Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional signal processing and analysis techniques (beat detection, interval measurement, rhythm analysis) and does not mention AI/ML terms or methodologies. The performance studies rely on standard ECG databases and metrics, not typical for AI/ML model evaluation.

Therapeutic

No.
The device is described as an "Automatic Analysis and Interpretation Software Library" intended for assessing arrhythmias using historic ambulatory ECG data, providing ECG signal processing and analysis. It does not perform any therapeutic function.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the software library is intended "for the assessment of arrhythmias using historic ambulatory ECG data," and can analyze data from "any device used for the arrhythmia diagnostics." The "Device Description" also details its capabilities for "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," all of which are diagnostic functions.

SaMD (Software as a Medical Device)

Yes

The device is described as a "Software Library" and an "object library" consisting of "callable functions". It is intended to be integrated into other computer-based ECG systems or used as an accessory to an ECG management application. The description focuses solely on the software components and their functionality, with no mention of accompanying hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Automatic Analysis and Interpretation Software Library analyzes historic ambulatory ECG data. ECG data is a recording of the electrical activity of the heart, obtained from electrodes placed on the body. It is a physiological measurement, not a sample taken from the body.
Intended Use: The intended use is for the assessment of arrhythmias using this historic ECG data. This is a form of physiological signal analysis, not a diagnostic test performed on a biological sample.

While the software provides analysis and interpretation that can aid in diagnosis, the input data (ECG) is not an in vitro sample. Therefore, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DPS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult

Intended User / Care Setting

qualified medical professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The bench test results of the software using AHA and MIT-BIH databases per ANSI/AAMI EC 57 are shown in the table below:
Database Summary results of AHA and MIT testing: AHA, MIT-BIH, NST
The bench test results of the software using CSE database per IEC 60601-2-51 are shown in the tables below:
Database Summary results of CSE DB testing.
Summary results of MIT DB arrhythmia statement testing.
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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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
Mean difference	Acceptable
standard
deviation	Monebo mean
difference	Monebo standard
deviation

Summary results of MIT DB arrhythmia statement testing:

Accuracy of Arrhythmia Detection
Sensitivity	Specificity	Positive Predictive
Accuracy	Negative Predictive
Accuracy
96	97	73	97

Accuracy of Arrhythmia Statements
Arrhythmias	Sensitivity	Specificity	Positive
Predictive
Accuracy	Negative
Predictive
Accuracy
MIT DB
Normal sinus
rhythm	100	100	95	100
PVC	100	100	86	100
APC	96	66	70	66
Atrial Fibrillation	100	100	77	100
Ventricular
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
Trigeminy	50	84	100	84
Ventricular
Bigeminy	81	93	81	93
AIVR	100	100	15	100
Pause	Insufficient data	Insufficient data	Insufficient data	Insufficient data
CU DB
Ventricular
Flutter*	100	94	*	*

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.

| Rhythm | Sensitivity | Positive
Predictivity | Specificity | False
Positive
Rate | Negative
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
(Mobitz 1) | 96.77 | 100.00 | 100.00 | 0.00 | 99.55 |
| 2nd degree AV block
(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 |

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity, Specificity, Positive Predictive Accuracy, Negative Predictive Accuracy, Positive Predictivity, False Positive Rate, Negative Predictivity. Values are detailed in the tables under "Summary of Performance Studies"

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Monebo Automatic Arrhythmia Detection Software Library K043380, Agilent K003621, Brentwood K013717

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

K0622282
pg 1 of 4

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: 512-732-0235 512-732-0285 Fax: Email: dale.misczynski@monebo.com

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.

1

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

2

K062282
pg 3 of 4

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Summary results of MIT DB arrhythmia statement testing:

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

Accuracy of Arrhythmia Statements
Arrhythmias	Sensitivity	Specificity	Positive
Predictive
Accuracy	Negative
Predictive
Accuracy
MIT DB
Normal sinus
rhythm	100	100	95	100
PVC	100	100	86	100
APC	96	66	70	66
Atrial Fibrillation	100	100	77	100
Ventricular
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
Trigeminy	50	84	100	84
Ventricular
Bigeminy	81	93	81	93
AIVR	100	100	15	100
Pause	Insufficient data	Insufficient data	Insufficient data	Insufficient data
CU DB
Ventricular
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.

3

| Rhythm | Sensitivity | Positive
Predictivity | Specificity | False
Positive
Rate | Negative
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
(Mobitz 1) | 96.77 | 100.00 | 100.00 | 0.00 | 99.55 |
| 2nd degree AV block
(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.

4

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.

5

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

6

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