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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the ALEVE® Direct Therapy® medical device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Based on the provided document, the device is a TENS unit, and the acceptance criteria and study proving it meets these criteria are related to its safety and performance based on engineering and laboratory testing, rather than clinical efficacy studies for AI/ML performance.

Therefore, I cannot provide information on AI/ML specific criteria such as:

A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC).
Sample sizes for test sets in an AI/ML context.
Number of experts and their qualifications for ground truth establishment for an AI/ML test set.
Adjudication methods for an AI/ML test set.
MRMC comparative effectiveness studies.
Standalone (algorithm-only) performance.
Type of ground truth used in an AI/ML context.
Sample size for a training set (AI/ML).
How ground truth for a training set was established (AI/ML).

Here's a breakdown of what can be extracted from the document regarding the device's acceptance criteria and the study that proves it meets them, framed in the context of a medical device submission (Premarket Notification 510(k)) that relies on substantial equivalence to predicate devices:

Device: ALEVE® Direct Therapy® (Second Generation) - Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief

1. Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing):

The document does not present a formal table of explicit acceptance criteria with numerical performance targets for a new device. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicates through a series of non-clinical tests and shows comparable technological characteristics.

Acceptance Criteria Category (Implied by 510(k) Process)	Reported Device Performance / How Met (Based on Non-Clinical Testing and Comparison)
Safety & Effectiveness (Overall)	Demonstrated by substantial equivalence to legally marketed predicate devices. "does not raise new or different questions about safety or effectiveness."
Technological Characteristics	Very similar to Predicate 1 (ALEVE Direct Therapy TENS, first-generation) in intended use, outer dimensions, buttons, electrodes, materials, remote control, RF communication, pulse amplitude.
	Similar to Predicate 2 (Chattem SmartRelief) in indications for use and output specifications (pulse amplitude, frequency, duration).
Performance Verification	Met established specifications through: - Unit level testing - System testing - Software verification and validation
Usability Engineering	Testing performed and results contributed to meeting established specifications.
Biocompatibility	Met requirements per ISO 10993-1.
Electrical Safety	IEC 60601-1:2005 Ed. 3 + C1:2009 + A1:2012 (FDA Recognition Number 19-4) compliant.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014 Ed. 4 (FDA Recognition 19-8) compliant.
Home Healthcare Environment	IEC 60601-1-11 Edition 2.0 2015-01 (FDA Recognition Number 19-14) compliant.
TENS Specific Safety	IEC 60601-2-10 Edition 2.0 2012.06 (FDA Recognition Number 17-11) compliant.
Risk Management	ISO 14971 Second edition 2007-03-01 (FDA Recognition Number 5-40) compliant.
Software Life Cycle Processes	IEC 62304 Edition 1.1 2015-06 (FDA Recognition Number 13-79) compliant.
Chemical Characterization (Materials)	AAMI/ANSI/ISO 10993-10:2010 (FDA Recognition Number 2-173) compliant (implied by biocompatibility).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical trial or a machine learning test set. The validation is based on non-clinical bench and safety testing of the device itself (e.g., electrical safety, software validation, biocompatibility), not a dataset of patient data or clinical images. Therefore, the "test set" would refer to the physical units of the device tested in the laboratory. The document does not specify how many units were tested.
Data Provenance: Not applicable in the context of patient data. The data provenance is from laboratory testing performed by the manufacturer, Bayer HealthCare LLC. The document does not specify the country where these tests were conducted, but the company is based in Whippany, New Jersey, USA. The testing is retrospectively reported as part of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. Ground truth for a TENS device's safety and performance in the context of a 510(k) is established through adherence to recognized international and national standards (e.g., IEC, ISO, ANSI/AAMI) verified by laboratory testing, not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set:

Not applicable. There is no human adjudication process involved in verifying the compliance of a TENS device with electrical safety, EMC, or biocompatibility standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a therapeutic TENS unit.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of an AI/ML algorithm. The "standalone" performance here refers to the device's ability to operate according to its specifications (e.g., output electrical pulses within specified parameters) without human intervention during its operational cycle, which is verified through bench testing. The mobile app controls the device, but the "performance" validated is of the TENS output, not the app's diagnostic or interpretive capabilities.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with pre-defined technical specifications, safety standards, and performance characteristics as demonstrated through non-clinical bench testing, software verification/validation, and adherence to recognized standards (e.g., electrical safety, EMC, biocompatibility, risk management). It is essentially engineering and regulatory standard compliance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, this is not an AI/ML device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K171802

Device Name ALEVE® Direct Therapy®

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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2. 510(k) SUMMARY

510(k) NUMBER:	K171802
510(k) SUBMITTER:	Bayer HealthCare LLC100 Bayer BoulevardWhippany, NJ 07981
CONTACT:	Verna MecadonDirector, Regulatory AffairsVerna.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 thecounter 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)]

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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

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.

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Device Feature	Bayer HealthCare,ALEVE Direct Therapy(2nd generation)Subject Device	Bayer HealthCare,ALEVE DirectTherapyPrimary Predicate(Predicate 1)	Chattem,SmartReliefSecondary Predicate(Predicate 2)
510(k) Number	K171802	K152852	K131159
RegulationNumber	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 forUse	Temporary relief of painassociated with sore andaching muscles in thelower back due to strainfrom exercise or normalhousehold and workactivities.Symptomatic relief andmanagement of chronic,intractable pain and reliefof pain associated witharthritis.	Temporary relief of painassociated with sore andaching muscles in thelower back due to strainfrom exercise or normalhousehold and workactivities.	Temporary relief ofpain associated withsore and achingmuscles in the lowerback due to strain fromexercise or normalhousehold and workactivities.Symptomatic relief andmanagement ofchronic, intractablepain and relief of painassociated witharthritis.
AnatomicalLocation	Lower back	Lower back	Various locations(including lower back)
Power Source	Battery-powered	Battery-powered	Battery-powered
Control System	Microprocessor	Microprocessor	Microprocessor
OperatingMechanism	On-board buttons, remotecontrol, and smartphonemobile app	Remote control	On-board buttons
Average DCcurrentthroughelectrodes whenthe device is onbut no pulses arebeing applied(μΑ)	0	0	0
Waveform	Asymmetrical biphasic	Asymmetrical biphasic	Asymmetrical biphasic
Shape	Rectangular	Rectangular	Rectangular
Number ofOutput TENSModes	4	1	1
Number of	1	1	1
Output Channels
RegulatedCurrent orRegulatedVoltage?	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 @ noload.)	0 - 110mA(Measured peak @ noload.)	0 - 63mA(Measured peak @500 ohm load)
	0 - 80mA(Measured @ 500 ohmload)	0 - 80mA(Measured @ 500 ohmload)
AutomaticOverload Trip?	No	No	No
Automatic No-Load Trip?	No	No	No
Automatic ShutOff?	Yes	Yes	Yes
User OverrideControl	Yes, Off button stopstreatment immediately	Yes, Off button stopstreatment immediately	Yes, Off button stopstreatment immediately
Indicator Display	On/Off Status? YesLow Battery? YesVoltage/Current Level?No	On/Off Status? YesLow Battery? YesVoltage/Current Level?No	On/Off Status? YesLow Battery? YesVoltage/CurrentLevel? No
Timer Range	Nonadjustable,30 minutes	Nonadjustable,30 minutes 42 seconds	Nonadjustable,30 minutes
VoluntaryStandards	• FDA RecognitionNumber 19-4.ANSI/AAMIES60601-1:2005Ed. 3 + C1:2009 +A1:2012• FDA Recognition19-8. IEC 60601-1-2:2014 Ed. 4• FDA RecognitionNumber 19-14: IEC60601-1-11 Edition 2.02015-01• FDA RecognitionNumber 17-11: IEC60601-2-10 Edition2.0 2012.06	• FDA RecognitionNumber 19-4.ANSI/AAMIES60601-1:2005Ed. 3 + C1:2009+ A1:2012• FDA Recognition19-8. IEC 60601-1-2:2014 Ed. 4• FDA RecognitionNumber 19-14: IEC60601-1-11 Edition 2.02015-01• FDA RecognitionNumber 17-11: IEC60601-2-10 Edition2.0 2012.06	• ANSI/AAMIES60601-1:2005/©2012AND A1:2012 =• IEC 60601-1-2Edition 2014-02• IEC 60601-1-11Edition 1.02010-04• IEC 60601-2-10Edition 1.02012-06
	• FDA RecognitionNumber 5-40: ISO14971 Second edition2007-03-01• FDA RecognitionNumber 13-79: IEC62304 Edition 1.1 2015-06	• FDA RecognitionNumber 2-173,AAMI/ANSI/ISO10993-10:2010• FDA RecognitionNumber 5-40: ISO14971 Second edition2007-03-01
Compliance with21 CFR 898	Not applicable, devicenot contain electrodelead wires or patientcables.	Not applicable, devicenot contain electrodelead wires or patientcables.	Not applicable, devicenot contain electrodelead wires or patientcables.
Weight (lbs., oz.)	~4.8 oz. with batteriesincluded	~4.8 oz. with batteriesincluded	~4.8 oz. with batteriesincluded
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

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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

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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.

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).