Quell is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.

Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

Device Description

Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.

The device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g., K140586). to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used.

The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The LED array indicates stimulation status, battery charging, and error conditions.

A Quell user may initiate therapy, increase stimulation intensity and decrease stimulation intensity through a wireless control mechanism that is collectively referred to as the "virtual button." The virtual button is available through the Quell mobile app and is intended for use in the same environments as the Quell device.

AI/ML Overview

The provided text is a 510(k) premarket notification letter and summary for the Quell device, a Transcutaneous Electrical Nerve Stimulator (TENS). It describes the device, its intended use, and compares it to a predicate device (NeuroMetrix ASCEND).

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format requested. Instead, it details that Quell was found substantially equivalent to the predicate device, ASCEND (K140333), based on similar indications for use, technological characteristics, and compliance with various standards.

The acceptance criteria implicitly relate to meeting the performance and safety requirements of the predicate device and relevant industry standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Similar Indications for Use	Identical indications for use as ASCEND (K140333) for temporary relief of pain associated with sore and aching muscles in lower extremities and symptomatic relief/management of chronic intractable pain.
Similar Technological Characteristics (Basic Unit)	One stimulation channel, single output mode, user-controlled intensity, fixed therapy session timer, LED indicators, battery powered. Specific parameters like power source, leakage current, and output modes are within acceptable limits or identical to the predicate.
Similar Technological Characteristics (Output Specifications)	Biphasic, rectangular waveform. Maximum output voltage and current are identical to the predicate. Frequency is random with an 80 Hz mean (range 60-100 Hz), identical to the predicate. Net charge is nominally 0 µC. Differences in phase duration, maximum phase charge, maximum current density, maximum average current, and maximum average power density are acknowledged but deemed acceptable as they are within the range of other 510(k) cleared TENS devices and do not raise new safety/effectiveness questions.
New Features Do Not Raise New Safety/Effectiveness Questions	Features like On-skin Timer, Auto-restart Timer, Stimulation Lock, Sleep Settings, Sleep Tracking, Virtual Button, and Mobile App are justified as either convenience features or low-risk functions, with validation testing confirming safety and effectiveness where applicable (e.g., Virtual Button, Mobile App). Sleep tracking is explicitly stated as not for diagnosis or treatment of sleep disorders.
Compliance with Voluntary Standards	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 60601-1-11, and 21 CFR 898 (for Electromagnetic Compatibility).
Sufficient Performance & Safety Data	Verification, validation, and performance data from non-clinical testing demonstrate substantial equivalence.

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

The document states, "NeuroMetrix determined that bench and non-clinical testing were sufficient to demonstrate that Quell is as safe and effective as the predicate ASCEND device."

Sample Size for Test Set: Not applicable or not specified in terms of human subjects. The testing was primarily non-clinical (bench testing), focusing on electrical, mechanical, and software aspects.
Data Provenance: The data provenance is from non-clinical verification and validation testing conducted by NeuroMetrix, Inc. The document does not mention any human clinical trials for this 510(k) submission, nor does it refer to country of origin for human data.

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

As the evaluation was based on non-clinical testing and comparison to a predicate device, the concept of "ground truth" established by clinical experts for a test set (e.g., image interpretation) does not directly apply in this context. The "ground truth" here is adherence to engineering specifications, safety standards, and the performance characteristics of the predicate device. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at NeuroMetrix. Their specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving subjective interpretation requiring adjudication among experts. The "adjudication" was effectively through the established engineering and regulatory compliance processes of the manufacturer and subsequent FDA review.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is outside the scope of this device and documentation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical TENS unit. While it includes "embedded software" and a "mobile app" with "virtual button" functionality, it is not an algorithm that performs a diagnostic task independently. The "standalone" performance here refers to the device's electrical, mechanical, and software function as a physical unit without a human directly manipulating its physical buttons (though human interaction via the app is an extension of control).

The document notes:

"Verification testing of Quell included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions."
"Validation and performance testing demonstrates that the device meets as reflected in the functional specification."
The "virtual button functionality was validated in system testing, and in a validation protocol designed to confirm that the virtual button is safe and effective..."
"Those features of the mobile app that relate to the control and function of the Quell device were validated in system testing."

These statements confirm that the device's functional integrity, including its software and wireless control, was tested comprehensively in what can be considered standalone performance tests in an engineering context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this submission is primarily based on:

Engineering Specifications: The device's electrical, mechanical, and software characteristics meeting predefined targets.
Regulatory Standards: Compliance with relevant IEC standards (IEC 60601-1, 60601-1-2, 60601-1-6, 62304, 60601-1-11), and 21 CFR 898.
Predicate Device Equivalence: The performance and safety characteristics being substantially equivalent to the legally marketed predicate device (NeuroMetrix ASCEND K140333).
Risk Assessment: Demonstration that new features do not introduce new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission for a physical medical device, not a machine learning model that requires a distinct training set in the typical sense. The "training" for the device would be its design and manufacturing processes adhering to specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there isn't a "training set" in the context of machine learning. The "ground truth" for the device's design and manufacturing is established by engineering principles, regulatory requirements, and historical data from similar devices (especially the predicate).

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 5, 2016

Neurometrix, Inc. Rainer Maas Director of QA/RA/Compliance 1000 Winter Street Waltham, Massachusetts 02451

Re: K152954

Trade/Device Name: Ouell Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: October 5, 2015 Received: October 7, 2015

Dear Mr. Maas:

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) K152954

Device Name Quell

Indications for Use (Describe)

Ouell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

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 for Ouell®

SPONSOR

NeuroMetrix, Inc. 1000 Winter Street Waltham, MA 02451 USA

Contact Person:	Rainer Maas
Telephone:	(781) 314-2781
Date Prepared:	October 5, 2015

DEVICE NAME

Proprietary Name:	Quell
Common/Usual Name:	Transcutaneous Electrical Nerve Stimulator, TENS
Classification Name:	882.5890 NUHTranscutaneous electrical nerve stimulator for pain relief

PREDICATE DEVICE

NeuroMetrix ASCEND (K140333)

INTENDED USE

Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

DEVICE DESCRIPTION

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The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The push button initiates stimulation and controls the intensity. The LED array indicates stimulation status, battery charging, and error conditions.

Form of Wireless Technology	Bluetooth® low energy
Type	BLE113 Bluetooth® Smart Module (Silicon Labs, Austin, TX)
RF Frequencies	2.400 GHz - 2.4835 GHz ISM band
Maximum Output Power	0 dBm
Maximum Receiver Sensitivity	-93 dBm
Range	10 m (unobstructed)

The wireless technology details are summarized below.

COMPARISON TO PREDICATE

Quell has identical indications for use as the cleared ASCEND device (K140333); both are intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain, and may be used during sleep. Both devices are only labeled for use with compatible NeuroMetrix electrodes.

The Quell and ASCEND devices have similar technological characteristics as listed below.

One stimulation channel
Single output mode
User controlled intensity ●
Fixed therapy session timer
LED indicators (no intensity display) ●
Powered by battery

As demonstrated by the table below, there are no significant differences in basic unit characteristics between Quell and ASCEND that would raise new questions of safety or effectiveness.

Parameter	Quell	ASCEND K140333
Device Name and Model Number	Quell	ASCEND
Manufacturer	NeuroMetrix	NeuroMetrix
Power Source(s)	Rechargeable 3.7V Lithium-Ion battery	Rechargeable 3.7V Lithium-Ion battery
Method of Line Current Isolation	Cannot charge while used	Cannot charge while used
Patient Leakage CurrentNormal Condition	<10 μΑ	<10 μΑ
Patient Leakage CurrentSingle Fault Condition	<100 μΑ	<100 μΑ
Avg. DC current through electrodes when device on but no pulse applied (µA)	< 1 μΑ	< 1 μΑ
Number of Output Modes	1	1

Basic Unit Characteristics

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No. OutputChannels	Synchronous oralternatingMethod of chan. isolation	1	1
	N/A	N/A
	Regulated Current or Voltage	Current	Current
Software/Firmware/Micro. Control		Yes	Yes
Automatic Overload Trip?		Yes	Yes
Automatic No-Load Trip? (open circuit)		Yes	Yes
Automatic Shut Off?		Timer, trip	Timer, trip
User Override Control?		4 button presses	Double tap
Indicator	On/Off Status?	Yes	Yes
Display:	Low Battery?	Yes	Yes
	Voltage/Current Level?	No	No
Timer Range		60 minutes	60 minutes
	Compliance with Voluntary Standards	IEC 60601-1	IEC 60601-1
		IEC 60601-1-2	IEC 60601-1-2
		IEC 60601-1-6	IEC 60601-1-6
		IEC 62304	IEC 62304
		IEC 60601-1-11
Compliance with 21 CFR 898		Yes	Yes
Weight		62g (2.2 oz)	82g (2.9 oz)
Dimensions (W x H x D)		11mm (0.4") x 74mm (2.9") x 98mm (3.9")	16mm (0.6") x 63mm (2.5")x176mm (6.9")
Housing Materials & Construction		Plastic, Nylon, Spandex, Velcro®	Plastic, Nylon, Velcro®

A comparison of output specifications is provided in the table below. The only difference is that Quell has maximum phase duration of 200 µs versus 100 µs for ASCEND. This leads to higher maximum phase charge, maximum current density, maximum average current, and maximum average power density. Although larger in Quell, these values are within the range of other 510(k) cleared transcutaneous electrical nerve stimulators. As a result, the increased phase duration does not raise new questions of safety or effectiveness

Parameter	Quell	ASCEND K140333
Mode or Program Name	Single mode	Single Mode
Waveform	Biphasic	Biphasic
Shape (output current)	Rectangular	Rectangular
Maximum Output Voltage(10 +/- %)	50 V @500 Ω	50 V @500 Ω
	100 V @2000 Ω	100 V @2000 Ω
	100 V @10000 Ω	100 V @10000 Ω
Maximum Output Current(10 +/- %)	100 mA @500 Ω	100 mA @500 Ω
	50 mA @2000 Ω	50 mA @2000 Ω
	10 mA @10000 Ω	10 mA @10000 Ω
Duration of primary (depolarizing) phase	100 - 200 μs	100 μs
Pulse Duration (both phases)	200 - 400 μs, 30 μs inter-phase delay	200 μs, 30 μs inter-phase delay
Frequency	Random with 80 Hz mean(Range 60 - 100 Hz)	Random with 80 Hz mean(Range 60 - 100 Hz)
For multiphasic waveformsonly:	Symmetrical phases	Yes	Yes
	Phase Duration	100 - 200 μs	100 μs
	Initial Phase Polarity	Alternates with each pulse	Alternates with each pulse
Net Charge (per pulse)		Nominally 0 μC @ 500Ω,zero net current	Nominally 0 μC @ 500Ω, zeronet current
Maximum Phase Charge		20 μC @ 500Ω	10 μC @ 500Ω
	20 μC @ 1000Ω	10 μC @ 1000Ω
Maximum Current Density (r.m.s.)		0.71 mA/cm² @ 500Ω	0.51 mA/cm² @ 500Ω
Maximum Average Current		4 mA @ 500 Ω	1.6 mA @ 500 Ω
Maximum Average Power Density		7 mW/cm² @ 500Ω	3.6 mW/cm² @ 500Ω

Output Specifications

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Quell includes a number of new features or technological characteristics, as listed below. These features and technological characteristics do not raise new questions of safety or effectiveness.

On-skin Timer

This timer tracks the duration of time that the device and electrode have been on the user's skin continuously. At 4 hours the device alerts the user by pulsing stimulation at 1 Hz for 1 minute. The purpose of this alert is to encourage the user to ventilate their skin to reduce the risk of skin irritation, and therefore this feature does not raise new questions of safety or effectiveness.

Auto-restart Timer

If enabled, this timer automatically restarts therapy 1 hour following the end of the previous therapy session. The user retains control over stimulation and can start or halt therapy at any time. This feature is a convenience and therefore does not raise new questions of safety or effectiveness.

Stimulation Lock

If the user has been recumbent for a certain period of time then the device will ignore button presses that initiate therapy or increase the stimulation intensity. The ability to decrease the intensity and halt stimulation is not affected. The purpose of this feature is to prevent stimulation due to unintentional actuation of the push-button while the user is sleeping; therefore this feature does not raise new questions of safety or effectiveness.

Sleep Settings

There are three sleep settings. These settings offer the user the convenience of automatically reducing stimulation while sleeping, and therefore do not raise new questions of safety or effectiveness.

Sleep Tracking

Quell tracks sleep duration and quality based on body movement measured using an embedded accelerometer. This information helps the user track the quantity of their sleep patterns. The sleep tracking data are not linked with any disease or condition; nor are they intended for use in the diagnosis, mitigation, treatment, or prevention of sleep disorders or other related conditions. As such, the sleep-tracking feature is a low risk, general wellness function that does not raise new questions of safety or effectiveness.

Virtual Button

Stimulation may be initiated and halted, and stimulation intensity may be increased via a virtual button. The virtual button functionality was validated in system testing, and in a validation protocol designed to confirm that the virtual button is safe and effective as outlined in the FDA's "Radio Frequency Wireless Technology in Medical Devices. Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)." The results of testing confirmed that the virtual button is safe and effective. Moreover, the user retains control over stimulation and can override virtual button control through the hardwired push-button. The user may also inactivate the virtual button by disabling Bluetooth communication on the device. For the reasons described above, the virtual button functionality does not raise new questions of safety or effectiveness.

Mobile App

Quell includes an optional mobile app that provides several convenience features. The app is not required to operate the device. Those features of the mobile app that relate to the control and function of the Quell device were validated in system testing. The mobile app does not raise new questions of safety or effectiveness because it is an optional feature, only permits functions included in the device

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itself, i.e., it adds no new functionality to the Quell device, and validation testing confirms that the Quell device with the mobile app is as safe and effective as the predicate.

In summary, Quell has identical indications and similar technological characteristics as the cleared ASCEND device (K140333). The limited differences between the devices do not raise new types of safety or effectiveness questions. As a result, Quell is substantially equivalent to the cleared ASCEND device.

GUIDANCE DOCUMENT

The FDA's "Draft Guidance for Industry and Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use (April 5, 2010)" addresses transcutaneous electrical nerve stimulators with product code NUH. The recommendations from the draft guidance document were taken into account in preparing this 510(k) submission. NeuroMetrix believes that the Quell device complies with the special controls as outlined in the draft guidance, thereby providing additional assurance of safety and effectiveness.

This 510(k) submission also considered recent agency guidance on wireless technology; namely "Radio Frequency Wireless Technology in Medical Devices. Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)." Additional guidance documents considered included "Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff (February 9, 2015)" and "General Wellness: Policy for Low Risk Devices, Draft Guidance for Industry and Food and Drug Administration Staff (January 20, 2015)."

NON-CLINICAL TESTING

Verification testing of Quell included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions. Validation and performance testing demonstrates that the device meets as reflected in the functional specification.

Ouell conforms to the following standards:

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 (3td Ed) plus Amendments 1:2006 and 2:2007
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety -● Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2007)
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements for Safety -● Collateral standard: Usability (3td Ed) 2010-1
IEC 62304:2006 Medical device software Software life cycle processes ●
o IEC 60601-1-11:2010 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

CLINICAL TESTING

NeuroMetrix determined that bench and non-clinical testing were sufficient to demonstrate that Quell is as safe and effective as the predicate ASCEND device.

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CONCLUSION

The verification, validation, and performance data presented in this 510(k) submission demonstrate that Quell is substantially equivalent to the predicate ASCEND 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).