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.

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.

AI/ML Overview

The Applied Cardiac Systems, Inc. CORE™ (Cardiac Outpatient Realtime ECG) device is a multi-purpose device with MCT (Mobile Cardiac Outpatient Telemetry), Holter, and Multi-Lead (Resting EKG) modes. The acceptance criteria and the study results primarily focus on the MCT mode for arrhythmia detection.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for arrhythmia detection are derived from industry standards for evaluating ventricular arrhythmia detectors and are based on sensitivity (Se) and positive predictivity (+P) for event and duration. The reported device performance is compared against these metrics.

Arrhythmia Type	Metric	Acceptance Criteria (Predicate)	Reported Device Performance (ACS CORE)
Ventricular Fibrillation/Flutter	Event Sensitivity (Ese)	--- (See detailed comparison below)	99
	Event Positive Predictivity (E+P)	--- (See detailed comparison below)	100
	Duration Sensitivity (Dse)	--- (See detailed comparison below)	92
	Duration Positive Predictivity (D+P)	--- (See detailed comparison below)	97
Atrial Fibrillation/Flutter	Event Sensitivity (Ese)	88 (KOH) / 100 (Monebo)	96
	Event Positive Predictivity (E+P)	81 (KOH) / 77 (Monebo)	90
	Duration Sensitivity (Dse)	70 (KOH) / NA (Monebo)	97
	Duration Positive Predictivity (D+P)	55 (KOH) / NA (Monebo)	93
Pause (Asystole)	Event Sensitivity (Ese)	Insufficient Data (Monebo) / NA	99
	Event Positive Predictivity (E+P)	Insufficient Data (Monebo) / NA	100
	Duration Sensitivity (Dse)	Insufficient Data (Monebo) / NA	98
	Duration Positive Predictivity (D+P)	Insufficient Data (Monebo) / NA	96
Bradycardia	Event Sensitivity (Ese)	Insufficient Data (Monebo) / NA	97
	Event Positive Predictivity (E+P)	Insufficient Data (Monebo) / NA	79
	Duration Sensitivity (Dse)	Insufficient Data (Monebo) / NA	93
	Duration Positive Predictivity (D+P)	Insufficient Data (Monebo) / NA	76
Tachycardia	Event Sensitivity (Ese)	Insufficient Data (Monebo) / NA	92
	Event Positive Predictivity (E+P)	Insufficient Data (Monebo) / NA	100
	Duration Sensitivity (Dse)	Insufficient Data (Monebo) / NA	87
	Duration Positive Predictivity (D+P)	Insufficient Data (Monebo) / NA	95

Note on Predicate Comparison: The document primarily compares the CORE™ device's performance to predicate devices (Monebo Automated ECG Analysis and Interpretation Software Library (K062282) and Card Guard Scientific Survival Ltd. King of Hearts Express+AF Monitor (K020825)) rather than explicit acceptance criteria with numerical targets. The reported device performance for CORE™ is generally comparable to or exceeds the reported performance of the predicate devices where data is available. For some arrhythmias, the predicates had "insufficient data" or "NA", suggesting the CORE™ device demonstrated performance where the predicates did not provide comparable figures.

QRS Detection Sensitivity and Positive Predictivity (Table 5.1.3.3):

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

Overall Arrhythmia Detection Accuracy (Table 5.1.3.4):

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

2. Sample Size Used for the Test Set and Data Provenance

The primary test sets used for evaluating the QRS detection and arrhythmia detection accuracy were:

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)
CU (Creighton University Sustained Ventricular Arrhythmia Database)

These are well-known, publicly available, benchmark databases commonly used for evaluating ECG algorithms. The provenance is therefore well-established academic/research institutions, and the data is retrospective. The specific sample sizes (number of recordings/patients) from these databases for the test set are not explicitly stated in the provided text, but it is implied that the entire databases were utilized for testing, as is standard practice for these benchmarks.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the test sets (AHA, MIT-BIH, NST, CU databases) was established during the creation of these publicly available and widely accepted benchmark databases. These databases typically have annotations provided by medical experts, often cardiologists or electrophysiologists, or derived from expert consensus. The specific number and qualifications of experts involved in the original annotation of these databases are not detailed in this submission but are generally considered robust and peer-reviewed given their widespread use in the field.

4. Adjudication Method for the Test Set

The adjudication method for the ground truth of these standard databases (AHA, MIT-BIH, NST) would have been established by the creators of each respective database. While not explicitly stated in the provided document, these databases generally rely on expert review and consensus, potentially involving multiple independent reviewers to establish the "truth" annotations for arrhythmias and QRS complexes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the algorithm.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The tables showing "Accuracy of Arrhythmia Statements & Predicate Comparisons" and "Summary results of AHA, MIT, and NST testing" (Tables 5.1.3.1, 5.1.3.3, and 5.1.3.4) detail the performance of the Applied Cardiac Systems CORE™ algorithm itself, without human intervention. This evaluates the algorithm's ability to detect different arrhythmias and QRS complexes automatically against established ground truths.

7. Type of Ground Truth Used

The type of ground truth used for the QRS and arrhythmia detection evaluations was expert consensus / annotated databases. Specifically, electrocardiogram (ECG) waveform databases (AHA, MIT-BIH, NST, CU) which contain expert-annotated cardiac events and rhythms.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set of the CORE™ device's embedded algorithm. It only mentions the databases used for testing.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. Given that the test sets are standard benchmark databases with expert-annotated ground truth, it is highly probable that similar expert-annotated data (either from these databases or other similar datasets) was used for training. However, the specific methodology for training data ground truth establishment is not detailed in the provided text.

Summary

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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

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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.

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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,

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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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

(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

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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.

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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 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

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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.

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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.

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

5-1-1: CORE™ vs. CG-6108 (K071995)

Table compares the MCTmode 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	K071995Class II, DSI. 870.1025
Intended Use	The MCT mode of the CORE™ device isintended for outpatient use with remoteclinician data analysis as well as use within thephysician office setting by the medicalprofessional. The CORE™ device will providecontinuous measurement of heart rate andrhythm over several days, detectingasymptomatic events as well as manualrecordings and transmitting them immediatelyto a remote monitoring center, even when thepatient is ambulatory, allowing timelyintervention. The CORE™ device can be usedfor evaluation of recurrent unexplainedepisodes of pre-syncope, palpitations,dizziness or when a cardiac arrhythmia issuspected as the cause of the symptoms. TheCORE™ device is intended for use on adultpatients.	Intended for use by patientswho experience transientsymptoms that may suggestcardiac 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 AssociationDatabase for Evaluation of VentricularArrhythmia Detectors
MIT-BIH - The Massachusetts Institute ofTechnology-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 ECGAnalysis and Interpretation Software	Proprietary
Real-Time ECG interpretationalgorithm	Ventricular Fibrillation/Flutter, AtrialFibrillation/Flutter, Pause (Asystole),Bradycardia, Tachycardia	Atrial Fibrillation/Flutter,Pause, Pause, Bradycardia,Tachycardia

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儿 1037066 Pg 60f 22

Applied Cardiac Systems

Section 5: 510(k) Summary – Abbreviated Submission

ﺴﺴﺴﺴ

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K1037060 pg70f22

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

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Section 5: 510(k) Summary – Abbreviated Submission

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

Tables compare the Alarmsand Triggers functionality forMCT 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	K020825Class II, DSH, 870.2800
Intended Use	The MCT mode of the CORE™ device isintended for outpatient use with remoteclinician data analysis as well as usewithin the physician office setting by themedical professional. The CORE™ devicewill provide continuous measurement ofheart rate and rhythm over several days,detecting asymptomatic events as well asmanual recordings and transmitting themimmediately to a remote monitoringcenter, even when the patient isambulatory, allowing timely intervention.The CORE™ device can be used forevaluation of recurrent unexplainedepisodes of pre-syncope, palpitations,dizziness or when a cardiac arrhythmia issuspected as the cause of the symptoms.The CORE™ device is intended for use onadult patients.	The King of Hearts Express® AF recorderis a patient-activated recorder designedfor diagnostic evaluation of transientsymptoms; such as dizziness,palpitations and syncope. The recorderprovides single lead ECG morphologywhich may be used to visualizearrhythmias. It also provides automaticrecording for detected Bradycardia,tachycardia or atrial fibrillation rhythms.Using looping memory, the King ofHearts Express® AF recorder capturesECG data, both before and after thepatient experiences a cardiac symptomand the recording is activated. Thepatient wears the King of HeartsExpress® AF recorder day and nightwhile it continuously scans ECG activity.Upon activation, a cardiac event isrecorded and stored in solid-statememory. Used in conjunction with acompatible telephonic ECG receiver or areceiving service, the King of HeartsExpress® AF recorder provides a practicaland convenient method for collectingdiagnostic ECGs over an extended periodof time for patients with symptomssuggesting 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 @ 5HzAC ±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	CombinedResults AHAMIT and NST	91.4	97.3
	MIT-BIH	98.96	99.27
	NST	90.84	86.83
	AHA - The American Heart AssociationDatabase for Evaluation of VentricularArrhythmia DetectorsMIT-BIH - The Massachusetts Institute ofTechnology-Beth Israel ArrhythmiaDatabaseNST - The Noise Stress DatabaseSe - Sensitivity: True Positive/TruePositive + False Negative+P - Positive Predictivity: TruePositive/True Positive + False Positive			AHA - The American Heart AssociationDatabase for Evaluation of VentricularArrhythmia DetectorsMIT-BIH - The Massachusetts Institute ofTechnology-Beth Israel ArrhythmiaDatabaseNST - The Noise Stress DatabaseSe - Sensitivity: True Positive/TruePositive + False Negative+P - Positive Predictivity: TruePositive/True Positive + False Positive
SystemCommunication/Monitoring	Continuous			Interrupted for communication
Maximum Storage Memory	64GB (30+ days)			10 minutes
Data Transmission	Cellular Transmission andTranstelephonic			Transtelephonic only
Includes TranstelephonicCapability	Yes			Yes
Heart Rate Indicators	Yes			Yes
Alarm System	Yes			No
Retrieval of Digital Holter Data	30 days			N/A
Maximum Days for HolterAnalysis	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 DeviceCORE-ENG-SW-0048ACS7/14/2011
Rhythm	Alarm	Setting	CORE	CG-6108	KOH EXP	Notes
VentricularFibrillation/Flutter	Onset	Enabled	Y	N/A	N/A
VentricularFibrillation/Flutter	Onset	Priority	1	N/A	N/A
VentricularFibrillation/Flutter	Onset	Pre-Event (Seconds)	30	N/A	N/A
VentricularFibrillation/Flutter	Onset	Post-Event (Seconds)	30	N/A	N/A
VentricularFibrillation/Flutter	Offset	Enabled	Y	N/A	N/A
VentricularFibrillation/Flutter	Offset	Priority	4	N/A	N/A
VentricularFibrillation/Flutter	Offset	Pre-Event (Seconds)	0	N/A	N/A
VentricularFibrillation/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 ECGQRS Trigger andArrhythmia DetectionAlgorithm functionalityfor MCT mode	Applied Cardiac Systems, Inc.The CORE™(Subject Device)	Monebo Technologies, Inc.Monebo Automated ECG AnalysisAnd Interpretation SoftwareLibrary, 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	K062282Class 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 andInterpretation Software	Monebo Technologies, Inc.Monebo Automated ECG Analysis AndInterpretation Software Library

{17}------------------------------------------------

Section 5-1-3-1: Algorithm Results

Accuracy of Arrhythmia Statements & Predicate Comparisons
Arrhythmias	Event (Ese)Sensitivity			Event (E+P)Positive PredictiveAccuracy			Duration (Dse)Sensitivity			Duration (D+P)Positive PredictiveAccuracy
	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³	ACS¹	Monebo²	KOH³
VentricularFibrillation/Flutter7,8,9	99	100	NA	100	NA5	NA	92	NA	NA	97	NA	NA
AtrialFibrillation/Flutter7,10	96	100	88	90	7711(70)	81	97	NA	70	93	NA	55
Pause(Asystole)7	99	InsufficientData4	NA	100	InsufficientData4	NA	98	InsufficientData4	NA	96	InsufficientData4	NA
Bradycardia7,8,10	97	InsufficientData4	NA	79	InsufficientData4	NA	93	NA	NA	76	NA	NA
Tachycardia7,8,10	92	InsufficientData4	NA	100	InsufficientData4	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 CardiacSystems, IncCOREMCT	Monebo Automated ECGAnalysis and InterpretationSoftware LibraryK062282	Card Guard ScientificSurvival Ltd.KOH Express+AFMonitor K020825
Heart rate determination fornon-paced adult	YES	YES	YES
QRS Detection	YES	YES	YES
VF arrhythmia interpretation foradult patients	YES	YES	NO
AF arrhythmia interpretation foradult patients	YES	YES	YES
Non-paced ventriculararrhythmia calls for adultpatients	NO	YES	NO
Intervals measurement	YES	YES	NO
Ventricular ectopic beatdetection	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
	ACSCORE	Monebo AutomatedECG Analysis andInterpretationSoftware Library	ACSCORE	Monebo AutomatedECG Analysis andInterpretationSoftware 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	DurationSensitivity	DurationPredictivity
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 theCORE™ ReceivingModule Softwarefunctionality for MCTmode	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	K860249Class 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 ExchangeInterfaces	EMR-HL-7,XML,PDF	EMR-HL-7,XML,PDF
ECG Algorithm	Applied Cardiac Systems, Inc.Automated ECG Analysis andInterpretation Software (K860249)	Applied Cardiac Systems, Inc.Automated ECG Analysis andInterpretation Software
Resting ECGinterpretation algorithm	1. SINUS RHYTHM2. SINUS BRADYCARDIA3. SINUS TACHYCARDIA4. PREMATURE JUNCTIONALCONTRACTION5. JUNCTIONAL TACHYCARDIA6. FIRST DEGREE HEART BLOCK+ SINUS RHYTHM7. FIRST DEGREE HEART BLOCK+ SINUS TACHYCARDIA8. FIRST DEGREE HEART BLOCK+ SINUS BRADYCARDIA9. SECOND DEGREE HEARTBLOCK TYPE I	1. SINUS RHYTHM2. SINUS BRADYCARDIA3. SINUS TACHYCARDIA4. PREMATURE JUNCTIONALCONTRACTION5. JUNCTIONAL TACHYCARDIA6. FIRST DEGREE HEART BLOCK+ SINUS RHYTHM7. FIRST DEGREE HEART BLOCK+ SINUS TACHYCARDIA8. FIRST DEGREE HEART BLOCK+ SINUS BRADYCARDIA9. SECOND DEGREE HEARTBLOCK TYPE I
	10. SECOND DEGREE HEARTBLOCK TYPE II	10. SECOND DEGREE HEARTBLOCK TYPE II
	11. THIRD DEGREE (COMPLETE)HEART BLOCK	11. THIRD DEGREE (COMPLETE)HEART BLOCK
	12. PREMATURE ATRIALCONTRACTION	12. PREMATURE ATRIALCONTRACTION
	13. SUPRAVENTRICULARTACHYCARDIA	13. SUPRAVENTRICULARTACHYCARDIA
	14. ATRIALFIBRILLATION/FLUTTERSVR	14. ATRIALFIBRILLATION/FLUTTERSVR
	15. ATRIALFIBRILLATION/FLUTTERCVR	15. ATRIALFIBRILLATION/FLUTTERCVR
	16. ATRIALFIBRILLATION/FLUTTERRVR	16. ATRIALFIBRILLATION/FLUTTERRVR
	17. PAUSE	17. PAUSE
	18. PREMATURE VENTRICULARCONTRACTION	18. PREMATURE VENTRICULARCONTRACTION
	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. VENTRICULARTACHYCARDIA	24. VENTRICULARTACHYCARDIA
	25. SLOW VENTRICULARTACHYCARDIA	25. SLOW VENTRICULARTACHYCARDIA
	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

{22}------------------------------------------------

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

Table compares the Holter	Applied Cardiac Systems, Inc.CORE™	Memtec CorporationModel 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	K102723Class 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 to32,000 samples per second	Selectable 128, 256, 512, or 1024samples per second
A/D Resolution (bits)	16-20 at 3.25µV/Bit	Selectable 8, 10 or 12 bits perchannel 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 shutdownwhen battery is exhausted(protecting against batteryleakage).Not user changeable.	One AA alkaline, lithium, orrechargeable NiMH battery withreverse polarity protection andauto shutdown when battery isexhausted (protecting againstbattery leakage)
Pacemaker Detection	Yes	Yes
Lead Sets	12 Lead (optional 3 channel 5lead available)	12 Lead patient Cable (optional 3channel 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 timestamped records with CRC-16 in2 min. intervals (patent pending)
LCD Screen	3.2" TFT 256K Colors	Large monochrome 119 x 73 LCDdisplay
Keyboard	5-Button	5-button
Touchscreen	Yes	No
SDHC Flash Storage	Up to 64 GB	SD or SDHC storage card (up to4GB, removable)
USB Built into Cable set	No - Cable set needs to beremoved – uses custom USBcable	No - Cable set needs to beremoved - uses standard USBmini 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 theResting 12-lead EKGfunctionality 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	K870880Class 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 ExchangeInterfaces	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 TemperatureRange	0 to +45 °C	10 deg. C to 40 deg. C
Transport & StorageTemperature	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 ECGinterpretation 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.

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.