Omron Model BP7900 Blood Pressure Monitor + EKG

K182579 · Omron Healthcare, Inc. · DXN · Mar 14, 2019 · Cardiovascular

Device Facts

• Record ID: K182579
• Device Name: Omron Model BP7900 Blood Pressure Monitor + EKG
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: AI/ML

Intended 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 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.

Device Story

Battery-powered, home-use digital monitor; measures blood pressure (BP) via oscillometric method using arm cuff and pulse rate; records single-channel ECG via four electrodes (two for signal, two for noise reduction). User places thumbs/fingers on electrodes; ECG data transmitted via ultrasonic acoustics to smartphone running 'Omron connect' app. App displays ECG rhythms, BP trends, and heart rate; performs automated ECG analysis to identify atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm. Used by patients or healthcare professionals. BP measurement uses integral pump/valve; ECG analysis uses cleared AliveCor algorithm. Provides objective data for clinical decision-making; enables remote monitoring of heart conditions.

Clinical Evidence

Two clinical investigations validated BP measurement accuracy per ANSI/AAMI/ISO 81060-2:2013 using auscultation comparator. Bench testing included comparative performance, cleaning verification, usability, biocompatibility (ISO 10993-1), electrical safety/EMC (IEC60601/80601), and software V&V.

Technological Characteristics

Oscillometric BP measurement; single-lead ECG (300 samples/sec, 16-bit, 0.67-40Hz). Materials: biocompatible per ISO 10993. Power: 4 AA batteries. Connectivity: Bluetooth (BP), ultrasonic acoustics (ECG) to smartphone. Software: proprietary ECG analysis algorithm. Dimensions: 231x98x123mm. Sterilization: non-sterile.

Indications for Use

Indicated for adult population (17-42cm arm circumference) for measuring blood pressure, pulse rate, and recording/storing/transferring single-channel ECG rhythms. Detects atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm. Intended for healthcare professionals, patients with known/suspected heart conditions, and health-conscious individuals. Not for pediatric use.

Regulatory Classification

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.

Predicate Devices

• Omron Model HEM-7311 (K133379)
• AliveCor Health Monitor (K142743)

Reference Devices

• AliveCor KardiaAI (K181823)

Submission Summary (Full Text)

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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

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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 [phone] 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

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### 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)

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#### 510(k) Notification K182579

#### GENERAL INFORMATION [807.92(a)(1)]

#### Applicant:

Omron Healthcare, Inc. 1925 West Field Court Lake Forest. IL 60045 USA Phone: [phone] FAX: [phone]

#### Contact Person:

Ronald S. Warren Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] FAX: [phone]

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

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### 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.

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#### 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

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#### 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

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#### 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.

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| | Proposed Device<br>Omron BP7900<br>K182579 | Predicate Devices | | Reference Device<br>AliveCor KardiaAI<br>(K181823) | SE Assessment to Predicate Devices<br>and Reference Device |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| CFR Classification | 21 CFR§870.1130,<br>Noninvasive blood pressure<br>measurement system. | BP measurement<br>Omron Healthcare, Inc.<br>Model HEM-7311<br>(K133379) | ECG recording<br>AliveCor, Inc.<br>AliveCor Heart Monitor<br>(K142743) | 21CFR§870.1425,<br>Programmable diagnostic<br>computer | Same as K133379<br>Bradycardia and Tachycardia<br>detection same as K181823 |
| Class I/II/III | II | 21 CFR§870.1130,<br>Noninvasive blood<br>pressure measurement<br>system. | 21 CFR§870.2920, Telephone<br>electrocardiograph transmitter<br>and receiver. | II | No difference. The proposed device<br>and predicate devices have the same<br>Class. |
| Product Code | DXN - Noninvasive blood<br>pressure measurement<br>DXH - Telephone<br>electrocardiograph transmitter<br>and receiver<br>DPS - Electrocardiograph | II | II | DQK - Computer, Diagnostic,<br>Programmable<br>DPS - Electrocardiograph | Product codes include those for<br>predicates and reference device. |

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| Indications for Use | Proposed Device<br>Omron BP7900<br>K182579 | Predicate Devices<br>BP measurement<br>Omron Healthcare, Inc.<br>Model HEM-7311<br>(K133379) | ECG recording<br>AliveCor, Inc.<br>AliveCor Heart Monitor<br>(K142743) | Reference Device<br>AliveCor KardiaAI<br>(K181823) | SE Assessment to Predicate Devices<br>and Reference Device |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is intended to<br>measure blood pressure only,<br>electrocardiogram (ECG) only<br>or blood pressure and ECG<br>simultaneously.<br>The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate<br>in adult population.<br>The device is intended to<br>record, store, and transfer<br>single-channel<br>electrocardiogram (ECG)<br>rhythms. The device also<br>displays ECG rhythms and<br>detects the presence of atrial<br>fibrillation, bradycardia,<br>tachycardia and normal sinus<br>rhythm (when prescribed or<br>used under the care of a<br>physician). The device is<br>intended for use by healthcare<br>professionals, patients with<br>known or suspected heart<br>conditions, and health-<br>conscious individuals. The<br>device has not been tested and<br>it is not intended for pediatric<br>use. | The device is a digital<br>monitor intended for use<br>in measuring blood<br>pressure and pulse rate in<br>adult patient population.<br>The device detects the<br>appearance of irregular<br>heartbeats during<br>measurement and gives a<br>warning signal with<br>readings.<br><br>Environments of Use:<br>Home<br>Patient Population: Adult | The AliveCor Heart Monitor<br>is intended to record, store<br>and transfer single-channel<br>electrocardiogram (ECG)<br>rhythms. The AliveCor Heart<br>Monitor also displays ECG<br>rhythms and detects the<br>presence of atrial fibrillation<br>and normal sinus rhythm<br>(when prescribed or used<br>under the care of a physician)<br>The AliveCor Heart Monitor<br>is intended for use by<br>healthcare professionals,<br>patients with known or<br>suspected heart conditions and<br>health conscious individuals.<br>The device has not been tested<br>and it is not intended for<br>pediatric use. | KardiaAI is a software<br>analysis library intended to<br>assess ambulatory<br>electrocardiogram (ECG)<br>rhythms from adult subjects.<br>The device supports analyzing<br>data recorded in compatible<br>formats from any ambulatory<br>ECG devices such as event<br>recorders, or other similar<br>devices. The library is<br>intended to be integrated into<br>other device software.<br>The library is not intended for<br>use in life supporting, or<br>sustaining systems, or ECG<br>monitors, or cardiac alarm, or<br>OTC use only devices.<br>KardiaAI provides the<br>following capabilities:<br>• ECG noise filtering,<br>• heart rate measurement<br>from ECGs,<br>• detection of noisy ECGs,<br>and<br>• ECG rhythm analysis for<br>detecting the presence of<br>normal sinus rhythm, atrial<br>fibrillation, bradycardia, and<br>tachycardia (when prescribed<br>or used under the care of a<br>physician). | No difference of intended purpose.<br>The proposed indication for use is<br>the same as the cleared indications<br>for use of the predicate devices. The<br>measurement of irregular heartbeats<br>is captured under the ECG rhythm<br>analysis.<br><br>BP7900 includes reference to<br>detection of bradycardia and<br>tachycardia. BP7900 uses same<br>algorithm for these capabilities at<br>that cleared for the reference device<br>under K181823. |
| | Proposed Device<br>Omron BP7900<br>K182579 | Predicate Devices<br>BP measurement<br>Omron Healthcare, Inc.<br>Model HEM-7311<br>(K133379) | Predicate Devices<br>ECG recording<br>AliveCor, Inc.<br>AliveCor Heart Monitor<br>(K142743) | Reference Device<br>AliveCor KardiaAI<br>(K181823) | SE Assessment to Predicate Devices<br>and Reference Device |
| Environment of Use | Home Use (OTC) | Home Use (OTC) | Mobile/active users at rest<br>(ambulatory) | OTC and Prescription Use | OTC use same as predicates.<br>Physician use (for bradycardia and<br>tachycardia detection) same as<br>reference device. |
| Patient Population | Adults | Adults | Adult (non-pediatric) | Adults | Same as predicates and reference<br>device. |
| Contraindications/<br>Warnings/ Precautions | Added contraindications (n=2)<br>against use in ambulatory<br>environments and aircraft. | There are no known<br>contraindications. | There are no known<br>contraindications. | There are no known<br>contraindications. | The BP7900 includes two (2)<br>additional contraindications to be<br>consistent with recent FDA requests<br>received during the review process for<br>Omron's other non-invasive blood<br>pressure monitors. They are not due<br>to technological differences and do<br>not alter the Intended Use of the<br>device. |
| Single Use | No | No | No | No | Same as predicates and reference<br>device. |
| Sterility | External contacting device,<br>nonsterile | External contacting<br>device, nonsterile | External contacting device,<br>nonsterile | External contacting device,<br>nonsterile | Same as predicates and reference<br>device. |
| Label Information | Labeled for both OTC (Home<br>Use) and Rx (Prescription<br>Use) | Labeled for OTC (Home<br>Use) | Labeled for both OTC (Home<br>Use) and Rx (Prescription<br>Use) | Labeled for both OTC (Home<br>Use) and Rx (Prescription<br>Use) | Same as predicates and reference<br>device. |
| Specifications/Features | Measurement Method /<br>Principal of Operation | | | | |
| | BP measurement:<br>Cuff oscillometric method<br>ECG recording:<br>User completes circuit with<br>skin contact and hardware<br>transmits audio signal to MCP<br>to convert and display ECG | Cuff oscillometric method<br>User completes circuit with<br>skin contact and hardware<br>transmits audio signal to MCP<br>to convert and display ECG | - An interface that provides<br>tools to process and analyze<br>ECGs through various<br>algorithms<br>- The automated proprietary<br>ECG algorithms provide<br>supportive information for<br>ECG diagnosis. The library<br>can be accessed by directly<br>connecting to the KardiaAI's<br>Application Programming<br>Interface | BP measurement:<br>Same as HEM-7311.<br>ECG recording:<br>Same as Heart Monitor. The minor<br>differences in orientation of the<br>sensors and additional noise sensors<br>do not raise different questions of<br>safety or effectiveness. Bradycardia<br>and Tachycardia detection same as<br>reference device. | |
| Measurement Range | BP measurement:<br>Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180<br>beats/min. | Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180<br>beats/min.<br>ECG recording:<br>Pulse Rate: 30 to 300<br>beats/min. | Pulse Rate: 30 to 300<br>beats/min. | n/a | BP measurement:<br>Same as HEM-7311.<br>ECG recording:<br>Same as Heart Monitor. |
| Pressure Sensor | Semiconductor pressure<br>sensor | Semiconductor pressure<br>sensor | None | n/a | Same as HEM-7311. |
| Applicable cuff<br>(Arm Circumference) | 17-22cm (HEM-CS24-B)<br>22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24)<br>22-32cm (HEM-CR24)<br>22-42cm (HEM-RML31) | None | n/a | Similar to HEM-7311.<br>Cuff and tubing are identical to HEM-<br>7311 cuffs (HEM-CS24, HEM-<br>RML31) and only the plug shape has<br>changed from HEM-7311 cuffs in<br>order to comply with the ISO<br>standards (ISO 80369-1/-5) for small-<br>bore connector. The diameter of plug<br>and connector are increased in<br>accordance with hazard analysis.<br>This change does not raise different<br>questions of safety or effectiveness. |
| Accuracy of pressure<br>indicator | Within ±3mmHg or 2% of<br>reading | Within ±3mmHg or 2% of<br>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<br>electric pump | Automatic inflation by<br>electric pump | None | n/a | Same as HEM-7311. |
| Deflation Method | |…