ZywieAI Software Library

K142693 · Zywie, Inc. · DPS · Feb 20, 2015 · Cardiovascular

Device Facts

• Record ID: K142693
• Device Name: ZywieAI Software Library
• Applicant: Zywie, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The ZywieAI Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAI Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring. Verification of the output from ZywieAI Software is the responsibility of a trained healthcare professional or physician. The ZywieAI Software Library is used for analyzing ECG data for adult patient population.

Device Story

ZywieAI Software Library is an object library (callable functions) for automated ECG analysis. It ingests historic ambulatory ECG data from Holter, Event, or MCT monitors; processes signals via API or web service; and performs beat-by-beat analysis. Outputs include QRS detection, heart rate, and various arrhythmia interpretations (e.g., PAC, tachycardia, bradycardia, flutter/fibrillation, ST changes). Used by qualified medical professionals in clinical settings to support diagnostic decision-making. Healthcare providers review software-generated annotations to confirm rhythm assessments. Benefits include efficient analysis of large ECG datasets for outpatient cardiac monitoring.

Clinical Evidence

Bench testing only. Software verification and validation performed per FDA guidance for moderate level of concern. Performance validated against standardized databases: MIT-BIH Arrhythmia Database (MITDB), MIT-BIH Noise Stress Test Database (NSTDB), QT Database (QTDB), and European ST-T Database (ESCDB).

Technological Characteristics

Object library (compiled machine code/IDL) for integration into ECG monitoring systems. Operates via API or web service. Complies with ANSI/AAMI EC57:2012 (rhythm/ST segment algorithm testing) and IEC 62304:2006 (software lifecycle).

Indications for Use

Indicated for adult patients requiring assessment of arrhythmias using historic ambulatory ECG data, including those with symptoms like dizziness, syncope, dyspnea, palpitations, or those requiring drug monitoring, post-cardiac surgery monitoring, sleep-disordered breathing evaluation, or stroke/ischemia etiology investigation. Contraindicated for potentially life-threatening arrhythmias requiring inpatient monitoring.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Monebo Automatic ECG Analysis and Interpretation Software Library (K062282)
• IQmark Digital Holter (K031466)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

Zywie, Inc. % Jon Ward President and CEO AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, Florida 33572

Re: K142693

> Trade/Device Name: ZywieAI Software Library Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 12, 2015 Received: January 13, 2015

Dear Jon Ward,

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K142693

Device Name: ZywieAI Software Library

The ZywieAI Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAI Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls.

The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring.

Verification of the output from ZywieAI Software is the responsibility of a trained healthcare professional or physician.

The ZywieAI Software Library is used for analyzing ECG data for adult patient population.

Prescription Use X Prescription Use X

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

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# 510(k) SUMMARY (as required by 807.92)

#### I. SUBMITTER

Zywie, Inc. 12000 Findley Road, Suite 360 Johns Creek, GA 30097

Phone: [phone] Fax: [phone]

Contact Person: Latha Ganeshan Date Prepared: September 19, 2014

# REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572

Phone: [phone] Fax: [phone]

Contact Person: Jon Ward, President Email: [e-mail]

#### II. DEVICE

Name of Device: ZywieAI Software Library Common or Usual Name: Automated ECG Analysis and Interpretation Software Classification Name: Electrocardiograph Device Panel: Cardiovascular Regulatory Class: II Product Code: DPS

#### III. PREDICATE DEVICE

The ZywieAI Software Library is substantially equivalent in intended use and similar technological characteristics of Monebo Automatic ECG Analysis and Interpretation Software Library cleared as part of K062282 and the IQmark Digital Holter which was cleared under K031466.

These predicates have not been subject to a design-related recall. No reference devices were used in this submission

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#### IV. DEVICE DESCRIPTION

The ZywieAI Software Library is an "object library". An object library is a collection of callable functions that have been compiled (or assembled) into machine code or Interactive Data Language (IDL) code for the computer on which they execute.

The basic software application reads the input ECG signals from a file into computer memory and passes that data to ZywieAI Software Library for analyzing, annotating, and creating output. This output is sent back to the basic software application where the output is written to a file. The read input signal may invoke some or all of the functions in the object library. An application program could be written to write input data to a file using web services. The same or a different application program could be written to consume the output file using web services.

The ZywieAI Software Library provides ECG signal processing, ORS Detection, Nonpaced Arrhythmia Interpretation, PAC, Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV Conduction Block, ST Change Episodes detection, Non-paced Ventricular Arrhythmia calls and rhythm interpretation.

The library can be accessed through an Application Program Interface (API) as a callable function or using a web service call. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product.

Zywie will compile the ZywieAI Software Library as specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer. who can then integrate it into application software for their ECG analysis. Typically the software library is used along with ECG monitoring devices and ECG management software for patients:

- > With symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded: and c) dyspnea (shortness of breath).
- A With palpitations with or without know arrhythmias to obtain correlation of rhythm with symptoms.
- > Who require monitoring effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- A Recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
- A With diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
- A Requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
- A With co-morbid conditions such as hyperthyroidism or chronic lung disease

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#### V. INDICATIONS FOR USE

The ZywieAI Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAI Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls.

The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring.

Verification of the output from ZywieAI Software is the responsibility of a trained healthcare professional or physician.

The ZywieAI Software Library is used for analyzing ECG data for adult patient population.

#### VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The monitoring of basic physiological parameters is the technological principle for both the subject and predicate devices. At a high level, the subject and predicate devices are based on the following same technological characteristics:

# K062282 - Monebo Automated ECG Analysis and Interpretation Software

- Read raw ECG signal data and analyze
- device algorithms are proprietary software library and are server based 0

# K031466 - IQmark Digital Holter

- device algorithms are proprietary software library and are server/pc based .

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The following technological differences exist between the subject and predicate devices:

# K062282 - Monebo Automated ECG Analysis and Interpretation Software

- o Predicate device doesn't have the ST segment change detection capabilities
- . The predicate device reports "Insufficient data" for Pause, Tachycardia, and Bradycardia, whereas subject device testing was done using sufficient data from the MITDB (The MIT-BIH Arrhythmia Database), NSTDB (The MIT-BIH Noise Stress Test Database), QTDB (The QT Database -PhysioNet) & ESCDB (The European ST-T Database -PhysioNet)databases. Positive and Negative Predicative Accuracy cannot be calculated for Ventricular Flutter/Fibrillation because all records contain VF

# K031466 - IQmark Digital Holter

- . Predicate device doesn't have the ORS Detection. PAC, Tachycardia, Bradycardia Atrial and Ventricular Flutter/Fibrillation, Ventricular Tachycardia, AV Conduction Block, Non-paced Ventricular Arrhythmia calls capabilities
#### VII. PERFORMANCE DATA

The following performance date were provided in support of the substantial equivalence determination

# Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could directly result in minor injury to the patient or operator.

# Reference Standards

The ZywieAI Software Library meets the requirements of following performance standards in accordance with FDA Guidance for the content of Premarket Submission for Software Contained in Medical Devices Document for Class II Moderate Level of Concern:

- ANSI/AAMI EC57:20012 Testing and reporting performance results of ● cardiac rhythm and ST segment measurement algorithms
- IEC 62304:2006 Medical device software Software lifecvcle processes .

# VIII. CONCLUSIONS

The testing completed demonstrates that the ZywieAI Software Library exhibits comparable technical and functional characteristics to the predicate devices.

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Based on those characteristics, the ZywieAI Software Library is substantially equivalent to the predicate device in safety and effectiveness in addition to being intended for the same uses.