(84 days)
Not Found
No
The description details a standard TENS device with manual controls and no mention of adaptive algorithms or learning capabilities.
Yes
The device is described as a "transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain," and its intended use is for "temporary relief of pain associated with sore and aching muscles." This directly aligns with the definition and purpose of a therapeutic device.
No
Explanation: The device description states its purpose is to provide "temporary relief of pain" by "electrically stimulating peripheral nerves across the skin," not to diagnose medical conditions.
No
The device description explicitly states it is comprised of a TENS unit with integral electrodes, hydrogel pads, batteries, and a remote control, all of which are hardware components. While it mentions software verification and validation, the core functionality relies on physical hardware for electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ALEVE Direct Therapy device is a TENS unit that applies electrical stimulation to the skin for pain relief. It does not involve testing any samples from the body.
- Intended Use: The intended use is for temporary relief of pain, not for diagnosing or detecting any condition through testing bodily samples.
Therefore, based on the provided information, the ALEVE Direct Therapy device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.
The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.
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)
Conformance with the following voluntary, FDA-recognized standards is provided in this 510(k) submission:
- . Recognition Number 5-40: ISO 14971 Second Edition 2007-03-01, Medical devices application of risk management to medical devices.
- . Recognition Number 19-4: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment part 1: General requirements for basic safety and essential performance.
- . Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic disturbances - requirements and tests.
- Recognition Number 19-14: IEC 60601-1-11 Edition 1.0 2010-04, Medical electrical ● equipment - part 1-11: General requirements for basic safety and essential performance collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06, Medical electrical equipment - part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- Recognition Number 2-156: AAMI/ANSVISO 10993-1:2009/(R) 2013, Biological evaluation . of medical devices - part 1: Evaluation and testing within a risk management process.
- Recognition Number 2-153, AAMI/ANSI/ISO 10993-5:2009/(R) 2014, Biological evaluation . of medical devices - part 5: Tests for in vitro cytotoxicity.
- Recognition Number 2-173, AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of ● medical devices - part 10: Tests for irritation and skin sensitization.
Performance Testing: Data in support of the device waveform, and verification of output characteristics, was provided in this submission.
Software Verification and Validation Testing: Software verification and validation testing was conducted, and documentation in accordance with a Moderate level concern device was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Usability: A 15 subject usability study was conducted by Hollywog and reported to the FDA during the review of predicate K120500, based on feedback provided from the FDA during Pre-IDE submission correspondence. The submitter has a right of reference to this study, as the devices and labeling are sufficiently similar, in support of the usability of the ALEVE Direct Therapy device.
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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
Bayer Healthcare, LLC William Walsh Director, Us Regulatory Affairs 100 Bayer Boulevard Whippany, New Jersey 07981-0915
Re: K152852
Trade/Device Name: Aleve Direct Therapy (Aleve Direct Therapy Tens Device) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 25, 2015 Received: September 29, 2015
Dear Mr. Walsh:
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 (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J. Heetderks -S
for Carlos L. Peña. PhD, MS 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) K152852
Device Name ALEVE Direct Therapy TENS Device
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
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
SUBMITTER I.
| Company Name: | Bayer HealthCare LLC, Consumer Care
100 Bayer Boulevard
Whippany, NJ 07981-0915 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William R. Walsh, R.Ph.
Phone: (862)-404-6355
bill.walsh@bayer.com |
| Date Prepared: | September 29, 2015 |
| II.
DEVICE | |
| Trade Name:
Common Name: | ALEVE Direct Therapy
Transcutaneous electrical nerve stimulator for pain relief intended
for over the counter use (TENS) |
| Classification Name:
Device Classification: | Stimulator, Nerve, Transcutaneous, Over-The-Counter
21 CFR 882.5890, Class II, NUH |
| III.
PREDICATE DEVICE | |
| Predicate Devices: | The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch®
K120500
21 CFR 882.5890, Class II, NUH |
| -------------------- | ---------------------------------------------------------------------------------------------- |
|---|
IV. DEVICE DESCRIPTION
The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.
The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.
4
V. INDICATIONS FOR USE
The ALEVE Direct Therapy is 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
This product is nearly identical to the predicate device except for minor differences: trade name, color of the non-conductive area of the integral silicone electrodes (change to ultramarine blue), non-significant modifications to the labeling and label designs, and an updated version of the software due to non-significant revisions made during the marketing of the PainPilot (Neubac) / WiTouch compared to the version cleared in 2012. All device components and accessories, basic unit characteristics, and output specifications are the same as the predicate device.
A comparison of the Basic Unit Characteristics is provided below.
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Basic Unit Characteristics Comparison
| Characteristic | Bayer HealthCare, LLC
ALEVE Direct Therapy
Subject of this Submission | Hollywog Pain Pilot
(Neubac) / WiTouch
K120500 | Comparison |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source(s) | Battery Powered | Battery Powered | IDENTICAL |
| Number, Size, and Type
of Batteries | 2 AAA 1.5v DC batteries (TENS device)
1 Lithium coin battery 3.0v DC (wireless remote) | 2 AAA 1.5v DC batteries (TENS device)
1 Lithium coin battery 3.0v DC (wireless remote) | IDENTICAL |
| Average DC current
through electrodes when
device is on but no pulses
are being applied (µΑ) | 0 | 0 | IDENTICAL |
| Number of Output
Modes | 1 | 1* | IDENTICAL |
| Number of Output
Channels | 1 | 1 | IDENTICAL |
| Regulated Current or
Regulated Voltage? | Voltage | Voltage | IDENTICAL |
| Software/Firmware/
Microprocessor Control? | Yes | Yes | IDENTICAL |
| Automatic Overload
Trip? | No | No | IDENTICAL |
| Automatic No-Load
Trip? | No | No | IDENTICAL |
| Automatic Shut Off? | Yes | Yes | IDENTICAL |
| User Override Control? | Yes | Yes | IDENTICAL |
| Indicator Display | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level? No | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level? No | IDENTICAL |
| Timer Range | Nonadjustable
30 minutes 42 seconds | Nonadjustable
30 minutes 42 seconds | IDENTICAL |
| Compliance with | ISO 14971:2007 | ISO 14971:2007 | Substantially Equivalent |
| Characteristic | Bayer HealthCare, LLC
ALEVE Direct Therapy
Subject of this Submission | Hollywog Pain Pilot
(Neubac) / WiTouch
K120500 | Comparison |
| Voluntary Standards | AAMI ANSI ES60601-
1:2005/(R)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 AAMI/ANSI/ISO 10993-
1:2009/(R) 2013 AAMI/ANSI/ISO 10993-5:2009
(R)2014 AAMI/ANSI/ISO 10993-10:2010 | IEC 60601-1: 1995 IEC 60601-1-2: 2001 IEC 60601-1-4:2000 IEC 60601-2-10: 2001 ISO 10993-1:2009 ISO 10993-5:2009 ISO 10993-10:2010 | Current device complies with
updated versions of standards. |
| Compliance with 21 CFR
898 | N/A, device does not contain
electrode lead wires or patient cables. | N/A, device does not contain
electrode lead wires or patient
cables. | IDENTICAL |
| Weight (lbs., oz.) | 4.8 oz.
w/ batteries included | 4.8 oz.
w/ batteries included | IDENTICAL |
| Dimensions (in.) [W x H
x D] | 7.5 (w) x 3.5 (h) x 0.7 in (d) | 7.5 (w) x 3.5 (h) x 0.7 in (d) | IDENTICAL |
| Patient Contacting
Materials including
Housing Materials and
Construction | Hydrogel (Gel pads)
ABS plastic enclosure (Housing)
Integral silicone electrodes with
conductive (carbon rubber) area and
non-conductive area with ultramarine
blue colorant (CAS # 57455-37-5) | Hydrogel (Gel pads)
ABS plastic enclosure (Housing)
Conductive (carbon) silicone
electrodes
Non-conductive area of the
integral silicone electrodes, of
green color | Substantially Equivalent. The
safety of this colorant has
been demonstrated (Section
12, Biocompatibility). A
difference in colorant does
not affect the performance
characteristics of the device,
and the difference does not
raise new questions of safety
or effectiveness. |
6
7
VII. PERFORMANCE DATA
Conformance with the following voluntary, FDA-recognized standards is provided in this 510(k) submission:
- . Recognition Number 5-40: ISO 14971 Second Edition 2007-03-01, Medical devices application of risk management to medical devices.
- . Recognition Number 19-4: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment part 1: General requirements for basic safety and essential performance.
- . Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic disturbances - requirements and tests.
- Recognition Number 19-14: IEC 60601-1-11 Edition 1.0 2010-04, Medical electrical ● equipment - part 1-11: General requirements for basic safety and essential performance collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06, Medical electrical equipment - part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- Recognition Number 2-156: AAMI/ANSVISO 10993-1:2009/(R) 2013, Biological evaluation . of medical devices - part 1: Evaluation and testing within a risk management process.
- Recognition Number 2-153, AAMI/ANSI/ISO 10993-5:2009/(R) 2014, Biological evaluation . of medical devices - part 5: Tests for in vitro cytotoxicity.
- Recognition Number 2-173, AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of ● medical devices - part 10: Tests for irritation and skin sensitization.
Performance Testing
Data in support of the device waveform, and verification of output characteristics, was provided in this submission.
Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation in accordance with a Moderate level concern device was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Usability
A 15 subject usability study was conducted by Hollywog and reported to the FDA during the review of predicate K120500, based on feedback provided from the FDA during Pre-IDE submission correspondence. The submitter has a right of reference to this study, as the devices
8
and labeling are sufficiently similar, in support of the usability of the ALEVE Direct Therapy device.
VIII. CONCLUSIONS
The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided in the 510(k) submission is sufficient to demonstrate substantial equivalence to the predicate device. As the ALEVE Direct Therapy TENS device is nearly identical to the predicate device, with identical indications for use and essentially identical technological characteristics, the ALEVE Direct Therapy TENS device is substantially equivalent to the predicate device.