(243 days)
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.
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.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria for device performance and the specific study that proves the device meets those criteria, particularly in the context of an AI-powered medical device and the requested elements:
- A table of acceptance criteria and reported device performance: This is not present, nor are specific performance metrics related to AI algorithm accuracy provided. The document focuses on regulatory compliance and substantial equivalence to a predicate device.
- Sample size and data provenance for the test set: There is no mention of a test set, its size, or the origin of the data.
- Number and qualifications of experts for ground truth: No information is provided about expert involvement in establishing ground truth for a test set.
- Adjudication method: Not discussed.
- MRMC comparative effectiveness study: There is no mention of a multi-reader multi-case study or the effect size of AI assistance on human readers. The document primarily concerns the device as an ambulatory cardiac monitoring system, not specifically an AI-assisted diagnostic tool in the typical sense of imaging AI.
- Standalone algorithm performance: While the device has an "Arrythmia detection algorithm (Proprietary / Server side)", there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) provided for this algorithm in a standalone capacity.
- Type of ground truth: Not specified for any performance evaluation.
- Sample size for training set: No information is provided about a training set or its size.
- How ground truth for training set was established: Not discussed.
The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device (NowCardio™ System). It highlights technological characteristics, compliance with various medical device standards (e.g., electrical safety, biocompatibility, risk management, software life cycle), and general design verification activities. However, it does not provide the specific performance study details, acceptance criteria, and ground truth methodologies typically expected for a detailed AI device performance evaluation.
The closest relevant statement is under "G. Non-Clinical Performance Data," which mentions "complete design verification activities which included verification of all design input requirements and ECG Analysis performance vs. recognized Databases, ECG analysis software validation". However, it does not elaborate on what these "recognized Databases" are, the specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection), the acceptance criteria for these metrics, or the methodologies used to establish ground truth within those databases.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study as outlined in your prompt based on the provided text.
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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.
| ComparisonCharacteristic | Liba3 System (SubjectDevice) | Previously Cleared Device,NowCardio System(K162956) |
|---|---|---|
| Indications for use | The Liba3™ System is anambulatory cardiacmonitoring systemprescribed by a physician orother qualified healthcareprofessional for out-patientindividuals with knownnon-lethal arrhythmias suchas:• Atrial Fibrillation• Bradycardia• Tachycardia | The NowCardio System isan ambulatory cardiacmonitoring systemprescribed by a physician orother qualified healthcareprofessional for out-patientindividuals with known non-lethal arrhythmias such as:• Atrial Fibrillation• Bradycardia• Tachycardia• Pause |
| ComparisonCharacteristic | Liba3 System (SubjectDevice) | Previously Cleared Device,NowCardio System(K162956) |
| It continuously monitors, records, and storeselectrocardiographic (ECG) data. If equipped with atransmitter, the Liba3 TM willalso periodically transmit ECG Cardiac Event to aremote computer server.Both recorded andtransmitted ECG data are available to HealthCareProviders for analysis and reporting. Liba3TM isintended to be used with adult patients 22 years andolder, but not designed for pediatric patients. | records, and storeselectrocardiographic (ECG)data. If equipped with atransmitter, the NowCardiowill also periodicallytransmit ECG Cardiac Eventto a remote computer server.Both recorded andtransmitted ECG data areavailable to HealthCareProviders for analysis andreporting. NowCardio isintended to be used withadult patients 22 years andolder, but not designed forpediatric patients. | |
| FDA classification | Class II | Class II |
| ProductCode/classification/common name | 21 CFR 870.1025Patient Physiologicalmonitor (with Arrythmiadetection)Arrythmia Detection andAlarm | 21 CFR 870.1025Patient Physiologicalmonitor (with Arrythmiadetection)Arrythmia Detection andAlarm |
| User event trigger | Yes | Yes |
| Environment ofuse | Home Use, Physicianpractices, clinics, researchinstitutions | Home Use, Physicianpractices, clinics, researchinstitutions |
| Prescription use | Yes | Yes |
| Physician access topatientphysiological andevent information | Yes | Yes |
| Arrythmiadetectionalgorithm | Proprietary / Server side | Proprietary / Server side |
| Safety standards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 |
| ComparisonCharacteristic | Liba3 System (SubjectDevice) | 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 usepatient population | Liba3 System is intendedfor use by individuals whoare at risk of having cardiacdisease and haveintermittent symptomsindicative of cardiacdisease. Adults 22 years orolder. | NowCardio System isintended for use byindividuals who are at riskof having cardiac diseaseand have intermittentsymptoms indicative ofcardiac disease. Adults 22years or older |
| Preliminary dataprocessing | Certified Technician,Remote Monitoring DataCenter | Certified Technician,Remote Monitoring DataCenter |
| Placement ofsensor | Precordium | Precordium |
| Type ofelectrode/patch | Custom cutaneouselectrodes integral withLiba3 Sensor. | Custom cutaneouselectrodes for use withNowCardio Sensor. |
| Conductive gel | Hydrogel | Hydrogel |
| Sterility | Not Sterile | Not Sterile |
| Patient contactmaterials | Hydro Gel electrode.Electrodes have a pressuresensitive adhesive thatenables the electrodes to beapplied to the patient's skin. | Hydro Gel electrode.Electrodes have a pressuresensitive adhesive thatenables the electrodes to beapplied to the patient's skin. |
| Interfaceconnection fordata transmission | Bluetooth Low Energy(BLE) | Bluetooth or USB |
| Battery | Non-rechargeable coin cell.(disposable sensor) 7.5 daybattery life | Rechargeable 48 hourbattery life for sensor,transmitter 24 hour |
| Water resistant | Yes IP64 | Yes IP24 |
| Electrode shelf life | 6 months | 1 year |
| Dimensions | 35mm width X 88mmlength X 7mm height | 54.6 mm width x 75.3mm x11.9mm height |
| Associated | Sensor, Wireless | Sensor, wireless transmitter, |
| ComparisonCharacteristic | Liba3 System (SubjectDevice) | Previously Cleared Device,NowCardio System(K162956) |
| Components | transmitter, ECG AnalysisSW | battery charger, ECGanalysis SW |
| Software features | Software will be provided toallow Physicians andCardiology Technologist'sto receive, analyze,interpret, and report on theresults of the ECG test | Software will be provided toallow Physicians andCardiology Technologist'sto receive, analyze,interpret, and report on theresults of the ECG test |
| Hardware features | Disposable sensor modulewith integral adhesiveelectrodes, accelerometer torecord patient triggeredevents, LED indicator | Sensor module, adhesiveelectrodes, Wirelesstransmitter, battery charger,charging cradle, Triggeralarm, LED indicator |
| Data Transmissionmethods | Bluetooth LE and cellulardirect wired connection (fordepot use only) | Bluetooth and cellular |
| Data storagecapacity – sensor | 7.5 days | 32 days |
| Heart ratemeasurementrange | 10-250 Beats/min | 10-250 Beats/min |
| ECG samplingrate | 250Hz | 250 Hz |
| A/D resolution | 24 bit | 12 bit |
| Visual indicatorLEDs | Yes | Yes |
| Auditoryindicators | No | Yes |
| Patient symptomtrigger | 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.
§ 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.