(256 days)
No
The summary explicitly states, "The device does not include automated analysis except for heart rate calculation." There are no mentions of AI, ML, or related technologies.
Yes
The device is a monitoring device that captures and displays ECG information, which is then reviewed by a physician to render a diagnosis. It does not provide any treatment or therapy.
Yes
The device captures, stores, transmits, and displays ECG information for review by a physician to "render a diagnosis based on clinical judgment and experience," indicating its role in providing diagnostic data.
No
The device description explicitly lists hardware components: the QardioCore sensor, chest strap, and USB charging cable. While software (Qardio App, cloud server, ECG Viewer) is a significant part of the system, it is not the sole component.
Based on the provided text, the QardioCore ECG ambulatory monitoring device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The QardioCore device captures electrical signals from the body's surface (ECG).
- The device's function is to capture, store, transmit, and display ECG information. It does not perform any analysis of biological samples.
- The diagnosis is made by a physician based on the collected ECG data. The device itself does not provide a diagnostic result based on analyzing a sample.
The QardioCore is a medical device that collects physiological data (ECG) from the patient's body.
N/A
Intended Use / Indications for Use
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
Product codes
DSH
Device Description
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
The QardioCore ECG Monitor is composed of six main components: i) the QardioCore sensor with Bluetooth technology, ii) a chest strap that allows fitting of OardioCore sensor, iii) a USB charging cable, iv) the Qardio App (can be downloaded and installed from the respective App store) and runs on any iOS device with iOS version 10.0 or later, v) the cloud based server where the Qardio App stores and retrieves data, and vi) the ECG Viewer which provides a web interface to the doctor to view the data sent by the iPhone application.
The QardioCore device is a wearable device that captures information through a single-channel ECG. The data is then encrypted and transmitted via Bluetooth Low Energy to the Qardio App, installed on a compatible mobile platform. The OardioCore is supplied with chest straps accommodating chest sizes ranging from 27-5 to 43 inches. An optional XL chest strap is available from 41.7 to 59.8 inches. The device is provided with a USB Type-A cable to charge the device.
The Qardio App (which can be installed from the user's respective app store), can transmit the data, via Wi-Fi or standard data mobile telephony, to Qardio cloud based server for storage processing and transmission to an expert medical professional.
The ECG Viewer application provides a web interface to the doctor to view the ECG data collected from the iPhone Application. All data that a patient accumulates using the QardioCore device is stored in the central server. The ECG Viewer provides the doctor with ECG data and Heart Rate (BPM), which a doctor can use as additional information for forming a medical diagnosis. The doctor is able to see both the ECG data and Heart Rate (BPM) as soon as the data becomes available in the central server provided that the patient accepts the doctor's request for access. The device does not include automated analysis except for heart rate calculation. QardioCore is not suitable for physicians who need to perform ECG diagnoses such as myocardial ischemia, left ventricular hypertrophy or specific bundle branch blocks that require multiple and precise electrode placement and consistent wave amplitude.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
prescription-only device, review by a physician
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
The purpose of the study was to demonstrate the accuracy of the QardioCore ECG Monitor in generating ambulatory ECG signal non-inferior in terms of signal quality to standard ECG parameters provided by a conventional. FDA-cleared. 3-channel ECG-Holter monitor device over a 24-hour recording time. The reference device used in the Spiderview Holter ECG recorder manufactured by ELA Medical, Inc., Plymouth, MN, (K032466).
The study was conducted in a population consistent with the device indications for use. ECGs from the subject and reference devices were collected and analyzed in a blinded fashion at various timepoints representative of realistic device use. Various qualitative and quantitative metrics, including signal quality, relevant ECG waveform amplitude and intervals, artifact burden, and comfort, were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 28, 2021
Qardio Inc. Rosario Iannella Chief Technology Officer 345 California Street, Suite 600 & 700 San Francisco, California 94104
Re: K201644
Trade/Device Name: QardioCore Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: June 15, 2020 Received: June 17, 2020
Dear Rosario Iannella:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih 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
Enclosure
2
Indications for Use
510(k) Number (if known) K201644
Device Name
QardioCore ECG ambulatory monitoring device
Indications for Use (Describe)
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
QARDIO®
345 California Street, Suite Francisco, CA, 94104, USA
Tel: 415-670-9613 Email: compliance@getgardio.com
510(k) Summary (per 21 CFR 807.92)
Submitter's information
Name: Qardio, Inc. Address: 345 California Street, Suite 600 & 700, San Francisco, CA, 94104, USA Contact Person: Rosario Iannella, Chief Technology Officer Phone number: (415) 670-9613 Date of preparation: January 22, 2021
Device Information
| Trade name: | QardioCore |
|---|---|
| Device name: | QardioCore ECG Monitor |
| Device model: | C100 |
| Classification name: | Medical Magnetic Tape Recorder (21 CFR 870.2800) |
| Common name: | Electrocardiograph |
| Classification: | 2 |
| Specialty: | Cardiovascular |
| Product code: | DSH |
Predicate device
iRhythm Technologies, Inc., Zio Patch, K121319
Reference device (Clinical study)
ELA Medical, Inc., Spiderview Holter ECG recorder, K032466
Device Description and Test Principle
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
The QardioCore ECG Monitor is composed of six main components: i) the QardioCore sensor with Bluetooth technology, ii) a chest strap that allows fitting of OardioCore sensor, iii) a USB charging cable, iv) the Qardio App (can be downloaded and installed from the respective App store) and runs on any iOS device with iOS version 10.0 or later, v) the cloud based server where the Qardio App stores and retrieves data, and vi) the ECG Viewer which provides a web interface to the doctor to view the data sent by the iPhone application.
4
345 California Street, Suit Francisco. CA. 94104. USA
Tel: 415-670-9613
Email: compliance@getgardio.com
The QardioCore device is a wearable device that captures information through a single-channel ECG. The data is then encrypted and transmitted via Bluetooth Low Energy to the Qardio App, installed on a compatible mobile platform. The OardioCore is supplied with chest straps accommodating chest sizes ranging from 27-5 to 43 inches. An optional XL chest strap is available from 41.7 to 59.8 inches. The device is provided with a USB Type-A cable to charge the device.
The Qardio App (which can be installed from the user's respective app store), can transmit the data, via Wi-Fi or standard data mobile telephony, to Qardio cloud based server for storage processing and transmission to an expert medical professional.
The ECG Viewer application provides a web interface to the doctor to view the ECG data collected from the iPhone Application. All data that a patient accumulates using the QardioCore device is stored in the central server. The ECG Viewer provides the doctor with ECG data and Heart Rate (BPM), which a doctor can use as additional information for forming a medical diagnosis. The doctor is able to see both the ECG data and Heart Rate (BPM) as soon as the data becomes available in the central server provided that the patient accepts the doctor's request for access. The device does not include automated analysis except for heart rate calculation. QardioCore is not suitable for physicians who need to perform ECG diagnoses such as myocardial ischemia, left ventricular hypertrophy or specific bundle branch blocks that require multiple and precise electrode placement and consistent wave amplitude.
Indications for use
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | K201644 | K121319 | K032466 |
| Applicant | Qardio, Inc. | iRhythm Technologies, | |
| Inc. | ELA Medical, Inc. | ||
| Device Name | QardioCore ECG | ||
| Monitor | Zio Patch | Spider View Holter ECG recorder | |
| Classification | |||
| Regulation | 21 CFR 870.2800 | 21 CFR 870.2800 | 21 CFR 870.2800 |
Comparison Tables Table 5.A Comparison of applied regulations
5
Image /page/5/Picture/0 description: The image shows the logo for Qardio. The logo consists of a green letter "Q" followed by the word "ARDIO" in black. There is a registered trademark symbol to the right of the letter "O" in "ARDIO".
345 California Street, Suite Francisco, CA, 94104, USA
Tel: 415-670-9613
| Product Code | DSH | MWJ | |
|---|---|---|---|
| Prescription | |||
| Use Only | Yes | Yes | Yes |
Table 5.B Comparison of IFU
| Device | Indications For Use |
|---|---|
| Subject device | |
| QardioCore, C100 | The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam. |
The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience. |
| Predicate device
Zio® Patch
(K121319) | The Zio® Patch is a prescription-only, single-patient-use, continuously recording EGG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. |
As shown above, the indications for use for the QardioCore ECG Monitor are similar to the primary predicate device in that they are both intended for adult patients, are not intended to be diagnostic devices, are prescription-only devices, and they are intended to provide additional information to healthcare professionals.
6
345 California Street, Suite 600 & 700, San Francisco, CA, 94104, USA
Tel: 415-670-9613
Email: compliance@getqardio.com
Table 5.C
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Wear Time | Up to 24 hours for a single session | ||
| and can be used for multiple | |||
| recording periods allowing long-term | |||
| monitoring and evaluation. | Up to 14 days | 24-96 hours (4 days) | |
| Memory Capacity | 12 hours when not connected to an | ||
| iOS device. Once connected, memory | |||
| capacity is essentially unlimited due | |||
| to transmission to remote memory. | Up to 14 days | 16, 32 or 64 MB | |
| Recording Format | Continuous | Continuous | Unknown |
| Ambulatory Use | Yes | Yes | Unknown |
| Sterilization | Non-Sterile | Non-sterile | Unknown |
| System | |||
| Architecture | Requires an external device to | ||
| constitute a complete | |||
| electrocardiograph system | Requires an external | ||
| device to constitute a | |||
| complete | |||
| electrocardiograph | |||
| system | Unknown | ||
| Patient Interface | Integrated electrodes placed on | ||
| patient's chest | Integrated electrodes | ||
| placed on patient's | |||
| chest | Unknown | ||
| Display and User | |||
| Interaction | Data is displayed via the mobile app. | Data is displayed via | |
| a mobile app or | |||
| website. | Graphic LCD | ||
| Battery Type | Lithium polymer cell | Lithium polymer cell | 1 AA 1.5V battery or 1 AA |
| 1.2V NiMH rechargeable | |||
| battery | |||
| Activity Sensor | Yes | None | Unknown |
| Heart Rate (HR) | |||
| Measurement | Yes | Yes | Unknown |
| Data Telemetry | Yes | ||
| Bluetooth, Cellular network / Wi-Fi | None | Unknown | |
| Telemetry Device | Commercial smartphone/tablet | N/A | Unknown |
| Dimensions | 7.3 x 3.4 x 0.4 in | ||
| (185 x 87 x 9mm) | 4.79 x 2.07 x 0.42 in | ||
| (123 x 53 x 10.7mm) | 3.82 x 2.13 x 0.91 in (97 x | ||
| 54 x 23 mm) | |||
| Weight | 0.287 lbs. (130g) | 0.0749 lbs. (34g) | 110g with batteries and |
| flash card | |||
| Operating | |||
| conditions | -4 to 104° F (-20 to 40° C) for | ||
| discharging | |||
| 25 - 90% RH (non-condensing) | 36 to 104° F | ||
| (2 to 40° C) | Unknown | ||
| 32 to 104°F (0 to 40 0C) | |||
| For charging | Unknown | Unknown | |
| Email: compliance@getgardio.com | |||
| Subject Device | Predicate Device | Reference Device | |
| Operating | |||
| Altitude | Up to 9,842 ft (3,000 m) | -1,000 to 10,000 ft (- | |
| 305 to 3,048 m) | Unknown | ||
| Storage | |||
| Conditions | -4 to 104° F (-20 to 40° C) | ||
| 45 to 85% RH (non-condensing) | 64 to 80° F | ||
| (18 to 27° C) | |||
| 10 to 95% RH | |||
| (non-condensing) | Unknown | ||
| Storage Altitude | Up to 9,842 ft (3,000 m) | -1,000 to 14,000 ft | |
| (-305 to 4,267 m) | Unknown | ||
| Frequency | |||
| Response | 0.05 Hz to 40 Hz | Unknown | 0.05 to 25 Hz |
| Input Impedance | ≥ 100 Mohm | ≥3 Mohm | Unknown |
| Differential Range | ± 5 mV | ± 1.65 mV | ± 16 mV |
| A/D Sampling | |||
| Rate | 600 samples / second (600 Hz) | 200 samples / second | |
| (200Hz) | 1000 samples/second (1000 Hz) | ||
| Resolution | 16 bits | 10 bits | 15 bits |
| Common Mode | |||
| Rejection | |||
| Ratio (CMRR) | 120 dB | ||
| Conforming to IEC 60601-2-47 | |||
| Section 201.12.4.4.103 | ≥60 dB | ||
| Conforming to IEC | |||
| 60601-2-47 | |||
| Section | |||
| 201.12.4.4.103 | Unknown |
7
345 California Street, Suite Francisco, CA, 94104, USA Tel: 415-670-9613
Substantial Equivalence Discussions
The subject device is similar to the predicate device and reference device in terms of technical specifications and performance. The minor differences in the recording characteristics, data transmission characteristics, physical characteristics and environmental specifications do not raise new questions of safety and effectiveness. Performance testing is described below and demonstrates that the subject device meets the specifications for its intended use. Clinical testing is described below and demonstrates that the subject device performs as intended and is capable of providing clinically useful ECG information that is comparable to the FDA cleared Zio Patch (K121319).
Non-Clinical Testing in Support of Substantial Equivalence Determination
All necessary performance testing was conducted on the QardioCore to support determination of substantial equivalence to the predicate devices. The results are confirmed by examination and provision of objective evidence that the design output meets the design input requirements in conformance with the following list of international standards:
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012): Generalrequirements ● for basic safety and essential performance, FDA recognition number: 19-4
- IEC 60601-1-2:2014: General requirements for basic safety and essential performance -● Collateral Standard: Electromagnetic disturbances - Requirements and tests, FDA recognition number: 19-8
8
QARDIO®
345 California Street, Suite San Francisco, CA, 94104, USA
Tel: 415-670-9613
Email: compliance@getaardio.com
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic ● safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, FDA recognition number: 19-14
- IEC 60068-2-64: Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband ● random and guidance
- IEC 60068-2-27:2008: Environmental testing Part 2-27: Tests Test Ea and guidance: Shock ●
- . IEC 60601-2-47: 2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems, FDA recognition number: 3-155
- . IEC 62133: 2012: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications, FDA recognition number: 19-13
- UN ST/SG/AC.10/11/Rev.6/Section 38.3, Recommendations on the TRANSPORT OF ● DANGEROUS GOODS
- EN ISO 10993-1: 2009/AC 2010: Biological evaluation of medical devices Part 1: Evaluation ● of testing within a risk management process, FDA recognition number: 2-220
- EN ISO 10993-5: 2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, FDA recognition number: 2-245
- . EN ISO 10993-10: 2010: Biological evaluation of medical devices – Tests for irritation and skin sensitization, FDA recognition number: 2-174
- ANSVAAMI EC57: 2012: Testing and reporting performance results of cardiac rhythm and ST . segment measurement algorithms, FDA recognition number: 3-118
Clinical Testing in Support of Substantial Equivalence Determination
The purpose of the study was to demonstrate the accuracy of the QardioCore ECG Monitor in generating ambulatory ECG signal non-inferior in terms of signal quality to standard ECG parameters provided by a conventional. FDA-cleared. 3-channel ECG-Holter monitor device over a 24-hour recording time. The reference device used in the Spiderview Holter ECG recorder manufactured by ELA Medical, Inc., Plymouth, MN, (K032466).
The study was conducted in a population consistent with the device indications for use. ECGs from the subject and reference devices were collected and analyzed in a blinded fashion at various timepoints representative of realistic device use. Various qualitative and quantitative metrics, including signal quality, relevant ECG waveform amplitude and intervals, artifact burden, and comfort, were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device.
Conclusion
Testing results of the electrical safety, EMC, non-clinical performance testing and clinical testing presented in the submission demonstrate that any difference in the technological characteristics does not raise any new issue affecting the safety and effectiveness of the QardioCore device as compared to the predicate devices. Thus, the subject device QardioCore is substantially equivalent to the identified predicate device.