(176 days)
Yes
The summary explicitly states that the device utilizes the same ECG analysis algorithm as the AliveCor KardiaAI device cleared under K181823, and the "Mentions AI, DNN, or ML" section specifically calls out "AliveCor KardiaAI".
No
The device is intended for measurement and detection, not for treatment or therapy. It provides information about blood pressure and ECG rhythms, which aids in diagnosis and monitoring, but does not directly treat a condition.
Yes
The device is described as detecting the presence of atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm, which are diagnostic statements.
No
The device description clearly states it is a "battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use" and includes physical components like an arm cuff, integral pump, electric valve, and electrodes. While it utilizes software for analysis and display, it is fundamentally a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The description clearly states the device measures blood pressure and records electrocardiogram (ECG) rhythms. Both of these are measurements taken directly from the body (in vivo).
- No Sample Analysis: There is no mention of the device analyzing any biological samples.
The device is a non-invasive medical device for physiological measurements.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DXH, DPS
Device Description
The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use.
The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm. respectively. Other than the difference in circumference, the two cuffs function in the same manner.
The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared AliveCor Heart Monitor algorithm (K142743) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.
In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared AliveCor Heart Monitor or OMRON Connect App. These two applications are effectively the same, with the only difference being branding. The cleared app allows the user to view their ECG and the results of analysis using the AliveCor algorithm (cleared under K142743) which detects the presence of atrial fibrillation, and normal sinus rhythm.
The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. All software V&V testing performed and submitted in this 510(k) utilized this algorithm.
The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cvcle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archiving and review by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, Left hand fingers to right hand fingers
Indicated Patient Age Range
Adult population.
The device has not been tested and it is not intended for pediatric use.
Intended User / Care Setting
healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals.
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)
Nonclinical Testing Summary: The nonclinical, bench testing included: Comparative performance testing against both predicate devices; Performance verification testing; Cleaning verification testing; and Usability testing to confirm device use in representative home users. In addition to the above bench testing, the BP7900 also underwent the following testing: Biocompatibility of patient-contacting materials per ISO 10993-1 requirements; Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic discharge requirements per IEC60601 and 80601 requirements; Software verification and validation. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Blood Pressure Monitor + EKG meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Blood Pressure Monitor + EKG does not raise different questions of safety or effectiveness when compared to the predicate devices.
Clinical Testing Summary: Two clinical investigations were conducted with the objective of validating the accuracy of blood pressure measurements. One study employed the HEM-7311 device with the HEM-RML31 Cuff, and the other study used the HEM-7130 device with the HEM-CS24 Cuff. Both of these BPM devices have the same algorithm and hardware components related to BP measurement as are used in the BP7900, and employ the same cuffs used for BP7900. The studies were performed to demonstrate comparability of performance of BP measurement based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. This study was conducted in accordance with guidelines per ANSI/AAMI/ISO 81060-2:2013 Noninvasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. The results demonstrated that BP7900 performed equivalently to the auscultation method and is in conformance with ANSI/AAMI/ISO 81060-2:2013.
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.
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 14, 2019
Omron Healthcare, Inc. % Ronald Warren Vice President, Regulatory Affairs Experien Group. LLC 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K182579
Trade/Device Name: Omron Model BP7900 Blood Pressure Monitor + EKG Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXH, DPS Dated: March 13. 2019 Received: March 14, 2019
Dear Ronald Warren:
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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.
Jessica E. Paulsen -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) K182579
Device Name
Omron Model BP7900 Blood Pressure Monitor + EKG
Indications for Use (Describe)
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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."
3
510(k) Notification K182579
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Omron Healthcare, Inc. 1925 West Field Court Lake Forest. IL 60045 USA Phone: 847-247-5626 FAX: 847-680-6269
Contact Person:
Ronald S. Warren Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-505-3926 FAX: 408-400-0856
Date Prepared: March 13, 2019
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Omron Model BP7900 Blood Pressure Monitor + EKG
Generic/Common Name:
Noninvasive blood pressure measurement system, DXN Telephone electrocardiograph transmitter and receiver, DXH Electrocardiograph, DPS
Classification:
21CFR §870.1130, Noninvasive blood pressure measurement system, Class II 21 CFR8870.2920, Telephone electrocardiograph transmitter and receiver, Class II 21 CFR§870.2340, Electrocardiograph, Class II
Product Code:
DXN, Noninvasive Blood Pressure Measurement System DXH, Telephone electrocardiograph transmitter and receiver DPS. Electrocardiograph
4
PREDICATE DEVICES [807.92(a)(3)]
The Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the Omron Healthcare. Inc. Model HEM-7311 (K133379) and the AliveCor, Inc. AliveCor Health Monitor (K142743). The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. In this regard KardiaAI (K181823) is included as a reference device.
DEVICE DESCRIPTION [807.92(a)(4)]
The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG)1 measurement system intended for home use.
The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm. respectively. Other than the difference in circumference, the two cuffs function in the same manner.
The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared AliveCor Heart Monitor algorithm (K142743) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.
In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared AliveCor Heart Monitor or OMRON Connect App. These two applications are effectively the same, with the only difference being branding. The cleared app allows the user to view their ECG and the results of analysis using the AliveCor algorithm
1 Note: ECG is used throughout this submission and technical documentation, however EKG may also be used in labeling and product trade name information for lay persons.
5
510(k) SUMMARY
(cleared under K142743) which detects the presence of atrial fibrillation, and normal sinus rhythm.
The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. All software V&V testing performed and submitted in this 510(k) utilized this algorithm.
The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cvcle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archiving and review by the user.
INDICATIONS FOR USE [807.92(a)(5)]
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The proposed BP7900 combines the intended use of the Omron Healthcare, Inc. Model HEM-7311 ("HEM-7311") (K133379) for the blood pressure function and the AliveCor, Inc. AliveCor Health Monitor (K142743) for the ECG function. Similarly, BP7900 is substantially equivalent to both with regard to intended use, product labeling, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. With respect to technological characteristics, the BP7900 is equivalent to the HEM-7311 and AliveCor Heart Monitor devices in regard to the BP7900 BP functions and ECG functions, respectively.
In regard to BP function, the proposed BP7900 has the same intended use as its predicate device. Both the BP7900 and the HEM-7311 are intended for home use for the oscillometric measurement of blood pressure and pulse rate utilizing an arm cuff. Both devices have the same cuff pressure range of 0 to 299mmHg and the same pulse rate range of 40 to 180 beats/minute. In both the proposed and predicate device, pulse rate is determined using the same algorithm in which the device measures and records time for several dozen pulse waves. When the measured pulse stabilizes during cuff inflation, the software calculates numbers of pulses per minute based on the time and numbers of pulse waves measured. Both devices utilize arm cuffs which cover the same range of circumferences of 17 to 42cm, though the BP7900 has consolidated the size options down to two model sizes of cuff that were employed for the
6
510(k) SUMMARY
predicate device: 17-22cm (Model HEM-CS24-B Cuff); and, 22-42cm (Model HEM-RML31-B Cuff) ). The predicate device used the same 17-22cm and 22-42cm cuff but also included a mid-range 22-32cm cuff. Both devices also have the same accuracy with respect to pressure indicator and pulse rates and include detection of irregular heartbeats and give a warning signal with readings.
In regard to ECG function, the BP7900 employs the algorithm used for the AliveCor Heart Monitor. The BP7900 does not have an "Irregular Heartbeat Detection" feature which Omron BPMs normally have (estimated from measured BP pulse). Instead, it has an irregular pulse detection feature to identify possible AF, tachycardia which are estimated from ECG waveforms, not from blood pressure pulse. When BP and ECG are measured simultaneously, the device detects and shows pulse rate from BP pulse (displayed on the device and App), and the heart rate from ECG waveform (displayed on the App only). This is described on Page 17 of the BP7900 Instruction Manual. Thus, for the irregular pulse detection feature (given by AliveCor's algorithm), only the heart rate from the ECG waveform is used.
The BP7900 and both predicate devices are comparable with respect to safety characteristics. The BP7900 and HEM-7311 both have safety features to prevent over-pressurization of the cuff. In addition, all three devices have successfully passed electrical safety, and electromagnetic compatibility and interference requirements per IEC60601 standards. The user-contacting materials of all three devices have also passed biocompatibility testing requirements.
There are other minor differences in the technical specifications and features offered in the BP7900 and HEM-7311. For example, the BP7900 does not have the hypertension indicator that is included in the HEM-7311 which provides an additional alert to the user once the blood pressure measurements exceed the criteria (135/85) established by the JNC 7 guideline. Aside from these minor differences, there are no differences in the principle of operation, measurement range, accuracy of pressure measurement, or accuracy of pulse measurement. In regard to safety and technological characteristics, the BP7900 does not raise different questions of safety or effectiveness and is substantially equivalent to the HEM-7311.
Both the BP7900 and AliveCor Heart Monitor devices are intended for OTC and Prescription Use and employ the same ECG analysis algorithm to detect the appearance of irregular heartbeats. Both devices also measure a pulse rate of 30 to 300 beats/minute, have very similar data acquisition characteristics (i.e., the same number of ECG channels, resolution, and sample rate), and measure ECG using the same anatomical sites (i.e., left-hand fingers to the right-hand fingers). Additionally, both devices also transmit the gathered data in the same method, utilizing ultrasonic acoustics to communicate with a smartphone.
There are minor differences in the technical specifications and features offered in the BP7900 and the AliveCor Heart Monitor. This includes a slightly different frequency response range for the BP7900 (0.67-40Hz) versus the AliveCor Heart Monitor (0.5-40Hz). The electrodes for the ECG gathering are also slightly different, as the form factor of the BP7900 differs from that of the AliveCor Heart Monitor however both devices still utilize a single lead ECG gathering data from the left-hand fingers to the right-hand fingers. In order to account for potential noise generated by the operation of the BPM, the BP7900 also introduces two additional electrode sensors which help reduce noise interference during the ECG readings. The minor differences in orientation of the sensors and additional noise sensors do not raise different questions of safety or effectiveness. Finally, the proposed BP7900 device utilizes the same ECG analysis algorithm
7
510(k) SUMMARY
including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. In this regard KardiaAI (K181823) is included as a reference device. In regard to safety and technological characteristics, the BP7900 does not raise different questions of safety or effectiveness and is substantially equivalent to the AliveCor Heart Monitor.
8
| | Proposed Device
Omron BP7900
K182579 | Predicate Devices | | Reference Device
AliveCor KardiaAI
(K181823) | SE Assessment to Predicate Devices
and Reference Device |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| CFR Classification | 21 CFR§870.1130,
Noninvasive blood pressure
measurement system. | BP measurement
Omron Healthcare, Inc.
Model HEM-7311
(K133379) | ECG recording
AliveCor, Inc.
AliveCor Heart Monitor
(K142743) | 21CFR§870.1425,
Programmable diagnostic
computer | Same as K133379
Bradycardia and Tachycardia
detection same as K181823 |
| Class I/II/III | II | 21 CFR§870.1130,
Noninvasive blood
pressure measurement
system. | 21 CFR§870.2920, Telephone
electrocardiograph transmitter
and receiver. | II | No difference. The proposed device
and predicate devices have the same
Class. |
| Product Code | DXN - Noninvasive blood
pressure measurement
DXH - Telephone
electrocardiograph transmitter
and receiver
DPS - Electrocardiograph | II | II | DQK - Computer, Diagnostic,
Programmable
DPS - Electrocardiograph | Product codes include those for
predicates and reference device. |
9
| of the should should the me
| w The |
|---|
| 2 |
| 1 |
| Indications for Use | Proposed Device
Omron BP7900
K182579 | Predicate Devices
BP measurement
Omron Healthcare, Inc.
Model HEM-7311
(K133379) | ECG recording
AliveCor, Inc.
AliveCor Heart Monitor
(K142743) | Reference Device
AliveCor KardiaAI
(K181823) | SE Assessment to Predicate Devices
and Reference Device |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is intended to
measure blood pressure only,
electrocardiogram (ECG) only
or blood pressure and ECG
simultaneously.
The device is a digital monitor
intended for use in measuring
blood pressure and pulse rate
in adult population.
The device is intended to
record, store, and transfer
single-channel
electrocardiogram (ECG)
rhythms. The device also
displays ECG rhythms and
detects the presence of atrial
fibrillation, bradycardia,
tachycardia and normal sinus
rhythm (when prescribed or
used under the care of a
physician). The device 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. | The device is a digital
monitor intended for use
in measuring blood
pressure and pulse rate in
adult patient population.
The device detects the
appearance of irregular
heartbeats during
measurement and gives a
warning signal with
readings.
Environments of Use:
Home
Patient Population: Adult | 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. | 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). | No difference of intended purpose.
The proposed indication for use is
the same as the cleared indications
for use of the predicate devices. The
measurement of irregular heartbeats
is captured under the ECG rhythm
analysis.
BP7900 includes reference to
detection of bradycardia and
tachycardia. BP7900 uses same
algorithm for these capabilities at
that cleared for the reference device
under K181823. |
| | Proposed Device
Omron BP7900
K182579 | Predicate Devices
BP measurement
Omron Healthcare, Inc.
Model HEM-7311
(K133379) | Predicate Devices
ECG recording
AliveCor, Inc.
AliveCor Heart Monitor
(K142743) | Reference Device
AliveCor KardiaAI
(K181823) | SE Assessment to Predicate Devices
and Reference Device |
| Environment of Use | Home Use (OTC) | Home Use (OTC) | Mobile/active users at rest
(ambulatory) | OTC and Prescription Use | OTC use same as predicates.
Physician use (for bradycardia and
tachycardia detection) same as
reference device. |
| Patient Population | Adults | Adults | Adult (non-pediatric) | Adults | Same as predicates and reference
device. |
| Contraindications/
Warnings/ Precautions | Added contraindications (n=2)
against use in ambulatory
environments and aircraft. | There are no known
contraindications. | There are no known
contraindications. | There are no known
contraindications. | The BP7900 includes two (2)
additional contraindications to be
consistent with recent FDA requests
received during the review process for
Omron's other non-invasive blood
pressure monitors. They are not due
to technological differences and do
not alter the Intended Use of the
device. |
| Single Use | No | No | No | No | Same as predicates and reference
device. |
| Sterility | External contacting device,
nonsterile | External contacting
device, nonsterile | External contacting device,
nonsterile | External contacting device,
nonsterile | Same as predicates and reference
device. |
| Label Information | Labeled for both OTC (Home
Use) and Rx (Prescription
Use) | Labeled for OTC (Home
Use) | Labeled for both OTC (Home
Use) and Rx (Prescription
Use) | Labeled for both OTC (Home
Use) and Rx (Prescription
Use) | Same as predicates and reference
device. |
| Specifications/Features | Measurement Method /
Principal of Operation | | | | |
| | BP measurement:
Cuff oscillometric method
ECG recording:
User completes circuit with
skin contact and hardware
transmits audio signal to MCP
to convert and display ECG | Cuff oscillometric method
User completes circuit with
skin contact and hardware
transmits audio signal to MCP
to convert and display ECG | - 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 | BP measurement:
Same as HEM-7311.
ECG recording:
Same as Heart Monitor. The minor
differences in orientation of the
sensors and additional noise sensors
do not raise different questions of
safety or effectiveness. Bradycardia
and Tachycardia detection same as
reference device. | |
| Measurement Range | BP measurement:
Pressure: 0 to 299mmHg
Pulse Rate: 40 to 180
beats/min. | Pressure: 0 to 299mmHg
Pulse Rate: 40 to 180
beats/min.
ECG recording:
Pulse Rate: 30 to 300
beats/min. | Pulse Rate: 30 to 300
beats/min. | n/a | BP measurement:
Same as HEM-7311.
ECG recording:
Same as Heart Monitor. |
| Pressure Sensor | Semiconductor pressure
sensor | Semiconductor pressure
sensor | None | n/a | Same as HEM-7311. |
| Applicable cuff
(Arm Circumference) | 17-22cm (HEM-CS24-B)
22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24)
22-32cm (HEM-CR24)
22-42cm (HEM-RML31) | None | n/a | Similar to HEM-7311.
Cuff and tubing are identical to HEM-
7311 cuffs (HEM-CS24, HEM-
RML31) and only the plug shape has
changed from HEM-7311 cuffs in
order to comply with the ISO
standards (ISO 80369-1/-5) for small-
bore connector. The diameter of plug
and connector are increased in
accordance with hazard analysis.
This change does not raise different
questions of safety or effectiveness. |
| Accuracy of pressure
indicator | Within ±3mmHg or 2% of
reading | Within ±3mmHg or 2% of
reading | None | n/a | Same as HEM-7311. |
| Accuracy of pulse rate | Within 5% of reading | Within 5% of reading | Unknown | n/a | Same as HEM-7311. |
| Inflation Method | Automatic inflation by
electric pump | Automatic inflation by
electric pump | None | n/a | Same as HEM-7311. |
| Deflation Method | | | | | |
| Display | Automatic pressure release valve
LCD digital display on device and Smartphone display | Automatic pressure release valve
LCD digital display | None | Smartphone display | Same as HEM-7311. |
| Power Source | 4 "AA" batteries | 4 "AA" batteries or AC adapter | n/a | 1 Lithium Manganese Dioxide Coin Cells | Same as HEM-7311 and Heart Monitor.
Proposed device is battery powered. This feature does not affect fundamental BP measurement function nor ECG recordings. |
| Operating Conditions | 10 to 40°C
15 to 90% RH | 10 to 40°C
15 to 90% RH | n/a | 10 to 40°C | Same as HEM-7311. |
| Storage Conditions | -20 to 60°C
10 to 95% RH | -20 to 60°C
10 to 95% RH | n/a | -20 to 60°C | Same as HEM-7311. |
| Dimensions (mm) | 231 (W) × 98 (D) × 123 (H) mm | 183 (W) × 230 (D) × 99 (H) mm | n/a | 118 (W) × 62 (D) × 16.5 (H) mm | Similar.
Size is not a factor in function of the device and these differences do not raise different questions of safety or effectiveness. |
| Weight | Approximately 21oz (600g) (not including batteries) | Approx. 22 5/8oz (640g) (not including battery) | n/a | 40g | This minor difference does not impact or raise different question on the safety or effectiveness of the device. |
| Irregular Heart Beat Detection | Yes | Yes | n/a | Yes
ECG detectors (Unreadable and Possible Atrial Fibrillation etc.) by APP refers to this specification. | Yes, includes 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).
Same as Heart Monitor. Bradycardia and Tachycardia detection same as reference device. |
| Body Movement Detection | Yes, for BP measurement | Yes, for BP measurement | n/a | No | Same as HEM-7311. |
| Hypertension indicator | No | Yes | n/a | No | This feature does not affect fundamental BP measurement function. As such removal of this feature does not introduce different questions of safety or effectiveness |
10
11
12
13
| Provides an average of 3 measurements | Multiple Users | Communications | Data Acquisition for ECG recording: | ||
|---|---|---|---|---|---|
| No | No | BP measurement: | |||
| Bluetooth | |||||
| ECG recording: | |||||
| Ultrasonic Acoustics acquired by phone | Yes | ||||
| Yes | Yes (2) | None | None | ||
| No | No | Ultrasonic Acoustics acquired by phone | Yes | The 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). | |||||
| n/a | n/a | n/a | ECG recording: | ||
| Similar to predicate device (AliveCor Health Monitor). The minor difference in frequency response does not affect fundamental ECG recording function or raise different questions of safety or effectiveness. | |||||
| Bradycardia and tachycardia detection algorithm same as reference device. | |||||
| 0.67 - 40Hz | |||||
| Single Channel | |||||
| 16-bit | |||||
| 300 samples/second | 0.5 - 40Hz | ||||
| Single Channel | |||||
| 16-bit | |||||
| 300 samples/second |
14
| SUMMARY |
|---|
| 510(k) |
| Memory Capacity | Technology/Features | ||||
|---|---|---|---|---|---|
| BP measurement: | |||||
| 90 BP readings can be stored in the internal memory. | |||||
| ECG recording: | |||||
| Essentially unlimited due to real-time transmission to MCP memory (size of ECG file is miniscule - kilobytes compared to device memory capacity - gigabytes) | Power Supply | Regulates power voltage regardless of battery voltage. | Regulates power voltage regardless of battery voltage. | n/a | BP measurement: |
| This minor difference does not impact safety and effectiveness of the device. | |||||
| ECG recording: | |||||
| Same as Heart Monitor. | |||||
| Microprocessor | BP measurement: | ||||
| • determines blood pressure and pulse rate | |||||
| • controls the pump, the valve, and the display | |||||
| • detects switch operations | |||||
| • stores measurement results | |||||
| • manages date and time | • determines blood pressure and pulse rate | ||||
| • controls the pump, the valve, and the display | |||||
| • detects switch operations | |||||
| • stores measurement results | |||||
| • manages date and time | |||||
| ECG recording: | |||||
| None | |||||
| (ECG rhythm is analyzed by AliveCor engine) | n/a | Same as HEM-7311. | |||
| Pressure Sensor | Semiconductor pressure sensor | n/a | Same as HEM-7311. | ||
| Rapid Exhaust/Deflation Valve | Active electronic control valve that performs cuff air bleeding and release | n/a | Same as HEM-7311. | ||
| Inflation Source | DC rolling diaphragm pump | n/a | Same as HEM-7311. |
15
| P. W |
|---|
| the program and should the count |
| 1 |
| 1 |
| 7 |
| 2 |
| 1 |
| 14 |
| 1 |
| 1 |
| Display | Controls | Number of ECG Leads | Anatomical sites | User Interface for ECG
recording: | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BP measurement:
LCD (Liquid Crystal Display) displays:
• current cuff pressure
• systolic blood pressure
• diastolic blood pressure
• pulse rate
• error messages
ECG recording:
Smartphone (App) displays;
• ECG rhythm
• ECG detectors (Normal / Possible Atrial Fibrillation / Bradycardia / Tachycardia Unclassified / Unreadable)
• Past ECG recording in the memory
• Some other user convenient information | • START/STOP Button
• Connection Button | Single lead, 4 electrodes (2 neutral electrodes) | BP measurement:
Upper arm
ECG recording:
Left hand fingers to right hand fingers | | Yes | None | Yes | n/a | |
| LCD (Liquid Crystal Display) displays:
• current cuff pressure
• systolic blood pressure
• diastolic blood pressure
• pulse rate
• error messages
• measurement results in the memory | • START/STOP Button
• Date/Time setting Button
• Up/Down Button
• User ID Selections Button
None | Single Lead, 2 electrodes | n/a
Left hand fingers to right hand fingers | Primary Lead | Lead I, Left to right | - | Lead I, Left to right | n/a | ECG recording:
Similar to Heart Monitor.
The minor difference does not affect
fundamental ECG recording function
or raise different questions of safety
or effectiveness. |
| Smartphone (App) displays;
• ECG rhythm
ECG detectors (Normal / Possible Atrial Fibrillation / Bradycardia / Tachycardia Unclassified / Unreadable)
• Past ECG recording in the memory
• Some other user convenient information | None
(When electrode is held by users it starts recording) | n/a | n/a | Data Acquisition | Ultrasonic acoustics | - | Ultrasonic acoustics | | |
| n/a | n/a | n/a | BP measurement:
Similar to HEM-7311.
ECG recording:
Same as Heart Monitor. | Hardware | Universal module | - | iPhone case and Universal
module | | |
| n/a | n/a | n/a | BP measurement:
Similar to HEM-7311.
ECG recording:
Same as Heart Monitor. | Software interface | Apple iOS-based software | - | Apple iOS-based software | | |
| n/a | n/a | n/a | ECG recording:
Similar to Heart Monitor. | Materials | Patient contact materials of
the cuff have been tested in
accordance with ISO 10993
and FDA guidance | Patient contact materials
of the cuff have been tested in
accordance with ISO 10993
and FDA guidance | Patient contact materials of
the cuff have been tested in
accordance with ISO 10993
and FDA guidance | n/a | |
| n/a | n/a | n/a | BP measurement:
Similar to HEM-7311.
ECG recording:
Same as Heart Monitor. The minor differences in orientation of the sensors and additional noise sensors do not raise different questions of safety or effectiveness | | | | | | Same as predicate devices. |
16
17
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Blood Pressure Monitor + EKG. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(B)]
All necessary bench and clinical testing was conducted on the Blood Pressure Monitor + EKG to support a determination of substantial equivalence to the predicate devices.
Nonclinical Testing Summary [807.92(b)(1)]:
The nonclinical, bench testing included:
- Comparative performance testing against both predicate devices; ●
- . Performance verification testing;
- Cleaning verification testing; and
- o Usability testing to confirm device use in representative home users.
In addition to the above bench testing, the BP7900 also underwent the following testing:
- o Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic o discharge requirements per IEC60601 and 80601 requirements
- Software verification and validation o
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Blood Pressure Monitor + EKG meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Blood Pressure Monitor + EKG does not raise different questions of safety or effectiveness when compared to the predicate devices.
Clinical Testing Summarv [807.92(b)(2)]:
Two clinical investigations were conducted with the objective of validating the accuracy of blood pressure measurements. One study employed the HEM-7311 device with the HEM-RML31 Cuff, and the other study used the HEM-7130 device with the HEM-CS24 Cuff. Both of these BPM devices have the same algorithm and hardware components related to BP measurement as are used in the BP7900, and employ the same cuffs used for BP7900. The studies were performed to demonstrate comparability of performance of BP measurement based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. This study was conducted in accordance with guidelines per ANSI/AAMI/ISO 81060-2:2013 Noninvasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. The results demonstrated that BP7900 performed equivalently to the auscultation method and is in conformance with ANSI/AAMI/ISO 81060-2:2013.
18
CONCLUSIONS [807.92(b)(3)]
Based on the results from the nonclinical and clinical tests performed in support of the BP7900, it is concluded that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate devices.
SUMMARY
The BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices. The software algorithm for bradycardia and tachycardia detection is equivalent to the reference device KardiaAI (K181823). The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. In this regard KardiaAI (K181823) is included as a reference device.
The Blood Pressure Monitor + EKG, and the predicate devices are both designed for the measurement of blood pressure, pulse rate, ECG and detection of irregular pulses in adult population for home use. These devices have the same indications for use and similar performance characteristics related to BP measurement, pulse rate and ECG analysis. Further, BP7900 includes bradycardia and tachycardia detection capabilities consistent with the reference device (when prescribed or used under the care of a physician.) The minor differences in labeling and technological characteristics between the proposed device and the predicate devices have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed BP7900 is substantially equivalent to the predicate device.