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.

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.

AI/ML Overview

This document is a 510(k) summary for the ALEVE Direct Therapy TENS device, claiming substantial equivalence to a predicate device (Pain Pilot™ / WiTouch® K120500). As such, it focuses on demonstrating similarity rather than presenting a detailed de novo study with specific acceptance criteria and performance against those criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for the device's clinical performance (e.g., pain reduction scores). Instead, it relies on demonstrating substantial equivalence to a predicate device, meaning its performance is expected to be similar or identical.

The performance data primarily focuses on engineering and safety standards, and a single usability study.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety Standards Compliance	Conformance with a suite of ISO and IEC standards including: - ISO 14971:2007 (risk management) - AAMI/ANSI ES60601-1:2005/(R)2012 (general basic safety and essential performance) - IEC 60601-1-2 Ed 4.0 2014-02 (EMC) - IEC 60601-1-11 Ed 1.0 2010-04 (home healthcare environment) - IEC 60601-2-10 Ed 2.0 2012-06 (nerve and muscle stimulators)
Biocompatibility Standards Compliance	Conformance with ISO standards: - AAMI/ANSI/ISO 10993-1:2009/(R) 2013 (biological evaluation, risk management) - AAMI/ANSI/ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity) - AAMI/ANSI/ISO 10993-10:2010 (irritation and skin sensitization) (Note: The document states "The safety of this colorant has been demonstrated (Section 12, Biocompatibility).")
Software Verification and Validation (Moderate Level Concern)	Software verification and validation testing conducted, documentation provided in accordance with FDA's guidance for "Moderate level concern device."
Device Output Characteristics	Data in support of the device waveform and verification of output characteristics provided. (The specific characteristics are listed in the "Basic Unit Characteristics Comparison" table on page 5, which are all "IDENTICAL" or "Substantially Equivalent" to the predicate, implying conformity to the predicate's established performance).
Usability	A 15-subject usability study was conducted for the predicate device (K120500) and reported to the FDA. The submitter (Bayer HealthCare, LLC) references this study due to the devices and labeling being "sufficiently similar." This implies the predicate device met usability criteria, and by extension, the new device is considered to meet them.
Substantial Equivalence	The overall acceptance criterion is "substantial equivalence" to the predicate device (Pain Pilot™ / WiTouch® K120500). The document concludes: "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- For the usability study (which is the only human-based performance data mentioned), the sample size was 15 subjects.
- No other human clinical "test set" data is explicitly described for performance on the primary indication (pain relief). The submission relies on the predicate device's established effectiveness.
Data Provenance: The usability study was conducted by Hollywog (the original manufacturer of the predicate device). The document doesn't specify the country of origin for this study, nor does it explicitly state if it was retrospective or prospective, though usability studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a TENS unit for pain relief, not an AI/imaging diagnostic device. Ground truth, in the sense of expert annotation, is not relevant to the usability study or the engineering/safety tests described. Pain relief, if directly measured in a clinical trial, would typically rely on patient-reported outcomes, not expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as described in point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device (TENS unit), not a software algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the usability study, the "ground truth" would be the direct experience and feedback of the 15 subjects regarding the device's ease of use and functionality. For the safety and engineering tests, the "ground truth" is compliance with recognized standards or objective measurements of electrical characteristics. For the primary indication (pain relief), the justification relies on the predicate device's established clinical effectiveness, which would have been based on patient outcomes data (e.g., pain scores) in its original approval.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

Not applicable, as described in point 8.

Summary

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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.

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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

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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 Care100 Bayer BoulevardWhippany, NJ 07981-0915
Contact Person:	William R. Walsh, R.Ph.Phone: (862)-404-6355bill.walsh@bayer.com
Date Prepared:	September 29, 2015
II.DEVICE
Trade Name:Common Name:	ALEVE Direct TherapyTranscutaneous electrical nerve stimulator for pain relief intendedfor over the counter use (TENS)
Classification Name:Device Classification:	Stimulator, Nerve, Transcutaneous, Over-The-Counter21 CFR 882.5890, Class II, NUH
III.PREDICATE DEVICE

Predicate Devices:	The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch®K12050021 CFR 882.5890, Class II, NUH
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IV. DEVICE DESCRIPTION

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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, LLCALEVE Direct TherapySubject of this Submission	Hollywog Pain Pilot(Neubac) / WiTouchK120500	Comparison
Power Source(s)	Battery Powered	Battery Powered	IDENTICAL
Number, Size, and Typeof 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 currentthrough electrodes whendevice is on but no pulsesare being applied (µΑ)	0	0	IDENTICAL
Number of OutputModes	1	1*	IDENTICAL
Number of OutputChannels	1	1	IDENTICAL
Regulated Current orRegulated Voltage?	Voltage	Voltage	IDENTICAL
Software/Firmware/Microprocessor Control?	Yes	Yes	IDENTICAL
Automatic OverloadTrip?	No	No	IDENTICAL
Automatic No-LoadTrip?	No	No	IDENTICAL
Automatic Shut Off?	Yes	Yes	IDENTICAL
User Override Control?	Yes	Yes	IDENTICAL
Indicator Display	On/Off Status? YesLow Battery? YesVoltage/Current Level? No	On/Off Status? YesLow Battery? YesVoltage/Current Level? No	IDENTICAL
Timer Range	Nonadjustable30 minutes 42 seconds	Nonadjustable30 minutes 42 seconds	IDENTICAL
Compliance with	ISO 14971:2007	ISO 14971:2007	Substantially Equivalent
Characteristic	Bayer HealthCare, LLCALEVE Direct TherapySubject of this Submission	Hollywog Pain Pilot(Neubac) / WiTouchK120500	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 1.02010-04 IEC 60601-2-10 Edition 1.02012-06 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 withupdated versions of standards.
Compliance with 21 CFR898	N/A, device does not containelectrode lead wires or patient cables.	N/A, device does not containelectrode lead wires or patientcables.	IDENTICAL
Weight (lbs., oz.)	4.8 oz.w/ batteries included	4.8 oz.w/ batteries included	IDENTICAL
Dimensions (in.) [W x Hx 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 ContactingMaterials includingHousing Materials andConstruction	Hydrogel (Gel pads)ABS plastic enclosure (Housing)Integral silicone electrodes withconductive (carbon rubber) area andnon-conductive area with ultramarineblue colorant (CAS # 57455-37-5)	Hydrogel (Gel pads)ABS plastic enclosure (Housing)Conductive (carbon) siliconeelectrodesNon-conductive area of theintegral silicone electrodes, ofgreen color	Substantially Equivalent. Thesafety of this colorant hasbeen demonstrated (Section12, Biocompatibility). Adifference in colorant doesnot affect the performancecharacteristics of the device,and the difference does notraise new questions of safetyor effectiveness.

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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

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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.

Regulation Number and Section

§ 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).