(118 days)
Yes
The device name itself is "KardiaAI", and the description explicitly mentions "automated proprietary ECG algorithms". While it doesn't detail the specific AI/ML techniques, the naming convention and the term "algorithms" in this context strongly suggest the use of AI/ML for ECG analysis.
No.
KardiaAI is a software analysis library that provides analytical capabilities for ECG rhythms, such as noise filtering, heart rate measurement, and detection of various heart conditions like atrial fibrillation and bradycardia. It is intended to be integrated into other medical device software and provides supportive information for ECG diagnosis rather than directly treating a condition.
Yes
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms. It provides capabilities such as reporting heart rate, detecting noisy ECGs, and reporting ECG rhythm analysis for various conditions like atrial fibrillation and bradycardia. This analysis of physiological data to identify specific medical conditions indicates its diagnostic purpose. The text also states that "The automated proprietary ECG algorithms provide supportive information for ECG diagnosis."
Yes
The device is explicitly described as a "software library" and "Software as a Medical Device (SaMD)" that provides an API for integration into other devices. It does not include any hardware components itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device analyzes electrical signals generated by the human body (ECG rhythms). While the ECG is a physiological measurement, it's not a sample like blood, urine, or tissue that is analyzed in vitro (outside the body).
- The intended use is to assess ambulatory ECG rhythms. This is a direct measurement of a physiological function, not an analysis of a biological sample.
- The device description focuses on processing and analyzing ECG signals. It describes algorithms for filtering, detecting rhythms, and classifying beats, all based on the electrical activity of the heart.
Therefore, KardiaAI falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.
The KardiaAI library provides the following capabilities:
- Filtering ECG noise.
- Reporting heart rate measurement from ECGs, ●
- o Detecting noisy ECGs,
- Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, ● bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy,
- Detecting QRS complexes in an ECG,
- For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC ● beat, and
- o Generating an average beat from an ECG
The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DPS
Device Description
KardiaAI is a software library that implements various ECG processing and analysis algorithms. This Software as a Medical Device (SaMD) computes various physiologic parameters from an ECG and provides these capabilities in the form of an Application Program Interface (API) library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults (over 18)
Intended User / Care Setting
when prescribed or used under the care of a physician
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
Nonclinical testing, similar to that conducted to support the predicate device, was conducted to assess algorithm performance and to verify that KardiaAI performs as intended.
Software testing was conducted for KardiaAI. Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications. Specifically, for the algorithm outputs which are present in both KardiaAI and the predicate device, comparative testing was conducted, and it was found that the subject device demonstrated equivalent performance to the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing, similar to that conducted to support the predicate device, was conducted to assess algorithm performance and to verify that KardiaAI performs as intended.
Software testing was conducted for KardiaAI. Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications. Specifically, for the algorithm outputs which are present in both KardiaAI and the predicate device, comparative testing was conducted, and it was found that the subject device demonstrated equivalent performance to the predicate device. The results of the testing demonstrate that KardiaAI performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.
In addition, a human factors usability study was conducted in accordance with recommendations in IEC 62366-1:2015, "Medical devices - Part 1: Application of usability engineering to medical devices", and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The results of the study demonstrated that users can use the device and understands its outputs based on labeling, and further understand appropriate actions if symptoms are present, such as when to seek medical care.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
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November 12, 2020
AliveCor, Inc. % Prabhu Raghavan Principal MDQR, LLC 444 Castro Street, Suite 600 Mountain View. California 94041
Re: K201985
Trade/Device Name: KardiaAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: October 12, 2020 Received: October 13, 2020
Dear Prabhu Raghavan:
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
1
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) 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,
Jennifer Shih 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) K201985
Device Name
KardiaAI
Indications for Use (Describe)
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.
The KardiaAl library provides the following capabilities:
- · Filtering ECG noise,
- · Reporting heart rate measurement from ECGs,
- · Detecting noisy ECGs.
· Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy;
· Detecting QRS complexes in an ECG.
- · For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and
- · Generating an average beat from an ECG
The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.
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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3
Image /page/3/Picture/0 description: The image shows the logo for AliveCor. The logo is in a teal color and features the company name in a simple, sans-serif font. A registered trademark symbol is located to the upper right of the name.
510(k) Summary for K201985
Prepared in accordance with the requirements of 21 CFR 807.92
Submitter Information [807.92(a)(1)]
| Submitter/Applicant | AliveCor, Inc.
444 Castro Street, Suite 600
Mountain View, CA 94041
Phone: 650-396-8553
Fax: 650-282-7932 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Prabhu Raghavan
Regulatory Consultant for AliveCor
MDQR, LLC
444 Castro Street, Suite 600
Mountain View, CA 94041
Phone: 408-316-5707
Fax: 650-282-7932
Email: prabhu@mdqr.solutions |
| Submitter and
Secondary Contact Person | Saket Bhatt
VP of Regulatory and Quality
444 Castro Street, Suite 600
Mountain View, CA 94041
Phone: 408-701-7319
Fax: 650-282-7932
Email: ra@alivecor.com |
Date Prepared
July 15, 2020
Device Information [807.92(a)(2)]
| Trade Name | KardiaAI |
|---|---|
| Common Name | Programmable diagnostic computer |
| Classification | 21 CFR§870.1425 |
| Device Class | Class II |
| Product Code | DQK |
| Subsequent Product Code | DPS |
Predicate Information [807.92(a)(3)]
Predicate(s)
AliveCor, Inc., KardiaAI, K181823
Device Description [807.92(a)(4)]
KardiaAI is a software library that implements various ECG processing and analysis algorithms. This Software as a Medical Device (SaMD) computes various physiologic parameters from an ECG and provides these capabilities in the form of an Application Program Interface (API)
4
510(k) Summary for KardiaAI AliveCor, Inc.
library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).
Indications for use [807.92(a)(5)]
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.
The KardiaAI library provides the following capabilities:
- Filtering ECG noise.
- Reporting heart rate measurement from ECGs, ●
- o Detecting noisy ECGs,
- Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, ● bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy,
- Detecting QRS complexes in an ECG,
- For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC ● beat, and
- o Generating an average beat from an ECG
The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.
Substantial Equivalence
The subject device has the same intended use as the predicate devices intended are to process (e.g., filter and detect noise) and analyze a single channel ECG signal to detect the presence of arrhythmias. These ECG analysis outputs from the subject and predicate device all represent potential findings to be reviewed and interpreted by a qualified healthcare professional, and do not represent complete diagnoses. Both devices are software-only API libraries and are intended to be incorporated into other Alive Cor-designed medical devices ("target device"). Both the subject and predicate device process and analyze recorded ECGs, the output of which are stored, transferred, and displayed by the target device.
5
The subject device includes all the software outputs of the predicate device with updates in algorithm design and provides several new analysis outputs which are within the general intended use shared with the predicate device. Like the predicate device, the subject device's ECG analysis functionalities with respect to arrhythmia detection are prescription features.
As such, the subject device has the same intended use and technological characteristics as the predicate device. Differences between the subject device and the predicate device do not raise different questions of safety or effectiveness from the predicate device, and performance testing has demonstrated that the subject device meets its performance specifications and is as safe and as effective as the predicate device for their intended use. Therefore, KardiaAI is substantially equivalent to the predicate device.
| Feature | AliveCor KardiaAI
(Subject Device) | AliveCor KardiaAI (K181823)
(Predicate Device) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK, Computer, Diagnostic,
Programmable | DQK, Computer, Diagnostic,
Programmable |
| | DPS, Electrocardiograph | DPS, Electrocardiograph |
| Regulation | 21 CFR§870.1425, Programmable
diagnostic computer | 21 CFR§870.1425, Programmable
diagnostic computer |
| | Class II | Class II |
| Feature | AliveCor KardiaAI
(Subject Device) | AliveCor KardiaAI (K181823)
(Predicate Device) |
| Indications for
use | KardiaAI is a software analysis library
intended to assess ambulatory
electrocardiogram (ECG) rhythms from
adult subjects (when prescribed or used
under the care of a physician). The
device supports analyzing data recorded
in compatible formats from any
ambulatory ECG devices such as event
recorders, or other similar devices. The
library is intended to be integrated into
other device software. The library is not
intended for use in life supporting, or
sustaining systems, or ECG monitors, or
cardiac alarm, or OTC use only devices.
The KardiaAI library provides the
following capabilities:
• Filtering ECG noise,
• Reporting heart rate measurement
from ECGs,
• Detecting noisy ECGs,
• Reporting ECG rhythm analysis for
the presence of sinus rhythm, atrial
fibrillation, bradycardia, and
tachycardia; for ECGs detected as
sinus rhythm, detecting normal sinus
rhythm, sinus rhythm with wide
QRS, sinus rhythm with premature
ventricular contractions (PVC), and
sinus rhythm with supraventricular
ectopy,
• Detecting QRS complexes in an
ECG,
• For ECGs detected as sinus rhythm,
classifying individual beats as a PVC
or non-PVC beat, and
• Generating an average beat from an
ECG
The device is not intended for use in
patients who have pacemakers, ICDs, or
other implanted electronic devices | KardiaAI is a software analysis library
intended to assess ambulatory
electrocardiogram (ECG) rhythms from
adult subjects.
The device supports analyzing data
recorded in compatible formats from
any ambulatory ECG devices such as
event recorders, or other similar devices.
The library is intended to be integrated
into other device software.
The library is not intended for use in life
supporting, or sustaining systems, or
ECG monitors, or cardiac alarm, or
OTC use only devices.
KardiaAI provides the following
capabilities:
• ECG noise filtering,
• heart rate measurement from ECGs,
• detection of noisy ECGs, and
• ECG rhythm analysis for detecting
the presence of normal sinus rhythm,
atrial fibrillation, bradycardia, and
tachycardia (when prescribed or used
under the care of a physician). |
| Target
population | Adults (over 18) | Adults (over 18) |
| Components | Software only | Software only |
| Feature | AliveCor KardiaAI
(Subject Device) | AliveCor KardiaAI (K181823)
(Predicate Device) |
| Software
Functionalities | An interface that provides tools to
process and analyze ECGs through
various algorithms The automated proprietary ECG
algorithms provide supportive
information for ECG diagnosis. The
library can be accessed by directly
connecting to the KardiaAI's
Application Programming Interface | An interface that provides tools to
process and analyze ECGs through
various algorithms The automated proprietary ECG
algorithms provide supportive
information for ECG diagnosis. The
library can be accessed by directly
connecting to the KardiaAI's
Application Programming Interface |
| Compatible
ECG Devices | Triangle System (K183319) KardiaMobile System (K182396) Omron Model BP7900 Blood
Pressure Monitor + EKG (K182579) | Triangle System (K183319) KardiaMobile System (K182396) KardiaBand System (K171816) Omron Model BP7900 Blood
Pressure Monitor + EKG (K182579) |
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
6
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
7
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
Performance Data [807.92(b)]
All necessary testing was conducted on KardiaAI to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary [807.92(b)(1)]
Nonclinical testing, similar to that conducted to support the predicate device, was conducted to assess algorithm performance and to verify that KardiaAI performs as intended.
Software testing was conducted for KardiaAI. Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications. Specifically, for the algorithm outputs which are present in both KardiaAI and the predicate device, comparative testing was conducted, and it was found that the subject device demonstrated equivalent performance to the predicate device. The results of the testing demonstrate that KardiaAI performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.
In addition, a human factors usability study was conducted in accordance with recommendations in IEC 62366-1:2015, "Medical devices - Part 1: Application of usability engineering to medical devices", and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The results of the study demonstrated that users can use the device and understands its outputs based on labeling, and further understand appropriate actions if symptoms are present, such as when to seek medical care.
8
510(k) Summary for KardiaAI AliveCor, Inc.
Conclusions [807.92(b)(3)]
KardiaAI has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Differences between the subject device and the predicate device have been tested to ensure that the device meets its intended use. The results of nonclinical testing specifically demonstrate that KardiaAI meets its intended use which is equivalent to that of the predicate device. Therefore, KardiaAI is substantially equivalent to the predicate device.