(243 days)
Not Found
No
The document describes a standard cardiac monitoring system with data recording, transmission, and analysis capabilities by healthcare providers. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with such technologies. The analysis is performed by qualified healthcare providers, not an automated AI/ML system.
No.
This device is for monitoring and recording cardiac data to aid in diagnosis, not for treating any medical conditions.
Yes
The device is an ambulatory cardiac monitoring system that continuously monitors, records, and stores ECG data for analysis and reporting by healthcare providers to identify non-lethal arrhythmias. This process of collecting and analyzing data to identify a medical condition is characteristic of a diagnostic device.
No
The device description explicitly states the system consists of a "wearable electronic component" (Liba3TM Sensor) and an "optional transmitting device" (Liba3 transmitting device), which are hardware components.
Based on the provided information, the Liba3™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Liba3™ Function: The Liba3™ System directly monitors and records electrical activity of the heart (ECG data) from the patient's body. It does not analyze samples taken from the body.
The Liba3™ System is a medical device used for in vivo (within the living body) monitoring of cardiac activity.
N/A
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 data are available to HealthCare Providers for analysis and reporting. Liba3TM is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.
Product codes
DSI, MHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Precordium
Indicated Patient Age Range
adult patients 22 years and older
Intended User / Care Setting
Home Use, Physician practices, clinics, research institutions / physician or other qualified healthcare professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
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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: | don@510kmedical.com |
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
Characteristic | Liba3 System (Subject
Device) | Previously Cleared Device,
NowCardio System
(K162956) |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The NowCardio 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 |
| Comparison
Characteristic | Liba3 System (Subject
Device) | Previously Cleared Device,
NowCardio System
(K162956) |
| | It continuously monitors, records, and stores
electrocardiographic (ECG) data. If equipped with a
transmitter, the Liba3 TM 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. Liba3TM is
intended to be used with adult patients 22 years and
older, but not designed for pediatric patients. | records, and stores
electrocardiographic (ECG)
data. If equipped with a
transmitter, the NowCardio
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. NowCardio is
intended to be used with
adult patients 22 years and
older, but not designed for
pediatric patients. |
| FDA classification | Class II | Class II |
| Product
Code/classification
/common name | 21 CFR 870.1025
Patient Physiological
monitor (with Arrythmia
detection)
Arrythmia Detection and
Alarm | 21 CFR 870.1025
Patient Physiological
monitor (with Arrythmia
detection)
Arrythmia Detection and
Alarm |
| User event trigger | Yes | Yes |
| Environment of
use | Home Use, Physician
practices, clinics, research
institutions | Home Use, Physician
practices, clinics, research
institutions |
| Prescription use | Yes | Yes |
| Physician access to
patient
physiological and
event information | Yes | Yes |
| Arrythmia
detection
algorithm | Proprietary / Server side | Proprietary / Server side |
| Safety standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Comparison
Characteristic | Liba3 System (Subject
Device) | Previously Cleared Device,
NowCardio System
(K162956) |
| | IEC 60601-1-11 | IEC 60601-1-11 |
| | IEC 60601-2-47 | IEC 60601-2-47 |
| | IEC 62366 | IEC 62366 |
| Intended use
patient population | Liba3 System is intended
for use by individuals who
are at risk of having cardiac
disease and have
intermittent symptoms
indicative of cardiac
disease. Adults 22 years or
older. | NowCardio System is
intended for use by
individuals who are at risk
of having cardiac disease
and have intermittent
symptoms indicative of
cardiac disease. Adults 22
years or older |
| Preliminary data
processing | Certified Technician,
Remote Monitoring Data
Center | Certified Technician,
Remote Monitoring Data
Center |
| Placement of
sensor | Precordium | Precordium |
| Type of
electrode/patch | Custom cutaneous
electrodes integral with
Liba3 Sensor. | Custom cutaneous
electrodes for use with
NowCardio Sensor. |
| Conductive gel | Hydrogel | Hydrogel |
| Sterility | Not Sterile | Not Sterile |
| Patient contact
materials | Hydro Gel electrode.
Electrodes have a pressure
sensitive adhesive that
enables the electrodes to be
applied to the patient's skin. | Hydro Gel electrode.
Electrodes have a pressure
sensitive adhesive that
enables the electrodes to be
applied to the patient's skin. |
| Interface
connection for
data transmission | Bluetooth Low Energy
(BLE) | Bluetooth or USB |
| Battery | Non-rechargeable coin cell.
(disposable sensor) 7.5 day
battery life | Rechargeable 48 hour
battery life for sensor,
transmitter 24 hour |
| Water resistant | Yes IP64 | Yes IP24 |
| Electrode shelf life | 6 months | 1 year |
| Dimensions | 35mm width X 88mm
length X 7mm height | 54.6 mm width x 75.3mm x
11.9mm height |
| Associated | Sensor, Wireless | Sensor, wireless transmitter, |
| Comparison
Characteristic | Liba3 System (Subject
Device) | Previously Cleared Device,
NowCardio System
(K162956) |
| Components | transmitter, ECG Analysis
SW | battery charger, ECG
analysis SW |
| Software features | Software will be provided to
allow Physicians and
Cardiology Technologist's
to receive, analyze,
interpret, and report on the
results of the ECG test | Software will be provided to
allow Physicians and
Cardiology Technologist's
to receive, analyze,
interpret, and report on the
results of the ECG test |
| Hardware features | Disposable sensor module
with integral adhesive
electrodes, accelerometer to
record patient triggered
events, LED indicator | Sensor module, adhesive
electrodes, Wireless
transmitter, battery charger,
charging cradle, Trigger
alarm, LED indicator |
| Data Transmission
methods | Bluetooth LE and cellular
direct wired connection (for
depot use only) | Bluetooth and cellular |
| Data storage
capacity – sensor | 7.5 days | 32 days |
| Heart rate
measurement
range | 10-250 Beats/min | 10-250 Beats/min |
| ECG sampling
rate | 250Hz | 250 Hz |
| A/D resolution | 24 bit | 12 bit |
| Visual indicator
LEDs | Yes | Yes |
| Auditory
indicators | No | Yes |
| Patient symptom
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.