THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

{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. - 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. - 3. 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. - 2. 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. - 3. 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. - 4. 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 - 5. Memtec Corp. Model 950-12L as cleared by the FDA under 510(k) number K102723; Product Classification Code MWJ, Regulation 870.2800. - 6. 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. - 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, pre-Syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. - 3. 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<br>mode device functionality | Applied Cardiac Systems, Inc.<br>The CORE™<br>(Subject Device) | Card Guard Scientific Survival,<br>Ltd.<br>CG-6108<br>(Predicate Device) | | |--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------| | Manufacturer | Applied Cardiac Systems, Inc. | Card Guard Scientific Survival,<br>Ltd. | | | 510(k) Number | Class II, DSI, 870.1025,<br>DSH, 870.2800, DPS, 870.2340 | K071995<br>Class II, DSI. 870.1025 | | | Intended Use | The MCT mode of the CORE™ device is<br>intended for outpatient use with remote<br>clinician data analysis as well as use within the<br>physician office setting by the medical<br>professional. The CORE™ device will provide<br>continuous measurement of heart rate and<br>rhythm over several days, detecting<br>asymptomatic events as well as manual<br>recordings and transmitting them immediately<br>to a remote monitoring center, even when the<br>patient is ambulatory, allowing timely<br>intervention. The CORE™ device can be used<br>for evaluation of recurrent unexplained<br>episodes of pre-syncope, palpitations,<br>dizziness or when a cardiac arrhythmia is<br>suspected as the cause of the symptoms. The<br>CORE™ device is intended for use on adult<br>patients. | Intended for use by patients<br>who experience transient<br>symptoms that may suggest<br>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<br>Database for Evaluation of Ventricular<br>Arrhythmia Detectors | | | | | MIT-BIH - The Massachusetts Institute of<br>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<br>Analysis and Interpretation Software | Proprietary | | Real-Time ECG interpretation<br>algorithm | Ventricular Fibrillation/Flutter, Atrial<br>Fibrillation/Flutter, Pause (Asystole),<br>Bradycardia, Tachycardia | Atrial Fibrillation/Flutter,<br>Pause, Pause, Bradycardia,<br>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<br>and Triggers functionality for<br>MCT mode | Applied Cardiac Systems, Inc.<br>The CORE™<br>(Subject Device) | Card Guard Scientific Survival, Ltd.<br>King of Hearts Express+AF<br>(Predicate Device) | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Applied Cardiac Systems, Inc.…