(150 days)
Not Found
Yes
The device description explicitly states that the device utilizes the computing power of the Apple Watch to "analyze" the single-channel ECG and "detects the presence of atrial fibrillation and normal sinus rhythm". While the terms AI or ML are not explicitly used, the function of analyzing and detecting patterns in biological signals like ECGs is a common application of machine learning algorithms in medical devices. The predicate device (K142743 AliveCor Heart Monitor) is also known to utilize algorithms for rhythm analysis.
No
The device is intended to record, store, transfer, and display ECG rhythms, and detect the presence of atrial fibrillation and normal sinus rhythm. These functions are diagnostic or monitoring in nature, not therapeutic.
Yes
The device is intended to detect the presence of atrial fibrillation and normal sinus rhythm, which describes a diagnostic function.
No
The device description explicitly states that the Kardia Band System consists of "the Kardia Band Hardware (watchband)" in addition to the software components. This indicates it is not a software-only medical device.
Based on the provided information, the Kardia Band System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on samples like blood, urine, or tissue.
- Kardia Band System's Function: The Kardia Band System directly measures electrical activity of the heart (ECG) from the body surface. It does not analyze specimens derived from the body.
- Intended Use: The intended use describes recording, storing, transferring, and displaying ECG rhythms, and detecting the presence of atrial fibrillation and normal sinus rhythm. This is a direct physiological measurement and analysis, not an in vitro test.
Therefore, the Kardia Band System falls under the category of a medical device that performs physiological measurements and analysis, but it is not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System 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 Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
Product codes
DXH, DPS
Device Description
The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes the computing power of the Apple, Inc. Apple Watch to obtain and analyze single-channel ECG. The Kardia Band System consists of the Kardia Band Hardware (watchband), the Kardia watch app software (installed on the Apple Watch), and the Kardia phone app software (installed on the Apple iPhone). The Kardia Band System transmits the ECG signal from its electrode to the Kardia watch app on the Apple Watch to be analyzed and presented to the user. All ECGs are synced with the user's account.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right wrist or vice versa
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
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)
Nonclinical Testing: All necessary performance testing was conducted on the Kardia Band System to support a determination of substantial equivalence to the predicate device. This testing included testing to the following standards: IEC 60601-1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance, IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, and IEC 60601-2-47:2012 Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems. The collective results of the non-clinical testing demonstrate that the Kardia Band System meets the established specifications and complies with the aforementioned standards.
Clinical Testing: Clinical performance testing was conducted to demonstrate that the AliveCor Kardia Band System generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis. The presented data shows very strong mathematical correlation and qualitative clinical equivalence. The study is sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains 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.
November 16, 2017
Alivecor, Inc % Anna Libman Senior Manager, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K171816
Trade/Device Name: Kardia Band System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH, DPS Dated: October 11, 2017 Received: October12, 2017
Dear Anna Libman:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Hillebrand
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)
Device Name Kardia Band System
Indications for Use (Describe)
The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System 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 Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Notification K_________________________________________________________________________________________________________________________________________________________
GENERAL INFORMATION
Applicant:
AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 Phone: 650-396-8553 Fax: 650-282-7932
Applicant Contact Person:
Anna Libman Regulatory Consultant to AliveCor, Inc. Senior Manager, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-400-0856 Fax: 408-400-0865 Email: anna@experiengroup.com
Date Prepared:
June 16, 2017
DEVICE INFORMATION
Trade Name: Kardia Band System Generic/Common Name: Telephone electrocardiograph transmitter and receiver Classification: 21 CFR $870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II Product Code: DXH, DPS
PREDICATE DEVICE(S)
4
510(k) SUMMARY
INDICATIONS FOR USE
The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System 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 Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
DEVICE DESCRIPTION
The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes the computing power of the Apple, Inc. Apple Watch to obtain and analyze single-channel ECG. The Kardia Band System consists of the Kardia Band Hardware (watchband), the Kardia watch app software (installed on the Apple Watch), and the Kardia phone app software (installed on the Apple iPhone). The Kardia Band System transmits the ECG signal from its electrode to the Kardia watch app on the Apple Watch to be analyzed and presented to the user. All ECGs are synced with the user's account.
| Feature | Kardia Band System | Kardia Mobile
K142743 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Code | DXH, DPS | Same |
| Mechanism of
Action | User completes circuit with skin contact
and hardware transmits audio signal to
MCP to convert and display ECG
waveform | Same |
| Where used
(intended use) | Mobile/active users at rest (ambulatory) | Same |
| Anatomical sites | Left hand fingers to right wrist or vice
versa | Left hand fingers to right hand fingers |
| Data Acquisition: | | Same |
| Frequency
Response | 0.5 Hz - 40 Hz | |
| ECG channels | Single Channel | |
| Resolution | 16 bit | |
| Sample Rate | 300 Samples/Second | |
| Memory
Capacity: | Essentially unlimited due to real-time
transmission to MCP memory (size of
ECG file is miniscule – kilobytes
compared to device memory capacity -
gigabytes) | Same |
Physical and Technological Characteristics of the Kardia Band System
5
510(k) SUMMARY
| Feature | Kardia Band System | Kardia Mobile
K142743 |
|--------------------------------------|--------------------------------------------------------------------|----------------------------------------|
| Number of ECG
Leads | Single lead, 2 electrodes | Same |
| Power Supply: | Same | Same |
| Battery
Battery Life
(typical) | 1 Lithium Manganese Dioxide Coin
Cells
100 hours operational | Same |
| User Interface: | | |
| Primary Lead | Lead I, Left to Right | Same |
| Data acquisition | Ultrasonic acoustics | Same |
| Hardware | Apple Watch Band and Sensor | iPhone Case and Universal Module |
| Software
interface | Apple iOS based software and Apple
WatchOS based software | Apple iOS based software |
| Physical Specs: | | |
| Dimensions | 24.5 x 24.5 x 6.5 mm | 118 x 62 x 16.5 mm |
| Weight | 9 grams | 40 grams |
| Prescribed: | Prescription and OTC | Same |
| Environmental: | | Same |
| Operating Temp | 10 to 40 degrees C | |
| Storage Temp | -20 to 60 degrees C | |
| Communications | Ultrasonic Acoustics acquired by watch | Ultrasonic Acoustics acquired by phone |
SUBSTANTIAL EQUIVALENCE
The Kardia Band System is substantially equivalent to the previously cleared Kardia Mobile product (AliveCor Heart Monitor hardware and software (K142743), also known as Kardia Mobile). The new Kardia Band System has been redesigned to fit on an Apple Watch band and has the same intended use and similar technological characteristics as those of the predicate device. Differences in technological characteristics have been evaluated through performance testing, and therefore the proposed device is substantially equivalent to the predicate device.
NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary performance testing was conducted on the Kardia Band System to support a determination of substantial equivalence to the predicate device. This testing included testing to the following standards: IEC 60601-1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance, IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, and IEC 60601-2-47:2012 Medical Electrical Equipment --
6
510(k) SUMMARY
Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems. The collective results of the non-clinical testing demonstrate that the Kardia Band System meets the established specifications and complies with the aforementioned standards.
CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Clinical performance testing was conducted to demonstrate that the AliveCor Kardia Band System generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis.
The presented data shows very strong mathematical correlation and qualitative clinical equivalence. The study is sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria.
CONCLUSION
The results of both clinical and nonclinical testing demonstrate that the Kardia Band System is substantially equivalent to the predicate device.