ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

K131045 · Cardiac Designs, LLC · DQK · May 29, 2013 · Cardiovascular

Device Facts

• Record ID: K131045
• Device Name: ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
• Applicant: Cardiac Designs, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: May 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Software tool for ECG signal processing and analysis; inputs ambulatory or resting ECG data from Holter, Event Monitors, or ECG management systems. Performs beat-by-beat analysis; includes QRS and ventricular ectopic beat detection, QRS feature extraction, interval measurement, and heart rate measurement. Output is a report containing analysis metrics for clinician review. Used by medical professionals in clinical settings to assist in arrhythmia assessment; does not provide diagnostic interpretation. Clinical decision-making remains with the provider based on clinical judgment and experience. Software can be integrated into computerized ECG monitoring devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based ECG analysis tool; performs signal processing and beat-by-beat analysis. Compatible with various ECG data formats from Holter, Event Monitors, and ECG management systems. Integrated into computerized ECG monitoring devices or used as standalone software. No specific hardware materials or energy sources described.

Indications for Use

Indicated for qualified medical professionals to assist in arrhythmia assessment using ambulatory or resting ECG data from Holter, Event Monitors, or similar diagnostic devices. Not for use in life-supporting/sustaining systems or as an ECG alarm device.

Regulatory Classification

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.

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 20993-002

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

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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 [phone] or [phone] 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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K131045

## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

n P. Faris -S 05.29 15:54:27