K Number

Device Name

Manufacturer

CORCAM TECHNOLOGIA, SA

Date Cleared

2014-05-23

(80 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia.

Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath).
Adult patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
Adult patients who require outpatient monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

Device Description

The Corcam Heart Monitor is a battery operated, non-invasive, portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. The device allows for autonomous remote monitoring via a Global System for Mobile Communications/General Packet Radio Service (GSM/ GPRS). The device is connected to the patient via four commercially available electrodes (Derivations I. II. III. and ground) and is equipped with an accelerometer to detect patient falls, GPS for geographical and accurate location of the user, and a speaker system to allow communication to or with the Monitoring Center. A vibrating mechanism and lights, when activated, provide physical and visual signals to the user. Indicator lights also show the operating status of the unit. An SOS/ Help button can be pressed by the user to send a help signal to the monitoring center. In addition to the transmission of patient data to the monitoring center, the monitoring center or clinician at any given moment can conditionally request a new exam on demand allowing for actual and accurate tracking of a cardiac event. Once the monitor detects an irregular heartbeat, the device generates an electrocardiogram (ECG) and sends it to the monitoring center. A clinician in the monitoring center carries out an analysis on the received ECG. Depending upon the analysis of the clinician can check the symptoms of the patient, request another ECG transmission, or initiate immediate assistance for the form of an ambulance/ emergency services.

AI/ML Overview

Here's an analysis of the provided text regarding the Corcam Heart Monitor, outlining its acceptance criteria and the study conducted:

Acceptance Criteria and Device Performance

The provided document describes the Corcam Heart Monitor as meeting performance criteria related to the detection and transmission of ECG data when an irregular heartbeat is detected.

Acceptance Criteria	Reported Device Performance
Automated ECG generation and transmission to Central Monitoring Station within a specified timeframe.	"Results showed that in 92% of the cases evaluated, the Central Monitoring Station received the ECGs automatically generated by the Corcam device within 3 minutes. ECGs that took between 4 and 5 minutes to send were generated at peak times, when there is greater data traffic over the cellular network."
Ability of the device to detect relevant ECG changes.	"The study concluded that the Corcam Heart Monitor has the ability to detect relevant ECG changes and generate an electrocardiogram and transmit it automatically (without human intervention) within minutes to a Central Monitoring Station." (Note: The study describes what the device does, not a specific accuracy metric for detecting "relevant ECG changes." It implies that it does detect them, as it generates an ECG when an "irregular heartbeat" is detected.)
Absence of adverse events during use (implied safety aspect).	"There were no adverse events."
Compliance with various electromedical equipment and wireless communication standards (non-clinical performance).	The device meets requirements of numerous standards, including NBR IEC 60601-1, ABNT NBR IEC 60601-1-2, ABNT NBR IEC 60601-2-27, IEC 62209-01, IEC 62209-02, IEEE Std 1528, ETSI TS 151 010-1, AAMI / ANSI EC38, and AAMI/ANSI EC 57.

Study Information

The document describes a clinical study to assess the accuracy and performance of the Corcam Heart Monitor.

Sample size used for the test set and the data provenance:
- Sample Size: 152 consecutive patients.
- Data Provenance: The study was conducted from May to August 2012, involving "inpatients or outpatients with established clinical diagnoses (as reported in medical records)". The sponsor is based in São Paulo, Brazil, suggesting the data is likely from Brazil. It is a prospective observational study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth ("conventional ECG") was analyzed by a "clinician in the monitoring center" at a "Central Monitoring Station" after the Corcam device transmitted the ECG. It's unclear how many clinicians were involved in establishing the "ground truth" for the conventional ECG, or their specific qualifications. The document states a "clinician" carries out an analysis, implying perhaps one per case, but doesn't specify a number for the overall ground truth establishment.
- Qualifications: "Clinician in the monitoring center." No specific qualifications (e.g., years of experience, board certification) are provided.
Adjudication method for the test set:
- Not explicitly stated. The study compares the Corcam device's ECG to "conventional ECG (gold standard)" which implies the conventional ECG served as the reference. There's no mention of multiple readers for the conventional ECG or a specific adjudication process to resolve discrepancies.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compares the device's automatic transmission capability and detection of relevant ECG changes against a "conventional ECG (gold standard)," not the performance of human readers with vs. without AI assistance from the Corcam device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance aspect was evaluated regarding the device's automated function. The device "automatically generated and sent an ECG to the Central Monitoring Station without human intervention, either from the patient or the investigator." The performance metric reported (92% of cases received within 3 minutes) directly relates to this standalone, automatic functionality. The subsequent analysis by a "clinician" suggests a human-in-the-loop for interpretation, but the detection and transmission itself is standalone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established using conventional electrocardiography (ECG), referred to as the "gold standard." This conventional ECG was then analyzed by a "clinician in the monitoring center." Thus, it's essentially expert interpretation of conventional ECGs.
The sample size for the training set:
- The document does not provide any information regarding a training set size. The described "Performance Data (Clinical)" section details a single clinical study that appears to serve as the test set for performance evaluation. This suggests the device might have been developed using internal data or prior knowledge, but explicit details on a training set are absent.
How the ground truth for the training set was established:
- As no training set is described, there is no information provided on how its ground truth was established.

Summary

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Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for Corcam's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Corcam Heart Monitor is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

Sponsor:	Corcam Technologica S/ARua Sampaio Viana, n. 202, conjs. 104 / 105, Paraíso,São Paulo, Brazil
Contact:	Jennifer A. DaudelinM Squared Associates575 Eighth Avenue, Suite 1212New York, NY 10018Ph: 703-562-9800 x251Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	March 3, 2014
Proposed Class:	II
Proprietary Name:	Corcam Heart Monitor
Common Name:	Arrhythmia Detector and Alarm
Classification Name:	Arrhythmia Detector and Alarm
Regulation Number:	21 CFR 870.1025
Product Codes:	DSI

Class Manufacturer Device Name Common Name Procode II CardioNet ECG DSI Arrhythmia Detector and CardioNet, Inc. Alarm Monitor with Arrhythmia Detection Patient Physiological II MHX, Preventice, Inc. Body Guardian Monitor, Arrhythmia DSI Detector and Alarm II DSI, Arrhythmia Detector and Applied Cardiac CORE™ ECG Monitor Systems DSH, Alarm DPS

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Indication for Use

、i

The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia.

1. Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
1. Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath).
1. Adult patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
1. Adult patients who require outpatient monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

Device Description

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Performance Data (Non-Clinical)

The Corcam Heart Monitor meets the requirements of the following standards:

NBR IEC 60601-1:1994, Electromedical Equipment Part 1 General Safety Prescriptions ●
NBR IEC 60601-1, Amendment 1: 1997 .
ABNT NBR IEC 60601-1-2:2006, Electromedical Equipment Part 1-2: Collateral . Standard: Electromagnetic Compatibility - Requirements and tests.
ABNT NBR IEC 60601-2-27:1997, Medical Electrical Equipment Part 2: Particular . Requirements For the Safety of Electrocardiographic Monitoring Equipment
· NBR IEC 60601-2-27:1997, Part 2: Specific Prescriptions for the Equipment Safety for the Electrocardiogram Software
IEC 62209-01: 2005, Human exposure to radio frequency fields from hand-held and body-mounted . wireless communication devices- Human models, instrumentation, and procedures - Part 1: Procedure to determine the specific absorption rate (SAR) for hand-held devices used in close proximity to the ear (frequency range of 300 MHz to 3 GHz
IEC 62209 02: 2010, Procedure to determine the Specific Absorption Rate (SAR) in the head and . body for 30 MHz to 6 GHz Handheld and Body-Mounted Devices used in close proximity to the Bodv
IEEE Std 1528, IEEE Recommended Practice for Determining the Peak Spatial- Average Specific . Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Techniques
ETSI TS 151 010-1 V6.5.0 (2005-11) (3GPP TS 51.010-1 version 6.5.0 Release 6), Digital . cellular telecommunications system (Phase 2+); Mobile Station (MS) conformance specification; Part 1: Conformance specification
AAMI / ANSI EC38: 2007, Medical Electrical Equipment Part 2-47: Particular Requirements for . the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)
AAMI/ANSI EC 57 1998/(R ) 2003 Testing and Reporting Performance Results of Cardiac . Rhythm and ST Segment Measurement Algorithms

Performance Data (Clinical)

A cross-sectional observational study was designed to assess the accuracy of this monitor as compared to that of conventional ECG (gold standard) as a screening tool for the detection of arrhythmias and myocardial ischemia. From May to August 2012, 152 consecutive patients were included in the study. Patients were inpatients or outpatients with established clinical diagnoses (as reported in medical records) and ECGs meeting the eligibility criteria of the study. Inclusion criteria were patients over 18 years of age with cardiac arrhythmias or myocardial ischemia and an established diagnosis of attial fibrillation, acute coronary syndromes, or ventricular arrhythmias or bradyarrhythmias. All patients underwent conventional electrocardiography and had an electrocardiogram (ECG) generated by the Corcam device. For the Corcam Heart Monitor ECGs, the device was installed onto the patient and automatically generated and sent an ECG to the Central Monitoring Station without human intervention, either from the patient or the investigator. Both tests were performed within a 10-minute window. There were no adverse

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events. Results showed that in 92% of the cases evaluated, the Central Monitoring Station received the ECGs automatically generated by the Corcam device within 3 minutes. ECGs that took between 4 and 5 minutes to send were generated at peak times, when there is greater data traffic over the cellular network. The study concluded that the Corcam Heart Monitor has the ability to detect relevant ECG changes and generate an electrocardiogram and transmit it automatically (without human intervention) within minutes to a Central Monitoring Station.

Technological Characteristics and Substantial Equivalence

The Corcam Heart Monitor has the same indications for use and similar design features as compared with the predicate arrhythmia detectors. Additionally, both the Corcam device and the predicate CORE™ ECG Monitor use an accelerometer to detect accelerated motion. The bench testing along with the clinical data demonstrate that the performance characteristics of the Corcam Heart Monitor is equivalent to those of other legally marketed arrhythmia detectors, and therefore supports a determination of Substantial Equivalence for the proposed indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing the world.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

May 23, 2014

Corcam Technologia, SA % Ms. Jennifer Daudelin Consultant for Corcam M Squared Associates, Inc. 575 Eighth Ave, Ste 1212 New York, New York 10018

K140548 Re:

Trade/Device Name: Corcam Heart Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm Regulatory Class: Class II Product Code: DSI Dated: March 25, 2014 Received: March 26, 2014

Dear Ms. Jennifer Daudelin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your bection by 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 commerce pror to May 20, 1977 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 I ou may, access, mains of the Act include requirements for annual registration, listing of general controls provisions gractice, 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), II your device is classified (500 actrols. 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

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Page 2 - Ms. Jennifer Daudelin

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); medical device reporting (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/default.htm for 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Image /page/5/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, geometric design. The logo appears to be a black and white image. The logo is likely associated with the Food and Drug Administration.

for 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 Statement

K140548 510(k) Number:

Corcam Heart Monitor Device Name:

Indications for Use:

The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia.

1. Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
1. Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath).
1. Adult patients with palpitations without known arrhythmias to obtain correlation of rhythm with symptoms.
1. Adult patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

AND/OR

Prescription Use __X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __ 1 __

FDA 2014.05.23
0651-04'00'

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.