LIVIA

K183110 · Lifecare , Ltd. · NUH · May 4, 2020 · Neurology

Device Facts

• Record ID: K183110
• Device Name: LIVIA
• Applicant: Lifecare , Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 4, 2020
• 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 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. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Device Story

Livia is a TENS device for pain management. It delivers high-frequency, continuous, mild electrical pulses through skin-applied electrodes to peripheral nerves; pulses block pain signals to the brain. Low-frequency bursts stimulate natural pain control (beta-endorphins). Device is used by patients in home or daily settings. Output is controlled via microprocessor; device features include on/off status, low battery, and intensity level indicators. Patients use the device to achieve pain relief, potentially reducing reliance on oral pain medication. The device is identical to the predicate (K163153) in technology and operation, with the addition of dysmenorrhea to the indications.

Clinical Evidence

Randomized, controlled, multi-center, crossover, double-blind clinical study (n=65) comparing Livia to a sham device for primary dysmenorrhea. Primary endpoint: pain reduction via Visual Analogue Scale (VAS). Results: Livia reduced VAS by 28.1 points vs. 17.6 points for sham (p<0.0001). Quality of Life (QoL) scores improved in both groups compared to baseline. No technical problems reported.

Technological Characteristics

TENS device; 3.7V rechargeable Li-ion battery; PC/ABS plastic housing. Dimensions: 55x55x18mm; Weight: 36g. Waveform: Symmetrical biphasic rectangular. Frequency: 100Hz. Pulse duration: 100µs. Microprocessor-controlled output; automatic overload/no-load trip. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5/10.

Indications for Use

Indicated for adult patients experiencing chronic pain, muscle soreness/aching in shoulder, waist, back, neck, arms, or legs due to exercise or household strain, and dysmenorrhea (menstrual cramps). Applied to normal, healthy, dry, clean skin.

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

• LIVIA (K163153)

Submission Summary (Full Text)

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May 4, 2020

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

Re: K183110

Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: June 11, 2019 Received: March 3, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Vivek J. Pinto -S

Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K183110

Device Name Livia

## Indications for Use (Describe)

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, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

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

| | Registration Use (Part 1 CFR 221 Subpart B) |
|--|-----------------------------------------------------|
| | Service-Type Contracting (Part 1 CFR 221 Subpart C) |

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Section 5: 510(K) SUMMARY

The assigned 510(K) Number: K183110

#### 1. Submitter's Identification:

LifeCare Ltd.

Zipori St.2 1424602, Tiberias, Israel

Date Summary Prepared: May 1, 2020

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 21 CFR Part 882.5890 Requlation: Product Code: NUH

#### 4. Predicate Device Information:

LIVIA K163153

#### 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 patient get relief. Low frequency bursts

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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.

#### 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. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.

#### 7. Comparison to Predicate Devices:

The Livia proposed device technological characteristics are identical to Livia K163153. The indications for use are the same except that the Indications for Use of the proposed device includes dysmenorrhea (menstrual cramps) as a kind of pain which may be treated by the device. In the User Manual of the predicate device, menstrual cramps are included as an appropriate use of the device, along with illustrations of electrode placement for such use. The purpose of the instant 510K is to include menstrual pain in the types of pain included in the Indications for Use, for the education of the consumer who may be searching for a product which is appropriate for that use, before or at the point of sale. While the predicate device already contains menstrual pain as a use of the device, LifeCare has conducted a clinical trial designed to show efficacy and safety in that indication. The report of this trial is included in this application. 020_Performance Testing-Clinical.

## TABLE 1: Indication For Use Comparison Table

| Parameter | Proposed Device | Predicate Device |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | LIVIA |
| Indication<br>For Use | The Livia is designed for<br>symptomatic relief and<br>management of chronic pain,<br>and for temporary relief of<br>pain associated with sore and | The Livia is designed for<br>symptomatic relief and<br>management of chronic pain,<br>and for temporary relief of pain<br>associated with sore and aching |

Comparison Tables - Technological Characteristics

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| | aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm) and<br>lower (extremities) leg due to<br>strain from exercise or normal<br>household work activities and<br>for temporary relief of pain<br>associated with<br>dysmenorrhea (menstrual<br>cramps).<br>It should be applied to normal,<br>healthy, dry and clean skin of<br>adult patients, and is to be<br>used for stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance. | muscles in the shoulder, waist,<br>back, neck, upper extremities<br>(arm) and lower (extremities)<br>leg due to strain from exercise<br>or normal household workIt should be applied to normal,<br>healthy, dry and clean skin of<br>adult patients, and is to be used<br>for stimulate healthy muscles in<br>order to improve and facilitate<br>muscle performance. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | II | II |
| Product<br>Code | NUH | NUH |
| Regulation<br>Number | 21 CFR 882.5890 | 21 CFR 882.5890 |

# Table 2: Basic Unit Characteristics Comparison Table

| Parameter | Proposed | Predicate - | Significant |
|----------------------------------|----------------|----------------|-------------|
| | Device | Livia | Differences |
| 510(k) Number | | K163153 | N/A |
| Device Name and Model Number | LIVIA | LIVIA | N/A |
| Manufacturer | Life Care Ltd | Life Care Ltd | N/A |
| Power Source(s) | 3.7V Lithium- | 3.7V Lithium- | ldentical |
| | ion battery | ion battery | |
| | (rechargeable) | (rechargeable) | |
| Method of Line Current Isolation | Output is | Output is | ldentical |
| | electrically | electrically | |
| | disabled when | disabled when | |
| | connect to | connect to | |
| | charger, by | charger, by | |

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| | | means of<br>microprocessor<br>charging circuit | means of<br>microprocessor<br>charging circuit | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| Patient Leakage Current<br>- Normal Condition (μΑ) | | Battery<br>powered<br>(< 10μA) | Battery<br>powered<br>(< 10μA) | Identical | |
| Patient Leakage Current<br>- Single Fault Condition (μΑ) | | Battery<br>powered<br>(< 50μA) | Battery<br>powered<br>(< 50μA) | Identical | |
| | Average DC current through<br>Electrodes when device is on but<br>no pulses<br>are being applied (µA) | 0 μΑ | 0 µA | Identical | |
| | Number of Output Modes | 1 | 1 | Identical | |
| | Number of<br>Output<br>Channels: | Synchronous or<br>Alternating<br>Method of Channel<br>Isolation | 1 | 1 | Identical |
| | | N/A | N/A | Identical | |
| | | Regulated Current or Regulated<br>Voltage | Current | Current | Identical |
| | | 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<br>Low Battery<br>Voltage/Current<br>Level | Yes | Yes | Identical |
| | | Yes | Yes | Identical | |
| | Timer Range (minutes) | The Livia has<br>no internal<br>timer, a minor<br>difference, as<br>there is no<br>treatment time<br>limitation for<br>using the<br>Livia—see<br>Instructions for<br>Use. | The Livia has<br>no internal<br>timer, a minor<br>difference, as<br>there is no<br>treatment time<br>limitation for<br>using the<br>Livia—see<br>Instructions for<br>Use. | Identical | |
| | Compliance with Voluntary<br>Standards? | IEC 60601-1,<br>IEC<br>60601-1-2, IEC<br>60601-2-10,<br>ISO | IEC 60601-1,<br>IEC 60601-1-2<br>IEC 60601-1-<br>11<br>IEC 60601-2- | Identical | |

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| | 10993-5 and -<br>10 | 10,<br>ISO 10993-5<br>and -10 | |
|---------------------------------------|---------------------|-------------------------------|-----------|
| Compliance with 21 CFR 898? | Yes | Yes | Identical |
| Weight (g) | 36g | 36 g | Identical |
| Dimensions (mm) (W x H x D) | 55 x 55 x 18 | 55 x 55 x 18 | Identical |
| Housing Materials and<br>Construction | PC/ABS plastic | PC/ABS plastic | Identical |

Table 3: Output Specification for TENS Mode Comparison Table

| Parameter | Proposed Device | Predicate - Livia | Significant Differences | |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----|
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic, Symmetrical | Biphasic, Symmetrical | Identical | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Identical | |
| Maximum Output Voltage (volts) (+/-10%) | 50V @ 500Ω<br>64V @ 2kΩ<br>64V @ 2kΩ | 50V @ 500Ω<br>64V @ 2kΩ<br>64V @ 2kΩ | Identical | |
| Maximum Output Current (mA) (+/-10%) | 50 mA @ 500Ω<br>31mA @ 2kΩ<br>6.4mA @ 10kΩ | 50 mA @ 500Ω<br>31mA @ 2kΩ<br>6.4mA @ 10kΩ | Identical | |
| Duration of primary (depolarizing) phase (usec) | 100 µs | 100 µs | Identical | |
| Pulse Duration (both phases) (usec) | 100 µs | 100 µs | Identical | |
| Frequency (Hz) | 100 Hz | 100 Hz | Identical | |
| For multiphasic waveforms only: | Symmetrical phases<br>Yes<br>Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical)<br>100µs | Symmetrical phases<br>Yes<br>Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical)<br>100µs | Identical | |
| Net Charge (microcoulombs (µC) per pulse) (If zero, state how this was achieved) | 0uC @ 500Ω | 0uC @ 500Ω | Identical | |
| Maximum Phase Charge, (µC) | 6.4 µC @ 500Ω | 6.4 µC @ 500Ω | Identical | |
| Maximum Current Density, (mA/cm2, r.m.s.) | 0.38 mA/cm2 @500Ω | 0.38 mA/cm2 @500Ω | Identical | |
| Maximum Average Current (average absolute value), mA | 1.19 mW/cm2 @500Ω | 1.19 mW/cm2 @500Ω | Identical | |
| Maximum Average Power Density, (W/cm2), (using smallest conductive | 2.05 mW/cm2 @500Ω | 2.05 mW/cm2 @500Ω | Identical | |
| surface area) | | | | |
| NBurst 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 only difference between the candidate and predicate devices is the addition of dysmenorrhea to the list of the examples of pain relieved and managed by the device. Otherwise, the candidate device is the same as the predicate devices in its major claims. The 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:

Not Applicable.

The proposed device is the same as the predicate device. Accordingly, no additional Non-Clinical tests are needed for the proposed device.

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

A clinical study was performed to assess the efficacy of the Livia device in treating dysmenorrhea. The study, entitled "A Randomized, Controlled, Multi-Center, Crossover, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering from Primary Dysmenorrhea," was a randomized, controlled, multi-center, crossover, doubleblind clinical study assessing the Livia® device in women suffering from primary dysmenorrhea. The study, conducted at four study sites, compared results from the Livia to a sham device. The trial evaluated the safety and efficacy of Livia vs. Sham using 65 Participants at 4 different sites.

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Subjects in the study experienced a decline in pain as assessed by the Visual Analogue Scale (VAS).

The use of Livia succeeded in reducing the VAS score by an average of 28.1 points. The use of the Sham device reduced the VAS score by 17.6 points.

A statistically significant difference between Livia and the Sham device was observed (P<0.0001).

Most subjects used pain relief pills in all treatment sequences. The QoL score was higher in both sequence treatment groups compared to Baseline. The improvement in QoL was higher in sequence A (first Livia, then sham) compared to sequence B (first sham, then Livia).

Usability of the device received good scores by users and no technical problems were detected.

#### 10. Conclusions:

LifeCare considers Livia to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.