(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as identical in design, battery, and software to a previously cleared device, with no mention of AI/ML capabilities.
Yes.
The device is intended for "symptomatic relief of chronic, intractable pain," "symptomatic relief of acute pain," and "as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which are all therapeutic uses.
No
The device is described as a "Neuromodulation Pain Therapy Device" intended to provide "symptomatic relief of acute, chronic, and post-operative pain." Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "battery-powered device" and delivers electrical signals between electrodes, indicating it includes hardware components beyond just software.
Based on the provided information, the BioWaveGO Rx is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "Symptomatic relief of chronic, intractable pain," "Symptomatic relief of acute pain," and "As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." These are all related to treating pain within the body, not analyzing samples taken from the body.
- Device Description: The description explains that the device delivers electrical signals between electrodes to provide pain relief. This is a form of neuromodulation, which acts directly on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The BioWaveGO Rx operates externally and directly on the body to alleviate pain.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional testing was required for this Special 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
February 24, 2021
BioWave Corporation % Dave Mcgurl Director, Regulatory Affairs Mcra LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K210202
Trade/Device Name: BioWaveGO RX Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: January 12, 2021 Received: January 25, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210202
Device Name BioWaveGO Rx
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Device Trade Name: | BioWaveGO Rx System |
|---|---|
| Manufacturer: | BioWave Corporation |
| 8 Knight Street, Suite 201 | |
| Norwalk, CT 06851 | |
| Contact: | Bradford Siff |
| Founder & President | |
| BioWave Corporation | |
| 8 Knight Street, Suite 201 | |
| Norwalk, CT 06851 | |
| Phone: 203-247-9020 | |
| Fax: 203-286-2518 | |
| brad.siff@biowave.com | |
| Prepared by: | Mr. Dave McGurl |
| Director, Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Office: 202.552.5797 | |
| Fax: 202.552.5798 | |
| dmcgurl@mcra.com | |
| Date Prepared: | February 24, 2021 |
| Regulation Number: | 21 CFR §882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator For Pain Relief |
| Regulatory Class: | II |
| Product Code: | GZJ |
Indications for Use:
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
Device Description:
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.
4
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.
Predicate Device:
BioWave Corporation's BioWaveGO Neuromodulation Pain Therapy Device is substantially equivalent to the predicates previously cleared with respect to indications, design, function, and materials, as outlined below.
| Manufacturer | Device Name | K-Number |
|---|---|---|
| BioWave Corporation | BioWaveGO | K180943 (primary predicate) |
| BioWave Corporation | BioWaveHOME | K152437 (reference device) |
Performance Testing Summary:
No additional testing was required for this Special 510(k).
Substantial Equivalence:
The subject device, the BioWaveGO Rx, was demonstrated to be substantially equivalent to the primary predicate device cited in the table above with respect to indications, design, materials, function, manufacturing, and/or performance and to the predicate devices with respect to availability (i.e. prescription) and indications. The subject device is identical in indications and design. The only difference is to make the device available as a prescription use device. There is no additional risk as a healthcare professional would be prescribing the device to the patient.
5
| Predicate Comparison Table | ||||
|---|---|---|---|---|
| Subject Device | ||||
| BioWaveGO Rx Device | Primary Predicate Device | |||
| BioWaveGO OTC Device | Reference Device | |||
| BioWaveHOME Device | Comparison | |||
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Trade Name | BioWaveGO Rx | BioWaveGO | BioWaveHOME | - |
| 510(k) | K210202 (subject) | K180943 | K152437 | Identical. Both the primary |
| predicate and subject device | ||||
| have Bluetooth. | ||||
| Bluetooth Capable | Yes | Yes | No | Identical. Both the primary |
| predicate and subject device | ||||
| have Bluetooth. | ||||
| Smartphone Interface | Yes | Yes | No | Identical. Both the primary |
| predicate and subject device | ||||
| have a smart phone interface. | ||||
| Prescription or Over-the- | ||||
| Counter | Prescription | Over-the-Counter | Prescription | Similar. The primary predicate |
| is for OTC use. The reference | ||||
| and subject devices are for | ||||
| prescription use. | ||||
| Image | Image: BioWaveGO | Image: BioWaveGO | Image: BioWaveHOME | - |
6
| | Subject Device
BioWaveGO Rx Device | Primary Predicate Device
BioWaveGO OTC Device | Reference Device
BioWaveHOME Device | Comparison |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | The BioWaveGO Rx
Neuromodulation Pain
Therapy Device is indicated
for prescription use for: | The BioWaveGO
Neuromodulation Pain Therapy
Device is indicated for over-the-
counter use for: | The BioWaveHOME
Neuromodulation Pain Therapy
Device is indicated for
prescription use for: | |
| Indications | - 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 | - Symptomatic relief of
chronic, intractable pain, post-
surgical, and post-traumatic
acute pain - Symptomatic relief of acute
pain - Symptomatic relief of post-
operative pain | Identical. The indications for
use are the same as the
primary predicate. |
7
| Device Name, Model | BioWave Corporation
BioWaveGO RX Device
(Subject) | BioWave Corporation
BioWaveGO Device (K180943) | BioWave Corporation
BioWaveHOME Device
(K152437) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------|
| | BioWaveGO Rx | BioWaveGO | BioWaveHOME | - |
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Power Source(s) | one 3.2V 1100mAh rechargeable
lithium iron phosphate battery | one 3.2V 1100mAh rechargeable
lithium iron phosphate battery | two 3.2V 3300mAh
rechargeable lithium iron
phosphate batteries | Identical
(BioWaveGO only) |
| Method of Line Current Isolation | Battery + interlocks | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | None | Identical |
| Normal condition | None | None | None | Identical |
| Single fault condition | None | None | None | Identical |
| Number of Output Modes | One | One | One | Identical |
| Number of Output Channels | One | One | One | Identical |
| Synchronous or Alternating? | N/A | N/A | N/A | - |
| Method of Channel Isolation | N/A | N/A | N/A | - |
| Regulated Current or Regulated
Voltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/Microprocessor
Control? | Yes | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic No-Load Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic Shut Off? | Yes | Yes | Yes | Identical |
| Patient Override Control? | Yes | Yes | Yes | Identical |
| Indicator Display: | Yes | Yes | Yes | Identical |
| On/Off Status? | Yes | Yes | Yes | Identical |
| Low Battery? | Yes | Yes | Yes | Identical |
| Voltage/Current Level? | Yes (% of full scale) | Yes (% of full scale) | Yes (% of full scale) | Identical |
| Timer Range - (minutes) | 30 | 30 | 30 | Identical |
| Compliance with Voluntary
Standards? | Yes | Yes | Yes | Identical |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Identical |
| Weight | 6 ounces | 6 ounces | 1.0 lbs | Identical
(BioWaveGO only) |
| | BioWave Corporation
BioWaveGO RX Device
(Subject) | BioWave Corporation
BioWaveGO Device (K180943) | BioWave Corporation
BioWaveHOME Device
(K152437) | Comparison |
| Dimensions (in.) (W x H x D) | 3.0" x"4.0" x 1.0" | 3.0" x"4.0" x 1.0" | 3.75" x 6.0" x 1.75" | Identical
(BioWaveGO only) |
| Housing Materials and Construction | ABS via conventional injection
molding | ABS via conventional injection
molding | ABS via conventional
injection molding | Identical |
Comparison of Basic Unit Characteristics for BioWayeHOME (K152437) and RioWayeGO (K180943)
8
Comparison of Output Specifications for BioWaveGO Rx to BioWaveHOME (K152437) and BioWaveGO (K180943)
| | BioWave Corporation
BioWaveGO Rx Device
(Subject) | BioWave Corporation
BioWaveGO Device
(K180943) | Parent BioWave Corporation
BioWaveHOME Device
(K152437) | Comparison |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Waveform | Biphasic | Biphasic | Biphasic | Identical |
| Shape | Sum of 2 sine waves | Sum of 2 sine waves | Sum of 2 sine waves | Identical |
| Maximum Output Voltage Available
(+1-2%) (with software calibration
correction) | 80V p-p @ 500 Ω
20 V AC RMS | 80V p-p @ 500 Ω
20 V AC RMS | 110V p-p @ 500 Ω
27.5 V AC RMS | Identical
(BioWaveGO only)
BioWaveGO Rx offers a
decreased maximum
voltage compared to
BioWaveHOME |
| Maximum Output Current (+1- 2
%) (current depends on load) | 160mA p-p @ 500 Ω
40mA RMS
40 mA p-p @ 2kΩ
Trip out @ 10kΩ | 160mA p-p @ 500 Ω
40mA RMS
40 mA p-p @ 2kΩ
Trip out @ 10kΩ | 220mA p-p @ 500 Ω
55mA RMS
55 mA p-p @ 2kΩ
Trip out @ 10kΩ | Identical
(BioWaveGO only)
BioWaveGO Rx has a
lower maximum current
density compared to
BioWaveHOME. |
| Pulse Width | Continuous modulation | Continuous modulation | Continuous modulation | Identical |
| Frequency (Hz) | 4062 Hz + 3940 Hz | 4062 Hz + 3940 Hz | 3980 Hz + 3858 Hz | Equivalence based on
frequency difference |
| For interferential modes only:
- Beat Frequency (Hz) | 122 Hz | 122 Hz | 122 Hz | Identical |
| For multiphasic waveforms only: - Symmetrical phases?
- Phase Duration | N/A
N/A | N/A
N/A | N/A
N/A | - |
9
| | BioWave Corporation
BioWaveGO Rx Device
(Subject) | BioWave Corporation
BioWaveGO Device
(K180943) | Parent BioWave Corporation
BioWaveHOME Device
(K152437) | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Net Charge (m C per pulse) (If zero,
state method of achieving zero net
charge.) | 0 @ 500 Ω
biphasic - AC coupled
continuous wave | 0 @ 500 Ω
biphasic - AC coupled
continuous wave | 0 @ 500 Ω
biphasic - AC coupled
continuous wave | Identical |
| Maximum Phase Charge, (μ C) | N/A | N/A | N/A | - |
| Maximum Current Density,
(µmA/cm²)
(with 1.375" diam pad = 9.58 cm2
area) | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density, (W/cm²)
(using 1.375" diam 9.58 cm² electrode
conductive surface area) | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
| Burst Mode
a. Pulses per burst
b. Bursts per second
c. Burst duration (seconds)
d. Duty Cycle [Line (b) x Line (c)] | N/A | N/A | N/A | - |
| ON Time (seconds) | N/A | N/A | N/A | - |
| OFF Time (seconds) | N/A | N/A | N/A | - |
| Additional Features (if applicable) | Many safety interlocks: cable
connected to unit, pads
connected to cable, pads
connected to body, max power
density, battery ok for
treatment, charger connected
(trip off) | Many safety interlocks: cable
connected to unit, pads
connected to cable, pads
connected to body, max power
density, battery ok for
treatment, charger connected
(trip off) | Many safety interlocks: cable
connected to unit, pads
connected to cable, pads
connected to body, max power
density, battery ok for treatment,
charger connected (trip off) | Identical |
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Conclusion:
The BioWaveGO Rx device has been found to be substantially equivalent to the previously cleared predicate device, BioWaveGO, with respect to its intended use, design, function, materials, and performance.