(44 days)
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Not Found
No
The summary describes standard ECG signal processing and analysis techniques (beat detection, interval measurement, rhythm analysis) without mentioning AI or ML.
No
The software is an analysis tool for diagnostic purposes and does not directly provide a therapeutic effect or intervention.
No
The software provides analysis of ECG data to assist with arrhythmia assessment, but explicitly states, "The report does not contain diagnostic interpretation; the reported analysis is provided for review by the care provider to render a diagnosis based on clinical judgment and experience." Therefore, it is a tool for analysis, not for diagnosis itself.
Yes
The device is described as "Enterprise ECG Analysis / Interpretation Software" and its function is solely focused on processing and analyzing ECG data. There is no mention of any associated hardware component being part of the device itself.
Based on the provided information, the "Enterprise ECG Analysis / Interpretation Software" is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is explicitly described as a tool used by qualified medical professionals to assist with the assessment of arrhythmias using ambulatory ECG data. ECG data, while collected from the body, is analyzed in vitro (outside the body) by the software.
- Analysis of Biological Data: The software performs analysis on biological data (ECG signals) to provide information about a patient's physiological state (heart rhythm and potential arrhythmias).
- Assisting with Diagnosis: While the software doesn't provide a definitive diagnosis, it provides analysis metrics and a report that are intended to be reviewed by a care provider to render a diagnosis. This places it within the scope of devices used to provide information for diagnostic purposes.
The fact that it analyzes data from devices like Holter monitors, Event Monitors, and other ECG devices, and provides analysis metrics for clinical review, aligns with the definition of an IVD. The analysis is performed on the collected biological signal, not directly on the patient.
N/A
Intended Use / Indications for Use
The "Enterprise ECG Analysis / Interpretation Software" is a tool used by qualified medical professionals to assist with the assessment of arrhythmias using ambulatory EGG data. The software supports downloading and analyzing data recorded in compatible formats from devices used for arrhythmia diagnostics such as Holter, Event Monitor, ambulatory or resting EGG devices, or other similar devices when assessment of the rhythm is necessary. The software can be electronically interfaced, and perform analysis with data transferred from other computer based EGG systems, such as an EGG management system. The software provides EGG signal processing and analysis on a beat by beat basis. ORS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for the captured data. The software is not for use in life supporting or life sustaining systems or EGG Alarm devices. The software can be integrated into computerized EGG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include beat by beat heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the care provider to render a diagnosis based on clinical judgment and experience.
Product codes
DOK, DPS
Device Description
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 29, 2013
Cardiac Designs. LLC Raymond Kelly, IV Regulatory Consultant 57 Lazy Brook Rd Monroe, CT 06468 US
Re: K131045
Trade/Device Name: Enterprise ECG Analysis / Interpretation Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: April 12, 2013 Received: April 15, 2013
Dear Raymond Kelly, IV:
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
1
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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Enterprise ECG Analysis / Interpretation Software
Indications For Use:
The "Enterprise ECG Analysis / Interpretation Software" is a tool used by qualified medical professionals to assist with the assessment of arrhythmias using ambulatory EGG data. The software supports downloading and analyzing data recorded in compatible formats from devices used for arrhythmia diagnostics such as Holter, Event Monitor, ambulatory or resting EGG devices, or other similar devices when assessment of the rhythm is necessary. The software can be electronically interfaced, and perform analysis with data transferred from other computer based EGG systems, such as an EGG management system. The software provides EGG signal processing and analysis on a beat by beat basis. ORS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for the captured data. The software is not for use in life supporting or life sustaining systems or EGG Alarm devices. The software can be integrated into computerized EGG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include beat by beat heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the care provider to render a diagnosis based on clinical judgment and experience.
Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
n P. Faris -S 05.29 15:54:27