(282 days)
K142743, AliveCor Heart Monitor
No
The summary does not mention AI, ML, or related terms, and the performance study description focuses on traditional statistical metrics without indicating the use of complex algorithmic training or testing.
No
The device is described as medical device software that determines heart rhythm conditions and detects Atrial Fibrillation. It is intended for monitoring and recording heart rhythms, not for treating them.
Yes
The device is described as "medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation," and performance metrics like sensitivity, specificity, and predictive values are provided, which are indicative of a diagnostic device.
Yes
The device description explicitly states "FibriCheck is medical device software" and that it "makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data)." While it relies on a mobile device for data collection, the device itself is the software that processes this data and determines heart rhythm conditions. The web application is also described as an online tool for displaying data and managing patients, further supporting the software-only nature.
Based on the provided information, FibriCheck is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- FibriCheck's Mechanism: FibriCheck uses optical sensing from a mobile device to collect photoplethysmogram (PPG) data. This is a non-invasive method that measures changes in blood volume in the skin, typically from a fingertip. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for self-testing by patients to monitor and record heart rhythms. While this information can be used for diagnostic purposes by a physician, the device itself is not performing a test on a biological sample.
Therefore, FibriCheck falls under the category of a medical device that analyzes physiological signals from the body, rather than an IVD that analyzes biological specimens.
N/A
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.
Product codes
DXH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical sensing from a mobile device to collect photoplethysmogram data (PPG data).
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Self-testing by patients
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 clinical performance of FibriCheck was compared to the reference device Kardia (AliveCor) in a study where 223 subjects participated. In total 100/223 subjects suffered from atrial fibrillation. Both technologies were compared towards a gold-standard 12-lead ECG device. The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14% and for Kardia 94.09%/97.47%/91.59%/89.53%/98%/95.09% This means that both methods have comparable diagnostic results.
Key Metrics
FibriCheck: sensitivity 95.60%, specificity 96.55%, positive predictive value 95.60%, negative predictive value 96.55%, accuracy 96.14%.
Kardia: sensitivity 94.09%, specificity 97.47%, positive predictive value 91.59%, negative predictive value 89.53%, accuracy 95.09%.
Predicate Device(s)
K132206, Melys Atrial Fibrillation Monitor
Reference Device(s)
K142743, AliveCor Heart Monitor
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K173872
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
1. SUBMITTER
| Submitter Name: | Qompium NV |
|---|---|
| Submitter Address: | Kempische Steenweg 311/27 |
| 3500 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 receiver |
| 21 CFR 870.2920 | |
| DXH | |
| II | |
| Cardiovascular |
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 susceptible |
| to developing, atrial fibrillation and who would like to monitor | |
| and 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
4
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
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.
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.
5
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. |
| Regulation | |||
| Number | 870.2920 | 870.2920 | 870.2920 |
| Device | |||
| Classification | |||
| Name | Telephone electrocardiograph | ||
| transmitter and receiver | Telephone electrocardiograph | ||
| transmitter and receiver | Telephone electrocardiograph transmitter and receiver | ||
| Product Code | DXH | DXH | DXH, DPS |
| 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. | The Melys Atrial Fibrillation | ||
| Monitor 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. | The AliveCor Heart Monitor is intended to record, store | ||
| and 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 heart conditions and | |||
| health conscious individuals. The device has not been | |||
| tested and it is not intended for pediatric use. | |||
| Intended User | Adult | Adult | Adults |
| Prescription | |||
| device for home | |||
| Use | Yes | Yes | Yes |
| Single Patient Use | Yes | Yes | Yes |
| Monitors | |||
| regularity of | |||
| heartbeat | Yes | Yes | Yes |
| Alerts user to an | |||
| irregularity in | |||
| their pulse | |||
| through a light | |||
| indicator. | No, text indicator | Yes | No, text indicator |
| Principle of | |||
| Operation | FibriCheck receives data from | ||
| the Mobile Platform device, from | |||
| which the waveform is directly | |||
| created. The irregularity is | |||
| indicated with a text indicator. | The monitor passes light through | ||
| the fingertip sensor and receives | |||
| data from which the waveform is | |||
| directly created. | |||
| Displays regularity or irregularity | |||
| with a light indicator. | The device attaches to compatible smartphone or tablet | ||
| and has electrodes to transmit ECG rhythms to the | |||
| smartphone or tablet. Furthermore, the mobile app is | |||
| used to collect, view, save, and wirelessly transmit | |||
| recordings to the AliveCor server. | |||
| Device Design | FibriCheck obtains waveform via | ||
| Mobile Platform camera and | |||
| displays signal in real time on the | |||
| Mobile Platform device with an | |||
| arrhythmia index. | |||
| Text display (green, amber, or | |||
| blue) indicates heart regularity or | |||
| irregularity. | |||
| All tests are stored. | Monitor obtains waveform via | ||
| finger sensor and displays | |||
| waveform in real time on the | |||
| monitor with an arrhythmia index. | |||
| Light display (green, amber, or | |||
| red) indicates heart regularity or | |||
| irregularity. | |||
| Last 8 tests are stored on the | |||
| display by light indicator not | |||
| Arrhythmia Index number. | The device utilizes the processing power of a mobile | ||
| computing platform (MCP) while reducing the complexity | |||
| of the electronics hardware associated with data | |||
| acquisition and transmission. The AliveCor Heart | |||
| Monitor can also analyze ECG signals and indicate the | |||
| presence of noise, normal sinus rhythm and atrial | |||
| fibrillation for each ECG recording. | |||
| Functional | |||
| Features | |||
| User | |||
| programmable | No | No | No |
| Recording length | 60 seconds | 10 seconds | |
| (Recommended four (4) | |||
| consecutive measurement should | |||
| show same indication (red, amber | |||
| or green) before a conclusion is | |||
| drawn) | 30 seconds to 5 minutes | ||
| Differences | |||
| Data acquisition | PPG signal from the mobile | ||
| computing 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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7
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 the
FibriCheck indicates that it meets its predefined product's
requirements and requirements from the following product
standard:
AAMI/ANSI/IEC 62304:2006, Medical Device
Software - Software Life Cycle Processes ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012
Medical Electrical Equipment - Part 1-8: General
requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical
systems. |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance
Testing | The clinical performance of FibriCheck was compared to the
reference device Kardia (AliveCor) in a study where 223
subjects participated. In total 100/223 subjects suffered from
atrial fibrillation. Both technologies were compared towards a
gold-standard 12-lead ECG device. The diagnostic results
yielded in a sensitivity/specificity/positive predictive
value/negative predictive value and accuracy for FibriCheck
of 95.60%/96.55%/95.60%/96.55%/96.14% and for Kardia
94.09%/97.47%/91.59%/89.53%/98%/95.09% This means
that both methods have comparable diagnostic results. |
8
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.