(139 days)
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No
The document describes standard ECG signal processing and analysis techniques (QRS detection, feature extraction, beat detection) and mentions testing against standard databases (AHA, MIT-BIH). There is no mention of AI, ML, deep learning, or any related concepts. The description of the software as an "object library" with callable functions is consistent with traditional software development, not necessarily AI/ML.
No
The device is a software library for detecting arrhythmias from ECG data, intended for use by qualified medical professionals for assessment, not for direct therapy.
Yes
The intended use explicitly states, "The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data." Assessing medical data to identify conditions like arrhythmias is a diagnostic function.
Yes
The device is described as a "Software Library" and an "object library" consisting of "callable functions" and "application software program". It processes and analyzes ECG data but does not include any hardware components. It is intended to be integrated into other computerized ECG monitoring devices, which would then require their own 510(k) submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "assessing historic ambulatory ECG data" and "ECG signal processing and analysis". This involves analyzing electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a software library that processes ECG data. It doesn't involve any reagents, instruments, or procedures for analyzing biological samples.
- Input Modality: The input is ECG data, which is a physiological measurement, not a biological sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This software processes electrical signals generated by the heart, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data. The product allows downloading and analyzing data recorded in compatible format by Holter or Event monitoring devices. The Automatic Arrhythmia Detection Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, and QRS feature extraction.
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 Automatic Arrhythmia Detection 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 Automatic Arrhythmia Detection Software Library consists of a basic application for viewing, analyzing and annotating ECG data and 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 Automatic Arrhythmia Detection Software Library provides ECG signal processing, QRS detection, QRS feature extraction, and ventricular ectopic beat detection for up to 12 leads of captured ECG data.
Monebo will compile the Automatic Arrhythmia Detection Software Library specified by an ECG analysis 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. The device manufacturer will be required to submit a 510k with the specific requirements for that device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified medical professionals
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
The bench test results of the software using AHA and MIT-BIH databases are show in the table below:
| 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 |
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed using AHA and MIT-BIH databases. Key results show QRS sensitivity (QRS Se) for AHA at 99.56% and for MIT-BIH at 99.45%. QRS +P (positive predictivity) for AHA was 99.9% and for MIT-BIH was 99.45%. Ventricular ectopic beat sensitivity (VEB Se) for AHA was 82.49% and for MIT-BIH was 87.03%. VEB +P for AHA was 95.65% and for MIT-BIH was 87.76%. An NST database also was used, showing QRS Se at 91.56%, QRS +P at 85.66%, VEB Se at 81.79%, and VEB +P at 53.19%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
QRS Se, QRS +P, VEB Se, VEB +P
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.
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.
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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).
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§ 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).
0
510(k) Summary of Safety and Effectiveness
510(k) Notification K043380 Date: April 21, 2005 Submitter: Monebo Technologies, Inc. 1800 Barton Creek Blvd Austin, Texas 78735-1606
Contact Person: Dale J. Misczynski Phone: 512-732-0235 512-732-0285 Fax: Email: dale.misczynski@monebo.com
Trade/Device Name: Monebo Automatic Arrhythmia Detection Software Library, Version 1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS
Predicate Devices:
The Monebo Automatic Arrhythmia Detection Software Library, Agilent and Brentwood ST/AR predicate are software only devices that monitor cardiac function. Table 1 compares the features of the Automatic Arrhythmia Detection Software Library to predicate devices.
| Feature | Automatic
Arrhythmia
Detection
Software
Library | Agilent
510(k)
K003621 | Brentwood
510(k)
K013717 |
|-----------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------|--------------------------------|
| Heart rate determination for
non-paced adult | NO | YES | YES |
| Non-paced ventricular
arrhythmia calls for adult
patients | YES | YES | YES |
| Ventricular ectopic beat
detection | YES | YES | YES |
| Patient Populations | Adult | Adults,
Pediatric,
Neonatal | Adult |
1
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Test Results
The bench test results of the software using AHA and MIT-BIH databases are show in the table below:
| 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 |
Summary results of AHA and MIT testing
Device Description:
The Monebo Automatic Arrhythmia Detection 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 Automatic Arrhythmia Detection Software Library consists of a basic application for viewing, analyzing and annotating ECG data and 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 Automatic Arrhythmia Detection Software Library provides ECG signal processing, QRS detection, QRS feature extraction, and ventricular ectopic beat detection for up to 12 leads of captured ECG data.
Monebo will compile the Automatic Arrhythmia Detection Software Library specified by an ECG analysis 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. The device manufacturer will be required to submit a 510k with the specific requirements for that device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the top and left side of the circle. The eagle is black, and the text is also in black.
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Monebo Technologies, Inc. c/o Mr. Dale J. Misczynski President 1800 Barton Creek Blvd. Austin, TX 78735
Re: K043380
Trade Name: Monebo Automatic Arrhythmia Detection Software Library, Version 1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 18, 2005 Received: March 21, 2005
Dear Mr. Misczynski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of l'ederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Dale J. 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 begin 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K043380
Device Name: Monebo Automatic Arrhythmia Detection Software Library
Indications For Use:
The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data. The product allows downloading and analyzing data recorded in compatible format by Holter or Event monitoring devices. The Automatic Arrhythmia Detection Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, and QRS feature extraction.
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 AND/OR 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) .
Blummana
on Sign-Off Division of Cardiova 510(k) Number