SENSUS

K121184 · Neurometrix, Inc. · GZJ · Aug 2, 2012 · Neurology

Device Facts

• Record ID: K121184
• Device Name: SENSUS
• Applicant: Neurometrix, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Aug 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

Device Story

SENSUS is a one-channel transcutaneous electrical nerve stimulator (TENS) for chronic intractable pain management. Device uses microprocessor-controlled high-voltage circuit to generate biphasic, rectangular electrical pulses (80 Hz, 100 µs phase duration). Input: patient-controlled intensity via accelerometer-detected taps on enclosure; push-button for power/start/stop. Output: electrical stimulation delivered via two disposable, self-adhering electrodes (≥ 20 cm2). Powered by rechargeable Lithium-Ion battery. Used by patients under medical professional direction. Device provides symptomatic pain relief by delivering controlled electrical pulses to nerves. Safety features include automatic overload/no-load trips and automatic shut-off after 60-minute timer.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including electrical, mechanical, and software verification/validation against target specifications and voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304).

Technological Characteristics

Plastic housing; 22mm x 66mm x 108mm; 95g. Single-channel, biphasic, rectangular waveform (80 Hz, 100 µs phase duration). Powered by 3.7V rechargeable Li-Ion battery. Microprocessor-controlled stimulation. Connectivity: USB for charging. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304. Sterilization: N/A (disposable electrodes).

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients requiring prescription-based transcutaneous electrical nerve stimulation.

Regulatory Classification

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.

Predicate Devices

• EMPI Active Transcutaneous Nerve Stimulator (K090922)

Submission Summary (Full Text)

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# 5. 510(K) SUMMARY

510(k) Summary for NeuroMetrix SENSUS™

K121184

SPONSOR

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

| Contact Person: | Rainer Maas |
|-----------------|----------------|
| Telephone: | [phone] |
| Date Prepared: | July 23, 2012 |

## DEVICE NAME

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

### PREDICATE DEVICE

EMPI Active Transcutaneous Nerve Stimulator (K090922)

#### INTENDED USE

The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

# DEVICE DESCRIPTION

SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter.

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The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector.

The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.

# COMPARISON TO PREDICATE

The NeuroMetrix SENSUS device and predicate Empi Active Transcutaneous Nerve Stimulator (ACTIVE) have the same intended use, i.e., they are intended for the symptomatic relief and management of chronic intractable pain. The SENSUS Indications for Use represent a subset of the predicate Indications for Use. Specifically, while both SENSUS and the predicate are indicated for the relief and management of chronic intractable pain, the predicate is additionally indicated for the relief of pain associated with arthritis and as an adjunctive treatment for post-surgical and post-trauma acute pain. Both are prescription devices to be used under the direction of a medical professional.

SENSUS and the predicate have the same basic technological characteristics as listed below.

- . One stimulation channel
- Single output mode .
- Patient controlled intensity .
- LED indicators (no intensity display) .
- Powered by rechargeable battery .

SENSUS and the predicate device have output characteristics that are within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators. The basic unit characteristics and output specifications of the two devices are summarized in the tables below.

| Parameter | NeuroMetrix SENSUS | Empi Active Transcutaneous<br>Nerve Stimulator (K090922) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number | (to be assigned) | K090922 |
| Device Name and Model Number | SENSUS | Active Transcutaneous Nerve<br>Stimulator |
| Manufacturer | NeuroMetrix | Empi |
| Power Source(s) | 1 rechargeable 3.7V Lithium-<br>Ion battery | 1 rechargeable battery (type<br>unknown) |
| Method of Line Current Isolation | Physically isolated; device<br>cannot connect to electrodes<br>and battery recharger<br>concurrently | Physically isolated; device cannot<br>connect to electrodes and battery<br>recharger concurrently |
| Patient Leakage Current | | |
| Normal Condition | < 10 µA, battery powered | Unknown |
| Single Fault Condition | < 100 µA, battery powered | Unknown |
| Average DC current through<br>electrodes when device is on but no | < 1 μΑ | Unknown |

### Basic Unit Characteristics.

NeuroMetrix, Inc. SENSUS 510(k)

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| pulse are being applied (µA) | | | |
|---------------------------------------------|-------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Number of Output Modes | | 1 | 1 |
| Number<br>of output<br>channels | Synchronous or<br>alternating | 1 | 1 |
| Method of channel<br>isolation | | N/A | N/A |
| Regulated Current or Regulated<br>Voltage | | Current | Nominally constant voltage in the<br>positive phase, nominally constant<br>current in the negative phase |
| Software/Firmware/Microprocessor<br>Control | | Yes | Yes |
| Automatic Overload Trip? | | Yes | No |
| Automatic No-Load Trip? | | Yes | No |
| Automatic Shut Off? | | Yes after timer elapses | Yes if left at 0 mA for 5 minutes |
| User Override Control? | | Yes, press STIM button | Yes, press POWER button |
| Indicator<br>Display: | On/Off Status? | Yes, upon pressing STIM<br>button | Yes, status LED flashes when on |
| | Low Battery? | Yes | Yes |
| | Voltage/Current<br>Level? | No | No |
| Timer Range | | 60 minutes | N/A |
| Compliance with Voluntary<br>Standards | | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1-2<br>UL: 60601-01<br>CAN/CSA C22.2 No.601.1-M90<br>with Amendment A2.2005 |
| Compliance with 21 CFR 898 | | Yes | Yes |
| Weight | | 95g (3.4 oz) | 0.99 oz |
| Dimensions (W x H x D) | | 22mm (0.9") x 66mm (2.6")<br>x108mm (4.3") | 0.57"x1.94"x2.54" |
| Housing Materials & Construction | | Plastic | Plastic |

## Output Specifications.

t

| Parameter | NeuroMetrix SENSUS | Empi Active Transcutaneous<br>Nerve Stimulator (K090922) |
|------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------|
| Mode or Program Name | N/A | N/A |
| Waveform | Biphasic | Biphasic |
| Shape (output current) | Rectangular | Approximately rectangular<br>initial phase, slowly decaying<br>second phase |
| Maximum Output Voltage (10 +/- %) | 50 V @500 Ω<br>100 V @2000 Ω<br>100 V @10000 Ω | 25 V @500 Ω<br>35 V @2000 Ω<br>39 V @10000 Ω |
| Maximum Output Current (10 +/- %) | 100 mA @500 Ω<br>50 mA @2000 Ω<br>10 mA @10000 Ω | 50 mA @500 Ω<br>18 mA @2000 Ω<br>4 mA @10000 Ω |
| Duration of primary (depolarizing) phase | 100 μs | 400 μs at maximum intensity |
| Pulse Duration (both phases) | 230 μs, includes 30 μs inter-<br>phase delay | Approximately 1 msec, exact<br>duration unspecified due to<br>slowly decaying second phase |
| Frequency | Constant, 80 Hz | Modulated, 2-125 Hz |
| For multiphasic | Symmetrical phases Yes | No |

NeuroMetrix, Inc.
SENSUS 510(k)

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| waveforms only: | Phase Duration | | |
|----------------------------------|---------------------|-----------------------------------------|-------------------------------------------------------------|
| Net Charge (per pulse) | | Nominally 0 μC @ 500Ω, zero net current | Nominally 0 μC because pulse shape is described as balanced |
| Maximum Phase Charge | | 10 μC @ 500Ω<br>10 μC @ 1000Ω | 17 μC @ 500Ω<br>10 μC @ 1000Ω |
| Maximum Current Density (r.m.s.) | | 0.63 mA/cm² @ 500Ω | 1.73 mA/cm² @ 500Ω |
| Maximum Average Current | | 1.6 mA @ 500 Ω | 10 mA @ 500Ω |
| Maximum Average Power Density | | 4 mW/cm² @ 500Ω | 8 mW/cm² @ 500Ω |
| Burst Mode | Pulses per burst | N/A | N/A |
| | Bursts per second | N/A | N/A |
| | Burst duration | N/A | N/A |
| | Duty Cycle | N/A | N/A |
| ON Time | | N/A | N/A |
| OFF Time | | N/A | N/A |
| Additional Features | | N/A | N/A |
| | 100 μs (each phase) | | 400 μs (initial phase), at maximum intensity |

The primary differences between the two devices relate to the output specifications, specifically the (i) pulse waveform shape and duration, (ii) maximum output voltage and maximum output current, and (iii) pulse pattern.

- (i) Pulse waveform shape and duration: SENSUS generates a symmetrical biphasic rectangular output current pulse while ACTIVE generates a balanced asymmetrical biphasic pulse with the initial phase approximately rectangular and a slowly decaying second phase. The SENSUS pulse duration is fixed at 100 usec per phase while the initial phase of the ACTIVE pulse duration varies with the intensity setting, and the overall duration is approximately 1000 usec. Because the physiological effectiveness of nerve stimulation is primarily dependent on charge delivered, either pulse waveform shape will be effective. Therefore this difference does not raise new types of questions of safety or effectiveness. -
- (ii) Maximum output voltage and maximum output current: SENSUS has a higher maximum output voltage than ACTIVE (50 V for SENSUS versus 25V for ACTIVE into a 500Ω load). SENSUS also has a higher maximum output current, i.e, 100 mA as compared to 50 mA in ACTIVE (500Ω Because the SENSUS pulse duration is shorter and the charge delivered per pulse is load). titrated by the patient, the maximum charge per pulse is similar for the two devices. Therefore this difference does not raise new types of questions of safety or effectiveness.
- (iii)Pulse pattern: SENSUS stimulates with a fixed duration pulse at a constant frequency of 80 Hz while ACTIVE stimulates with pulses that automatically cycle through a range of durations and frequencies between 2 and 125 Hz. This difference between SENSUS and ACTIVE does not raise new types of safety or effectiveness questions because (i) neither device gives the patient control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (ii) constant frequency stimulation is standard practice, 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 ACTIVE, and can be achieved through either constant or modulated frequency and duration.

SENSUS and the predicate device have similar types of control over stimulation intensity, with minor differences in the specific user interaction sequences. These differences do not raise new types of safety or effectiveness questions because in both devices the (i) stimulation intensity is under patient control such that he/she can change the intensity, stop further intensity increases, and halt stimulation

NeuroMetrix, Inc. SENSUS 510(K)

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at any time and (ii) the stimulation intensity always starts at 0 mA and increases gradually, smoothly and predictably, thereby avoiding the risk of sudden changes in intensity that may startle the patient.

In sum, SENSUS and the predicate have the same intended use and the only technological differences relate to several output specifications and aspects of intensity control. As discussed above, these differences in technological characteristics are relatively minor and do not raise new types of safety or effectiveness questions and do not adversely affect the safety and effectiveness of the SENSUS device compared to the predicate. As a result, the SENSUS device is substantially equivalent to the predicate ACTIVE 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 (April 5, 2010)" addresses transcutaneous electrical nerve stimulators with product code GZJ. The recommendations from the draft guidance were taken into account in preparing this 510(k) submission. NeuroMetrix believes that SENSUS complies with the special controls as outlined in the draft guidance, thereby providing additional assurance of safe and effective use of the SENSUS device.

## NON-CLINICAL TESTING

Verification testing of SENSUS includes 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 it meets user needs as reflected in the functional specification.

SENSUS conforms to the following voluntary standards:

- . IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 (300 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 ●

### CLINICAL TESTING

NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient to demonstrate that SENSUS is as safe and effective as the predicate.

#### CONCLUSION

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

NeuroMetrix, Inc. SENSUS 510(K)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.

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

> 2 2012 AUG

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

Re: K121184

Trade/Device Name: SENSUS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: July 23, 2012 Received: July 24, 2012

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

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# Page 2 - Mr. Rainer Maas

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Device Name: NeuroMetrix SENSUS

Indications for Use:

The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121184

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CONFIDENTIAL