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.

Device Description

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.

AI/ML Overview

The provided text describes the QardioCore ECG ambulatory monitoring device and its substantial equivalence determination by the FDA. Here's a breakdown of the requested information, specifically focusing on the clinical testing to establish acceptance criteria and prove its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the purpose of the clinical study was to demonstrate the non-inferiority of the QardioCore ECG Monitor in terms of signal quality compared to a conventional, FDA-cleared, 3-channel ECG-Holter monitor device over a 24-hour recording time with continuous recording. While specific numerical acceptance criteria for "non-inferiority" are not listed, the general acceptance can be inferred from the conclusion that the device "demonstrated the substantial equivalence with the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
Non-inferiority in ECG signal quality compared to a standard 3-channel Holter monitor over 24 hours.	"The data provided demonstrated the substantial equivalence with the predicate device." The study measured various qualitative and quantitative metrics, including signal quality, relevant ECG waveform amplitude and intervals, artifact burden.

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

Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "a population consistent with the device indications for use," but does not give a numerical count of participants in the clinical study.
Data Provenance: The study was a prospective clinical study conducted to demonstrate the accuracy of the QardioCore. The country of origin of the data is not specified beyond the device being from a US-based company (San Francisco, California).

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The text mentions that ECGs from both devices "were collected and analyzed in a blinded fashion," implying expert review, but does not detail their numbers or qualifications.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The text mentions that ECGs "were collected and analyzed in a blinded fashion," which is a common practice in clinical studies, but gives no specifics on how disagreements among experts (if multiple were used) were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a device for capturing, storing, transmitting, and displaying ECG information. It specifically states: "The device does not include automated analysis except for heart rate calculation." Therefore, a comparative effectiveness study involving human readers improving with AI assistance would not be applicable, as the device's primary function is data acquisition and display for physician review, not AI-driven interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. The device's current functionality, as described, is for presenting data to a physician for review, with only heart rate calculation being automated. The "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience."

7. The Type of Ground Truth Used

The ground truth was established by comparison with a reference device, specifically the ELA Medical, Inc., Spiderview Holter ECG recorder (K032466), which is an FDA-cleared 3-channel ECG-Holter monitor. The study aimed to demonstrate non-inferiority in signal quality against this established medical device.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device for data acquisition and display, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would refer to the development and testing of the device's hardware and software according to recognized standards.

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

Not applicable, as there is no mention of a machine learning training set for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K201644

Device Name

QardioCore ECG ambulatory monitoring device

Indications for Use (Describe)

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)

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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 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.

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345 California Street, Suit Francisco. CA. 94104. USA

Tel: 415-670-9613

Email: compliance@getgardio.com

Indications for use

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 ECGMonitor	Zio Patch	Spider View Holter ECG recorder
ClassificationRegulation	21 CFR 870.2800	21 CFR 870.2800	21 CFR 870.2800

Comparison Tables Table 5.A Comparison of applied regulations

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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
PrescriptionUse Only	Yes	Yes	Yes

Table 5.B Comparison of IFU

Device	Indications For Use
Subject deviceQardioCore, 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 deviceZio® 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.

Device

Indications For Use

Subject deviceQardioCore, 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 deviceZio® 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.

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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 sessionand can be used for multiplerecording periods allowing long-termmonitoring and evaluation.	Up to 14 days	24-96 hours (4 days)
Memory Capacity	12 hours when not connected to aniOS device. Once connected, memorycapacity is essentially unlimited dueto 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
SystemArchitecture	Requires an external device toconstitute a completeelectrocardiograph system	Requires an externaldevice to constitute acompleteelectrocardiographsystem	Unknown
Patient Interface	Integrated electrodes placed onpatient's chest	Integrated electrodesplaced on patient'schest	Unknown
Display and UserInteraction	Data is displayed via the mobile app.	Data is displayed viaa mobile app orwebsite.	Graphic LCD
Battery Type	Lithium polymer cell	Lithium polymer cell	1 AA 1.5V battery or 1 AA1.2V NiMH rechargeablebattery
Activity Sensor	Yes	None	Unknown
Heart Rate (HR)Measurement	Yes	Yes	Unknown
Data Telemetry	YesBluetooth, 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 x54 x 23 mm)
Weight	0.287 lbs. (130g)	0.0749 lbs. (34g)	110g with batteries andflash card
Operatingconditions	-4 to 104° F (-20 to 40° C) fordischarging25 - 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
OperatingAltitude	Up to 9,842 ft (3,000 m)	-1,000 to 10,000 ft (-305 to 3,048 m)	Unknown
StorageConditions	-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
FrequencyResponse	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 SamplingRate	600 samples / second (600 Hz)	200 samples / second(200Hz)	1000 samples/second (1000 Hz)
Resolution	16 bits	10 bits	15 bits
Common ModeRejectionRatio (CMRR)	120 dBConforming to IEC 60601-2-47Section 201.12.4.4.103	≥60 dBConforming to IEC60601-2-47Section201.12.4.4.103	Unknown

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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

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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.

Regulation Number and Section

§ 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).