Predicate Devices

K071995, K020825, K062282, K860249, K102723, K870880

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes an "embedded algorithm" and "built-in hardware DSP engine" for real-time ECG analysis and arrhythmia detection. While this involves complex signal processing, the language used does not explicitly mention or suggest the use of AI or ML techniques. The performance metrics and testing described are standard for traditional ECG analysis algorithms.

Therapeutic

No
The device is primarily a diagnostic and monitoring tool, detecting and recording cardiac events for clinician analysis, rather than actively treating or mitigating a disease or condition. While its findings may lead to therapeutic interventions, the device itself is not therapeutic.

Diagnostic

Yes

Explanation: The device is described as having modes for Mobile Cardiac Outpatient Telemetry with "Arrhythmia Detection and Alarm," "Holter Mode" for monitoring various cardiac conditions, and "Multi-Lead (Resting EKG) Mode" for acquiring, storing, and viewing/printing ECG waveforms. It explicitly states that "The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs." This functionality directly involves the identification and diagnosis of cardiac arrhythmias, fitting the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a single component ECG monitor with an integrated cellular modem and an interface to four independent cable configurations, along with a list of numerous hardware components (microprocessor, ASIC, battery, transceivers, display, etc.). This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes electrical signals from the human body (ECG waveforms) through surface electrodes. It does not process biological samples.
The intended use and device description clearly focus on monitoring and analyzing electrical activity of the heart. This is a physiological measurement, not an in vitro test.
The performance studies and key metrics are related to the accuracy of ECG signal detection and arrhythmia analysis. These are typical performance indicators for cardiac monitoring devices, not IVDs.

The device is a cardiac monitoring and diagnostic device that falls under the category of medical devices used for physiological monitoring and analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmia The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs.
1. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
1. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.

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

QYX, DSI, DSH, DPS

Device Description

The ACS Cardiac Outpatient Real Time ECG (CORE™) monitor is a multipurpose device designed with the ability to perform: a 2-lead (2 or 3-electrode) Mobile Cardiac Outpatient Telemetry complete with Arrhythmia Detection and Alarm for up to 30 days; a 24-hour or longer 3-lead (5electrode) or a resting 12-lead (10-electrode) EKG. The ambulatory device may be used on an outpatient basis with remote clinician data analysis as well as use within the physician office setting by a medical professional.

The CORE™ monitor is comprised of 1) a single component ECG monitor with an integrated cellular modem and 2) an interface to four independent cable configurations through a single connector. The CORE™ device automatically changes functionality when a specific cable with the same form factor is inserted with the following configurations:

. 3-wire, ambulatory, snap electrode cable invokes a 1, or 2-lead MCT mode (Lead I, II - no anterior views).
5-wire, ambulatory, snap electrode cable invokes the Holter 3-lead mode by default (up . to 5-leads are available with anterior views).
10-wire, resting (lengthened for full body), alligator clip electrode cable invokes the . Resting 12-lead EKG mode (8-channels; derived Leads III, aVF, aVR, aVL).
A USB cable invokes the PC communication service mode. Cable is interchangeable with . ECG lead sets requiring disconnection from the body before connection to an external device can be made.

The built-in cellular modem technology pushes and pulls information to and from the device in a HIPAA compliant fashion using the cryptographic protocol; Transport Layer Security (TLS). Additional data integrity is performed by Error Correction Coding (ECC) and MD5 hash sums.

The CORE™ device houses a microprocessor for running the algorithm and an Application Specific Integrated Circuit (ASIC) for controlling the CORE™ device, a rechargeable battery, real time ECG Arrhythmia Detection using built-in hardware DSP engine in any mode, ECG capture circuitry provided by the ASIC and the multiple components, GSM/GPRS/EGPRS/WCDMA/HSPA network transceivers for cellular communication, Cellular SIM card, high-capacity SD flash card (up to 1024 GB), internal EEPROM, GPS module, a Bluetooth transceiver and a Zigbee (IEEE 802.15.4) transceiver for bi-directional communication with external devices, a full-color LCD touch screen display, 5-button keyboard, Power and Event button, 3-axis accelerometer, RGB color LED indication module, speaker/microphone, external battery charger, and a USB device port.

The CORE™ device utilizes an embedded algorithm developed by Applied Cardiac Systems, Inc. to analyze ECG signals in real-time. Upon detection of an arrhythmic or patient-activated event, the ECG signal is transmitted wirelessly via the cellular network to a remote Monitoring Center for additional analysis and intervention by a clinician. When cellular service is unavailable, the event will be stored until such time the cellular network becomes available or the patient transmits the data using a land telephone line.

When in the resting 12-lead EKG mode, the device can capture and display 12 channels of ECG. The ECG can be streamed in real-time to a PC wirelessly via the 802.15.4 network transceiver to be displayed, printed, and stored. An embedded SQL database is used in the device for ECG storage and reporting in all modes - MCT, Holter, and resting 12-lead.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ECG

Anatomical Site

Chest, Arms, Legs

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Outpatient (home) or Physician's Office / Hospital

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The document provides summary results of AHA, MIT, and NST testing for QRS detection sensitivity and positive predictivity, as well as accuracy of arrhythmia detection. It states:
"Summary Results of AHA and MIT Testing" for QRS Detection Sensitivity (Se) and Positive Predictivity (+P) based on AHA, MIT-BIH, and NST databases.

AHA Database: QRS Se = 97.84, QRS +P = 99.55
MIT-BIH Database: QRS Se = 98.96, QRS +P = 99.27
NST Database: QRS Se = 90.84, QRS +P = 86.83

For Accuracy of Arrhythmia Detection:

Event Sensitivity: 97.59
Event Predictivity: 94.85
Duration Sensitivity: 97.35
Duration Predictivity: 94.30

Accuracy of Arrhythmia Statements & Predicate Comparisons:

Ventricular Fibrillation/Flutter: Event Sensitivity (ACS¹) = 99, Event Positive Predictive Accuracy (ACS¹) = 100, Duration Sensitivity (ACS¹) = 92, Duration Positive Predictive Accuracy (ACS¹) = 97
Atrial Fibrillation/Flutter: Event Sensitivity (ACS¹) = 96, Event Positive Predictive Accuracy (ACS¹) = 90, Duration Sensitivity (ACS¹) = 97, Duration Positive Predictive Accuracy (ACS¹) = 93
Pause (Asystole): Event Sensitivity (ACS¹) = 99, Event Positive Predictive Accuracy (ACS¹) = 100, Duration Sensitivity (ACS¹) = 98, Duration Positive Predictive Accuracy (ACS¹) = 96
Bradycardia: Event Sensitivity (ACS¹) = 97, Event Positive Predictive Accuracy (ACS¹) = 79, Duration Sensitivity (ACS¹) = 93, Duration Positive Predictive Accuracy (ACS¹) = 76
Tachycardia: Event Sensitivity (ACS¹) = 92, Event Positive Predictive Accuracy (ACS¹) = 100, Duration Sensitivity (ACS¹) = 87, Duration Positive Predictive Accuracy (ACS¹) = 95

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

QRS Detection Sensitivity (Se):

AHA: 97.84
MIT-BIH: 98.96
NST: 90.84

QRS Positive Predictivity (+P):

AHA: 99.55
MIT-BIH: 99.27
NST: 86.83

Accuracy of Arrhythmia Detection:

Event Sensitivity: 97.59
Event Predictivity: 94.85
Duration Sensitivity: 97.35
Duration Predictivity: 94.30

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.

K071995, K020825, K062282, K860249, K102723, K870880

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

§ 870.1025 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 15, 2023

Applied Cardiac Systems, Inc. R. Ben Ghadimi Director Regulatory Affairs 22912 El Pacifico Dr Laguna Hills, California 92653

Re: K103706

Trade/Device Name: The Core (cardiac Outpatient Realtime Ecg) Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: QYX, DSI

Dear R. Ben Ghadimi:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 24, 2011. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, jennifer.kozen@fda.hhs.gov.

Sincerely,

Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction 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 bird-like figure.

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

Applied Cardiac Systems, Inc c/o Mr. Ben Ghadimi 22912 El Pacifico Drive Laguna Hills, CA 92653

AUG 2 4 2011

Re: K103706

Trade Name: The CORE (Cardiac Outpatient Realtime ECG) Regulation Number: 21 CFR 870.1025 Regulation Name: Detector and Alarm, Arrhythmia Regulatory Class: Class II (two) Product Code: DSI Dated: August 9, 2011 Received: August 17, 2011

Dear Mr. Ghadimi:

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.

2

Page 2 - Mr. Ben Ghadimi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.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 yours,

2

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Applied Cardiac S Section 4: Indications For Use

Section 4: Indications for use

510(k) Number (if known):

K 103706

The CORE™ (Cardiac Outpatient Realtime ECG) Device Name:

Indications for Use:

1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmia The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs.
1. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
1. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.

Contra-indications for use:

1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring; and patients who the attending physician thinks should be hospitalized.
  The device continuously monitors patient's ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center.

The software does not perform diagnosis. The ECG data is provided to the medical practitioner for evaluation and diagnosis.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

8/9/11

3

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

Concurrence of CDRH_Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103796

4

Section 5: 510(k) Summary - Abbreviated Submission

AUG 2 4 2011

Section 5: 510(k) Summary

Submitter:

Company:	Applied Cardiac Systems
Address:	22912 El Pacifico Drive
	Laguna Hills, CA 92653
Contact:	Ben Ghadimi
Phone:	949.855.9366
Fax:	949.581.1009
Email:	bghadimi@appliedcardiacsystems.com
Date Prepared:	July 16, 2011

Device:

Trade Name:	Cardiac Outpatient Real -time ECG (CORE™)
Common Name:	Arrhythmia Detector and Alarm
Classification:	Detector and Alarm, Arrhythmia
Product Code:	DSI, DSH, DPS
Regulation:	870.1025, 870.2800, 870.2340
Class:	II, Special Controls

Predicate Devices:

The following are the predicate devices chosen to demonstrate substantial equivalence:

1. Card Guard Scientific Survival, Ltd. CG-6108 Continuous ECG Monitor & Arrhythmia Detector, cleared by the FDA under 510(k) number K071995; Product Classification Code DSI, Regulation 870.1025.
1. Card Guard Scientific Survival, Ltd. King Of Hearts Express+AF monitor, cleared by the FDA under 510(k) number K020825 Product Classification Code DSH, Regulation 870.2800.
1. Monebo Technologies, Inc. Monebo Automated ECG Analysis And Interpretation Software Library, Version 3.0, cleared by the FDA under 510(k) number K062282 Product Classification Code DPS, Regulation 870.2340.
1. Applied Cardiac System The Holter Reporter as cleared by the FDA under 510(k) number K860249; Product Classification Code DPS, Regulation 870.2340.

5

K103706 pg 2 of 22

Applied Cardiac Systems Section 5: 510(k) Summary - Abbreviated Submission

1. Memtec Corp. Model 950-12L as cleared by the FDA under 510(k) number K102723; Product Classification Code MWJ, Regulation 870.2800.
1. Burdick Corp. EK10 Electrocardiograph (non-interpretive), as cleared by the FDA under 510(k) number K870880; Product Classification Code DPS, Regulation 870.2340.

Device Description:

The ACS Cardiac Outpatient Real Time ECG (CORE™) monitor is a multipurpose device designed with the ability to perform: a 2-lead (2 or 3-electrode) Mobile Cardiac Outpatient Telemetry complete with Arrhythmia Detection and Alarm for up to 30 days; a 24-hour or longer 3-lead (5electrode) or a resting 12-lead (10-electrode) EKG. The ambulatory device may be used on an outpatient basis with remote clinician data analysis as well as use within the physician office setting by a medical professional.

The CORE™ monitor is comprised of 1) a single component ECG monitor with an integrated cellular modem and 2) an interface to four independent cable configurations through a single connector. The CORE™ device automatically changes functionality when a specific cable with the same form factor is inserted with the following configurations:

. 3-wire, ambulatory, snap electrode cable invokes a 1, or 2-lead MCT mode (Lead I, II - no anterior views).
5-wire, ambulatory, snap electrode cable invokes the Holter 3-lead mode by default (up . to 5-leads are available with anterior views).
10-wire, resting (lengthened for full body), alligator clip electrode cable invokes the . Resting 12-lead EKG mode (8-channels; derived Leads III, aVF, aVR, aVL).
A USB cable invokes the PC communication service mode. Cable is interchangeable with . ECG lead sets requiring disconnection from the body before connection to an external device can be made.

The built-in cellular modem technology pushes and pulls information to and from the device in a HIPAA compliant fashion using the cryptographic protocol; Transport Layer Security (TLS). Additional data integrity is performed by Error Correction Coding (ECC) and MD5 hash sums.

The CORE™ device houses a microprocessor for running the algorithm and an Application Specific Integrated Circuit (ASIC) for controlling the CORE™ device, a rechargeable battery, real time ECG Arrhythmia Detection using built-in hardware DSP engine in any mode, ECG capture circuitry provided by the ASIC and the multiple components, GSM/GPRS/EGPRS/WCDMA/HSPA network transceivers for cellular communication, Cellular SIM card, high-capacity SD flash card (up to 1024 GB), internal EEPROM, GPS module, a Bluetooth transceiver and a Zigbee (IEEE 802.15.4) transceiver for bi-directional communication with external devices, a full-color LCD touch screen display, 5-button keyboard, Power and Event button, 3-axis accelerometer, RGB

6

Applied Cardiac Systems Section 5: 510(k) Summary – Abbreviated Submission

color LED indication module, speaker/microphone, external battery charger, and a USB device port.

The CORE™ device utilizes an embedded algorithm developed by Applied Cardiac Systems, Inc. to analyze ECG signals in real-time. Upon detection of an arrhythmic or patient-activated event, the ECG signal is transmitted wirelessly via the cellular network to a remote Monitoring Center for additional analysis and intervention by a clinician. When cellular service is unavailable, the event will be stored until such time the cellular network becomes available or the patient transmits the data using a land telephone line.

When in the resting 12-lead EKG mode, the device can capture and display 12 channels of ECG. The ECG can be streamed in real-time to a PC wirelessly via the 802.15.4 network transceiver to be displayed, printed, and stored. An embedded SQL database is used in the device for ECG storage and reporting in all modes - MCT, Holter, and resting 12-lead.

Intended Use:

The CORE™ device is intended for outpatient use with remote clinician data analysis (MCT and Holter modes) as well as use within the physician office setting by the medical professional (resting EKG mode). The CORE™ device will provide continuous measurement of heart rate and rhythm over several days, detecting asymptomatic events as well as manual recordings and transmitting them immediately to a remote monitoring center, even when the patient is ambulatory, allowing timely intervention. The CORE™ device can be used for evaluation of recurrent unexplained episodes of presyncope, palpitations, dizziness or when a cardiac arrhythmia is suspected as the cause of the symptoms. The MCT, Holter and Resting 12-lead EKG modes are intended for use on adult patients only.

Indications for Use:

1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs.
1. Holter Mode: Use on adult patients experiencing palpitations, syncope, pre-Syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
1. Multi-Lead Resting EKG Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.

7

Contra-indications for use:

1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring; and patients who the attending physician thinks should be hospitalized.

8

2. 5-1: CORE™ Device Comparison to Predicate Tables:

5-1-1: CORE™ vs. CG-6108 (K071995)

| Table compares the MCT
mode device functionality | Applied Cardiac Systems, Inc.
The CORE™
(Subject Device) | Card Guard Scientific Survival,
Ltd.
CG-6108
(Predicate Device) | |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | Applied Cardiac Systems, Inc. | Card Guard Scientific Survival,
Ltd. | |
| 510(k) Number | Class II, DSI, 870.1025,
DSH, 870.2800, DPS, 870.2340 | K071995
Class II, DSI. 870.1025 | |
| Intended Use | The MCT mode of the CORE™ device is
intended for outpatient use with remote
clinician data analysis as well as use within the
physician office setting by the medical
professional. The CORE™ device will provide
continuous measurement of heart rate and
rhythm over several days, detecting
asymptomatic events as well as manual
recordings and transmitting them immediately
to a remote monitoring center, even when the
patient is ambulatory, allowing timely
intervention. The CORE™ device can be used
for evaluation of recurrent unexplained
episodes of pre-syncope, palpitations,
dizziness or when a cardiac arrhythmia is
suspected as the cause of the symptoms. The
CORE™ device is intended for use on adult
patients. | Intended for use by patients
who experience transient
symptoms that may suggest
cardiac arrhythmia. | |
| Anatomical Sites | Chest | Chest | |
| Environment of Use | Outpatient (home) or Physician's Office | Home or Physician's Office | |
| Analog/Digital | Digital | Digital | |
| Input Impedance (Ohm) | 5 Megohms (min) | 20 ΜΩ | |
| Electrode Configuration | 3-lead /3-electrode | 3-lead/3-electrode | |
| Frequency Response | 0.05 - 40 Hz | 0.05 - 40 Hz | |
| CMRR (dB) | 100 (min) dB 115 (typical) dB | 60 | |
| Input Dynamic Range (mVp-p) | $1.75 V ± 1 μV$ | 6 | |
| DC offset correction (mV) | $± 300mV (25μV inherent)$ | $± 150$ | |
| Band Width (Hz) | 0.05 - 100Hz | 0.05-40Hz | |
| Pacemaker Pulse Marker | Yes | Yes | |
| QRS Detection Sensitivity | Summary Results of AHA and MIT Testing | Not available | |
| | Database QRS Se QRS +P | | |
| | AHA | | |
| | 97.84 | 99.55 | |
| | MIT-BIH | | |
| | 98.96 | 99.27 | |
| | NST | | |
| | 90.84 | 86.83 | |
| AHA - The American Heart Association
Database for Evaluation of Ventricular
Arrhythmia Detectors | | | |
| MIT-BIH - The Massachusetts Institute of
Technology-Beth Israel Arrhythmia Database | | | |
| NST - The Noise Stress Database | | | |
| Se - Sensitivity: True Positive/True Positive + False Negative | | | |
| +P - Positive Predictivity: True Positive/True Positive + False Positive | | | |
| Power / Noise Ratio | 50nV/rt-Hz at 75µA | | Not available |
| System | Continuous | | Continuous |
| Communication/Monitoring | | | |
| Lead Displacement Detection | Yes | | Yes |
| Maximum Storage Memory | 64GB (30+ days) | | 24 hours |
| Data Transmission | Cellular Transmission | | |
| Includes Transtelephonic Capability | Yes | | |
| Heart Rate Indicators | Yes | | Yes |
| Alarm System | Yes | | Yes |
| Retrieval of Digital Holter Data | 30 days | | 48 Hours |
| Maximum Days for Holter Analysis | 30 days | | 7 Days |
| Auto Detect/Auto Send | Yes | | Yes |
| Manual Trigger | Yes | | Yes |
| Power Input/Battery Type | 3.7V Li-ion | | 3.6V AA |
| Battery Life | 3 - 7 days | | 3 - 7 Days |
| Low Battery Indication | Yes | | Yes |
| Enclosure | Molded Plastic | | Molded Plastic |
| ST Deviation | NEB Configuration | | NEB Configuration |
| Number of Channels | 1, 2 or 3 | | 3 |
| Number of Electrodes | 3 | | 4 |
| Number of Lead Sets | 1 | | 1 |
| Storage Type (Digital or Tape) | Digital | | Digital |
| Operating Temperature Range | 0 to +45 °C | | +10 to +40°C (50 to 104°F) |
| Transport & Storage Temperature | 0 to 65°C | | 20 to +65°C (-4 to 149°F) |
| Relative Humidity | 10% - 95% Non-condensing | | 30% - 85% |
| Dimensions | 5.3 x 2.8 x .8 inches | | 75 x 58 x 23 mm (max.) |
| Weight | 7 oz | | 54 gr |
| ECG Algorithm | | Applied Cardiac Systems, Inc. Automated ECG
Analysis and Interpretation Software | Proprietary |
| Real-Time ECG interpretation
algorithm | Ventricular Fibrillation/Flutter, Atrial
Fibrillation/Flutter, Pause (Asystole),
Bradycardia, Tachycardia | Atrial Fibrillation/Flutter,
Pause, Pause, Bradycardia,
Tachycardia | |

9

儿 1037066 Pg 60f 22

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

ﺴﺴﺴﺴ

10

K1037060 pg70f22

Applied Cardiac Systems Section 5: 510(k) Summary – Abbreviated Submission

11

Section 5: 510(k) Summary – Abbreviated Submission

5-1-2: CORE™ vs. King of Hearts Express+AF (K020825)

| Tables compare the Alarms
and Triggers functionality for
MCT mode | Applied Cardiac Systems, Inc.
The CORE™
(Subject Device) | Card Guard Scientific Survival, Ltd.
King of Hearts Express+AF
(Predicate Device) |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Applied Cardiac Systems, Inc. | Card Guard Scientific Survival, Ltd. |
| 510(k) Number | Class II, DSH, 870.2800,
DSI, 870.1025, DPS, 870.2340 | K020825
Class II, DSH, 870.2800 |
| Intended Use | The MCT mode of the CORE™ device is
intended for outpatient use with remote
clinician data analysis as well as use
within the physician office setting by the
medical professional. The CORE™ device
will provide continuous measurement of
heart rate and rhythm over several days,
detecting asymptomatic events as well as
manual recordings and transmitting them
immediately to a remote monitoring
center, even when the patient is
ambulatory, allowing timely intervention.
The CORE™ device can be used for
evaluation of recurrent unexplained
episodes of pre-syncope, palpitations,
dizziness or when a cardiac arrhythmia is
suspected as the cause of the symptoms.
The CORE™ device is intended for use on
adult patients. | The King of Hearts Express® AF recorder
is a patient-activated recorder designed
for diagnostic evaluation of transient
symptoms; such as dizziness,
palpitations and syncope. The recorder
provides single lead ECG morphology
which may be used to visualize
arrhythmias. It also provides automatic
recording for detected Bradycardia,
tachycardia or atrial fibrillation rhythms.
Using looping memory, the King of
Hearts Express® AF recorder captures
ECG data, both before and after the
patient experiences a cardiac symptom
and the recording is activated. The
patient wears the King of Hearts
Express® AF recorder day and night
while it continuously scans ECG activity.
Upon activation, a cardiac event is
recorded and stored in solid-state
memory. Used in conjunction with a
compatible telephonic ECG receiver or a
receiving service, the King of Hearts
Express® AF recorder provides a practical
and convenient method for collecting
diagnostic ECGs over an extended period
of time for patients with symptoms
suggesting a cardiac arrhythmia. |
| Anatomical Sites | Chest | Chest |
| Environment of Use | Outpatient (home) or Physician's Office | Outpatient (home) or Physician's Office |
| Analog/Digital | Digital | Digital |
| Input Impedance (Ohm) | 5 Megohms (min) | 3 Mohm |
| Electrode Configuration | 1 or 2 lead /3 electrodes | 1 Lead / 2 Electrodes |
| Frequency Response | 0.05 - 100 Hz | 0.05 - 40 Hz |
| CMRR (dB) | 100 (min) dB 115 (typical) dB | 60 dB |
| Input Dynamic Range (mVp-p) | $1.75 V ± 1 μV$ | ECG input range @ 5Hz
AC ±2 mV |

.

12

K1037060 Pr 90f-22

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

Band Width (Hz)	0.05 - 100Hz			DC ±250 mV
Pacemaker Pulse Marker	Yes			0.05 - 40 Hz
QRS Detection Sensitivity	Yes			No
		Summary Results of AHA and MIT Testing		Summary Results of AHA and MIT Testing
	Database	QRS Se	QRS +P	Database	QRS Se	QRS +P
	AHA	97.84	99.55	Combined
Results AHA
MIT and NST	91.4	97.3
	MIT-BIH	98.96	99.27
	NST	90.84	86.83
	AHA - The American Heart Association
Database for Evaluation of Ventricular
Arrhythmia Detectors
MIT-BIH - The Massachusetts Institute of
Technology-Beth Israel Arrhythmia
Database
NST - The Noise Stress Database
Se - Sensitivity: True Positive/True
Positive + False Negative
+P - Positive Predictivity: True
Positive/True Positive + False Positive			AHA - The American Heart Association
Database for Evaluation of Ventricular
Arrhythmia Detectors
MIT-BIH - The Massachusetts Institute of
Technology-Beth Israel Arrhythmia
Database
NST - The Noise Stress Database
Se - Sensitivity: True Positive/True
Positive + False Negative
+P - Positive Predictivity: True
Positive/True Positive + False Positive
System
Communication/Monitoring	Continuous			Interrupted for communication
Maximum Storage Memory	64GB (30+ days)			10 minutes
Data Transmission	Cellular Transmission and
Transtelephonic			Transtelephonic only
Includes Transtelephonic
Capability	Yes			Yes
Heart Rate Indicators	Yes			Yes
Alarm System	Yes			No
Retrieval of Digital Holter Data	30 days			N/A
Maximum Days for Holter
Analysis	30 days			N/A
Auto Detect/Auto Send	Yes			Yes/No
Manual Trigger	Yes			Yes
Power Input/Battery Type	3.7V Li-ion			2 - AAA
Battery Life	3 - 7 days			7 days
Low Battery Indication	Yes			Yes
Enclosure	Molded Plastic			Molded Plastic
ST Deviation	NEB Con			N/A
Number of Channels	1 or 2			1
Number of Electrodes	3			2
Number of Lead Sets	1			1
Storage Type (Digital or Tape)	Digital			Digital
Operating Temperature Range	0 to +45 °C			10 to 40 °C
Transport & Storage	0 to 65°C			-10 to 60 °C

13

K1037066 pg100fzz

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

Temperature
Relative Humidity	10% - 95% Non-condensing	10% - 95% Non-condensing
Dimensions	5.3 x 2.8 x .8 inches	3.38 x 2.13 x .7 inches
Weight	7 oz	3.53 oz
ECG Algorithm	Applied Cardiac Systems, Inc. Automated ECG Analysis and Interpretation Software	Proprietary Algorithm for Detection of A-Fib
Real-Time ECG interpretation algorithm	Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, Tachycardia	Atrial Fibrillation/Flutter, Pause, Bradycardia, Tachycardia

:

14

K1037060 pg110f22

		ALARM & TRIGGER PREDICATE COMPARISON
Project Name:
Document Number:
Document Owner:
Date:		CORE Device
CORE-ENG-SW-0048
ACS
7/14/2011
Rhythm	Alarm	Setting	CORE	CG-6108	KOH EXP	Notes
Ventricular
Fibrillation/Flutter	Onset	Enabled	Y	N/A	N/A
Ventricular
Fibrillation/Flutter	Onset	Priority	1	N/A	N/A
Ventricular
Fibrillation/Flutter	Onset	Pre-Event (Seconds)	30	N/A	N/A
Ventricular
Fibrillation/Flutter	Onset	Post-Event (Seconds)	30	N/A	N/A
Ventricular
Fibrillation/Flutter	Offset	Enabled	Y	N/A	N/A
Ventricular
Fibrillation/Flutter	Offset	Priority	4	N/A	N/A
Ventricular
Fibrillation/Flutter	Offset	Pre-Event (Seconds)	0	N/A	N/A
Ventricular
Fibrillation/Flutter	Offset	Post-Event (Seconds)	0	N/A	N/A
Atrial Fibrillation/Flutter	Onset	Enabled	Y	Y	Y
Atrial Fibrillation/Flutter	Onset	Priority	1	1	N/A
Atrial Fibrillation/Flutter	Onset	Pre-Event (Seconds)	30	60	60
Atrial Fibrillation/Flutter	Onset	Post-Event (Seconds)	30	30	30
Atrial Fibrillation/Flutter	Offset	Enabled	Y	Y	N/A	Offsets cannot be disabled for the ACT
Atrial Fibrillation/Flutter	Offset	Priority	4	1	N/A
Atrial Fibrillation/Flutter	Offset	Pre-Event (Seconds)	0	60	N/A
Atrial Fibrillation/Flutter	Offset	Post-Event (Seconds)	0	30	N/A
Pause (Asystole)	Complete	Enabled	Y	Y	N/A
Pause (Asystole)	Complete	Priority	1	1	N/A
Pause (Asystole)	Complete	Duration (Seconds)	3	3	N/A
Pause (Asystole)	Complete	Pre-Event (Seconds)	30	60	N/A
Pause (Asystole)	Complete	Post-Event (Seconds)	30	30	N/A
Bradycardia	Onset	Enabled	Y	Y	Y	AFX enables Tachy/Brady (single HR)
Bradycardia	Onset	Priority	1	1	N/A
Bradycardia	Onset	Threshold (BPM)	40	40	30
Bradycardia	Onset	Duration (Seconds)	5	25	N/A	Duration is not a settable value
Bradycardia	Onset	Pre-Event (Seconds)	30	60	60
Bradycardia	Onset	Post-Event (Seconds)	30	30	30
Bradycardia	Offset	Enabled	Y	Y	N/A	Offsets cannot be disabled for the ACT
Bradycardia	Offset	Priority	4	1	N/A
Bradycardia	Offset	Threshold (BPM)	40	40	N/A
Bradycardia	Offset	Duration (Seconds)	5	20	N/A
Bradycardia	Offset	Pre-Event (Seconds)	0	60	N/A
Bradycardia	Offset	Post-Event (Seconds)	0	30	N/A
Tachycardia	Onset	Enabled	Y	Y	Y	AFX enables Tachy/Brady (single HR)
Tachycardia	Onset	Priority	1	1	N/A
Tachycardia	Onset	Threshold (BPM)	160	150	150
Tachycardia	Onset	Duration (Seconds)	3	10	N/A	Duration is not a settable value
Tachycardia	Onset	Pre-Event (Seconds)	30	60	60
Tachycardia	Onset	Post-Event (Seconds)	30	30	30
Tachycardia	Offset	Enabled	Y	Y	N/A	Offsets cannot be disabled for the ACT
Tachycardia	Offset	Priority	4	1	N/A
Tachycardia	Offset	Threshold (BPM)	160	150	N/A
Tachycardia	Offset	Duration (Seconds)	3	10	N/A
Tachycardia	Offset	Pre-Event (Seconds)	0	60	N/A
Tachycardia	Offset	Post-Event (Seconds)	0	30	N/A
User	Complete	Enabled	Y	Y	Y
User	Complete	Priority	1	1	N/A
User	Complete	Pre-Event	30	60	60
User	Complete	Post-Event	30	30	30

15

K103706 12 of 22

Applied Cardiac Systems Section 5: 510(k) Summary – Abbreviated Submission

Table 5.1.2 Alarm and Trigger Predicate Comparison

LEGEND

Cannot be set in this device Only a global setting, not individual

Not Applicable

16

5-1-3: CORE™ vs. Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 (K062282)

| Table compares the ECG
QRS Trigger and
Arrhythmia Detection
Algorithm functionality
for MCT mode | Applied Cardiac Systems, Inc.
The CORE™
(Subject Device) | Monebo Technologies, Inc.
Monebo Automated ECG Analysis
And Interpretation Software
Library, Version 3.0
(Predicate Device) |
|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Applied Cardiac Systems, Inc. | Monebo Technologies, Inc. |
| 510(k) Number | Class II, DPS, 870.2340,
DSI, 870.1025, DSH, 870.2800 | K062282
Class II, DPS, 870.2340 |
| Intended Use | MCT mode | Analysis mode |
| Anatomical Sites | Chest | Chest |
| Environment of Use | Physician Office / Hospital | Physician Office / Hospital |
| ECG Algorithm | Applied Cardiac Systems, Inc.
Automated ECG Analysis and
Interpretation Software | Monebo Technologies, Inc.
Monebo Automated ECG Analysis And
Interpretation Software Library |

17

Section 5-1-3-1: Algorithm Results

Accuracy of Arrhythmia Statements & Predicate Comparisons
Arrhythmias	Event (Ese)
Sensitivity			Event (E+P)
Positive Predictive
Accuracy			Duration (Dse)
Sensitivity			Duration (D+P)
Positive Predictive
Accuracy
	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³
Ventricular
Fibrillation/
Flutter7,8,9	99	100	NA	100	NA5	NA	92	NA	NA	97	NA	NA
Atrial
Fibrillation/
Flutter7,10	96	100	88	90	7711
(70)	81	97	NA	70	93	NA	55
Pause
(Asystole)7	99	Insufficient
Data4	NA	100	Insufficient
Data4	NA	98	Insufficient
Data4	NA	96	Insufficient
Data4	NA
Bradycardia7,8,10	97	Insufficient
Data4	NA	79	Insufficient
Data4	NA	93	NA	NA	76	NA	NA
Tachycardia7,8,10	92	Insufficient
Data4	NA	100	Insufficient
Data4	NA	87	NA	NA	95	NA	NA

ACS CORE Accuracy of Arrhythmia Detection and Comparison to Table 5.1.3.1 Predicate Devices

18

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

1. Applied Cardiac Systems, Inc CORE MCT
1. Monebo Automated ECG Analysis and Interpretation Software Library, K062282 predicate device for comparison purposes
Card Guard Scientific Survival Ltd. King of Hearts (KOH) Express+AF Monitor (with Alarms and ನ್ Triggers), K020825
1. Monebo reports "Insufficient data" (ACS was able to collect sufficient data from the AHA, MIT & NST databases. Reference Section 3.4)
1. Monebo reports "Positive and Negative Accuracy cannot be calculated because all records contain VF"
KOH reports Episode/Duration Sensitivity & Episode/Duration positive predictivity റ്.
MIT BIH Massachusetts Institute of Technology Beth Israel Hospital Arrhythmia Database 7.
1. AHA - American Heart Association Database for the Evaluation of Ventricular Arrhythmia Detectors
റ്റ് CU - Creighton University Sustained Ventricular Arrhythmia Database
NST Noise Stress Test Database 10.
Monebo predicate reports 100% for Se, Sp, and -P but 77% for +P. Since the +P is reported as 11. 77%, this implies a Sp of 70% not 100%. It is also unclear if the Monebo predicate is reporting on AF episodes or AF durations. AF episodes is assumed.

| Feature | Applied Cardiac
Systems, Inc
CORE
MCT | Monebo Automated ECG
Analysis and Interpretation
Software Library
K062282 | Card Guard Scientific
Survival Ltd.
KOH Express+AF
Monitor K020825 |
|-----------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Heart rate determination for
non-paced adult | YES | YES | YES |
| QRS Detection | YES | YES | YES |
| VF arrhythmia interpretation for
adult patients | YES | YES | NO |
| AF arrhythmia interpretation for
adult patients | YES | YES | YES |
| Non-paced ventricular
arrhythmia calls for adult
patients | NO | YES | NO |
| Intervals measurement | YES | YES | NO |
| Ventricular ectopic beat
detection | NO | YES | NO |
| Patient Populations | ADULT | ADULT | ADULTS |
| Alarms & Triggers | YES | NO | YES |

19

Section 5: 510(k) Summary – Abbreviated Submission

Summary results of AHA, MIT, and NST testing
Database	QRS Se		QRS +P
	ACS
CORE	Monebo Automated
ECG Analysis and
Interpretation
Software Library	ACS
CORE	Monebo Automated
ECG Analysis and
Interpretation
Software Library
AHA	97.84	99.56	99.55	99.9
MIT-BIH	98.96	99.45	99.27	99.45
NST	90.84	91.56	86.83	85.66

Table 5.1.3.2 Feature Comparison of ACS CORE MCT with Predicate Device

Table 5.1.3.3 ACS CORE QRS / VEB Results

Accuracy of Arrhythmia Detection
Event Sensitivity	Event Predictivity	Duration
Sensitivity	Duration
Predictivity
97.59	94.85	97.35	94.30

Table 5.1.3.4 ACS CORE Accuracy Arrhythmia Detection

ﺴﯿﺴﯿﺴ

20

Applied Cardiac Systems Section 5: 510(k) Summary – Abbreviated Submission

5-1-4: CORE™ vs. The Holter Reporter™ (K860249)

| Table compares the
CORE™ Receiving
Module Software
functionality for MCT
mode | Applied Cardiac Systems, Inc.
The CORE™
(Subject Device) | Applied Cardiac Systems, Inc.
The Holter Reporter™
(Predicate Device) |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Applied Cardiac Systems, Inc. | Applied Cardiac Systems |
| 510(k) Number | Class II, DPS, 870.2340,
DSI, 870.1025, DSH, 870.2800 | K860249
Class II, DPS, 870.2340 |
| Intended Use | Resting 12-lead EKG | 3,12-lead ECG |
| Anatomical Sites | Chest, Arms, Legs | Chest |
| Environment of Use | Physician Office / Hospital | Physician Office / Hospital |
| Real-time 12-lead ECK | Yes | Yes |
| Preview | Yes | Yes |
| Monitor | Yes | Yes |
| 802.15.4 Transceiver | Yes | No |
| Storage | Up to 64 GB | 300 GB |
| Capture Mode | Yes | Yes |
| Transmit Wireless | Yes | Yes |
| 3+1, outputs | Yes | Yes |
| 3+3 output | Yes | Yes |
| 6-channel output | Yes | Yes |
| 12-channel output | Yes | Yes |
| Connectivity Options | USB, 802.15.4, Cellular Modem,
Bluetooth | LAN,USB |
| Information Exchange
Interfaces | EMR-HL-7,XML,PDF | EMR-HL-7,XML,PDF |
| ECG Algorithm | Applied Cardiac Systems, Inc.
Automated ECG Analysis and
Interpretation Software (K860249) | Applied Cardiac Systems, Inc.
Automated ECG Analysis and
Interpretation Software |
| Resting ECG
interpretation algorithm | 1. SINUS RHYTHM
2. SINUS BRADYCARDIA
3. SINUS TACHYCARDIA
4. PREMATURE JUNCTIONAL
CONTRACTION
5. JUNCTIONAL TACHYCARDIA
6. FIRST DEGREE HEART BLOCK

SINUS RHYTHM

FIRST DEGREE HEART BLOCK

SINUS TACHYCARDIA

FIRST DEGREE HEART BLOCK

SINUS BRADYCARDIA

SECOND DEGREE HEART
BLOCK TYPE I | 1. SINUS RHYTHM
SINUS BRADYCARDIA
SINUS TACHYCARDIA
PREMATURE JUNCTIONAL
CONTRACTION
JUNCTIONAL TACHYCARDIA
FIRST DEGREE HEART BLOCK

SINUS RHYTHM

FIRST DEGREE HEART BLOCK

SINUS TACHYCARDIA

FIRST DEGREE HEART BLOCK

SINUS BRADYCARDIA

SECOND DEGREE HEART
BLOCK TYPE I |
| | 10. SECOND DEGREE HEART
BLOCK TYPE II | 10. SECOND DEGREE HEART
BLOCK TYPE II |
| | 11. THIRD DEGREE (COMPLETE)
HEART BLOCK | 11. THIRD DEGREE (COMPLETE)
HEART BLOCK |
| | 12. PREMATURE ATRIAL
CONTRACTION | 12. PREMATURE ATRIAL
CONTRACTION |
| | 13. SUPRAVENTRICULAR
TACHYCARDIA | 13. SUPRAVENTRICULAR
TACHYCARDIA |
| | 14. ATRIAL
FIBRILLATION/FLUTTER
SVR | 14. ATRIAL
FIBRILLATION/FLUTTER
SVR |
| | 15. ATRIAL
FIBRILLATION/FLUTTER
CVR | 15. ATRIAL
FIBRILLATION/FLUTTER
CVR |
| | 16. ATRIAL
FIBRILLATION/FLUTTER
RVR | 16. ATRIAL
FIBRILLATION/FLUTTER
RVR |
| | 17. PAUSE | 17. PAUSE |
| | 18. PREMATURE VENTRICULAR
CONTRACTION | 18. PREMATURE VENTRICULAR
CONTRACTION |
| | 19. VENTRICULAR COUPLET | 19. VENTRICULAR COUPLET |
| | 20. VENTRICULAR TRIPLET | 20. VENTRICULAR TRIPLET |
| | 21. VENTRICULAR BIGEMINY | 21. VENTRICULAR BIGEMINY |
| | 22. VENTRICULAR TRIGEMINY . | 22. VENTRICULAR TRIGEMINY |
| | 23. IDIOVENTRICULAR RHYTHM | 23. IDIOVENTRICULAR RHYTHM |
| | 24. VENTRICULAR
TACHYCARDIA | 24. VENTRICULAR
TACHYCARDIA |
| | 25. SLOW VENTRICULAR
TACHYCARDIA | 25. SLOW VENTRICULAR
TACHYCARDIA |
| | 26. VENTRICULAR FLUTTER | 26. VENTRICULAR FLUTTER |
| | 27. ARTIFACT | 27. ARTIFACT |
| Full Keyboard | Yes | Yes |
| Full-Size 8½ x 11 | Yes | Yes |

21

K103706 18 of 22 pg

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

t

22

		5-1-5: CORE™ vs. Model 950-12L (K102723)
--	--	-------------------------------------------	--

| Table compares the Holter | Applied Cardiac Systems, Inc.
CORE™ | Memtec Corporation
Model 950-12L |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| functionality mode | (Subject Device) | (Predicate Device) |
| Manufacturer | Applied Cardiac Systems, Inc. | Memtec Corporation |
| 510(k) Number | Class II, DSH, 870.2800,
DSI, 870.1025, DPS, 870.2340 | K102723
Class II, MWJ, 870.2800 |
| Intended Use | Holter Monitoring | Holter Monitoring |
| Anatomical Sites | Chest, Arms, Legs | Chest |
| Environment of Use | Physician Office / Hospital | Physician Office / Hospital |
| Sample Rate | 256,512,1024,2048 (3 & 12-
chan) Oversample rate: up to
32,000 samples per second | Selectable 128, 256, 512, or 1024
samples per second |
| A/D Resolution (bits) | 16-20 at 3.25µV/Bit | Selectable 8, 10 or 12 bits per
channel with 6K SPS over-
sampling per channel |
| Bandwidth | 0.05-100Hz (0.05-125KHz Pacer) | 0.05 to 60 Hz. (-3 db) |
| Battery | 3.7V Li-Ion with auto shutdown
when battery is exhausted
(protecting against battery
leakage).
Not user changeable. | One AA alkaline, lithium, or
rechargeable NiMH battery with
reverse polarity protection and
auto shutdown when battery is
exhausted (protecting against
battery leakage) |
| Pacemaker Detection | Yes | Yes |
| Lead Sets | 12 Lead (optional 3 channel 5
lead available) | 12 Lead patient Cable (optional 3
channel 5 or 7 lead available) |
| USB 2.0 Download | Yes | Yes |
| Cellular Download | Yes | No. |
| Data Integrity | ECC & MD5 every Min | Patient ID, date, and time
stamped records with CRC-16 in
2 min. intervals (patent pending) |
| LCD Screen | 3.2" TFT 256K Colors | Large monochrome 119 x 73 LCD
display |
| Keyboard | 5-Button | 5-button |
| Touchscreen | Yes | No |
| SDHC Flash Storage | Up to 64 GB | SD or SDHC storage card (up to
4GB, removable) |
| USB Built into Cable set | No - Cable set needs to be
removed – uses custom USB
cable | No - Cable set needs to be
removed - uses standard USB
mini Cable |
| USB Charging | No | No |
| Power Wall Charger | Yes | No |
| Maximum Recording Duration | 5 days @2048 SPS 12-Chan | Up to 48 hours in 12 lead mode /
In 3 Channel Mode; up to 120 |

・

23

K103706 pg 20 of 22

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

5-1-6: CORE™ vs. EK10 (K870880)

hours

| Table compares the
Resting 12-lead EKG
functionality mode | Applied Cardiac Systems, Inc.
The CORE™
(Subject Device) | Burdick Corp.
EK10 Electrocardiograph
(Predicate Device) |
|-----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Manufacturer | Applied Cardiac Systems, Inc. | Burdick Corporation |
| 510(k) Number | Class II, DPS, 870.2340,
DSI, 870.1025, DSH, 870.2800 | K870880
Class II, DPS, 870.2340 |
| Intended Use | Resting 12-lead EKG | Resting 12-lead EKG |
| Anatomical Sites | Chest, Arms, Legs | Chest, Arms, Legs |
| Environment of Use | Physician Office / Hospital | Physician Office / Hospital |
| Real-time 12-lead EKG | Yes | Yes |
| Preview | Yes | No |
| Monitor | Yes | No |
| 802.15.4 Transceiver | Yes | No |
| Storage | Up to 64 GB | None |
| Capture Mode | Yes | N/A |
| Transmit Wireless | Yes | N/A |
| 3+1, outputs | Yes | One channel at a time |
| 3+3 output | Yes | One channel at a time |
| 6-channel output | Yes | One channel at a time |
| 12-channel output | Yes | One channel at a time |
| Information Exchange
Interfaces | EMR-HL-7,XML,PDF | N/A |
| Input Impedance (Ohm) | 5 Megohms (min) | Greater than 50 Mohm |
| Power/Input/Battery | 3.7V Li-ion | 12.5Vdc nickel-cadmium |
| Type | AC power N/A | 120Vac |
| Operating Temperature
Range | 0 to +45 °C | 10 deg. C to 40 deg. C |
| Transport & Storage
Temperature | 0 to 65 °C | -34 deg. C to 70 deg. C |
| Relative Humidity | 10% to 95% Non-condensing | 15% to 90% Non-condensing |
| Dimensions | 5.3 x 2.8 x.8 inches | 11 x 13 x 3-3/16 inches |
| Weight | 7 oz. | 9 lb. (including optional battery) |
| ECG Algorithm | N/A | N/A |
| Resting ECG
interpretation algorithm | No | No |
| Full Keyboard | Multiple choice menu buttons | Multiple choice menu buttons |

24

As is evident from the above discussion, none of the above differences raises a question of safety and effectiveness, and the CORE™ device remains substantially equivalent to its predicate devices in indications and intended use, safety, and effectiveness.

Referenced Standards:

Prior to marketing the CORE™ device, verification testing activities will be conducted to meet specified acceptance criteria and establish compliance, performance and reliability characteristics of the CORE™ device. This is to include all applicable acceptance criteria and tests in the applicable standards; a statement of conformity to the standards is not made until testing has been completed.

Consensus Standards:

Included are the forms FDA FORM 3654 (as replicated by Applied Cardiac Systems), completed for each of the following consensus standards:

. IEC 60601-1-2 Ed 2.1:2004, (Ed 2:2001 with Amendment 1:2004); Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests;
트 ANSI/AAMI EC13:2002(R) 2007, Cardiac monitors, heart rate meters and alarms;
. ANSI/AAMI EC53:1995/(R) 2008, ECG cables and leadwires;
- I AAMI/ANSI EC57:1998/(R) 2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms;

Other standards:

Also included in this submission are FDA FORM 3654 (as replicated by Applied Cardiac Systems) completed for the following other standard.

. IEC 60601-1 Ed 2:1988, Amendment 1:1991, Amendment 2:1995; Medical Electrical Equipment Part 1: General requirements for safety (IEC 60601-1 Ed 2:1988, is the general standard to IEC 60601-1-2 Ed 2.1:2004 and as such is part of the consensus standard IEC 60601-1-2 ).
l IEC 60601-1-4:1999, General requirements for basic safety and essential performance -Collateral standard Programmable electrical medical systems.
ANSI/AAMI EC11:1991/(R) 2007, Diagnostic electrocardiographic devices.
l AAMI/ANSI EC38:2007, Medical electrical equipment – Part 2–47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems.
i 21 CFR Part 898, Performance Standard for Electrode Lead Wires and Patient Cables;

25

Section 5: 510(k) Summary - Abbreviated Submission

Additional testing:

The following documents at the end of this section address the request for additional testing documentation:

document number CORE-ENG-HW-0006 titled MCT Hardware Requirements 1. ACS Specification (MCT Recorder)
1. ACS document number CORE-ENG-HW-0008 titled Main Board Requirements Specification (MCT Recorder)
1. ACS document number CORE-ENG-HW-0010 titled ACS ECG Data Acquisition Module Specification ·
1. ACS document number CORE-ENG-HW-0007 titled MCT Hardware Test Requirements Specification (MCT Recorder)
1. ACS document number MS9-ENG-SW-0011 titled M9 CORE™ Processing Module Validation Test Plan

Substantial Equivalence Conclusion:

The CORE™ mobile cardiac telemetry (MCT) device by Applied Cardiac Systems, Inc. essentially has the same intended use and similar operating principles and technical characteristics as the predicate devices. It will be subjected to the same set of performance and safety tests as the predicate devices, as described in the Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm. Based upon the comparisons made, the CORE™ is safe, effective and poses no adverse health or safety risks and is therefore substantially equivalent to the predicate devices.