The ECG Check Universal family of devices is intended for self-testing by patients at home. These 1-lead cardiac monitors allow remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.

Specifically, the ECG Check Universal models are indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

· Skipped Beats
· Pounding Heart (Palpitations)
· Heart Racing or Irregular Pulse
· Lightheadedness or Faintness
· History of Arrhythmias

Device Description

The new ECG CHECK – UNIVERSAL model devices are personal 1 lead ECG Event Monitors specifically designed to operate over the cellular network with iPhone & Android cellular phone handsets. The new ECG CHECK – UNIVERSAL model devices include two models. The ECG CHECK -UNIVERSAL (Model ECG01-U) and the ECG CHECK - UNIVERSAL PLUS (Model ECG01-UPLUS). Both models are designed to capture a user's ECG data and transmit the data via Bluetooth to a cellular device, which will ultimately transmit the ECG data over the cellular network to the ECG Check web center. The difference between the two models is that the new ECG CHECK -UNIVERSAL PLUS allows for the storage of recordings on the device and includes a button for the added capability of transmitting these ECG data transtelephonically using landlines to the ECG Check web center. The button also provides indication of the number of saved ECG recordings as well as the ability to delete saved recordings. Both new ECG CHECK - UNIVERSAL model devices will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ECG Check - Universal and ECG Check - Universal Plus devices. It outlines the company's claim of substantial equivalence to a predicate device (ECG Check K122184) and summarizes non-clinical testing.

However, the document states: "No clinical testing was conducted in support of this 510(k) submission." This means there is no study described in this document that proves the device meets specific acceptance criteria based on human or expert evaluation of its diagnostic performance. The submission relies on bench testing demonstrating performance equivalent or superior to the predicate and compliance with relevant IEC standards for safety and essential performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I answer questions about:

Sample size used for a test set
Number of experts used to establish ground truth
Adjudication method for a test set
MRMC comparative effectiveness study
Standalone algorithm performance
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

Based on the provided document, the acceptance criteria and study details are as follows:

1. A table of acceptance criteria and the reported device performance:

Since no clinical testing was performed to assess diagnostic performance of the new device models against specific clinical acceptance criteria, a table for this purpose cannot be created from the provided text. The submission focuses on demonstrating safety, essential performance, and equivalence to the predicate device through non-clinical bench testing and adherence to standards.

The closest analogue to "reported device performance" in this context is the successful passing of various safety and performance standards.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Compliance with IEC 60601-1 (General requirements for basic safety and essential performance)	Successfully passed
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Successfully passed
Compliance with IEC 60601-1-6 (Usability)	Successfully passed
Compliance with IEC 60601-1-11 (Home Healthcare Environment)	Successfully passed
Compliance with IEC 60601-2-47 (Ambulatory electrocardiographic systems)	Successfully passed
Compliance with IEC 62366:2007 + A1:2014 (Application of Usability Engineering to Medical Devices)	Successfully passed
Bench testing to performance specifications compared to predicate device (K122184)	Successfully passed; performed as well as or better than
Functional Equivalence to Predicate Device (K122184) regarding core ECG capture and transmission (implied from the comparison table of technological characteristics)	Demonstrated through design and non-clinical testing

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable for a clinical test set, as no clinical testing was conducted. The non-clinical testing involved various bench tests on the device hardware and software.
Data provenance: Not applicable to clinical data. For non-clinical testing, it would be laboratory-generated data from device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert ground truth for diagnostic accuracy was used.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was adjudicated.

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:

No, an MRMC study was not done. The device is a 1-lead cardiac monitor for self-testing and transmission of ECG data, not an AI diagnostic algorithm assisting human readers in interpreting complex images or signals in a clinical study setting.

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

The document implies that the device captures and transmits ECG data to a "web center for analysis and assessment by qualified professionals," and that the web-based engine uses "standard analysis of ECG... in similar terms to a stoplight (Green, Yellow, Red)." While this suggests an algorithmic component to the "stoplight" assessment, the submission does not detail a standalone diagnostic performance study of this algorithm. The focus is on the device's ability to capture and transmit data reliably and safely.

7. The type of ground truth used:

For demonstrating substantial equivalence and safety/performance: The ground truth was established by adherence to recognized national and international standards (e.g., IEC 60601 series, IEC 62366) and direct comparison of the new devices' technical specifications and bench performance against the predicate device.
For diagnostic accuracy: Not applicable, as no clinical diagnostic accuracy study was conducted.

8. The sample size for the training set:

Not applicable. The document does not describe the development or training of an AI algorithm in the context of a public-facing dataset, but rather the device's hardware and software for ECG acquisition and transmission.

9. How the ground truth for the training set was established:

Not applicable.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 2, 2017

Cardiac Designs, Inc. % Cynthia Pillar President, Consultant CJP Consulting, Inc. 5831 N Kostner Ave Chicago, Illinois 60646

Re: K170506

Trade/Device Name: ECG Check - Universal, ECG Check - Universal Plus Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: September 20, 2017 Received: September 21, 2017

Dear Cynthia Pillar:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Wilhelm
for

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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Indications for Use

510(k) Number (if known) K170506

Device Name

ECG Check - Universal, ECG Check - Universal Plus

Indications for Use (Describe)

· Skipped Beats
· Pounding Heart (Palpitations)
· Heart Racing or Irregular Pulse
· Lightheadedness or Faintness
· History of Arrhythmias

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Cardiac Designs, Inc. The text above the logo states that the company uses traditional 510(k) models and performs ECG checks. The logo itself is a stylized heart shape with the company name written in a cursive font.

K170506 pg. 1 of 7

SECTION 5: 510(k) SUMMARY

TRADITIONAL 510(k) - 510(k) Summary

Date Prepared:	December 31, 2016
Submitter:Contact:	Cardiac Designs, Inc.25510 Interstate 45 N, Suite 202Spring, TX 77386Phone: 1 (844) 324-2432Facsimile: 1 (713) 589-7964Cynthia J. Pillar, Regulatory Consultant1 (773) 677-8886
Trade/ProprietaryName of Device:	ECG CHECK – UNIVERSAL PLUS andECG CHECK – UNIVERSAL
Common Nameof Device:	Transmitters and Receivers, Electrocardiograph, Telephone
Classification:	Class II per 21 CFR 870.2920, Telephoneelectrocardiograph transmitter and receiver, Product CodeDXH
Legally MarketedPredicateDevice:	ECG Check (K122184), manufactured by Cardiac Designs,Inc

Description of New ECG CHECK - UNIVERSAL PLUS Device:

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Image /page/4/Picture/2 description: The image contains the logo for Cardiac Designs. The logo features an orange heart-shaped design on the left, followed by the text "CardiacDesigns" in a serif font. The text is black and slightly italicized.

devices will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.

The ECG CHECK – UNIVERSAL model devices are indicated for monitoring symptoms that may suggest irreqular or abnormal heart rhythms. The ECG CHECK - UNIVERSAL model devices, when used in conjunction with the ECG Check web center, use standard analysis of ECG by the previously cleared webbased engine for objective assessment of the user in terms similar to a stoplight (Green, Yellow, Red). With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other careqivers via the application. The symptoms may include: skipped beats, palpitations, racing heart, fainting, lightheadedness, irregular rate, or history of other related heart abnormalities.

As mentioned above, there are two methods for ECG data transmission with the new ECG01-UPLUS model. Both ECG CHECK - UNIVERSAL model devices continue to use the same method for transmission as the predicate. While performing the recording, the results are continuously sent to the cellular phone by secure Bluetooth connection technology and, with a physician prescription, displayed for quality and observation purposes on the cellular phone ECG Check application. Users without a physician prescription will not be able to view the waveform. The data can be stored locally on the cellular device and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals.

The new ECG01-UPLUS device also stores ECG data on the device and includes a button that allows a user to send these stored recordings with or without connection to the cellular device application. The user can make recordings, which will remain stored on the device. The user can push the button when ready and transmit the ECG data over an analog telephone line whenever the user decides to transmit. The button on the ECG01-UPLUS model will also indicate the number of stored recordings and will allow deletion of stored recordings.

The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs. Inc. technicians and engineers, as well as with their own caregivers.

The ECG CHECK - UNIVERSAL model devices are intended for users that seek to manage their heart rate and rhythms over long periods of time. Additional features will be added to involve health care professionals in the service, with the intent to ensure that the device remains consumer focused and non-diagnostic.

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Image /page/5/Picture/0 description: The image shows the logo for Cardiac Designs, Inc. The text above the logo states "CARDIAC DESIGNS, INC - TRADITIONAL 510(k) ECG CHECK - UNIVERSAL MODELS". The logo itself is a stylized heart shape with the words "CardiacDesigns" written in a script font.

K170506 pg. 3 of 7

Indications for Use of the New Device:

. Skipped Beats
Pounding Heart (Palpitations) ●
Heart Racing or Irregular Pulse ●
Lightheadedness or Faintness ●
History of Arrhythmias ●

Comparison of the Technological Features of the New (Modified) Device and Predicate Device:

The new ECG CHECK – UNIVERSAL model devices indications for use are equivalent to the predicate ECG Check model ECG01-4S. The new ECG CHECK models and the predicate ECG Check model ECG01-4S device have identical patient populations and places of use. In addition, the parameters that are measured by the new ECG CHECK - UNIVERSAL model devices are identical to those measured by the predicate ECG Check model ECG01-4S.

There are few differences between the new ECG CHECK – UNIVERSAL model devices and the predicate ECG Check model ECG01-4S. The main differences are as follows:

1. Redesign of case
  The new ECG CHECK – UNIVERSAL model devices case has been redesigned to make it a stand-alone device. The materials of the new ECG CHECK -UNIVERSAL model devices are identical to those used in the predicate.
1. Addition of 'Offline' mode:
  The new ECG CHECK – UNIVERSAL model devices now include an 'Offline' mode for storing ECG data on the cellular device until the user is able to send the transmission.

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Image /page/6/Picture/1 description: The image shows the logo for CardiacDesigns. The logo features an orange heart shape on the left side, with the text "CardiacDesigns" in a cursive font to the right of the heart. The heart shape is stylized with a line running through it, creating a unique design.

1. Addition of Trans-telephonic data transmission capability to the ECG CHECK - UNIVERSAL PLUS model:
  The new ECG Check model ECG01-UNIVERSAL PLUS device now includes the capability for the user to send the ECG data over reqular analog phone lines (TTM). (The new ECG CHECK - UNIVERSAL model transmits using only cellular data connectivity and is therefore equivalent to the predicate device)

Addition of a button on the case:

The new ECG CHECK – UNIVERSAL PLUS model includes a button. The button initiates the sending of stored ECG data files trans-telephonically when held down for three (3) seconds. The button also performs the following:

When pressed for less than three (3) seconds, the LEDs will flash once for . each stored recording on the device. This will be accompanied by an audible beep for each stored recording.
. When pressed three (3) times quickly (within one (1) second) the device will delete all stored recordings.

(The new ECG CHECK - UNIVERSAL model does not contain the button and is therefore equivalent to the predicate device)

Change from replaceable to rechargeable battery:

Both new ECG CHECK - UNIVERSAL model devices contain an internal rechargeable 3V lithium battery.

1. Compatibility with Android Platform:
  The new ECG CHECK – UNIVERSAL model devices can now be used on both iPhone and Android devices.

ATTRIBUTE	NEW ECG CHECK -UNIVERSAL MODELDEVICES	PREDICATE: CardiacDesigns ECG Check(K122184)	VarianceExplanation
Indications forUseStatement:	The ECG Check modelECG01-UNIVERSALPLUS is intended for self-testing by patients athome. This 1-lead cardiacmonitor allows remotepatients to display andtransmit their ECG data tomedical professionals via acommunication device to aremote server.	The ECG Check modelECG01-4S is intendedfor self-testing bypatients at home. This 1-lead cardiac monitorallows remote patients todisplay and transmit theirECG data to medicalprofessionals via acommunication device toa remote server.	Identical
	Specifically, the ECGCheck model ECG01-UNIVERSAL PLUS isindicated for patients whoare concerned about theirheart rhythm and haveexperienced the followingsymptoms that aresuggestive of abnormalheart rhythms:• Skipped Beats• Pounding Heart(Palpitations)• Heart Racing orIrregular Pulse• Lightheadedness orFaintness• History ofArrhythmias	Specifically, the ECGCheck model ECG01-4Sis indicated for patientswho are concerned abouttheir heart rhythm andhave experienced thefollowing symptoms thatare suggestive ofabnormal heart rhythms:• Skipped Beats• Pounding Heart(Palpitations)• Heart Racing orIrregular Pulse• Lightheadednessor Faintness• History ofArrhythmias
Place of Use:	OTC, Home	OTC, Home	Identical
Population ofUse:	Adult	Adult	Identical
AnatomicalSites	Chest & Fingers	Chest & Fingers	Identical
Usage	Multi-use	Multi-use	Identical
TechnologicalCharacteristics	NEW ECG CHECK -UNIVERSAL MODELDEVICES	PREDICATE: CardiacDesigns ECG Check(K122184)	VarianceExplanation
Power	Battery	Battery	Identical
Battery Type	Internal 3V LithiumRechargeable Battery	CR2032 3V Lithium CoinCell	Seeexplanationabove
Battery Life	8 hours/480 recordings	8 hours/480 recordings	Identical
RecordingPeriod	30 seconds	30 seconds	Identical
RecordingMethod	Automatic	Automatic	Identical
OperatingTemperature	+10° to +40° C	+10° to +40° C	Identical
Transport &StorageTemperature	-20° to +65° C	-20° to +65° C	Identical
Humidity	30 - 85% noncondensing	30 - 85% noncondensing	Identical
Dimensions(max.)	ECG01-U: 87 x 49 x 7mm /ECG01-UPLUS: 85.95 x47.95 x 7.2mm	118 x 62 x 17mm	Seeexplanationabove
Weight	ECG01-U: 33 gramsECG01-UPLUS: 38 grams	40 grams	Seeexplanationabove
InternalMemory	ECG01-U: NoECG01-UPLUS: Yes	No	Seeexplanationabove
Features:ButtonFunctions(UPLUSModel Only):	1. Initiate send of storedrecordings2.Number of storedrecordings3. Deletion of storedrecordings	No Button	Seeexplanationabove
Commun-icationsDownload/Signal OutputConnection	1.Bluetooth technology2.Trans-telephonic overanalog phone lines(ECG01-UPLUS model)	Bluetooth technology	Seeexplanationabove
SoftwarePlatform	iOS 5 or Higher/MS Azureor Windows 2008/Android4.1 or greater	iOS 5 or Higher/MSAzure or Windows 2008	Seeexplanationabove
DeviceMaterials	NEW ECG CHECK -UNIVERSAL MODELDEVICES	PREDICATE: CardiacDesigns ECG Check(K122184)	VarianceExplanation
Device Casing& Button	PC Plastic	PC Plastic	Identical
Electrodes	Copper plated with Ag/Cl	Copper plated with Ag/Cl	Identical
USB Cord (forcharging)	Yes	N/A	Seeexplanationabove
Sterilization	N/A	N/A	Identical

A more detailed comparison is provided in TABLE 5.1 below:

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K170506 pg. 5 of 7

25510 Interstate 45 N, Spring, TX 77386

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K170506 pg. 6 of 7

TABLE 5.1 – TECHNOLOGICAL CHARACTERISTICS COMPARISON

Clinical Testing:

No clinical testing was conducted in support of this 510(k) submission.

Non-Clinical Testing:

The ECG CHECK device successfully passed safety and essential performance testing as required by:

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K170506 pg. 7 of 7

. IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility - Requirements and tests
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General . Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
. IEC 60601-1-11 - 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
IEC 60601-2-47 Particular requirements for the safety, including ● essential performance, of ambulatory electrocardiographic systems.
IEC 62366:2007 + A1:2014 – Medical Devices – Application of Usability Engineering to Medical Devices

In addition to the testing completed above, the new ECG CHECK - UNIVERSAL model devices were successfully bench tested to performance specifications and in comparison to the performance of the predicate device.

Conclusion:

The conclusions drawn from the specifications and performance testing of the new ECG CHECK - UNIVERSAL model devices demonstrate that the new ECG CHECK – UNIVERSAL model devices are at least as safe and as effective and perform as well as or better than the predicate ECG Check model ECG01-4S (K122184). For these reasons, we believe the new ECG CHECK - UNIVERSAL model devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).