(141 days)
FibriCheck (K173872)
Not Found
Unknown
The summary describes an "algorithm to filter and detect irregular pulse rhythm" but does not explicitly mention AI, ML, or related terms. While such an algorithm could be based on AI/ML, the provided text does not confirm this.
No.
The device is indicated for monitoring and recording pulse rhythms to alert physicians of irregular heart rhythms, not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is to alert physicians to "irregular heart rhythms." The "Device Description" also mentions that the algorithm is used to "filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF)." This indicates the device is used to identify a medical condition, which is the definition of a diagnostic device.
No
The device description explicitly states that the software "interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data". This indicates a dependency on specific hardware components (the monitoring system and smartwatch) for data acquisition, making it not solely a software device.
Based on the provided information, the LIVMOR Halo AF Detection System™ is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to "monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms." This involves analyzing physiological data (pulse rhythms from PPG) to provide information that aids in the diagnosis or monitoring of a medical condition (atrial fibrillation).
- Device Description: The system "consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data." This analysis of biological data (PPG) to identify a medical condition is a core function of an IVD.
- Input Data: The device uses Photoplethysmograph (PPG) data, which is a physiological signal collected from the patient.
- Output: The system provides an "alert the physician when irregular pulse rhythm suggestive of AF is detected." This output is intended to inform a medical professional about a potential medical condition.
- Comparison to Predicate: The predicate device, FibriCheck (K173872), is also an IVD device that analyzes PPG data for the detection of atrial fibrillation. This further supports the classification of the LIVMOR Halo AF Detection System as an IVD.
While the device doesn't directly analyze biological samples like blood or urine in a lab setting, the analysis of physiological data (PPG) collected from the patient's body for the purpose of aiding in the diagnosis or monitoring of a medical condition falls under the scope of IVD devices, particularly in the context of digital health and software as a medical device (SaMD).
N/A
Intended Use / Indications for Use
The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms.
The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers.
The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmograph (PPG)
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physician would consult with the patient if AF is suggested.
Prescription Use
Home use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing Validation and Verification Testing carried out on the Halo AF Detection System indicates that it meets its predefined product's requirements and requirements from the following product standards:
- AAMI/ANSI/IEC 62304:2006, Medical Device Software Software Life Cycle Processes
Clinical Performance Testing: The company performed a clinical study demonstrating sensitivity and specificity of the device in detecting atrial fibrillation when compared to ground truth as established by physician review of simultaneously collected ECG data with a Holter monitor. Mean values are presented below and are statistically significant. Device confirmed to meet performance goals.
Sample Size: n=92 (for LIVMOR device)
Key Results:
Sensitivity: 100.0%
Specificity: 93.0%
Positive Predictive Value: 89.7%
Negative Predictive Value: 100.0%
Accuracy: 95.7%
Software V&V Testing: Validation testing involved algorithm testing which validated the accuracy of Halo AF Detection System. The product was deemed fit for clinical use. Usability validation is part of the Clinical Performance data and Halo AF Detection System was tested and meets the requirements of the following standard:
- IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices.
- Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff; FEBRUARY 2016
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100.0%
Specificity: 93.0%
Positive Predictive Value: 89.7%
Negative Predictive Value: 100.0%
Accuracy: 95.7%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FibriCheck (K173872)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows 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.
September 23, 2020
Ken Persen Chief Executive Officer LIVMOR, Inc. 16470 Bake Pkwv.. Ste. 200 Irvine, California 92618
Re: K201208
Trade/Device Name: LIVMOR HALO AF Detection System™ Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: August 21, 2020 Received: August 24, 2020
Dear Ken Persen:
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/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 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer 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
2
Indications for Use
510(k) Number (if known) K201208
Device Name LIVMOR Halo AF Detection SystemTM
Indications for Use (Describe)
The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms.
The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.
| 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) SUMMARY
SUBMITTER
| Submitter Name: | LIVMOR, Inc. |
|---|---|
| Submitter Address: | 16470 Bake Parkway, Suite 200 |
| Irvine, CA 92618 | |
| Phone Number: | (612) 747-9595 |
| Contact Person: | Ken Persen, CEO |
| Date Prepared: | May 2, 2020 |
| DEVICE | |
| Device Trade Name: | LIVMOR Halo AF Detection System™ |
| Common Name: | Irregular Heart Rhythm Monitor |
| Classification Name: | Telephone electrocardiograph transmitter and receiver |
| Number: | 21 CFR 870.2920 |
| Product Code: | DXH |
| Class: | II |
| Classification Panel: | Cardiovascular |
PREDICATE DEVICE
| Primary Predicate: | FibriCheck (K173872) |
|---|---|
| Intended 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 | |
| pulse rhythms on an intermittent basis. |
The primary predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION
The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers.
The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.
4
INDICATIONS FOR USE
The LIVMOR Halo AF Detection System™ is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted of detected irregular heart rhythms.
The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring System™, and is not validated for use with other pulse monitoring systems.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The LIVMOR Halo AF Detection System has the same intended use, technological characteristics, and principles of operation as its predicate device. FibriCheck. The minor differences between the LIVMOR device and its predicate device do not raise new questions of safety or effectiveness.
The LIVMOR Halo AF Detection was evaluated for sensitivity and specificity in the intended use subjects.
The primary differences between the LIVMOR Halo AF Detection System and predicate are:
- Duration of recording LIVMOR Halo AF Detection System analyses data recorded for a duration of hours o automatically each night, and for periods of 10 minutes on patient initiation, with patient at rest, whilst Predicate records for 1 minute on patient initiation with patient at rest.
- . Delivery of result - The LIVMOR AF Detection System results are delivered to the overseeing physician through the LIVMOR HeartView Physician Web Portal, whilst the Predicate delivers AF detection results direct to the patient
| Device Name | LIVMOR Halo AF Detection System | FibriCheck |
|---|---|---|
| 510(k) Number | K201208 | K173872 |
| Manufacturer | LIVMOR | Qompium |
| Regulation | 870.2920 | 870.2920 |
| Device Classification Name | Telephone electrocardiograph | |
| transmitter and receiver | Telephone electrocardiograph | |
| transmitter and receiver | ||
| Product Code | DXH | DXH |
| Indication | ||
| Statement | The LIVMOR Halo AF Detection SystemTM is | |
| indicated for use by patients who have been | ||
| diagnosed with or are susceptible to developing | ||
| atrial fibrillation and who would like to monitor | ||
| and record their pulse rhythms on an | ||
| intermittent basis so that their physician can be alerted of detected irregular heart rhythms. |
The LIVMOR Halo AF Detection System is
intended for use in conjunction with the
LIVMOR Halo+ Home Monitoring SystemTM,
and is not validated for use with other pulse
monitoring systems. | 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. |
| Intended User | Adult | Adult |
| Prescription device for
home use | Yes | Yes |
| Single patient use | Yes | Yes |
| Monitors regularity of
heartbeat | Yes | Yes |
5
| Device Name | LIVMOR Halo AF Detection System | FibriCheck |
|---|---|---|
| Alerts user to irregular | ||
| rhythm | Physician would consult with the patient if | |
| AF is suggested. | User is notified when AF is detected | |
| and prompted to follow up with a | ||
| physician. | ||
| Device design | LIVMOR Halo AF Detection System obtains | |
| PPG waveform via a smart watch and | ||
| transmits to HeartView portal when connected | ||
| to Wifi | FibriCheck obtains PPG waveform via | |
| mobile phone camera and displays signal | ||
| in real time on the mobile phone with an | ||
| arrhythmia index. | ||
| User Interface | Web portal | Web portal |
| AF Detection Functionality & | ||
| Performance | Per Subject (n=92) | |
| Sensitivity: 100% | ||
| Specificity: 93.0% | ||
| Per Measurement (n=1834) | ||
| Sensitivity: 93.3% | ||
| Specificity: 99.1% | Per Subject (n=223) | |
| Sensitivity: 95.6% | ||
| Specificity: 96.6% | ||
| Per Measurement (n=547) | ||
| Sensitivity: 95.3% | ||
| Specificity: 96.2% |
PERFORMANCE DATA
Non-Clinical Testing Validation and Verification Testing carried out on the Halo AF Detection System indicates that it meets its predefined product's requirements and requirements from the following product standards:
- · AAMI/ANSI/IEC 62304:2006, Medical Device Software Software Life Cycle Processes
Clinical Performance Testing
The company performed a clinical study demonstrating sensitivity and specificity of the device in detecting atrial fibrillation when compared to ground truth as established by physician review of simultaneously collected ECG data with a Holter monitor. Mean values are presented below and are statistically significant. Device confirmed to meet performance goals.
| LIVMOR (n=92) | FibriCheck (n=223) | |
|---|---|---|
| Sensitivity | 100.0% | 95.6% |
| Specificity | 93.0% | 96.55% |
| Positive Predictive Value | 89.7% | 95.60% |
| Negative Predictive Value | 100.0% | 96.55% |
| Accuracy | 95.7% | 96.14% |
Software V&V Testing
Validation testing involved algorithm testing which validated the accuracy of Halo AF Detection System. The product was deemed fit for clinical use. Usability validation is part of the Clinical Performance data and Halo AF Detection System was tested and meets the requirements of the following standard:
- . IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices.
- Applying Human Factors and Usability Engineering to Medical ● Devices, Guidance for Industry and Food and Drug Administration
6
Staff; FEBRUARY 2016
Halo AF Detection System was designed and developed as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device". Halo AF Detection System was considered to represent "moderate" level of concern as it is not intended to provide recommendations for treatment. According to AAMI/ANSI/IEC 62304 Standard, Halo AF Detection System safety classification has been set toClass B.
Conclusion
The information discussed above and provided in the 510(k) submission demonstrate that the LIVMOR Halo AF Detection System (a SaMD device) is substantially equivalent to the predicate.