FibriCheck

K232804 · Qompium NV · QME · Jun 7, 2024 · Cardiovascular

Device Facts

• Record ID: K232804
• Device Name: FibriCheck
• Applicant: Qompium NV
• Product Code: QME · Cardiovascular
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2785
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Atrial fibrillation detection	—	—	Performance metrics are in line with the predicate device	—	—	NCT06282380: 252 cardiology patients recruited in-clinic or consulting the cardiac outpatient clinic	—

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.

Device Story

FibriCheck is a software-based medical device consisting of a mobile application and a web portal. The mobile app uses the smartphone camera to capture photoplethysmography (PPG) data by having the patient place their fingertip on the lens; the app detects volumetric changes to analyze heart rhythm. The system is intended for patient self-testing to monitor for atrial fibrillation. Captured data is transmitted to a web portal where healthcare providers can view measurements, manage patients, and issue prescriptions. The device provides intermittent monitoring, allowing providers to review rhythm data to inform clinical decision-making and patient management.

Clinical Evidence

Clinical validation study (NCT06282380) involved 252 cardiology patients (with or without AF) recruited from outpatient clinics. Participants performed PPG measurements using the subject device, which were compared against a gold-standard reference diagnosis. Results showed performance metrics in line with the predicate device, raising no new safety or effectiveness concerns.

Technological Characteristics

Software-based device utilizing smartphone camera for PPG signal acquisition. Features include mobile application for data capture and web portal for provider review. Employs signal processing for volumetric change detection and rhythm analysis. No specific hardware materials or energy sources beyond standard smartphone components.

Indications for Use

Indicated for patients diagnosed with or susceptible to atrial fibrillation for intermittent self-monitoring and recording of heart rhythms.

Regulatory Classification

Identification

The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.

Special Controls

In combination with the general controls of the FD&C Act, the software for optical camerabased measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include: (i) A full characterization of the software technical parameters, including algorithms; (ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements; (iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; (iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and (v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality. (2) Clinical data must be provided. This assessment must fulfill the following: (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner. (3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement. (4) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results; (iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information; (iv) The expected performance of the device for all intended use populations and environments; and (v) Robust instructions to ensure correct system setup.

Predicate Devices

• FibriCheck (K173872)

Submission Summary (Full Text)

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 7, 2024

Qompium nv Jo Van der Auwera Director of Compliance Kempische Steenweg 303/27 Hasselt, 3500 Belgium

Re: K232804

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: September 12, 2023 Received: May 7, 2024

Dear Jo Van der Auwera:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Kimberly

For: Jennifer Shih-Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

| Submission Number (if known) | |
|------------------------------|--|
|------------------------------|--|

K232804

Device Name

FibriCheck

Indications for Use (Describe)

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.

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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| 510(k) #: | K232804 | 510(k) Summary | Prepared on: 2024-05-07 |
|-----------|---------|----------------|-------------------------|
|-----------|---------|----------------|-------------------------|

| Contact Details | | 21 CFR 807.92(a)(1) |
|-----------------------------|------------------------------------------------|---------------------|
| Applicant Name | Qompium nv | |
| Applicant Address | Kempische Steenweg 303/27 Hasselt 3500 Belgium | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Jo Van der Auwera | |
| Applicant Contact Email | [e-mail] | |

| Device Name | | 21 CFR 807.92(a)(2) |
|---------------------|-----------------------------------------------------------|---------------------|
| Device Trade Name | FibriCheck | |
| Common Name | Telephone electrocardiograph transmitter and receiver | |
| Classification Name | Transmitters And Receivers, Electrocardiograph, Telephone | |
| Regulation Number | 870.2920 | |
| Product Code | DXH | |

| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
|------------------------------------|--|---------------------|
|------------------------------------|--|---------------------|

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K173872 | FibriCheck | DXH |

| Device Description Summary | | 21 CFR 807.92(a)(4) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------|--|
| FibriCheck is a medical device software that can be used to determine heart rhythm conditions, with a primary focus on the detection of atrial fibrillation. | | | |

The FibriCheck Mobile Application is a smartphone application for patients intended to record, display, store and transmit photoplethysmography (PG) data. Heart rhythm measurements are performed by placing the fingertip on the camera of a smartphone device. This way, volumetric changes can be detected.

The FibriCheck Portal is a web application for healthcare providers intended to display data that was captured by the FibriCheck Mobile Application. Healthcare providers can use the issue FibriCheck prescriptions, to manage their patients and to consult measurement data.

# Intended Use/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.

## Indications for Use Comparison

The subject device's indications for use are identical to the predicate and are provided below:

FibriCheck is indicated for self-testing by patients, who have been diagnosed with, or are susceptible to developing, atrial fibrillation and

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(5)

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who would like to monitor and record their heart rhythms on an intermittent basis.

## Technological Comparison

## 21 CFR 807.92(a)(6)

The subject device and the predicate device have intended use, the same key technological characteristics, and the same signal-acquisition capabilities. In clinical testing, FibriCheck demonstrated that it can achieve heart in line with the predicate device. Therefore, FibriCheck is substantially equivalent to the predicate device.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following non-clinical testings were conducted to demonstrate safety and effectiveness of the subject device:

- Skin tone quality verification
- External aggressor verification
- Software verification

No concerns regarding new safety or effectiveness issues were raised during this testing.

Our clinical validation study NCT06282380 included 252 cardiology patients recruited in-clinic or consulting the cardiac outpatient clinic, with or without AF. The participants were instructed to record PPG measurements using the subject device which were compared against the gold-standard reference diagnosis. The performance metrics are in line with those reported for the predicate device, and did not raise concerns regarding the safety or effectiveness of the subject device.

The subject device and predicate device have intended use, the same key technological characteristics, and the same signalacquisition capabilities. In clinical testing the demonstrated that it is capable of irregular rhythm detection accuracy in line with the predicate device. Therefore, the subject device as safe and as effective as the predicate device.