Livia

K163153 · Lifecare , Ltd. · NUH · Jun 28, 2017 · Neurology

Device Facts

• Record ID: K163153
• Device Name: Livia
• Applicant: Lifecare , Ltd.
• Product Code: NUH · Neurology
• Decision Date: Jun 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Livia is designed for symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance

Device Story

Livia is a TENS device for pain management and muscle stimulation. It delivers high-frequency electrical pulses via skin-surface electrodes to block pain signals to the brain and low-frequency bursts to stimulate natural pain control (beta-endorphins). Device is intended for OTC use by adults. Input: user-controlled intensity settings. Output: biphasic, symmetrical, rectangular electrical pulses. Operation: battery-powered (3.7V Li-ion) unit with microprocessor control; electrodes placed on peripheral nerves. Healthcare providers do not operate; patient self-administers. Output affects clinical decision-making by providing non-pharmacological pain relief. Benefits include symptomatic pain management and improved muscle performance without systemic drug side effects.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-10), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, -10), and a usability study (IEC 62366-1) confirming no user errors.

Technological Characteristics

TENS/EMS device; PC/ABS plastic housing; 3.7V rechargeable Li-ion battery; microprocessor-controlled; biphasic, symmetrical, rectangular waveform; 100µs pulse duration; 60-100Hz random frequency; output electrically disabled during charging. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for adult patients for symptomatic relief/management of chronic intractable pain and temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, upper/lower extremities due to exercise or household strain; also for stimulation of healthy muscles to improve/facilitate muscle performance.

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

• Philips Consumer Lifestyle PulseRelief (K151035)
• NeuroMetrix ASCEND (K10433)

Submission Summary (Full Text)

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

June 28, 2017

Lifecare Ltd. % Irving Wiesen Official Correspondent Cohen, Tauber, Spievack & Wagner 420 Lexington Avenue-suite 2400 New York, New York 10170

Re: K163153

Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: May 25, 2017 Received: May 30, 2017

Dear Irving Wiesen:

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

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S 2017.06.28 15:57:47 -04'00'

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) K163153

Device Name Livia

Indications for Use (Describe)

The Livia is designed for symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities.

It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 10px;">☐</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10px;">☑</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## Section 5: 510(K) SUMMARY

The assigned 510(K) Number: K163153

#### 1. Submitter's Identification:

### LifeCare Ltd.

Zipori St.2 1424602, Tiberias, Israel

Date Summary Prepared: May 25, 2017

Contact Person: Irving L. Wiesen, Esq. Law Offices of Irving L. Wiesen P.C. 420 Lexington Avenue - Suite 2400 New York, New York 10170 Tel [phone] Fax [phone] Email: [e-mail]

#### 2. Name of the Device:

Livia

#### 3. Common Name and Classification:

Stimulator, Nerve, Transcutaneous, Over-The-Counter Requlation: 21 CFR Part 882.5890 Product Code: NUH

#### 4. Predicate Device Information:

- Primary Predicate: Philips Consumer Lifestyle PulseRelief (K151035) ●
- Reference Predicate: NeuroMetrix ASCEND (K10433)

#### 5. Device Description:

The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes. which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patiernt get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.

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#### 6. Indication For Use:

The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be

used for stimulate healthy muscles in order to improve and facilitate muscle performance.

#### 7. Comparison to Predicate Devices:

The Livia device indications for use and technological characteristics are substantially equivalent to the Philips Consumer Lifestyle PulseRelief device application (K151035).

The primary predicate device is the Philips Consumer Lifestyle PulseRelief device and the reference predicate is NeuroMetrix ASCEND device application (K104333).

# TABLE 1: Indication For Use Comparison Table

| Parameter | Primary Predicate | Subject Device |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Philips Consumer<br>Lifestyle PulseRelief<br>(K151035) | LIVIA |
| Indication<br>For Use | The OTC TENS/EMS<br>stimulator PulseRelief is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities<br>(arm) and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities. It should be<br>applied to normal,<br>healthy, dry and clean<br>skin of adult patients, and<br>is to be used for stimulate<br>healthy muscles in order | The Livia is designed for symptomatic relief and<br>management of chronic pain, and for temporary<br>relief of pain associated with sore and aching<br>muscles in the shoulder, waist, back, neck, upper<br>extremities (arm) and lower (extremities) leg due<br>to strain from exercise or normal household<br>work activities.<br>It should be applied to normal, healthy, dry and<br>clean skin of adult patients, and is to be used for<br>stimulate healthy muscles in order to improve<br>and facilitate muscle performance. |

Comparison Tables - Technological Characteristics

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| | to improve and facilitate<br>muscle performance. | |
|-------------------|--------------------------------------------------|----------------------------------------|
| Class | II | II |
| Product Code | NUH; NGX | NUH; NGX |
| Regulation Number | 21 CFR 882.5890(b);<br>21 CFR 890.5850 | 21 CFR 882.5890(b);<br>21 CFR 890.5850 |

# Table 2: Basic Unit Characteristics Comparison Table

| Parameter | Primary Predicate<br>Philips Consumer<br>Lifestyle<br>PulseRelief<br>(K151035) | Livia | Significant<br>Differences | |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) Number | K151035 | K163153 | N/A | |
| Device Name and Model Number<br>Manufacturer | PulseRelief<br>Philips Consumer<br>Lifestyle | LIVIA<br>Life Care Ltd | N/A | |
| Power Source(s) | 3.7V Lithium-ion | 3.7V Lithium-ion<br>battery<br>(rechargeable) | Identical | |
| Method of Line Current Isolation | N/A | Output is<br>electrically<br>disabled when<br>connect to<br>charger, by<br>means of<br>microprocessor<br>charging circuit | Similar to the<br>reference predicate<br>Neurometrix<br>device cannot be used<br>while battery is<br>charging | |
| Patient Leakage Current<br>- Normal Condition (μΑ) | Battery powered<br>(< 10μΑ) | Battery powered<br>(< 10μΑ) | Identical | |
| Patient Leakage Current<br>- Single Fault Condition (μΑ) | Battery powered<br>(< 50μΑ) | Battery powered<br>(< 50μΑ) | Identical to Philips | |
| Average DC current through<br>Electrodes when device is on but no<br>pulses<br>are being applied (μA) | 0 μΑ | 0 μΑ | Identical to Philips | |
| Number of Output Modes | 15 TENS, 5 EMS | 1 | Similar to the<br>reference predicate<br>Neurometrix | |
| Number of Output<br>Channels: | Synchronous or<br>Alternating<br>Method of Channel | 1<br>N/A | 1<br>N/A | Identical |

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| | Isolation | | | |
|----------------------------------------------|--------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulated Current or Regulated | | Current | Current | Identical |
| Voltage | | | | |
| Software/Firmware/Microprocessor<br>Control? | | Yes | Yes | Identical |
| Automatic Overload Trip | | Yes | Yes | Identical |
| Automatic No-Load Trip | | Yes | Yes | Identical |
| Automatic Shut Off | | Yes | No | |
| User Override Control | | Yes | Yes | Identical |
| Indicator<br>Display: | On/Off Status | Yes | Yes | Identical |
| | Low Battery | Yes | Yes | Identical |
| | Voltage/Current<br>Level | Yes | Yes | Identical to Philip |
| Timer Range (minutes) | | 1-59 minutes | | The Livia has no<br>interal timer, a minor<br>difference, as there is<br>no treatment time<br>limitation for using the<br>Livia-see Instructions<br>for Use. |
| Compliance with Voluntary<br>Standards? | | IEC 60601-1, IEC<br>60601-1-2, IEC<br>60601-2-10, ISO<br>10993-5 and -10 | IEC 60601-1,<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10,<br>ISO 10993-5 and -<br>10 | Identical |
| Compliance with 21 CFR 898? | | Yes | Yes | Identical |
| Weight (g) | | 62 g | 36 g | None, all devices are<br>of hand-held weight |
| Dimensions (mm) (W x H x D) | | 2 units, each<br>54 x 54 x14 | 55 x 55 x 18 | None, all devices are<br>of hand-held size |
| Housing Materials and<br>Construction | | PC/ABS plastic | PC/ABS plastic | Identical |

Table 3: Output Specification for TENS Mode Comparison Table

| Parameter | Primary Predicate<br>Philips Consumer<br>Lifestyle<br>PulseRelief<br>(K151035) | Livia | Significant<br>Differences | |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform (e.g., pulsed | Biphasic,<br>Symmetrical | Biphasic,<br>Symmetrical | Identical | |
| monophasic, | | | | |
| biphasic) | | | | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Identical | |
| Maximum Output Voltage | 50V @ 500Ω | 50V @ 500Ω | Identical to the reference | |
| (volts) | | | predicate NeuroMetrix | |
| (+/-10%) | 100V @ 2kΩ | 64V @ 2kΩ | Similar to both devices and within | |
| | | | | their range |
| | | 100V @ 10kΩ | 64V @ 2kΩ | Similar; the maximum output<br>voltage of the Livia, although<br>slightly lower than the predicates,<br>provides the required intensity for<br>an effective treatment with lower<br>risk of discomfort to the user due<br>to high voltage |
| Maximum Output Current<br>(mA)<br>(+/-10%) | | 100mA @ 500Ω | 50 mA @ 500Ω | Similar to both devices and within<br>their range<br>The Livia was designed to supply<br>the minimum required output for<br>providing an effective treatment.<br>This in fact lowers the risk to the<br>patient |
| | | 50mA @ 2kΩ | 31mA @ 2kΩ | The Livia was designed to supply<br>the minimum required output for<br>providing an effective treatment.<br>This in fact lowers the risk to the<br>patient |
| | | 10mA @ 10kΩ | 6.4mA @ 10kΩ | The Livia was designed to supply<br>the minimum required output for<br>providing an effective treatment.<br>This in fact lowers the risk to the<br>patient |
| Duration of primary<br>(depolarizing)<br>phase (usec) | | 100 µs | 100 µs | Same as the reference predicate<br>NeuroMetrix |
| Pulse Duration (both phases)<br>(usec) | | 200µs, additional<br>30µs<br>inter-phase delay | 100 µs | Similar, within the range of the<br>predicate devices |
| Frequency (Hz) | | Random, mean<br>80Hz,<br>uniform<br>distribution<br>60-100Hz | 100 Hz | Identical to PulseRelief |
| For<br>multiphasic<br>waveforms<br>only: | Symmetrical<br>phases<br>Phase<br>Duration<br>(include units),<br>(state range, if<br>applicable),<br>(both phases,<br>if<br>asymmetrical) | Yes | Yes | Identical |
| | | 100µs (each<br>phase) | 100 µs | Identical to the reference<br>predicate NeuroMetrix |
| Net Charge (microcoulombs<br>(µC) | | Nominally 0uC<br>@ 500Ω | 0uC<br>@ 500Ω | Identical to PulseRelief |
| per pulse) (If zero, state how<br>this<br>was achieved) | zero net current | | | |
| Maximum Phase Charge, (µC) | 10 µC @<br>500Ω | 6.4 µC @<br>500Ω | Similar and within the range of<br>PulseRelief | |
| Maximum Current Density,<br>(mA/cm2, r.m.s.) | 0.51 mA/cm2<br>@ 500Ω | 0.38<br>mA/cm2<br>@500Ω | The minor differences are<br>resulting from the minor spec<br>difference as well as the<br>difference in electrode area. | |
| Maximum Average Current<br>(average absolute value), mA | 1.6 mA @ 500Ω | 1.19 mA @<br>500Ω | Similar PulseRelief | |
| Maximum Average Power<br>Density,<br>(W/cm2), (using smallest<br>conductive<br>surface area) | 3.6 mW/cm2 @<br>500Ω | 2.05<br>mW/cm2<br>@500Ω | Similar PulseRelief | |
| NBurst<br>Mode;<br>(i.e., pulse<br>trains) | (a) Pulses per<br>N/A | N/A | N/A | N/A |
| | (b) Bursts per<br>second | N/A | N/A | N/A |
| | (c) Burst<br>duration<br>(seconds) | N/A | N/A | N/A |
| | (d) Duty Cycle:<br>Line (b) x Line<br>(c) | N/A | N/A | N/A |

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The candidate device is similar or very close to the predicate devices in its all major claims. The minor differences between predicate and candidate device do not affect the safety and effectiveness.

#### 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical verification testing of the LIVIA device included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The LIVIA device was designed, verified, and validated according to the company's Design Control process and has been

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subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

### Safety :

- IEC 60601-1:2005/A1:202, EN 60601-1:2006/A1:2013
- EN 60601-2-10:2012/A1:2012
- IEC 60601-1-11:2015

## EMC:

- IEC 60601-1-2:2007
## Software:

- IEC 62304:2006
Biocompatibility:

- ロ ISO 10993-5:2009
- ISO 10993-10:2010

## Usability Study:

- ロ IEC 62366-1: 2015
The Livia device and its accompanying documentation, i.e., the IFU have met all usability specifications that were defined. No user errors or near errors were observed.

#### 9. Discussion of Clinical Tests Performed:

Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices.

#### 10. Conclusions:

Livia is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principal used, to the predicate devices.