(230 days)
K10433
No
The description focuses on the electrotherapy mechanism of TENS and does not mention any AI or ML components. The testing described is standard for medical devices and does not indicate AI/ML training or validation.
Yes.
The device is intended for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles. It also stimulates healthy muscles to improve performance, all of which are therapeutic indications.
No
The Livia device is a TENS unit designed for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly states that the LIVIA is a TENS device that sends electrical pulses into the body through electrodes, indicating it is a hardware device with electrical components, not solely software. The testing also includes electrical and mechanical tests, further confirming it is not software-only.
Based on the provided information, the Livia device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to diagnose, monitor, or screen for diseases or conditions.
- The Livia device is a TENS device. It works by applying electrical stimulation to the skin to alleviate pain. It does not involve the collection or analysis of any biological specimens.
- The intended use and device description clearly state its function as a pain management system through electrotherapy. There is no mention of analyzing any bodily fluids or tissues.
Therefore, the Livia device falls under the category of a therapeutic device, specifically a Transcutaneous Electrical Nerve Stimulator (TENS), and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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
Product codes
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K10433
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
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
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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
2
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) |
|---|
| ------------------------------------------------- |
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 212-381-8774 Fax 646-536-3185 Email: iwiesen@wiesenlaw.com
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.
4
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 | ||
| Lifestyle PulseRelief | ||
| (K151035) | LIVIA | |
| Indication | ||
| For Use | The OTC TENS/EMS | |
| stimulator PulseRelief is | ||
| designed to be used 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 | 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. |
Comparison Tables - Technological Characteristics
5
| | to improve and facilitate
muscle performance. | |
|-------------------|--------------------------------------------------|----------------------------------------|
| Class | II | II |
| Product Code | NUH; NGX | NUH; NGX |
| Regulation Number | 21 CFR 882.5890(b);
21 CFR 890.5850 | 21 CFR 882.5890(b);
21 CFR 890.5850 |
Table 2: Basic Unit Characteristics Comparison Table
| Parameter | Primary Predicate
Philips Consumer
Lifestyle
PulseRelief
(K151035) | Livia | Significant
Differences | |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) Number | K151035 | K163153 | N/A | |
| Device Name and Model Number
Manufacturer | PulseRelief
Philips Consumer
Lifestyle | LIVIA
Life Care Ltd | N/A | |
| Power Source(s) | 3.7V Lithium-ion | 3.7V Lithium-ion
battery
(rechargeable) | Identical | |
| Method of Line Current Isolation | N/A | Output is
electrically
disabled when
connect to
charger, by
means of
microprocessor
charging circuit | Similar to the
reference predicate
Neurometrix
device cannot be used
while battery is
charging | |
| Patient Leakage Current
- Normal Condition (μΑ) | Battery powered
(