FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Device Description

FibriCheck is medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation. It makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data). The recordings can be shared optionally with a physician or monitoring service.

The FibriCheck web application, an online tool, has the sole intention to display data. Professional users can use the web application for managing patients and reviewing FibriCheck data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA submission:

Device: FibriCheck (Atrial Fibrillation Monitor)
Intended Use: Self-testing by patients diagnosed with, or susceptible to, atrial fibrillation to monitor and record heart rhythms intermittently.

1. Acceptance Criteria and Reported Device Performance

The submission implicitly defines acceptance criteria through its clinical performance comparison. While explicit numerical thresholds for sensitivity/specificity/PPV/NPV/accuracy are not stated as "acceptance criteria," the comparison aims to demonstrate that FibriCheck's diagnostic performance is comparable to a legally marketed reference device (Kardia/AliveCor). The key performance metrics are presented as actual results.

Performance Metric	Acceptance Criteria (Implicit - Comparable to Kardia)	FibriCheck Reported Performance	Kardia Reported Performance
Sensitivity	Comparable to Kardia	95.60%	94.09%
Specificity	Comparable to Kardia	96.55%	97.47%
Positive Predictive Value (PPV)	Comparable to Kardia	95.60%	91.59%
Negative Predictive Value (NPV)	Comparable to Kardia	96.55%	89.53%
Accuracy	Comparable to Kardia	96.14%	95.09%

Note: The submission states, "This means that both methods have comparable diagnostic results," implying that meeting or exceeding Kardia's performance was the implicit acceptance goal.

2. Sample Size and Data Provenance

Test Set Sample Size: 223 subjects
Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It is a "clinical performance study" where subjects participated, which typically implies a prospective design.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the devices were "compared towards a gold-standard 12-lead ECG device." This implies that the interpretation of the 12-lead ECG (which serves as the "gold standard") would have been done by qualified medical professionals (e.g., cardiologists or electrophysiologists), but specifics are not provided in this excerpt.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described in the provided text. The reliance on a "gold-standard 12-lead ECG device" suggests that the 12-lead ECG readings were used as the definitive diagnosis, but how those readings themselves were confirmed (e.g., single expert, consensus of multiple experts) is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The study compared the device's performance (FibriCheck vs. Kardia) against a gold standard (12-lead ECG), not the improvement of human readers with or without AI assistance. This was a standalone performance comparison.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done for FibriCheck. The provided performance metrics (sensitivity, specificity, PPV, NPV, accuracy) for FibriCheck are its algorithm-only performance when compared against the 12-lead ECG ground truth.

7. Type of Ground Truth Used

The type of ground truth used was gold-standard 12-lead ECG device. This is a clinical diagnostic standard for cardiac rhythm analysis.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set used for FibriCheck's algorithm development. The performance data presented refers to the test set performance.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

Summary

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September 28, 2018

Qompium NV % Patsy Trisler Consultant Oserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, Maryland 20815

Re: K173872

Trade/Device Name: FibriCheck Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: August 19, 2018 Received: August 20, 2018

Dear Patsy Trisler:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Arielle Drummond -S

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) K173872

Device Name FibriCheck

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. SUBMITTER

Submitter Name:	Qompium NV
Submitter Address:	Kempische Steenweg 311/273500 Hasselt, Belgium
Phone Number:	+32479393153
Contact Person:	Jo Van der Auwera
Date Prepared:	28 September 2018
2. DEVICE
Device Trade Name:	FibriCheck
Common Name:	Atrial Fibrillation Monitor
Classification Name,Number &Product Code:Class:Classification Panel:	Telephone electrocardiograph transmitter and receiver21 CFR 870.2920DXHIICardiovascular

3. PREDICATE DEVICE

Primary Predicate	K132206, Melys Atrial Fibrillation Monitor
Device:	The Melys Atrial Fibrillation Monitor is indicated for self-testing
Intended use:	by patients, who have been diagnosed with, or are susceptibleto developing, atrial fibrillation and who would like to monitorand record their heart rhythms on an intermittent basis.

The primary predicate device has not been subject to a design-related recall.

4. REFERENCE DEVICE

Reference Device: K142743, AliveCor Heart Monitor The AliveCor Heart Monitor is intended to record, store and Intended use: transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected

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heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use.

The reference device has not been subject to a design-related recall.

5. DEVICE DESCRIPTION

The FibriCheck web application, an online tool, has the sole intention to display data. Professional users can use the web application for managing patients and reviewing FibriCheck data.

6. INDICATIONS FOR USE

FibriCheck is indicated for self-testing by patients, who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

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7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

	New Device	Primary Predicate Device	Reference Device
Device name	FibriCheck	Melys Atrial Fibrillation Monitor	Alivecor Heart Monitor
510(k) Number	K#	K132206	K142743
Manufacturer	Qompium	Advanced Fluidics, LLC	AliveCor, Inc.
RegulationNumber	870.2920	870.2920	870.2920
DeviceClassificationName	Telephone electrocardiographtransmitter and receiver	Telephone electrocardiographtransmitter and receiver	Telephone electrocardiograph transmitter and receiver
Product Code	DXH	DXH	DXH, DPS
Intended Use/Indications foruse	FibriCheck is indicated for self-testing by patients, who havebeen diagnosed with, or aresusceptible to developing, atrialfibrillation and who would like tomonitor and record their heartrhythms on an intermittent basis.	The Melys Atrial FibrillationMonitor is indicated for self-testingby patients, who have beendiagnosed with, or are susceptibleto developing, atrial fibrillation andwho would like to monitor andrecord their heart rhythms on anintermittent basis.	The AliveCor Heart Monitor is intended to record, storeand transfer single-channel electrocardiogram (ECG)rhythms. The AliveCor Heart Monitor also displays ECGrhythms and detects the presence of atrial fibrillationand normal sinus rhythm (when prescribed or usedunder the care of a physician). The AliveCor HeartMonitor is intended for use by healthcare professionals,patients with known or suspected heart conditions andhealth conscious individuals. The device has not beentested and it is not intended for pediatric use.
Intended User	Adult	Adult	Adults
Prescriptiondevice for homeUse	Yes	Yes	Yes
Single Patient Use	Yes	Yes	Yes
Monitorsregularity ofheartbeat	Yes	Yes	Yes
Alerts user to anirregularity intheir pulsethrough a lightindicator.	No, text indicator	Yes	No, text indicator
Principle ofOperation	FibriCheck receives data fromthe Mobile Platform device, fromwhich the waveform is directlycreated. The irregularity isindicated with a text indicator.	The monitor passes light throughthe fingertip sensor and receivesdata from which the waveform isdirectly created.Displays regularity or irregularitywith a light indicator.	The device attaches to compatible smartphone or tabletand has electrodes to transmit ECG rhythms to thesmartphone or tablet. Furthermore, the mobile app isused to collect, view, save, and wirelessly transmitrecordings to the AliveCor server.
Device Design	FibriCheck obtains waveform viaMobile Platform camera anddisplays signal in real time on theMobile Platform device with anarrhythmia index.Text display (green, amber, orblue) indicates heart regularity orirregularity.All tests are stored.	Monitor obtains waveform viafinger sensor and displayswaveform in real time on themonitor with an arrhythmia index.Light display (green, amber, orred) indicates heart regularity orirregularity.Last 8 tests are stored on thedisplay by light indicator notArrhythmia Index number.	The device utilizes the processing power of a mobilecomputing platform (MCP) while reducing the complexityof the electronics hardware associated with dataacquisition and transmission. The AliveCor HeartMonitor can also analyze ECG signals and indicate thepresence of noise, normal sinus rhythm and atrialfibrillation for each ECG recording.
FunctionalFeatures
Userprogrammable	No	No	No
Recording length	60 seconds	10 seconds(Recommended four (4)consecutive measurement shouldshow same indication (red, amberor green) before a conclusion isdrawn)	30 seconds to 5 minutes
Differences
Data acquisition	PPG signal from the mobilecomputing platform (MCP)	Finger Sensor (K101692)	ECG signal from the mobile computing platform (MCP)
Table 5.1: Comparison of new device to predicate device

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Equivalences:

The intended use is the same, and the technological characteristics are essentially the same, as those of the predicate, K132206, Melys Atrial Fibrillation Monitor. Both devices use Photoplethysmography (PPG) technique to detect blood volume changes and to determine heart rhythm.

Differences that are demonstrated to be substantially equivalent:

The most important difference with FibriCheck and Melys Atrial Fibrillation Monitor is that Melys Atrial Fibrillation Monitor uses Finger Sensor (K101692) for PPG signal acquisition and FibriCheck receives the PPG signal from the mobile computing platform (MCP). Furthermore, the predicate device is not a "mobile computing platform" device. However, recently FDA cleared several "mobile computing platform" devices which determine heart rhythm by using ECG technique (e.g. K142743 - reference device in this submission).

Performance testing was carried out to evaluate the diagnostic capability of FibriCheck compared to the reference device Kardia to assess the diagnostic accuracy of PPG versus single-lead ECG monitoring techniques to detection possible atrial fibrillation. The test results are available in the relevant sections of this 510(k) application. It is summarized below.

8. PERFORMANCE DATA

Non-Clinical testing	Validation and Verification Testing carried out on theFibriCheck indicates that it meets its predefined product'srequirements and requirements from the following productstandard:AAMI/ANSI/IEC 62304:2006, Medical DeviceSoftware - Software Life Cycle Processes ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012Medical Electrical Equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarm systemsin medical electrical equipment and medical electricalsystems.
Clinical PerformanceTesting	The clinical performance of FibriCheck was compared to thereference device Kardia (AliveCor) in a study where 223subjects participated. In total 100/223 subjects suffered fromatrial fibrillation. Both technologies were compared towards agold-standard 12-lead ECG device. The diagnostic resultsyielded in a sensitivity/specificity/positive predictivevalue/negative predictive value and accuracy for FibriCheckof 95.60%/96.55%/95.60%/96.55%/96.14% and for Kardia94.09%/97.47%/91.59%/89.53%/98%/95.09% This meansthat both methods have comparable diagnostic results.

Non-Clinical testing

Validation and Verification Testing carried out on theFibriCheck indicates that it meets its predefined product'srequirements and requirements from the following productstandard:AAMI/ANSI/IEC 62304:2006, Medical DeviceSoftware - Software Life Cycle Processes ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012Medical Electrical Equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarm systemsin medical electrical equipment and medical electricalsystems.

Clinical PerformanceTesting

The clinical performance of FibriCheck was compared to thereference device Kardia (AliveCor) in a study where 223subjects participated. In total 100/223 subjects suffered fromatrial fibrillation. Both technologies were compared towards agold-standard 12-lead ECG device. The diagnostic resultsyielded in a sensitivity/specificity/positive predictivevalue/negative predictive value and accuracy for FibriCheckof 95.60%/96.55%/95.60%/96.55%/96.14% and for Kardia94.09%/97.47%/91.59%/89.53%/98%/95.09% This meansthat both methods have comparable diagnostic results.

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Software Verification Validation testing involved algorithm testing which validated and Validation Testing the accuracy of FibriCheck. The product was deemed fit for clinical use. Usability validation is part of the Clinical Performance data and FibriCheck was tested and meets the requirements of following standard: ● IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices. FibriCheck was designed and developed as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device". FibriCheck was considered to represent "moderate" level of concern as it is not intended to provide recommendations for treatment nor to provide decisive information. According to AAMI/ANSI/IEC 62304 Standard, FibriCheck safetv classification has been set to Class B.

9. CONCLUSION

The information discussed above and provided in the 510(k) submission demonstrate that the FibriCheck device is substantially equivalent to the predicate.

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).