ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

K171802 · Bayer Healthcare, LLC · NUH · Mar 7, 2018 · Neurology

Device Facts

• Record ID: K171802
• Device Name: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
• Applicant: Bayer Healthcare, LLC
• Product Code: NUH · Neurology
• Decision Date: Mar 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the lower back.

Device Story

Battery-powered TENS device for lower back pain relief; utilizes TENS generator with integral electrodes and replaceable hydrogel pads. User places device on lower back; selects from four 30-minute preprogrammed stimulation modes via smartphone app (iOS/Android) or onboard mechanical buttons. Optional wireless RF remote control available. Device delivers asymmetrical biphasic rectangular electrical pulses to peripheral nerves. Healthcare provider/patient uses output to manage pain; device provides non-pharmacological analgesic benefit. Operates via microprocessor control; Bluetooth connectivity for app-based control; RF for remote. No clinical data required; substantial equivalence based on bench testing and comparison to predicate TENS devices.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including performance verification, system testing, software verification/validation, usability engineering, biocompatibility (ISO 10993-1), electrical safety, and electromagnetic compatibility (IEC 60601 series).

Technological Characteristics

Battery-powered TENS; microprocessor-controlled. Asymmetrical biphasic rectangular waveform. Pulse duration 120-250 μs; frequency 2-120 Hz; amplitude 0-110 mA (peak no load). Connectivity: Bluetooth (mobile app), RF (remote). Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 14971, IEC 62304. Biocompatibility per ISO 10993-10.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. Also indicated for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

• ALEVE Direct Therapy TENS, first-generation (K152852)
• Chattem SmartRelief (K131159)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services - USA logo, which features a stylized eagle. The second logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.

March 7, 2018

Bayer HealthCare LLC Verna Mecadon Director, Regulatory Affairs 100 Bayer Boulevard Whippany, New Jersey 07981-0915

Re: K171802

Trade/Device Name: ALEVE® Direct Therapy® Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: February 7, 2018 Received: February 7, 2018

Dear Verna Mecadon:

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

{1}------------------------------------------------

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); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

William J. Heetderks -S 2018.03.07 12:45:37 -05'00' Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171802

Device Name ALEVE® Direct Therapy®

Indications for Use (Describe)

For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

{3}------------------------------------------------

### 2. 510(k) SUMMARY

| 510(k) NUMBER: | K171802 |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| 510(k) SUBMITTER: | Bayer HealthCare LLC<br>100 Bayer Boulevard<br>Whippany, NJ 07981 |
| CONTACT: | Verna Mecadon<br>Director, Regulatory Affairs<br>[e-mail] |
| DATE PREPARED: | February 7, 2018 |
| PROPRIETARY NAME: | ALEVE® Direct Therapy® |
| PANEL: | Neurology |
| REGULATION NUMBER: | CFR Title 21, 882.5890 |
| CLASSIFICATION: | Class II |
| PRODUCT CODES: | NUH, NYN |
| COMMON NAME: | Transcutaneous electrical nerve stimulator<br>(TENS) for pain relief intended for over the<br>counter use |

#### Predicate Devices [807.92(a)(3)] 2.1

- ALEVE Direct Therapy TENS, first-generation (K152852) ●
- . Chattem SmartRelief (K131159)

#### 2.2 Device Description [807.92(a)(4)]

The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF)

{4}------------------------------------------------

connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The TENS unit adheres to the user's lower back across the spine in the area where pain is perceived. Once placed, a user can choose from four 30-minute preprogrammed stimulation output modes, and the level of intensity that is most comfortable.

#### 2.3 Intended Use and Indications for Use [807.92(a)(5)]

# Intended Use

The intended use is to provide approximately thirty minutes of analgesic electrical

stimulus to reduce the perception of pain by electrically stimulating peripheral

nerves across healthy intact skin of the lower back.

# Indications for Use

For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

### 2.4 Comparison of Technological Characteristics with the Predicate Devices [807.92(a)(6)]

The ALEVE® Direct Therapy® is substantially equivalent in design and labeling to the primary predicate device and secondary predicate device. As demonstrated in Table 2.1, the ALEVE Direct Therapy TENS device is identical to the primary predicate device, Predicate 1, with respect to intended use, outer dimensions of the TENS unit, On/Off button, electrodes, materials, hand-held remote control, RF communication, and pulse amplitude. The differences between the subject device and primary predicate device, Predicate 1, are the expanded indications for use, three additional treatment programs consisting of similar ranges of output specifications, up/down (+/-) buttons on the outer TENS cover, the Mobile App using Bluetooth communication, and a minor difference in the ranges for pulse duration and pulse frequency. Additionally, as shown in Table 2.1, the subject device is identical to the secondary predicate, Predicate 2, with respect to indications for use and substantially equivalent to Predicate 2 with output specifications of pulse amplitude, pulse frequency, and pulse duration. Nonclinical testing performed on the ALEVE® Direct Therapy® is sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices. The technological and labeling differences do not raise new or different questions about safety or effectiveness. ALEVE® Direct Therapy® second-generation device is substantially equivalent to the predicate devices.

{5}------------------------------------------------

| Device Feature | Bayer HealthCare,<br>ALEVE Direct Therapy<br>(2nd generation)<br>Subject Device | Bayer HealthCare,<br>ALEVE Direct<br>Therapy<br>Primary Predicate<br>(Predicate 1) | Chattem,<br>SmartRelief<br>Secondary Predicate<br>(Predicate 2) |
|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K171802 | K152852 | K131159 |
| Regulation<br>Number | CFR Title 21, 882.5890 | | |
| Product Code | NUH, NYN | NUH | NUH, NYN |
| Intended Use | Transcutaneous Electrical Nerve Stimulator for Pain Relief | | |
| Rx and/or OTC | OTC | OTC | OTC |
| Indications for<br>Use | Temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>lower back due to strain<br>from exercise or normal<br>household and work<br>activities.<br>Symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis. | Temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>lower back due to strain<br>from exercise or normal<br>household and work<br>activities. | Temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the lower<br>back due to strain from<br>exercise or normal<br>household and work<br>activities.<br>Symptomatic relief and<br>management of<br>chronic, intractable<br>pain and relief of pain<br>associated with<br>arthritis. |
| Anatomical<br>Location | Lower back | Lower back | Various locations<br>(including lower back) |
| Power Source | Battery-powered | Battery-powered | Battery-powered |
| Control System | Microprocessor | Microprocessor | Microprocessor |
| Operating<br>Mechanism | On-board buttons, remote<br>control, and smartphone<br>mobile app | Remote control | On-board buttons |
| Average DC<br>current<br>through<br>electrodes when<br>the device is on<br>but no pulses are<br>being applied<br>(μΑ) | 0 | 0 | 0 |
| Waveform | Asymmetrical biphasic | Asymmetrical biphasic | Asymmetrical biphasic |
| Shape | Rectangular | Rectangular | Rectangular |
| Number of<br>Output TENS<br>Modes | 4 | 1 | 1 |
| Number of | 1 | 1 | 1 |
| Output Channels | | | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Voltage | Voltage | Voltage |
| Pulse Duration<br>(μς) | 120-250 μς | 120-240 μς | 30 - 220μς |
| Pulse Frequency<br>(Hz) | 2-120Hz | 5-120hz | 1 - 100 Hz |
| Pulse Amplitude<br>(mA) | 0 - 110mA<br>(Measured peak @ no<br>load.) | 0 - 110mA<br>(Measured peak @ no<br>load.) | 0 - 63mA<br>(Measured peak @<br>500 ohm load) |
| | 0 - 80mA<br>(Measured @ 500 ohm<br>load) | 0 - 80mA<br>(Measured @ 500 ohm<br>load) | |
| Automatic<br>Overload Trip? | No | No | No |
| Automatic No-<br>Load Trip? | No | No | No |
| Automatic Shut<br>Off? | Yes | Yes | Yes |
| User Override<br>Control | Yes, Off button stops<br>treatment immediately | Yes, Off button stops<br>treatment immediately | Yes, Off button stops<br>treatment immediately |
| Indicator Display | On/Off Status? Yes<br>Low Battery? Yes<br>Voltage/Current Level?<br>No | On/Off Status? Yes<br>Low Battery? Yes<br>Voltage/Current Level?<br>No | On/Off Status? Yes<br>Low Battery? Yes<br>Voltage/Current<br>Level? No |
| Timer Range | Nonadjustable,<br>30 minutes | Nonadjustable,<br>30 minutes 42 seconds | Nonadjustable,<br>30 minutes |
| Voluntary<br>Standards | • FDA Recognition<br>Number 19-4.<br>ANSI/AAMI<br>ES60601-1:2005<br>Ed. 3 + C1:2009 +<br>A1:2012<br>• FDA Recognition<br>19-8. IEC 60601-<br>1-2:2014 Ed. 4<br>• FDA Recognition<br>Number 19-14: IEC<br>60601-1-11 Edition 2.0<br>2015-01<br>• FDA Recognition<br>Number 17-11: IEC<br>60601-2-10 Edition<br>2.0 2012.06 | • FDA Recognition<br>Number 19-4.<br>ANSI/AAMI<br>ES60601-1:2005<br>Ed. 3 + C1:2009<br>+ A1:2012<br>• FDA Recognition<br>19-8. IEC 60601-<br>1-2:2014 Ed. 4<br>• FDA Recognition<br>Number 19-14: IEC<br>60601-1-11 Edition 2.0<br>2015-01<br>• FDA Recognition<br>Number 17-11: IEC<br>60601-2-10 Edition<br>2.0 2012.06 | • ANSI/AAMI<br>ES60601-<br>1:2005/©2012<br>AND A1:2012 =<br>• IEC 60601-1-2<br>Edition 2014-02<br>• IEC 60601-1-11<br>Edition 1.0<br>2010-04<br>• IEC 60601-2-10<br>Edition 1.0<br>2012-06 |
| | • FDA Recognition<br>Number 5-40: ISO<br>14971 Second edition<br>2007-03-01<br>• FDA Recognition<br>Number 13-79: IEC<br>62304 Edition 1.1 2015-<br>06 | • FDA Recognition<br>Number 2-173,<br>AAMI/ANSI/ISO<br>10993-10:2010<br>• FDA Recognition<br>Number 5-40: ISO<br>14971 Second edition<br>2007-03-01 | |
| Compliance with<br>21 CFR 898 | Not applicable, device<br>not contain electrode<br>lead wires or patient<br>cables. | Not applicable, device<br>not contain electrode<br>lead wires or patient<br>cables. | Not applicable, device<br>not contain electrode<br>lead wires or patient<br>cables. |
| Weight (lbs., oz.) | ~4.8 oz. with batteries<br>included | ~4.8 oz. with batteries<br>included | ~4.8 oz. with batteries<br>included |
| Dimensions (in.)<br>[WxHxD] | 7.5(w) x 3.5 (h) x 0.7in.<br>(d) | 7.5(w) x 3.5 (h) x 0.7in.<br>(d) | 64 x 38x 13mm |

{6}------------------------------------------------

{7}------------------------------------------------

#### 2.5 Performance Data [807.92(b)(1), (b)(2)]

# Non-Clinical Testing Summary

The non-clinical bench and safety testing and assessments included:

- Performance verification consisting of unit level testing, system testing, and software verification and validation
- Usability Engineering testing ●
- Biocompatibility requirements per ISO 10993-1 ●
- Electrical Safety and Electromagnetic Compatibility testing ●

The verification, validation, electrical safety testing, electromagnetic compatibility testing, and human factors data presented in this 510(k) submission demonstrate the second-generation ALEVE® Direct Therapy® TENS device met the established specifications and its intended use. In addition, the testing demonstrated that the subject device does not raise new or different questions of safety or effectiveness when compared to the legally-marketed predicate devices.

# Clinical Testing Summary

Not applicable. Clinical testing was not performed to support this 510(k) submission.

#### 2.6 Conclusion [807.92(b)(3)]

The basis for substantial equivalence for the second-generation ALEVE® Direct Therapy® TENS device and the predicate devices is non-clinical data and conformity with recognized standards. Clinical testing was not required to support substantial equivalence for the second-generation ALEVE Direct Therapy TENS device as the intended use of TENS is well-established and the hardware and software verification and validation demonstrate that the subject device

{8}------------------------------------------------

performs comparably to the predicate devices that are marketed for the same intended use. Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the second-generation ALEVE Direct Therapy TENS device is as safe and effective as, and substantially equivalent to the predicate devices.