator for pain relief |

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Class: II

Product Codes: NUH, GZJ

### Indications For Use:

The BioWaveGO Neuromodulation Pain Therapy 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

## Device Description:

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.

## Predicate Device:

The Bio Wave Corporation's Bio WaveGO Neuromodulation Pain Therapy Device is substantially equivalent to the previously cleared with respect to indications, design, function, and materials, as outlined below.

| Manufacturer | Device Name | K-Number |
|--------------------------------------------|----------------------------|----------|
| BioWave Corporation<br>(primary predicate) | BioWaveHOME | K152437 |
| NeuroMetrix, Inc.<br>(reference device) | Quell | K152954 |
| Fuji Dynamics Ltd.<br>(reference device) | LL TENS 160A, LL TENS 160B | K152374 |

## Performance Testing Summary:

The testing of the BioWaveGO device and the smartphone app includes:

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- · Testing of basic operational modes to confirm that the session timer is only operational during active treatment time.
- · Battery testing to ensure charging only occurs when the device is not in use and that active treatment sessions cannot be started during charging.
- Testing to ensure consistent operation across various intensities and load impedances. .
- Testing to ensure recognition of the cable and electrodes before and during an active session. .
- Testing to ensure invalid load impendences are detected before and during an active session. ●
- Abuse of the battery charger input and output ports testing to determine if damage to the device or improper software operation occurs.
- · Testing in over-temperature situations to determine if the inherent protect draw on the battery outside safe operating temperatures.
- · Testing to determine if the hardware watchdog timers were functional at resetting the device.
- Evaluation of electrical safety. .

| Predicate Comparison Table | | | |
|-------------------------------------|------------------------------------|----------------------------------------|---------------------------|
| | Subject Device<br>BioWaveGO Device | Predicate Device<br>BioWaveHOME Device | Reference Device<br>Quell |
| Manufacturer | BioWave Corporation | BioWave Corporation | Neurometrix, Inc. |
| Trade Name | BioWaveGO | BioWaveHOME | Quell |
| 510(k) | K180943 | K152437 | K152954 |
| Bluetooth Capable | Yes | No | Yes |
| Smartphone<br>Interface | Yes | No | Yes |
| Prescription or<br>Over-the-Counter | Over-the-Counter | Prescription | Over-the-Counter |

## Substantial Equivalence:

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| | Subject Device | Predicate Device | Reference Device |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BioWaveGO Device | BioWaveHOME Device | Quell |
| Image | Image: BioWaveGO Device | Image: BioWaveHOME Device | Image: Quell |
| Indications | The BioWaveGO Neuromodulation Pain<br>Therapy Device is indicated for:<br>- Symptomatic relief of chronic,<br>intractable pain, post-surgical, and post-<br>traumatic acute pain<br>- Symptomatic relief of acute pain<br>- Symptomatic relief of post-operative<br>pain | The BioWaveHOME Neuromodulation<br>Pain Therapy Device is indicated for:<br>- Symptomatic relief of chronic,<br>intractable pain, post-surgical, and post-<br>traumatic acute pain<br>- Symptomatic relief of acute pain<br>- Symptomatic relief of post-operative<br>pain | Quell is intended for use as a<br>transcutaneous electrical nerve<br>stimulation device for the symptomatic<br>relief and management of chronic<br>intractable pain.<br>The device may be used during sleep. The<br>device is labeled for use only with<br>compatible NeuroMetrix electrodes. |
| | BioWave Corporation<br>BioWaveGO Device | BioWave Corporation<br>BioWaveHOME Device | Comparison of BioWaveGO and<br>BioWaveHOME |
| 510(k) Number | K180943 | K152437 | - |
| Device Name, Model | BioWaveGO | BioWaveHOME | - |
| Manufacturer | BioWave Corporation | BioWave Corporation | Identical |
| Availability | Over-the-Counter | Prescription | BioWaveGO is designed as an over-the-<br>counter neuromodulation pain therapy device<br>sharing identical specifications to the parent<br>device, BioWaveHOME, with the exception<br>of a decreased maximum voltage (20V versus<br>27.5V) |
| Power Source(s) | one 3.2V 1100mAh rechargeable<br>lithium iron phosphate battery | two 3.2V 3300mAh rechargeable<br>lithium iron phosphate batteries | Similar power source but a smaller battery<br>system in BioWaveGO vs BioWaveHOME |
| Method of Line Current Isolation | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | Identical |
| Normal condition | None | None | Identical |
| Single fault condition | None | None | Identical |
| Number of Output Modes | One | One | Identical |
| Number of Output Channels | One | One | Identical |
| Synchronous or Alternating? | N/A | N/A | - |
| Method of Channel Isolation | N/A | N/A | - |
| Regulated Current or Regulated<br>Voltage? | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes (software) | Yes (software) | Identical |
| Automatic No-Load Trip? | Yes (software) | Yes (software) | Identical |
| Automatic Shut Off? | Yes | Yes | Identical |
| Patient Override Control? | Yes | Yes | Identical |
| Indicator Display: | Yes | Yes | Identical |
| On/Off Status? | Yes | Yes | Identical |
| Low Battery? | Yes | Yes | Identical |
| Voltage/Current Level? | Yes (% of full scale) | Yes (% of full scale) | Identical |
| Timer Range - (minutes) | 30 | 30 | Identical |
| Compliance with Voluntary<br>Standards? | Yes | Yes | Identical |
| | BioWave Corporation<br>BioWaveGO Device | BioWave Corporation<br>BioWaveHOME Device | Comparison of BioWaveGO and<br>BioWaveHOME |
| Compliance with 21 CFR 898? | Yes | Yes | Identical |
| Weight | 6 ounces | 1.0 lbs | BioWaveGO is lighter |
| Dimensions (in.) (W x H x D) | 3.0" x 4.0" x 1.0" | 3.75" x 6.0" x 1.75" | BioWaveGO is smaller |
| Housing Materials and Construction | ABS via conventional injection<br>molding | ABS via conventional injection<br>molding | Identical |

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#### Comparison of Basic Unit Characteristics for BioWaveHOME and BioWaveGO

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#### Comparison of Output Specifications for BioWaveHOME and BioWaveGO

| | BioWave Corporation<br>BioWaveGO Device | Parent BioWave Corporation<br>BioWaveHOME Device | Comparison of BioWaveGO and<br>BioWaveHOME |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform | Biphasic | Biphasic | Identical |
| Shape | Sum of 2 sine waves | Sum of 2 sine waves | Identical |
| Maximum Output Voltage<br>Available(+1-2%) (with software<br>calibration correction) | 80V p-p @ 500 Ω<br>20 V AC RMS | 110V p-p @ 500 Ω<br>27.5 V AC RMS | BioWaveGO offers a decreased maximum<br>voltage to allow for over-the-counter<br>availability. The decrease in voltage does not<br>impact safety or performance of the device. |
| Maximum Output Current(+1- 2 %)<br>(current depends on load) | 160mA p-p @ 500 Ω<br>40mA RMS<br>40 mA p-p @ 2kΩ<br>Trip out @ 10kΩ | 220mA p-p @ 500 Ω<br>55mA RMS<br>55 mA p-p @ 2kΩ<br>Trip out @ 10kΩ | BioWaveGO has a lower maximum current<br>density. |
| Pulse Width | Continuous modulation | Continuous modulation | Identical |
| For multiphasic waveforms only:<br>- Symmetrical phases?<br>- Phase Duration | N/A<br>N/A | N/A<br>N/A | - |
| Net Charge (m C per pulse) (If zero,<br>state method of achieving zero net<br>charge.) | 0 @ 500 Ω<br>biphasic – AC coupled continuous<br>wave | 0 @ 500 Ω<br>biphasic – AC coupled continuous<br>wave | Identical |
| Maximum Phase Charge, (μ C) | N/A | N/A | - |
| Maximum Current Density,<br>(µmA/cm²) (with 1.375" diam pad =<br>9.58 cm2 area) | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density, (W/cm²)<br>(using 1.375" diam 9.58 cm² electrode<br>conductive surface area) | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
| Burst Mode<br>a. Pulses per burst<br>b. Bursts per second<br>c. Burst duration (seconds) | N/A | N/A | - |

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| | BioWave Corporation | Parent BioWave Corporation | Comparison of BioWaveGO and |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | BioWaveGO Device | BioWaveHOME Device | BioWaveHOME |
| d. Duty Cycle [Line (b) x Line (c)] | | | |
| ON Time (seconds) | N/A | N/A | - |
| OFF Time (seconds) | N/A | N/A | - |
| Additional Features (if applicable) | Many safety interlocks: cable<br>connected to unit, pads connected to<br>cable, pads connected to body, max<br>power density, battery ok for<br>treatment, charger connected (trip<br>off) | Many safety interlocks: cable<br>connected to unit, pads connected to<br>cable, pads connected to body, max<br>power density, battery ok for<br>treatment, charger connected (trip<br>off) | Identical |

The subject device, the BioWaveGO, was demonstrated to be substantially equivalent to predicate device K152437 cited in the table above with respect to design, materials, function, manufacturing, and to the reference devices (K152374 and K152954) with respect to IFU and over-the-counter use.

# Conclusion:

The BioWaveGO device has been found to be substantially equivalent to the previously cleared predicate device, BioWaveHOME (K152437), with respect to its design, function, materials, and the reference devices, LL TENS 160A, LL TENS 160B (K152374) and Quell (K152954) with respect to indications for use and over-the-counter availability.