(261 days)
Not Found
No
The document describes a standard TENS device controlled via a mobile app and/or physical buttons. There is no mention of AI, ML, or any features that would suggest adaptive or learning algorithms. The performance studies focus on standard electrical safety, usability, and biocompatibility, not on the performance metrics typically associated with AI/ML models.
Yes.
The device is indicated for temporary relief of pain associated with sore and aching muscles and chronic, intractable pain, which are therapeutic claims.
No
The device is described as a TENS device for relieving pain, not for diagnosing conditions. Its intended use is for symptomatic relief and management of pain, not for identifying the cause of pain.
No
The device description clearly states it is a battery-powered transcutaneous electrical nerve stimulator (TENS) device with integral electrodes, batteries, and hydrogel pads, in addition to the software component (Mobile App). This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles and for the symptomatic relief and management of chronic, intractable pain and pain associated with arthritis. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a transcutaneous electrical nerve stimulator (TENS). TENS devices deliver electrical impulses to the body for pain relief. This is a physical therapy modality, not a diagnostic test performed on samples from the body.
- No mention of in vitro testing: The description does not mention any testing of samples (like blood, urine, tissue, etc.) outside of the body, which is the hallmark of an in vitro diagnostic device.
Therefore, the device described is a therapeutic device, specifically a TENS unit, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NYN
Device Description
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) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
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.
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.
Not Found
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 PRAStaff@fda.hhs.gov
"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 |
| 100 Bayer Boulevard | |
| Whippany, NJ 07981 | |
| CONTACT: | Verna Mecadon |
| Director, Regulatory Affairs | |
| Verna.mecadon@bayer.com | |
| 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 |
| (TENS) for pain relief intended for over the | |
| counter use |
Predicate Devices [807.92(a)(3)] 2.1
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,
ALEVE Direct Therapy
(2nd generation)
Subject Device | Bayer HealthCare,
ALEVE Direct
Therapy
Primary Predicate
(Predicate 1) | Chattem,
SmartRelief
Secondary Predicate
(Predicate 2) |
|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K171802 | K152852 | K131159 |
| Regulation
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
Use | 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.
Symptomatic relief and
management of chronic,
intractable pain and relief
of pain associated with
arthritis. | 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. | 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.
Symptomatic relief and
management of
chronic, intractable
pain and relief of pain
associated with
arthritis. |
| Anatomical
Location | Lower back | Lower back | Various locations
(including lower back) |
| Power Source | Battery-powered | Battery-powered | Battery-powered |
| Control System | Microprocessor | Microprocessor | Microprocessor |
| Operating
Mechanism | On-board buttons, remote
control, and smartphone
mobile app | Remote control | On-board buttons |
| Average DC
current
through
electrodes when
the device is on
but no pulses are
being applied
(μΑ) | 0 | 0 | 0 |
| Waveform | Asymmetrical biphasic | Asymmetrical biphasic | Asymmetrical biphasic |
| Shape | Rectangular | Rectangular | Rectangular |
| Number of
Output TENS
Modes | 4 | 1 | 1 |
| Number of | 1 | 1 | 1 |
| Output Channels | | | |
| Regulated
Current or
Regulated
Voltage? | Voltage | Voltage | Voltage |
| Pulse Duration
(μς) | 120-250 μς | 120-240 μς | 30 - 220μς |
| Pulse Frequency
(Hz) | 2-120Hz | 5-120hz | 1 - 100 Hz |
| Pulse Amplitude
(mA) | 0 - 110mA
(Measured peak @ no
load.) | 0 - 110mA
(Measured peak @ no
load.) | 0 - 63mA
(Measured peak @
500 ohm load) |
| | 0 - 80mA
(Measured @ 500 ohm
load) | 0 - 80mA
(Measured @ 500 ohm
load) | |
| Automatic
Overload Trip? | No | No | No |
| Automatic No-
Load Trip? | No | No | No |
| Automatic Shut
Off? | Yes | Yes | Yes |
| User Override
Control | Yes, Off button stops
treatment immediately | Yes, Off button stops
treatment immediately | Yes, Off button stops
treatment immediately |
| Indicator Display | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level?
No | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level?
No | On/Off Status? Yes
Low Battery? Yes
Voltage/Current
Level? No |
| Timer Range | Nonadjustable,
30 minutes | Nonadjustable,
30 minutes 42 seconds | Nonadjustable,
30 minutes |
| Voluntary
Standards | • FDA Recognition
Number 19-4.
ANSI/AAMI
ES60601-1:2005
Ed. 3 + C1:2009 +
A1:2012
• FDA Recognition
19-8. IEC 60601-
1-2:2014 Ed. 4
• FDA Recognition
Number 19-14: IEC
60601-1-11 Edition 2.0
2015-01
• FDA Recognition
Number 17-11: IEC
60601-2-10 Edition
2.0 2012.06 | • FDA Recognition
Number 19-4.
ANSI/AAMI
ES60601-1:2005
Ed. 3 + C1:2009
- A1:2012
• FDA Recognition
19-8. IEC 60601-
1-2:2014 Ed. 4
• FDA Recognition
Number 19-14: IEC
60601-1-11 Edition 2.0
2015-01
• FDA Recognition
Number 17-11: IEC
60601-2-10 Edition
2.0 2012.06 | • ANSI/AAMI
ES60601-
1:2005/©2012
AND A1:2012 =
• IEC 60601-1-2
Edition 2014-02
• IEC 60601-1-11
Edition 1.0
2010-04
• IEC 60601-2-10
Edition 1.0
2012-06 |
| | • FDA Recognition
Number 5-40: ISO
14971 Second edition
2007-03-01
• FDA Recognition
Number 13-79: IEC
62304 Edition 1.1 2015-
06 | • FDA Recognition
Number 2-173,
AAMI/ANSI/ISO
10993-10:2010
• FDA Recognition
Number 5-40: ISO
14971 Second edition
2007-03-01 | |
| Compliance with
21 CFR 898 | Not applicable, device
not contain electrode
lead wires or patient
cables. | Not applicable, device
not contain electrode
lead wires or patient
cables. | Not applicable, device
not contain electrode
lead wires or patient
cables. |
| Weight (lbs., oz.) | ~4.8 oz. with batteries
included | ~4.8 oz. with batteries
included | ~4.8 oz. with batteries
included |
| Dimensions (in.)
[WxHxD] | 7.5(w) x 3.5 (h) x 0.7in.
(d) | 7.5(w) x 3.5 (h) x 0.7in.
(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.