Liba3 System

K182532 · National Cardiac, Inc. · DSI · May 15, 2019 · Cardiovascular

Device Facts

• Record ID: K182532
• Device Name: Liba3 System
• Applicant: National Cardiac, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: May 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Liba3™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as: Atrial Fibrillation Bradycardia Tachycardia Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Liba3™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. Liba3™ is intended to be used with adult patients 22 years and older, but not designed for pediative patients.

Device Story

Liba3 System: wearable, wireless ambulatory cardiac monitor. Input: single-lead ECG data collected via disposable sensor worn on precordium (up to 7.5 days). Operation: sensor records ECG; optional transmitter sends data to Remote Data Management System (RDMS) server. Output: ECG data for physician/technologist analysis/reporting. Used in home, clinic, or research settings. Patient triggers events via accelerometer (double-tap). Healthcare providers use RDMS to interpret results, aiding arrhythmia diagnosis and clinical decision-making. Benefits: continuous monitoring for intermittent symptoms.

Clinical Evidence

Bench testing only. Verification activities included ECG analysis performance validation against recognized databases, software validation, sensor firmware verification, and data integrity/cybersecurity testing. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, and ISO 10993 standards demonstrated.

Technological Characteristics

Wearable single-lead ECG sensor; disposable with hydrogel electrodes. Dimensions: 35mm x 88mm x 7mm. Connectivity: Bluetooth Low Energy (BLE) and cellular. Power: non-rechargeable coin cell (7.5-day life). IP64 water resistance. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ISO 10993-5/10, IEC 62304. Sampling rate: 250Hz; 24-bit A/D resolution.

Indications for Use

Indicated for adult patients 22 years and older with known non-lethal arrhythmias (Atrial Fibrillation, Bradycardia, Tachycardia, Pause) requiring ambulatory cardiac monitoring. Not for pediatric use.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• NowCardio System (K162956)

Submission Summary (Full Text)

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National Cardiac. Inc. % Don Canal Consultant 510k Medical, Inc. 1200 Post Oak Trail Southlake, Texas 76092

Re: K182532

Trade/Device Name: Liba3 System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: DSI, MHX Dated: April 16, 2019 Received: April 18, 2019

Dear Don Canal:

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 senclosure) 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K182532

Device Name Liba3IM System

Indications for Use (Describe)

The Liba3 ™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:

- · Atrial Fibrillation
- · Bradycardia
- · Tachycardia

· Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Liba3™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting.

Liba3™ is intended to be used with adult patients 22 years and older, but not designed for pediative patients.

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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FORM FDA 3881 (7/17)

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Image /page/3/Picture/1 description: The image shows the logo for National Cardiac. The logo has a series of overlapping circles in the colors teal, purple, green, and white. To the right of the circles is the text "NATIONAL CARDIAC" in a sans-serif font. The word "NATIONAL" is above the word "CARDIAC".

# 510(k) SUMMARY

#### A. Sponsor

National Cardiac, Inc. 221 W. Crest Street, Suite 205 Escondido, CA 92025

| Contact Person: | Don Canal (Consultant) |
|------------------------|------------------------|
| Contact Phone: | 972-955-7644 |
| Contact Email Address: | [e-mail] |

Date Prepared: September 9, 2018

#### Device Name B.

Trade Name: Liba3 System

| Classification Regulation: | 21 CFR 870.1025 |
|----------------------------|-----------------------------------------------------------------|
| Regulation Name: | Arrythmia Detector and Alarm (Including ST-Segment Measurement) |
| Regulatory Class: | Class II, Special Controls |
| Product Code: | MHX, DSI |

### Predicate/ Reference Devices C.

The Subject Device is a modification to the Context International Technologies, Inc. NowCardio™ System, cleared under K162956.

#### D. Intended Use / Indications for Use

The Liba3™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:

- Atrial Fibrillation
- Bradycardia
- Tachycardia
- · Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Liba3TM will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG

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data are available to HealthCare Providers for analysis and reporting. Liba3™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

#### E. Device Description

The Liba3™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of time. Each Sensor can be worn for up to 7.5 days. If the prescribed monitoring period exceeds 7.5 days. National Cardiac. Inc. will provide additional sensors. For a 30-day monitoring period, the patient would be required to use four (4) Sensor components. The Liba3 System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data.

The Liba3 system consists of: (1) a wearable electronic component that collects and monitors a patient's single lead ECG data referred to as a Liba3TM Sensor; (2) an optional transmitting device, referred to as the Liba3 transmitting device, that is used for ECG data transmission while the patient is wearing the sensor and for transmission of patient triggered events; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test.

#### F. Technological Characteristics

The following table contains a comparison of characteristics and specifications for the Subject Device and the predicate devices that are cleared under the same regulation number for the same indications for use.

| Comparison<br>Characteristic | Liba3 System (Subject<br>Device) | Previously Cleared Device,<br>NowCardio System<br>(K162956) |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Liba3™ System is an<br>ambulatory cardiac<br>monitoring system<br>prescribed by a physician or<br>other qualified healthcare<br>professional for out-patient<br>individuals with known<br>non-lethal arrhythmias such<br>as:<br>• Atrial Fibrillation<br>• Bradycardia<br>• Tachycardia | The NowCardio System is<br>an ambulatory cardiac<br>monitoring system<br>prescribed by a physician or<br>other qualified healthcare<br>professional for out-patient<br>individuals with known non-<br>lethal arrhythmias such as:<br>• Atrial Fibrillation<br>• Bradycardia<br>• Tachycardia<br>• Pause |
| Comparison<br>Characteristic | Liba3 System (Subject<br>Device) | Previously Cleared Device,<br>NowCardio System<br>(K162956) |
| | It continuously monitors, records, and stores<br>electrocardiographic (ECG) data. If equipped with a<br>transmitter, the Liba3 TM will<br>also periodically transmit ECG Cardiac Event to a<br>remote computer server.<br>Both recorded and<br>transmitted ECG data are available to HealthCare<br>Providers for analysis and reporting. Liba3TM is<br>intended to be used with adult patients 22 years and<br>older, but not designed for pediatric patients. | records, and stores<br>electrocardiographic (ECG)<br>data. If equipped with a<br>transmitter, the NowCardio<br>will also periodically<br>transmit ECG Cardiac Event<br>to a remote computer server.<br>Both recorded and<br>transmitted ECG data are<br>available to HealthCare<br>Providers for analysis and<br>reporting. NowCardio is<br>intended to be used with<br>adult patients 22 years and<br>older, but not designed for<br>pediatric patients. |
| FDA classification | Class II | Class II |
| Product<br>Code/classification<br>/common name | 21 CFR 870.1025<br>Patient Physiological<br>monitor (with Arrythmia<br>detection)<br>Arrythmia Detection and<br>Alarm | 21 CFR 870.1025<br>Patient Physiological<br>monitor (with Arrythmia<br>detection)<br>Arrythmia Detection and<br>Alarm |
| User event trigger | Yes | Yes |
| Environment of<br>use | Home Use, Physician<br>practices, clinics, research<br>institutions | Home Use, Physician<br>practices, clinics, research<br>institutions |
| Prescription use | Yes | Yes |
| Physician access to<br>patient<br>physiological and<br>event information | Yes | Yes |
| Arrythmia<br>detection<br>algorithm | Proprietary / Server side | Proprietary / Server side |
| Safety standards | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 |
| Comparison<br>Characteristic | Liba3 System (Subject<br>Device) | Previously Cleared Device,<br>NowCardio System<br>(K162956) |
| | IEC 60601-1-11 | IEC 60601-1-11 |
| | IEC 60601-2-47 | IEC 60601-2-47 |
| | IEC 62366 | IEC 62366 |
| Intended use<br>patient population | Liba3 System is intended<br>for use by individuals who<br>are at risk of having cardiac<br>disease and have<br>intermittent symptoms<br>indicative of cardiac<br>disease. Adults 22 years or<br>older. | NowCardio System is<br>intended for use by<br>individuals who are at risk<br>of having cardiac disease<br>and have intermittent<br>symptoms indicative of<br>cardiac disease. Adults 22<br>years or older |
| Preliminary data<br>processing | Certified Technician,<br>Remote Monitoring Data<br>Center | Certified Technician,<br>Remote Monitoring Data<br>Center |
| Placement of<br>sensor | Precordium | Precordium |
| Type of<br>electrode/patch | Custom cutaneous<br>electrodes integral with<br>Liba3 Sensor. | Custom cutaneous<br>electrodes for use with<br>NowCardio Sensor. |
| Conductive gel | Hydrogel | Hydrogel |
| Sterility | Not Sterile | Not Sterile |
| Patient contact<br>materials | Hydro Gel electrode.<br>Electrodes have a pressure<br>sensitive adhesive that<br>enables the electrodes to be<br>applied to the patient's skin. | Hydro Gel electrode.<br>Electrodes have a pressure<br>sensitive adhesive that<br>enables the electrodes to be<br>applied to the patient's skin. |
| Interface<br>connection for<br>data transmission | Bluetooth Low Energy<br>(BLE) | Bluetooth or USB |
| Battery | Non-rechargeable coin cell.<br>(disposable sensor) 7.5 day<br>battery life | Rechargeable 48 hour<br>battery life for sensor,<br>transmitter 24 hour |
| Water resistant | Yes IP64 | Yes IP24 |
| Electrode shelf life | 6 months | 1 year |
| Dimensions | 35mm width X 88mm<br>length X 7mm height | 54.6 mm width x 75.3mm x<br>11.9mm height |
| Associated | Sensor, Wireless | Sensor, wireless transmitter, |
| Comparison<br>Characteristic | Liba3 System (Subject<br>Device) | Previously Cleared Device,<br>NowCardio System<br>(K162956) |
| Components | transmitter, ECG Analysis<br>SW | battery charger, ECG<br>analysis SW |
| Software features | Software will be provided to<br>allow Physicians and<br>Cardiology Technologist's<br>to receive, analyze,<br>interpret, and report on the<br>results of the ECG test | Software will be provided to<br>allow Physicians and<br>Cardiology Technologist's<br>to receive, analyze,<br>interpret, and report on the<br>results of the ECG test |
| Hardware features | Disposable sensor module<br>with integral adhesive<br>electrodes, accelerometer to<br>record patient triggered<br>events, LED indicator | Sensor module, adhesive<br>electrodes, Wireless<br>transmitter, battery charger,<br>charging cradle, Trigger<br>alarm, LED indicator |
| Data Transmission<br>methods | Bluetooth LE and cellular<br>direct wired connection (for<br>depot use only) | Bluetooth and cellular |
| Data storage<br>capacity – sensor | 7.5 days | 32 days |
| Heart rate<br>measurement<br>range | 10-250 Beats/min | 10-250 Beats/min |
| ECG sampling<br>rate | 250Hz | 250 Hz |
| A/D resolution | 24 bit | 12 bit |
| Visual indicator<br>LEDs | Yes | Yes |
| Auditory<br>indicators | No | Yes |
| Patient symptom<br>trigger | Accelerometer/Double tap | Push button |

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## G. Non-Clinical Performance Data

National Cardiac, Inc. has declared conformance to their design controls and has conducted the appropriate risk management activities to ensure that there are no

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new issues of safety and effectiveness associated with the Subject Device when compared to the predicate device. Complete design verification activities which included verification of all design input requirements and ECG Analysis performance vs. recognized Databases, ECG analysis software validation, Sensor firmware verification, data integrity/cyber security, and testing was also completed to demonstrate compliance with FDA recognized industry standards as described in below.

#### H. Compliance with Standards

The Subject Device complies with the following standards:

- FDA Recognition Number 3-52, AAMI/ANSI EC-12:2000/(R)2012 Disposable ECG electrodes.
- FDA Recognition Number 3-127, ANSI AAMI IEC 60601-2-47:2012 (Second ● Edition) Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- . FDA Recognition Number 2-245, ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- . FDA Recognition Number 2-174, ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- FDA Recognition Number 19-4, ANSI AAMI ES60601-1:2005 (Third Edition)+CORR. 1:2006 + CORR. 2:2007+A1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- FDA Recognition Number 19-8, IEC 60601-1-2 Edition 4.0 2014-02 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- FDA Recognition Number 19-14, ANSI AAMI IEC 60601-1-11:2015 (second 0 Edition) General Requirements for basic Safety and essential performancecollateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- FDA Recognition Number 5-40, ISO14971:2007/(R)2010 medical devices -● Application of Risk Management to Medical Devices.
- FDA Recognition number 13-79, IEC 62304 Edition 1.1 2015-06 Medical Device Software - Software Life Cycle Processes
- ISO 13485 Medical devices Quality management systems Requirements for ● regulatory purposes

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#### l. Substantial Equivalence

The National Cardiac Liba3 System has the same intended use/indications for use, and the same technological characteristics and principles of operation. There are minor technological/design differences that do not raise any new issues of safety or effectiveness. Based on the test results, compliance with FDA recognized industry standards, and the analysis provided in this Notice, National Cardiac, Inc. concludes that the Subject Device is substantially equivalent to the NowCardio predicate device cleared under K162956.