ASCEND 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.

ASCEND 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

ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. 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 disposable electrodes placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study as described in the provided 510(k) summary for ASCEND™:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
At least 80% of participants successfully completed all five basic device tasks (checking battery, placing device and configuring, starting a therapy session, modifying stimulation intensity, and stopping a therapy session) based on reading and following the directions for use.	86.2% of participants successfully completed all five tasks (25 out of 29 participants). The lower bound of the 95% confidence interval (68.3%) was not explicitly stated to meet the 80% threshold but the upper bound of 96.1% exceeded 80% and the null hypothesis that the true pass rate was ≥ 80% could not be rejected.

Details of the Usability Study

2. Sample size used for the test set and the data provenance:

Sample Size: 29 participants.
Data Provenance: The study was a prospective usability study, likely conducted in the US where NeuroMetrix, Inc. is located. The document does not explicitly state the country of origin, but given the sponsor's address.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The study was a usability study focused on whether untrained users could operate the device based on its labeling. Therefore, the "ground truth" was the objective successful completion of predefined tasks by these users, not an expert assessment of a medical condition. No experts were used to establish ground truth in the traditional sense of medical diagnosis.

4. Adjudication method for the test set:

Not applicable in the context of a usability study where success is objectively measured by task completion by the participants themselves.

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:

No MRMC comparative effectiveness study was done. This study was a usability study for an over-the-counter transcutaneous electrical nerve stimulator (TENS) device, not an AI-powered diagnostic tool.

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

Not applicable. The device is a TENS unit, and the study was a human usability study.

7. The type of ground truth used:

The "ground truth" for this usability study was the objective successful completion of specific device-operation tasks by study participants, as outlined in the device's labeling (instructional video and quick start instructions). It was not based on expert consensus, pathology, or outcomes data related to disease diagnosis or treatment efficacy, but rather on the ability of lay users to correctly operate the device.

8. The sample size for the training set:

Not applicable. This was a usability study, not a machine learning model development study, so there was no "training set."

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

Not applicable. As noted above, there was no training set for a machine learning model.

Summary

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510(k) Summary for ASCEND™M

JUL 0 3 2014 KI40333

SPONSOR

NeuroMetrix, Inc. 62 Fourth Avenue : Waltham. MA 02451 USA

Contact Person:	Rainer Maas
Telephone:	(781) 314-2781
Date Prepared:	February 7, 2014

DEVICE NAME

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

PREDICATE DEVICE

NeuroMetrix SENSUS (K130919) PDI Works Pain-Aid (K113037)

INTENDED USE

ASCEND 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

ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. 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, The device is powered by an embedded rechargeable Lithium-Ion duration, pattern, and frequency. battery that is charged through a USB cable connected to an AC adapter.

The device delivers electrical stimulation to the user through disposable electrodes placed on the user's The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS body. Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four

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individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.

COMPARISON TO PREDICATES

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ASCEND has similar indications for use and identical technological characteristics as the cleared SENSUS device (K130919). The only substantive difference is that ASCEND is labeled for over-thecounter use while SENSUS is labeled for prescription use. The over-the-counter labeling is based on the substantial equivalence of ASCEND to PDI Works Pain-Aid (K 113037), a transcutaneous electrical nerve stimulator labeled for over-the-counter use and sold without a prescription. In further support of overthe-counter labeling, this submission includes results from a prospective usability study that demonstrates the safe, and effective use of ASCEND, as labeled, in the intended population.

Comparison of Indications for Use

As stated above, ASCEND has the similar indications for use as the cleared SENSUS device i.e., 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. The table below compares ASCEND, SENSUS and Pain-Aid indications for use. All three devices are indicated for the symptomatic relief and management of chronic intractable pain.

Comparison of Indications for Use.
NeuroMetrix ASCEND	NeuroMetrix SENSUS (K130919)	PDI Works Pain-Aid (K113037)
ASCEND is intended for use as atranscutaneous electrical nervestimulation device for temporaryrelief of pain associated with soreand aching muscles in the lowerextremities due to strain fromexercise or normal household andwork activities.	The NeuroMetrix SENSUS isintended for use as a transcutaneouselectric nerve stimulation device forthe symptomatic relief andmanagement of chronic intractablepain.	To be used for temporary relief ofpain associated with sore and achingmuscles in the upper and lowerback, and upper and lowerextremities due to strain fromexercise or normal household andwork activities.
ASCEND is intended for use as atranscutaneous electrical nervestimulation device for thesymptomatic relief and managementof chronic intractable pain.	The device may be used duringsleep. The device is labeled for useonly with the NeuroMetrix SENSUSElectrode	To be used for the symptomaticrelief and management of chronic,intractable pain and relief of painassociated with arthritis.
The device may be used duringsleep. The device is labeled for useonly with compatible NeuroMetrixelectrodes.

f Indications for Use

Comparison of Technological Characteristics

ASCEND and SENSUS have identical technological characteristics. ASCEND and Pain-Aid have the same basic technological characteristics as listed below.

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One stimulation channel
Single output mode
Patient controlled intensity .
Fixed therapy session timer .
LED indicator (no intensity display) .
. Powered by battery

Both ASCEND and Pain-Aid have output specifications that are within the range of other FDA cleared transcutaneous electrical nerve stimulators. In the case of ASCEND, the basic unit characteristics and output specifications are identical to those of the SENSUS device, which FDA recently cleared through its 510(k) review process (K130919); i.e., it is the same device. The basic unit characteristics and output specifications of ASCEND, SENSUS and Pain-Aid are summarized in the tables below.

There are no technical differences between ASCEND and SENSUS. The primary technical differences between ASCEND and Pain-Aid are the (i) pulse waveform shape and duration, (ii) maximum output current, (iii) pulse pattern, and (iv) trip conditions.

(i) Pulse waveform shape and duration: ASCEND generates a symmetrical biphasic rectangular output current pulse. Pain-Aid generates an asymmetrical biphasic pulse with the initial phase rectangular. The ASCEND pulse duration is fixed at 100 usec per phase while the initial phase of the Pain-Aid pulse duration is modulated between 30 and 220 usec. Because the physiological effectiveness of nerve stimulation is dependent on total charge delivered, the shape of the pulse waveform does not impact device's effectiveness. In other words, either pulse waveform shape is effective. Therefore this difference does not raise new types of questions of safety or effectiveness.
(ii) Maximum output current: ASCEND has a higher maximum output current; 100 mA as compared to Because the charge delivered per pulse is set by the patient to a strong but 63 mA in Pain-Aid. comfortable sensation, the charge delivered is, therapeutically effective with either device. Furthermore, ASCEND has the same maximum output current as the predicate SENSUS device. Therefore, this difference does not raise new types of questions of safety or effectiveness.
(iii)Pulse pattern: ASCEND stimulates with a fixed duration pulse at a randomly varying frequency between 60 and 100 HZ with mean 80 Hz. Pain-Aid stimulates with pulses that cycle through a range of durations and frequencies between 2 and 100 Hz. This difference between ASCEND and Pain-Aid does not raise new types of safety or effectiveness guestions because (i) neither device gives the 1 . patient control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (iii) random frequency stimulation is within the standard practice for TENS devices and is used in the predicate SENSUS device, and (iv) the clinical effectiveness of transcutaneous electrical nerve stimulation for chronic intractable pain is not dependent on the use of modulated pulse trains such as those generated by Pain-Aid, and can be equally achieved through random frequency stimulation as delivered by ASCEND.
(iv) Trip conditions: ASCEND has trip conditions not found in Pain-Aid. These include detection of over-load, no-load, insufficient charge, high impedance, and short circuit conditions. Detection of any of these immediately halts stimulation. ASCEND also includes an electrode peeling trip condition that addresses the potential hazard of electrode peeling during sleep. These trip conditions enhance the safety of ASCEND compared to Pain-Aid and therefore this difference does not raise · new types of questions of safety or effectiveness.

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	Basic Unit Characteristics.

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Parameter	NeuroMetrixASCEND	NeuroMetrixSENSUS	PDI WorksPain-Aid
510(k) Number	(to be assigned)	K130919	K113037
Device Name and Model Number	ASCEND	SENSUS	Pain-Aid
Manufacturer	NeuroMetrix	NeuroMetrix	PDI Works
Power Source(s)	3.7V Lithium-Ionbattery (rechargeable)	3.7V Lithium-Ionbattery (rechargeable)	3V Lithium battery (non-rechargeable)
Method of Line Current Isolation	Physically isolated; device cannot connect to electrodes and battery recharger concurrently	Physically isolated; device cannot connect to electrodes and battery recharger concurrently	Non-rechargeable, no connection to line current
Patient Leakage Current
Normal Condition	Battery powered (< 10 μA)	Battery powered (< 10 μA)	Battery powered
Single Fault Condition	Battery powered (< 100 μA)	Battery powered (< 100 μA)	Battery powered
Average DC current through electrodes when device is on but no stimulation	< 1 μA	< 1 μA	Information not available
Number of Output Modes	1	1	1
Number of output channels	Synchronous or alternating	1	1
Method of channel isolation	N/A	N/A	N/A
Regulated Current or Regulated Voltage	Current	Current	Current
Software/Firmware/Microprocessor Control	Yes	Yes	Yes
Automatic Overload Trip?	Yes	Yes	No
Automatic No-Load Trip?	Yes	Yes	No
Automatic Shut Off?	Yes, after timer elapses or on trip condition	Yes, after timer elapses or on trip condition	Yes, after timer elapses
User Override Control?	Yes	Yes	No
Indicator Display:
On/Off Status?	Yes	Yes	Yes
Low Battery?	Yes	Yes	No
Voltage/Current Level?	No	No	No
Timer Range	60 minutes	60 minutes	30 minutes
Compliance with Voluntary Standards	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2
Compliance with 21 CFR 898	Yes	Yes	Yes
Weight	82g	82g	20 g
Dimensions (W x H x D)	176mm x 63mm x 18mm	176mm x 63mm x 18mm	64mm x 38mm x 13mm
Housing Materials & Construction	Plastic, Velcro® straps (Nylon)	Plastic, Velcro® straps (Nylon)	Plastic

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Output Specifications.	Parameter	NeuroMetrixASCEND	NeuroMetrixSENSUS	PDI Works Pain-Aid (K113037)
Mode or Program Name		N/A	N/A	N/A
Waveform		Biphasic, Symmetrical	Biphasic, Symmetrical	Biphasic,Asymmetrical
Shape (output current)		Rectangular	Rectangular	Rectangular
Maximum Output Voltage (10 +/- %)		50 V @500 Ω100 V @2000 Ω100 V @10000 Ω	50 V @500 Ω100 V @2000 Ω100 V @10000 Ω	Information notavailable
Maximum Output Current (10 +/- %)		100 mA @500 Ω50 mA @2000 Ω10 mA @10000 Ω	100 mA @500 Ω50 mA @2000 Ω10 mA @10000 Ω	63 mA @500 Ω
Duration of primary (depolarizing) phase		100 µs	100 µs	30 - 220 µs(modulated)
Pulse Duration (both phases)		200 µs, additional 30µs inter-phase delay	200 µs, additional 30µs inter-phase delay	Information notavailable
Frequency		Random, mean 80 Hz,uniform distribution60 - 100 Hz	Random, mean 80 Hz,uniform distribution60 - 100 Hz	2 - 100 Hz(modulated)
For multiphasic waveformsonly:	Symmetricalphases	Yes	Yes	No
	Phase Duration	100 µs (each phase)	100 µs (each phase)	30 -220 µs(depolarizingphase, modulated)
Net Charge (per pulse)		Nominally 0 µC @500Ω, zero net current	Nominally 0 µC @500Ω, zero net current	Information notavailable
Maximum Phase Charge		10 µC @ 500Ω10 µC @ 1000Ω	10 µC @ 500Ω10 µC @ 1000Ω	Information notavailable
Maximum Current Density (r.m.s.)		0.51 mA/cm² @ 500Ω	0.51 mA/cm² @ 500Ω	Information notavailable
Maximum Average Current .		1.6 mA @ 500 Ω	1.6 mA @ 500 Ω	Information notavailable
Maximum Average Power Density		3.6 mW/cm² @ 500Ω	3.6 mW/cm² @ 500Ω	Information notavailable
Burst Mode	Pulses per burst	N/A	N/A	N/A
	Bursts per second	N/A	N/A	N/A
	Burst duration	N/A	N/A	N/A
	Duty Cycle	N/A	N/A	N/A
ON Time		N/A	N/A	N/A
OFF Time		N/A	N/A	N/A

Comparison of Usability Characteristics

ASCEND and SENSUS have identical usability characteristics. ASCEND and Pain-Aid have easy-to-use controls that support their over-the-counter use without a prescription. The primary differences between the devices are the number of push buttons used to control the device and the primary mode of setting the therapeutic intensity. ASCEND uses short and long button press sequences to accomplish the same control functions with 1 button for which Pain-Aid uses 3 buttons. This difference is a convenience that does not raise new types of safety or effectiveness questions. ASCEND offers a configuration procedure whereby the therapeutic intensity is determined from the user's sensation threshold. This function provides a convenient way to set the intensity within the expected therapeutic window. Once set through configuration, the intensity can be manually adjusted up or down. Pain-Aid does not provide a similar configuration procedure; the user must set the therapeutic intensity manually. This difference between

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the devices is one of convenience. Because both devices allow for manual adjustment, ASCEND's additional convenience feature does not raise new types of safety or effectiveness questions. Summarv

ASCEND has identical indications for use and technological characteristics as the cleared SENSUS device, and the only difference is that ASCEND is labeled for over-the-counter use. Usability testing discussed below shows this difference has no safety or effectiveness significance. ASCEND and Pain-Aid have unit characteristics and output specifications that are within the range of legally-marketed transcutaneous electrical nerve stimulators. Both devices are indicated for symptomatic relief and The differences management of chronic intractable pain and have similar usability characteristics. between the two devices do not raise new types of safety or effectiveness questions. As a result, ASCEND is substantially equivalent to SENSUS and Pain-Aid.

USABILITY STUDY

The objective of the usability study was to validate that previously untrained users can operate ASCEND in a safe and effective manner based on their reading and following of the directions for use contained in the device labeling without the supervision or assistance of a medical professional. Specifically, the usability study examined labeling consisting of an instructional video and quick start instructions. These materials cover five basic device tasks: checking battery, placing device and configuring, starting a therapy session, modifying stimulation intensity, and stopping a therapy session. The acceptance criterion was that at least 80% of participants successfully completed all five tasks.

A total of 29 participants were enrolled, all of which completed the study. No significant usability issues were identified. The percentage of participants completing all five tasks successfully was 86.2% (95% Cl, 68.3 - 96.1), i.e., 25 of 29 participants. The upper bound of the 95% confidence interval (96.1%) exceeded 80%, and therefore the null hypothesis that the true pass rate was ≥ 80% could not be rejected. Because the prospective study criterion was met, the usability study achieved its primary objective of validating that untrained users could operate the device in a safe and effective manner based on their reading and following of the directions for use contained in the device labeling without the supervision or assistance of a medical professional. Therefore the usability study results support the safe and effective use of ASCEND, as labeled, in the intended population.

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 ASCEND device complies with the special controls as outlined in the draft guidance, thereby providing additional assurance of safety and effectiveness.

NON-CLINICAL TESTING

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

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ASCEND conforms to the following standards:

IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and . essential performance 2005 (3rd 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 (3rd Ed) 2010-1
. IEC 62304:2006 Medical device software -- Software life cycle processes

CLINICAL TESTING

NeuroMetrix determined that bench, usability and non-clinical testing were sufficient to demonstrate that ASCEND is as safe and effective as the predicate SENSUS and Pain-Aid devices.

CONCLUSION

The verification, validation, performance, and usability data presented in this 510(k) submission demonstrate that ASCEND is substantially equivalent to the predicate SENSUS and Pain-Aid devices.

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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

July 3, 2014

NeuroMetrix. Inc. Mr. Rainer Maas Director of QA/RA 62 Fourth Ave. Waltham. MA 02451

Re: K140333

Trade/Device Name: ASCEND Regulation Number: 21 CFR 882,5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: May 30, 2014 Received: June 2, 2014

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

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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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Carios
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) K140333

Device Name ASCEND

Indications for Use (Describe)

ASCEND 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)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.07.03 17:21:37

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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).