(237 days)
Yes
The device description explicitly states that the ECG analysis uses "AliveCor's KardiaAI platform (K181823)" to detect abnormal heart rhythms.
No
The device is intended to measure blood pressure and record ECG rhythms, providing analysis of these measurements. While it helps in detecting heart conditions (like atrial fibrillation, bradycardia, tachycardia), it does not explicitly state an intention to treat or cure these conditions. It is a diagnostic and monitoring tool, not a therapeutic one.
Yes
The device directly analyzes ECG rhythms to detect the presence of atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm, which are specific medical conditions, making it a diagnostic device.
No
The device description clearly states it is a "battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system" and includes physical components like an arm cuff, integral pump, electric valve, and electrodes. While it utilizes software for analysis and data transfer, it is fundamentally a hardware device with integrated software.
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 measures blood pressure and records ECG signals from the body, but it doesn't analyze samples like blood, urine, or tissue in a laboratory setting.
- The measurements are taken directly from the patient. Blood pressure is measured non-invasively on the arm, and ECG signals are recorded via electrodes in contact with the skin. These are in-vivo measurements, not in-vitro (in glass/outside the body).
- The analysis is of physiological signals. The device analyzes the oscillometric data for blood pressure and the electrical signals for the ECG. This is analysis of physiological function, not analysis of biological samples.
The device is a medical device that performs physiological measurements and analysis, but it does not fit the definition of an In Vitro Diagnostic.
No
The input document does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. 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, QDA
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 software of the AliveCor, Inc. KardiaMobile System (K191406) 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 Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.
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 cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archive and review by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
This app makes use of the cleared software of the AliveCor, Inc. KardiaMobile System (K191406) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters.
The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.
Input Imaging Modality
Not Found
Anatomical Site
BP measurement: Upper arm
ECG recording: 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
Home Use
Healthcare professionals, 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 Summary: All necessary bench testing was conducted on the proposed device to support a determination of substantial equivalence to the predicate device. The same test standards and methods used to support the cleared BP7900 primary predicate device were employed for this proposed device. To support the minor changes, additional software verification was performed to confirm the minor change in onboarding procedures were successfully implemented, and that the device continues to perform as intended in accordance with its proposed intended use.
Clinical Testing Summary: No clinical testing was conducted in support of this 510(k) Premarket Notification.
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
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April 1, 2021
Omron Healthcare, Inc. % Kit Cariquitan Chief Regulatory Officer Experien Group 224 Airport Parkway Suite 250 San Jose, California 95110
Re: K202228
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. ODA Dated: February 26, 2021 Received: March 2, 2021
Dear Kit Cariquitan:
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,
LT Stephen Browning 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) K202228
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 the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Notification K_________________
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
Correspondent:
Kit Cariquitan Chief Regulatory Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA
Date Prepared: August 06, 2020
DEVICE INFORMATION [807.92(A)(2)]
Classification: 21 CFR 870.1130, Noninvasive blood pressure measurement system
Product Code:
DXN, System, Measurement, Blood-Pressure, Non-Invasive DXH, Transmitters and Receivers, Electrocardiograph, Telephone DPS, Electrocardiograph QDA, Electrocardiograph Software for Over-The-Counter Use
Trade/Proprietary Name:
Omron Model BP7900 Blood Pressure Monitor + EKG
Generic/Common Name:
Noninvasive Blood Pressure Monitor and Electrocardiograph
PREDICATE DEVICE(S) [807.92(A)(3)]
The Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and AliveCor, Inc. KardiaMobile System (K191406).
4
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) 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 software of the AliveCor, Inc. KardiaMobile System (K191406) 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 Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.
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 cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archive and review by the user.
5
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. 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 incorporates a software update to the cleared BP7900 primary predicate device (K182579), with no change in principles of operation, hardware components, or key specifications; to bring the proposed device's onboarding procedure for accessing ECG functionalities in alignment with the secondary predicate, the AliveCor KardiaMobile System (K191406). The proposed device is substantially equivalent to both predicate devices with regard to intended use, product labeling, anatomical sites, patient population, performance testing, technological characteristics, and safety characteristics.
With respect to technological characteristics, there are no differences between the proposed and primary predicate devices with respect to the key functionalities blood pressure measurement, ECG recording, or ECG analysis. The main difference between the devices, which prompted this 510(k) submission, is a change in the onboarding procedure to access the ECG features. The "unlock overread" restriction has been removed for the first use of the product. This change matches the proposed device's first-use onboarding procedure for accessing ECG functionalities with that of the secondary predicate device. Omron has conducted software testing to demonstrate that the updated onboarding procedure, which is identical to that of the secondary predicate device, has been successfully implemented in the updated software. The removal of the unlock overread restriction for first ECG use does not introduce any new risks or significantly modify existing risks, nor does it remove mitigations of risk as compared with the predicate device. This technological difference therefore does not raise different questions of safety or effectiveness from the predicate devices and supports that the proposed device is substantially equivalent to both predicate devices.
Table 1 presents a tabular substantial equivalence comparison between the proposed device and both predicate devices.
6
| | Proposed Device:
Omron Healthcare, Inc. | Primary Predicate:
Omron Healthcare, Inc. | Secondary Predicate:
AliveCor, Inc. | SE Assessment to |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Omron BP7900 Blood Pressure
Monitor + EKG | Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | KardiaMobile System
(K191406) | Predicate Devices |
| CFR Classification | 21 CFR§870.1130, Noninvasive blood
pressure measurement system. | 21 CFR§870.1130, Noninvasive blood
pressure measurement system. | 21 CFR§870.2920, Telephone
electrocardiograph transmitter and
receiver. | Same. Unchanged from the cleared
predicate device. |
| Regulatory Class | II | II | II | Same. Unchanged from the cleared
predicate device. |
| Product Codes | DXN - Noninvasive blood pressure
measurement
DXH - Telephone electrocardiograph
transmitter and receiver
DPS - Electrocardiograph
QDA - Electrocardiograph Software
for Over-The-Counter Use | DXN - Noninvasive blood pressure
measurement
DXH - Telephone electrocardiograph
transmitter and receiver
DPS - Electrocardiograph | DXH - Telephone electrocardiograph
transmitter and receiver
DPS - Electrocardiograph
QDA - Electrocardiograph Software
for Over-The-Counter Use | Product codes include those for
predicates. |
| 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
the output of ECG analysis including
detecting the presence of atrial
fibrillation, bradycardia, tachycardia
and normal sinus rhythm, and others.
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 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 KardiaMobile System is intended
to record, store and transfer single-
channel electrocardiogram (ECG)
rhythms.
The KardiaMobile System also
displays ECG rhythms and output of
ECG analysis from AliveCor's
KardiaAI platform including detecting
the presence of normal sinus rhythm,
atrial fibrillation, bradycardia,
tachycardia, and others. The
KardiaMobile System 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 is not intended for pediatric
use. | Similar. The Intended Use of the
proposed device is the same as the
predicate device.
The wording of the Indications for
Use statement with respect to ECG
analysis has been updated to reflect
the updated onboarding procedure
which is consistent with that of the
secondary predicate device. |
| Environment of Use | Home Use | Home Use | Home Use | Same as both predicate devices. |
| | Proposed Device:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG | Primary Predicate:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | Secondary Predicate:
AliveCor, Inc.
KardiaMobile System
(K191406) | SE Assessment to
Predicate Devices |
| Type of Use | OTC: blood pressure features and ECG
recording, display, and analysis | OTC: blood pressure features and ECG
recording
Rx: overread unlock restriction for ECG
display and analysis features | OTC: ECG recording, display, and
analysis | Same as the primary predicate
device for blood pressure features
and ECG recording. Same as the
secondary predicate device for ECG
display and analysis.
As the "overread unlock" restriction
has been removed from the proposed
device for the ECG functionalities,
as is consistent with the secondary
predicate device; the proposed
device is no longer indicated as a Rx
(prescription use) device. |
| Patient Population | Adults | Adults | Adult (non-pediatric) | Same as both predicate devices.
Unchanged from the cleared
predicate device. |
| Key Contraindications/
Warnings/Precautions | Contraindicated against use in
ambulatory environments and aircraft. | Contraindicated against use in
ambulatory environments and aircraft. | There are no known contraindications. | Same as both predicate devices.
Unchanged from the cleared
predicate device. |
| Single Use | No | No | No | Same as both predicate devices.
Unchanged from the cleared
predicate device. |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | External contacting device, nonsterile | Same as both predicate devices.
Unchanged from the cleared
predicate 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 | 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 | User completes circuit with skin
contact and hardware transmits audio
signal to MCP to convert and display
ECG | Same as primary predicate. No
change from cleared BP7900
device. |
| | Proposed Device:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG | Primary Predicate:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | Secondary Predicate:
AliveCor, Inc.
KardiaMobile System
(K191406) | SE Assessment to
Predicate Devices |
| Measurement Range | BP measurement:
Pressure: 0 to 299mmHg
Pulse Rate: 40 to 180 beats/min.
ECG recording:
Pulse Rate: 30 to 300 beats/min. | BP measurement:
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. | Same as primary predicate. No
change from cleared BP7900 device. |
| Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Applicable cuff
(Arm Circumference) | 17-22cm (HEM-CS24-B)
22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24-B)
22-42cm (HEM-RML31-B) | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Accuracy of pressure
indicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Accuracy of pulse rate | Within 5% of reading | Within 5% of reading | Unknown | Same as primary predicate. No
change from cleared BP7900 device. |
| Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Deflation Method | Automatic pressure release valve | Automatic pressure release valve | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Display | LCD digital display on device and
Smartphone display | LCD digital display on device and
Smartphone display | Smartphone display | Same as primary predicate. No
change from cleared BP7900 device. |
| Power Source | 4 AA" batteries | 4 AA" batteries | 1 Lithium Manganese Dioxide Coin
Cells | Same as primary predicate. No
change from cleared BP7900 device. |
| Operating Conditions | 10 to 40°C
15 to 90% RH | 10 to 40°C
15 to 90% RH | 10 to 40°C | Same as primary predicate. No
change from cleared BP7900 device. |
| Storage Conditions | -20 to 60°C
10 to 95% RH | -20 to 60°C
10 to 95% RH | -20 to 60°C | Same as primary predicate. No
change from cleared BP7900 device. |
| Dimensions (mm) | 231 (W) × 98 (D) × 123 (H) mm | 231 (W) × 98 (D) × 123 (H) mm | 118 (W) × 62 (D) × 16.5 (H) mm | Same as primary predicate. No
change from cleared BP7900
device. |
| Weight | Approximately 21oz (600g)
(not including batteries) | Approximately 21oz (600g)
(not including batteries) | 40g | Same as primary predicate. No
change from cleared BP7900
device. |
| | Proposed Device:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG | Primary Predicate:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | Secondary Predicate:
AliveCor, Inc.
KardiaMobile System
(K191406) | SE Assessment to
Predicate Devices |
| ECG Detectors | Provided by KardiaAI platform
(K181823): | Provided by KardiaAI platform
(K181823): | Provided by KardiaAI platform
(K181823): | Same as both predicate devices
with respect to the use of the |
| | • Normal Sinus Rhythm
• Atrial Fibrillation
• Bradycardia
• Tachycardia
• Unclassified
• Unreadable | • Normal Sinus Rhythm
• Atrial Fibrillation
• Bradycardia
• Tachycardia
• Unclassified
• Unreadable | • Normal Sinus Rhythm
• Atrial Fibrillation
• Bradycardia
• Tachycardia
• Unclassified
• Unreadable | cleared AliveCor, Inc. KardiaAI
(K181823) analysis functionalities.
No change from cleared BP7900
device. |
| Body Movement
Detection | Yes, for BP measurement | Yes, for BP measurement | No | Same as primary predicate. No
change from cleared BP7900
device. |
| Communications | BP measurement:
Bluetooth
ECG recording:
Ultrasonic Acoustics acquired by
phone | BP measurement:
Bluetooth
ECG recording:
Ultrasonic Acoustics acquired by phone | Ultrasonic Acoustics acquired by
phone | Same as primary predicate. No
change from cleared BP7900 device. |
| Data Acquisition for
ECG recording:
Frequency Response
ECG channels
Resolution
Sample Rate | 0.67 - 40Hz
Single Channel
16-bit
300 samples/second | 0.67 - 40Hz
Single Channel
16-bit
300 samples/second | 0.5 - 40Hz
Single Channel
16-bit
300 samples/second | Same as primary predicate. No
change from cleared BP7900 device. |
| Memory Capacity | 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) | 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) | Essentially unlimited due to real-time
transmission to MCP memory (size of
ECG file is miniscule - kilobytes
compared to device memory capacity -
gigabytes) | Same as primary predicate. No
change from cleared BP7900 device. |
| Technology/Features | | | | |
| Power Supply | Regulates power voltage regardless of
battery voltage. | Regulates power voltage regardless of
battery voltage. | Regulates power voltage regardless of
battery voltage. | Same as primary predicate. No
change from cleared BP7900 device. |
| | Proposed Device:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG | Primary Predicate:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | Secondary Predicate:
AliveCor, Inc.
KardiaMobile System
(K191406) | SE Assessment to
Predicate Devices |
| 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
ECG recording:
None. ECG rhythm is analyzed by
AliveCor engine. | 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
ECG recording:
None. ECG rhythm is analyzed by
AliveCor engine. | None
(ECG rhythm is analyzed by AliveCor
engine) | Same as primary predicate. No
change from cleared BP7900 device. |
| Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Rapid
Exhaust/Deflation
Valve | Active electronic control valve that
performs cuff air bleeding and release | Active electronic control valve that
performs cuff air bleeding and release | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Inflation Source | DC rolling diaphragm pump | DC rolling diaphragm pump | None | Same as primary predicate. No
change from cleared BP7900 device. |
| Display | 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 | BP measurement:
LCD 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 | 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 | BP measurement:
Same as primary predicate. No
change from cleared BP7900 device.
ECG recording:
Same as both predicate devices with
respect to types of information
displayed. The specific content
displayed to the user within the
software (e.g., on-screen text and
user interface) has been updated
from the primary predicate device to
be consistent with that of the
secondary predicate device. |
| | Proposed Device:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG | Primary Predicate:
Omron Healthcare, Inc.
Omron BP7900 Blood Pressure
Monitor + EKG
(K182579) | Secondary Predicate:
AliveCor, Inc.
KardiaMobile System
(K191406) | SE Assessment to
Predicate Devices |
| Controls | • START/STOP Button
• Connection Button | • START/STOP Button
• Connection Button | None (When electrode is held by users
it starts recording) | Same as primary predicate. No
change from cleared BP7900 device |
| Number of ECG Leads | Single lead, 4 electrodes (2 neutral
electrodes) | Single lead, 4 electrodes (2 neutral
electrodes) | Single Lead, 2 electrodes | Same as primary predicate. No
change from cleared BP7900 device |
| Anatomical sites | BP measurement:
Upper arm
ECG recording:
Left hand fingers to right hand fingers | BP measurement:
Upper arm
ECG recording:
Left hand fingers to right hand fingers | Left hand fingers to right hand fingers | Same as primary predicate. No
change from cleared BP7900 device |
| User Interface for ECG
recording: | | | | Same as primary predicate. No
change from cleared BP7900 device |
| Primary Lead | Lead I, Left to right | Lead I, Left to right | Lead I, Left to right | |
| Data Acquisition | Ultrasonic acoustics | Ultrasonic acoustics | Ultrasonic acoustics | |
| Hardware | Universal module | Universal module | iPhone case and Universal module | |
| Software interface | Apple iOS-based or Google Android-
based software | Apple iOS-based or Google Android-
based software | Apple iOS-based or Google Android-
based software | |
| 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 | Same as primary predicate. No
change from cleared BP7900 device |
7
8
9
10
Table 1: Substantial Equivalence Comparison (Cont.)
11
12
510(k) SUMMARY (CONT.)
SUBSTANTIAL EQUIVALENCE
The proposed Indications for Use for the proposed device, the Omron BP7900 Blood Pressure Monitor + EKG, is substantially equivalent to the Indications for Use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the Omron BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(b)]
All necessary performance testing was conducted on the proposed Omron Model BP7900 Blood Pressure Monitor + EKG to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Nonclinical Testing Summary:
All necessary bench testing was conducted on the proposed device to support a determination of substantial equivalence to the predicate device. The same test standards and methods used to support the cleared BP7900 primary predicate device were employed for this proposed device. To support the minor changes, additional software verification was performed to confirm the minor change in onboarding procedures were successfully implemented, and that the device continues to perform as intended in accordance with its proposed intended use.
[807.92(b)(2)] Clinical Testing Summary:
No clinical testing was conducted in support of this 510(k) Premarket Notification.
CONCLUSIONS [807.92(b)(3)]
Based on the results from the nonclinical tests performed in support of the updated BP7900, it is concluded that the proposed device performs at least as safely and effectively as the legally marketed predicate devices.
SUMMARY
The Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices.