MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0

K062282 · Monebo Technologies, Inc. · DPS · Mar 22, 2007 · Cardiovascular

Device Facts

• Record ID: K062282
• Device Name: MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
• Applicant: Monebo Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Automatic Analysis and Interpretation 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 Hotter, Event Monitor, 12 lead ambulatory or resting ECG devices, or other similar devices when assessment of the rhythm is necessary. The Automatic Analysis and Interpretation Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Automatic Analysis and Interpretation Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to sixteen(16) leads of captured data. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. 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.

Device Story

Monebo Automated ECG Analysis and Interpretation Software Library (v3.0) is an object library (callable functions) integrated into ECG management software or ECG devices. Input: captured ECG data (up to 16 leads). Processing: signal processing, QRS detection, feature extraction, interval measurement (PR, QT), heart rate calculation, and rhythm classification. Output: annotated ECG analysis and interpretation. Used by trained medical professionals to review data and render diagnostic/treatment decisions. Benefits: assists clinicians in identifying arrhythmias from historic ambulatory recordings. Not for real-time monitoring or life-support.

Clinical Evidence

Bench testing only. Performance validated using AHA, MIT-BIH, and CSE databases per ANSI/AAMI EC 57 and IEC 60601-2-51. Results: QRS sensitivity 99.45-99.56%, VEB sensitivity 81.79-87.03%. Arrhythmia detection sensitivity 96%, specificity 97%. Overall rhythm classification performance: 90.23% sensitivity, 96.42% specificity, 82.19% positive predictivity.

Technological Characteristics

Object library (callable functions) compiled into machine/IDL code. Operates on Microsoft .Net framework. Provides signal processing, QRS detection, feature extraction, and rhythm analysis for up to 16 leads. Software-only device; no physical materials. Algorithm class: automated signal processing and classification.

Indications for Use

Indicated for use by qualified medical professionals for assessment of arrhythmias in adult patients using historic ambulatory ECG data from Holter, event monitors, 12-lead ambulatory, or resting ECG devices. Not for use in life-supporting/sustaining systems or real-time monitoring/alarm devices.

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 Arrhythmia Detection Software Library (K043380)
• Agilent (K003621)
• Brentwood (K013717)

Submission Summary (Full Text)

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K0622282
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#### 510(k) Summary of Safety and Effectiveness

510(k) Notification Date: August 4, 2006 January 3, 2007 Revised March 6, 2007 Revised

MAR 2 2 2007

Submitter: Monebo Technologies, Inc. 1800 Barton Creek Blvd Austin, Texas 78735-1606

Contact Person: Dale J. Misczvnski Phone: [phone] Fax: Email: [e-mail]

Trade/Device Name: Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS

### Level of Concern Statement

The Monebo Automated ECG Analysis and Interpretation Software Library is a Moderate Level of Concern Software Device.

The library is intended for use with ECG management software which is a Moderate Level of Concern software device.

The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.

A latent design flaw, failure or malfunction of the software, which were not revealed during the validation, verification and testing process, is possible over the life of the product. The results could result in a delayed response of appropriate medical care that would lead to injury or further diagnostic evaluations. The intended end users of the ECG analysis information are trained medical professional who are responsible for reviewing the device output and rendering the final diagnostic or treatment decision.

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K062282
Pg 2 of 4

### Predicate Devices:

The Monebo Automatic Arrhythmia Detection Software Library, Agilent and Brentwood predicates are software only devices that monitor cardiac function. Table 1 compares the features of the Monebo Automated ECG Analysis and Interpretation Software Library to predicate devices.

| Feature | Monebo<br>Automated<br>ECG<br>Analysis and<br>Interpretation<br>Software<br>Library | Monebo<br>Automatic<br>Arrhythmia<br>Detection<br>Software<br>Library<br>510(k)<br>K043380 | Agilent<br>510(k)<br>K003621 | Brentwood<br>510(k)<br>K013717 |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------|
| Heart rate determination for<br>non-paced adult | YES | NO | YES | YES |
| QRS Detection | YES | YES | YES | YES |
| Non-paced arrhythmia<br>interpretation for adult<br>patients | YES | NO | YES | YES |
| Non-paced ventricular<br>arrhythmia calls for adult<br>patients | YES | YES | YES | YES |
| Intervals measurement | YES | NO | YES | YES |
| Ventricular ectopic beat<br>detection | YES | YES | YES | YES |
| Patient Populations | Adult | Adult | Adults,<br>Pediatric,<br>Neonatal | Adult |

## Test Results

The bench test results of the software using AHA and MIT-BIH databases per ANSI/AAMI EC 57 are shown in the table below:

| Summary results of AHA and MIT testing | | | | |
|----------------------------------------|--------|--------|--------|--------|
| Database | QRS Se | QRS +P | VEB Se | VEB +P |
| AHA | 99.56 | 99.9 | 82.49 | 95.65 |
| MIT-BIH | 99.45 | 99.45 | 87.03 | 87.76 |
| NST | 91.56 | 85.66 | 81.79 | 53.19 |

The bench test results of the software using CSE database per IEC 60601-2-51 are shown in the tables below:

| Summary results of CSE DB testing | | | | |
|-----------------------------------|-------------------------------|-------------------------------------|---------------------------|------------------------------|
| Measurement | Acceptable<br>Mean difference | Acceptable<br>standard<br>deviation | Monebo mean<br>difference | Monebo standard<br>deviation |

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K062282
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## Summary results of MIT DB arrhythmia statement testing:

| Accuracy of Arrhythmia Detection | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------------------------------|---------------------------------|
| Sensitivity | Specificity | Positive Predictive<br>Accuracy | Negative Predictive<br>Accuracy |
| 96 | 97 | 73 | 97 |
| Arrhythmias: Normal sinus rhythm, Sinus Bradycardia, Sinus Tachycardia, PVC, APC, Atrial Fibrillation,<br>Ventricular Tachycardia, Ventricular Flutter, Sinus Tachycardia, Pause (Asystole), AV block, BBB,<br>Ventricular trigeminy, Ventricular Bigeminy, AIVR | | | |

| Accuracy of Arrhythmia Statements | | | | |
|------------------------------------------------------------------------------------------------------------|-------------------|-------------------|------------------------------------|------------------------------------|
| Arrhythmias | Sensitivity | Specificity | Positive<br>Predictive<br>Accuracy | Negative<br>Predictive<br>Accuracy |
| MIT DB | | | | |
| Normal sinus<br>rhythm | 100 | 100 | 95 | 100 |
| PVC | 100 | 100 | 86 | 100 |
| APC | 96 | 66 | 70 | 66 |
| Atrial Fibrillation | 100 | 100 | 77 | 100 |
| Ventricular<br>Tachycardia | 75 | 89 | 60 | 89 |
| Bradycardia | Insufficient data | 96 | Insufficient data | 96 |
| Tachycardia | Insufficient data | 100 | Insufficient data | 100 |
| AV block | 57 | 87 | 26 | 87 |
| BBB | 77 | 88 | 25 | 88 |
| Ventricular<br>Trigeminy | 50 | 84 | 100 | 84 |
| Ventricular<br>Bigeminy | 81 | 93 | 81 | 93 |
| AIVR | 100 | 100 | 15 | 100 |
| Pause | Insufficient data | Insufficient data | Insufficient data | Insufficient data |
| CU DB | | | | |
| Ventricular<br>Flutter* | 100 | 94 | * | * |
| * Positive Predictive and Negative Predictive Accuracy cannot be calculated because all records contain VF | | | | |

The results covering Sensitivity, Positive Predictivity, Specificity, False Positive Rate, and Negative Predictivity and which are based on a database of 250 annotated ECG strips, renorded by various event recorders are in the table below.

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| Rhythm | Sensitivity | Positive<br>Predictivity | Specificity | False<br>Positive<br>Rate | Negative<br>Predictivity |
|-----------------------------------|-------------|--------------------------|-------------|---------------------------|--------------------------|
| | Se | +P | Sp | FPR | -P |
| Normal sinus rhythm | 91.18 | 100.00 | 100.00 | 0.00 | 96.81 |
| Atrial fibrillation | 90.91 | 80.00 | 95.15 | 4.85 | 98.00 |
| Nodal rhythm | 76.47 | 46.43 | 93.56 | 6.44 | 98.20 |
| SVTA | 100.00 | 61.90 | 92.86 | 7.14 | 100.00 |
| Ventricular tachycardia | 100.00 | 85.71 | 99.59 | 0.41 | 100.00 |
| BBB | 82.14 | 79.31 | 97.30 | 2.73 | 97.74 |
| 1st degree AV block | 88.46 | 74.19 | 96.43 | 3.57 | 98.63 |
| 2nd degree AV block<br>(Mobitz 1) | 96.77 | 100.00 | 100.00 | 0.00 | 99.55 |
| 2nd degree AV block<br>(Mobitz 2) | 100.00 | 100.00 | 100.00 | 0.00 | 100.00 |
| Complete AV block | 96.77 | 100.00 | 100.00 | 0.00 | 99.55 |
| Idioventricular rhythm | 72.73 | 88.89 | 99.58 | 0.42 | 98.76 |
| Sinus bradycardia | 91.67 | 100.00 | 100.00 | 0.00 | 98.62 |
| Sinus tachycardia | 77.78 | 100.00 | 100.00 | 0.00 | 98.31 |
| APC | 77.50 | 65.26 | 80.59 | 19.41 | 88.39 |
| PVC | 89.55 | 73.17 | 87.98 | 12.02 | 95.83 |
| Pause | 96.88 | 73.81 | 94.95 | 5.05 | 99.52 |
| Overall Performance | 90.23 | 82.19 | 96.42 | 3.58 | 98.23 |

### Device Description:

The Monebo Automated ECG Analysis and Interpretation Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Monebo Automated ECG Analysis and Interpretation Software Library consists of a basic application for viewing, analyzing and annotating ECG data, and a callable object library built on the Microsoft™ .Net framework. An application software program can be written to invoke some or all of the functions in an object library.

The Monebo Automated ECG Analysis and Interpretation Software Library provides ECG signal processing, QRS detection and measurement of duration, QRS feature extraction, classification of Normal and Ventricular Ectopic beats, heart rate measurement, measurement of PR and QT intervals, and rhythm interpretation for up to 16 leads of captured ECG data.

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

Monebo will compile the Monebo Automated ECG Analysis and Interpretation Software Library 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.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

APR 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Monebo Technologies Inc. c/o Mr. Dale Misczynski 1800 Barton Creek Blvd Austin, TX 78735

Re: K062282

Trade/Device Name: Monebo Automated ECG Analysis and Interpretation Software Library Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 6, 2007 Received: March 7, 2007

Dear Mr. Misczynski:

This letter corrects our substantially equivalent letter of March 22, 2007.

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 (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.

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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Page 2 - Mr. Misczynski

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B.J. Zimmerman fa

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: K062282

### Device Name: Monebo Automatic ECG Analysis and Interpretation Software Library

Indications for Use:

The Automatic Analysis and Interpretation 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 Hotter, Event Monitor, 12 lead ambulatory or resting ECG devices, or other similar devices when assessment of the rhythm is necessary. The Automatic Analysis and Interpretation Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Automatic Analysis and Interpretation Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to sixteen(16) leads of captured data. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices

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.

Prescription Use V

AND/OR

1000 1000 Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumimmo