(176 days)
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 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 cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archiving and review by the user.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the ECG analysis for atrial fibrillation, bradycardia, and tachycardia detection.
Part 1: Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Omron Model BP7900 Blood Pressure Monitor + EKG primarily relate to its substantial equivalence to predicate devices for blood pressure measurement and ECG recording and analysis. For the ECG analysis specifically distinguishing atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm, the device leverages the algorithm from the AliveCor KardiaAI (K181823) and AliveCor Heart Monitor (K142743). Therefore, the device's performance for these ECG detections is implicitly expected to meet the established performance of these cleared devices.
Since specific numerical acceptance criteria or reported device performance for the ECG detection capabilities (sensitivity, specificity, accuracy) of the BP7900 itself are not explicitly provided in this document, we must infer that the substantial equivalence claim relies on the prior clearance of the AliveCor algorithms. The document states:
- "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." (Page 5)
- "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." (Page 6)
- "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." (Page 10, "Irregular Heart Beat Detection" row)
Given this, the table below reflects an interpretation based on the provided text, implying that the acceptance for device performance is met by using a previously cleared and validated algorithm.
| Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Implied by Substantial Equivalence and Algorithm Use) |
|---|---|
| ECG rhythm analysis for detecting the presence of atrial fibrillation (consistent with AliveCor Heart Monitor - K142743) | Performed by the same cleared AliveCor Heart Monitor algorithm, therefore expected to meet its established performance for AF detection. |
| ECG rhythm analysis for detecting the presence of bradycardia (consistent with AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor KardiaAI algorithm, therefore expected to meet its established performance for bradycardia detection. |
| ECG rhythm analysis for detecting the presence of tachycardia (consistent with AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor KardiaAI algorithm, therefore expected to meet its established performance for tachycardia detection. |
| ECG rhythm analysis for detecting the presence of normal sinus rhythm (consistent with AliveCor Heart Monitor - K142743 and AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor Heart Monitor/KardiaAI algorithms, therefore expected to meet its established performance for normal sinus rhythm detection. |
| Software Verification and Validation performed (Page 17) | All software V&V testing performed and submitted to demonstrate safety and effectiveness. |
| Nonclinical performance testing against predicate devices (Page 17) | Conducted to support a determination of substantial equivalence (general statement, specific performance metrics not provided here for ECG). |
| Electrical safety, electromagnetic compatibility, and electrostatic discharge requirements met per IEC60601 and 80601 (Page 17) | Successfully passed these requirements. |
| Biocompatibility of patient-contacting materials met per ISO 10993-1 (Page 17) | Successfully passed these requirements. |
Part 2: Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for an independent test set for the ECG detection performance of the BP7900 itself. The justification for the ECG detection capabilities (AF, bradycardia, tachycardia, normal sinus rhythm) relies entirely on the fact that the BP7900 utilizes the same algorithm as the previously cleared AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) devices.
Therefore, any test set and data provenance information would refer to the studies originally conducted for the AliveCor devices, not a new, independent study for the BP7900's ECG detection performance. This document does not provide details of those original AliveCor studies.
Part 3: Number of Experts and Qualifications for Ground Truth
Similar to Part 2, the document does not provide details about the number and qualifications of experts specifically for the BP7900's ECG detection capabilities. This information would have been part of the original AliveCor submissions (K142743 and K181823). The BP7900's clearance for ECG detection is predicated on the re-use of these already cleared algorithms.
Part 4: Adjudication Method for the Test Set
As no specific new test set for the BP7900's ECG detection performance is detailed in this document, no adjudication method is described. This information would refer to the original AliveCor studies.
Part 5: Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance specifically for the Omron BP7900. The device's ECG capabilities are based on a standalone AI algorithm (from AliveCor) that performs the detection. Whether the original AliveCor clearances involved such MRMC studies is not detailed here.
Part 6: Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone (algorithm only) performance was done, not for the BP7900 as a new, independent study, but through the pre-existing clearance of the AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) algorithms. The BP7900 integrates these already validated algorithms. The document explicitly states: "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." (Page 5, and Page 18 under "Summary" and "Substantial Equivalence"). This phrasing indicates reliance on the standalone performance of those previously cleared algorithms.
Part 7: Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the original AliveCor algorithms. However, for ECG rhythm analysis, ground truth is typically established by:
- Expert Consensus: Multiple board-certified cardiologists or electrophysiologists independently reviewing ECG tracings and reaching a consensus diagnosis.
- Adjudicated Clinical Data: ECGs from patients with confirmed diagnoses based on a combination of clinical information, reference standard tests, and expert review.
Given the nature of ECG interpretation, expert consensus and/or adjudicated clinical data would be the most probable ground truth methods for the AliveCor algorithms.
Part 8: Sample Size for the Training Set
The document does not provide the sample size for the training set used to develop the AliveCor algorithms. This information would be specific to the original AliveCor submissions (K142743 and K181823).
Part 9: How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set of the AliveCor algorithms was established. As mentioned in Part 7, it would typically involve expert review and/or adjudicated clinical data from cardiologists or electrophysiologists.
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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
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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 (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
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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: 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
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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 DeviceOmron BP7900K182579 | Predicate Devices | Reference DeviceAliveCor KardiaAI(K181823) | SE Assessment to Predicate Devicesand Reference Device | ||
|---|---|---|---|---|---|
| CFR Classification | 21 CFR§870.1130,Noninvasive blood pressuremeasurement system. | BP measurementOmron Healthcare, Inc.Model HEM-7311(K133379) | ECG recordingAliveCor, Inc.AliveCor Heart Monitor(K142743) | 21CFR§870.1425,Programmable diagnosticcomputer | Same as K133379Bradycardia and Tachycardiadetection same as K181823 |
| Class I/II/III | II | 21 CFR§870.1130,Noninvasive bloodpressure measurementsystem. | 21 CFR§870.2920, Telephoneelectrocardiograph transmitterand receiver. | II | No difference. The proposed deviceand predicate devices have the sameClass. |
| Product Code | DXN - Noninvasive bloodpressure measurementDXH - Telephoneelectrocardiograph transmitterand receiverDPS - Electrocardiograph | II | II | DQK - Computer, Diagnostic,ProgrammableDPS - Electrocardiograph | Product codes include those forpredicates and reference device. |
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| of the should should the mew The |
|---|
| 2 |
| 1 |
| Indications for Use | Proposed DeviceOmron BP7900K182579 | Predicate DevicesBP measurementOmron Healthcare, Inc.Model HEM-7311(K133379) | ECG recordingAliveCor, Inc.AliveCor Heart Monitor(K142743) | Reference DeviceAliveCor KardiaAI(K181823) | SE Assessment to Predicate Devicesand Reference Device |
|---|---|---|---|---|---|
| The device is intended tomeasure blood pressure only,electrocardiogram (ECG) onlyor blood pressure and ECGsimultaneously.The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult population.The device is intended torecord, store, and transfersingle-channelelectrocardiogram (ECG)rhythms. The device alsodisplays ECG rhythms anddetects the presence of atrialfibrillation, bradycardia,tachycardia and normal sinusrhythm (when prescribed orused under the care of aphysician). The device isintended for use by healthcareprofessionals, patients withknown or suspected heartconditions, and health-conscious individuals. Thedevice has not been tested andit is not intended for pediatricuse. | The device is a digitalmonitor intended for usein measuring bloodpressure and pulse rate inadult patient population.The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings.Environments of Use:HomePatient Population: Adult | The AliveCor Heart Monitoris intended to record, storeand transfer single-channelelectrocardiogram (ECG)rhythms. The AliveCor HeartMonitor also displays ECGrhythms and detects thepresence of atrial fibrillationand normal sinus rhythm(when prescribed or usedunder the care of a physician)The AliveCor Heart Monitoris intended for use byhealthcare professionals,patients with known orsuspected heart conditions andhealth conscious individuals.The device has not been testedand it is not intended forpediatric use. | KardiaAI is a softwareanalysis library intended toassess ambulatoryelectrocardiogram (ECG)rhythms from adult subjects.The device supports analyzingdata recorded in compatibleformats from any ambulatoryECG devices such as eventrecorders, or other similardevices. The library isintended to be integrated intoother device software.The library is not intended foruse in life supporting, orsustaining systems, or ECGmonitors, or cardiac alarm, orOTC use only devices.KardiaAI provides thefollowing capabilities:• ECG noise filtering,• heart rate measurementfrom ECGs,• detection of noisy ECGs,and• ECG rhythm analysis fordetecting the presence ofnormal sinus rhythm, atrialfibrillation, bradycardia, andtachycardia (when prescribedor used under the care of aphysician). | No difference of intended purpose.The proposed indication for use isthe same as the cleared indicationsfor use of the predicate devices. Themeasurement of irregular heartbeatsis captured under the ECG rhythmanalysis.BP7900 includes reference todetection of bradycardia andtachycardia. BP7900 uses samealgorithm for these capabilities atthat cleared for the reference deviceunder K181823. | |
| Proposed DeviceOmron BP7900K182579 | Predicate DevicesBP measurementOmron Healthcare, Inc.Model HEM-7311(K133379) | Predicate DevicesECG recordingAliveCor, Inc.AliveCor Heart Monitor(K142743) | Reference DeviceAliveCor KardiaAI(K181823) | SE Assessment to Predicate Devicesand 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 andtachycardia detection) same asreference device. |
| Patient Population | Adults | Adults | Adult (non-pediatric) | Adults | Same as predicates and referencedevice. |
| Contraindications/Warnings/ Precautions | Added contraindications (n=2)against use in ambulatoryenvironments and aircraft. | There are no knowncontraindications. | There are no knowncontraindications. | There are no knowncontraindications. | The BP7900 includes two (2)additional contraindications to beconsistent with recent FDA requestsreceived during the review process forOmron's other non-invasive bloodpressure monitors. They are not dueto technological differences and donot alter the Intended Use of thedevice. |
| Single Use | No | No | No | No | Same as predicates and referencedevice. |
| Sterility | External contacting device,nonsterile | External contactingdevice, nonsterile | External contacting device,nonsterile | External contacting device,nonsterile | Same as predicates and referencedevice. |
| Label Information | Labeled for both OTC (HomeUse) and Rx (PrescriptionUse) | Labeled for OTC (HomeUse) | Labeled for both OTC (HomeUse) and Rx (PrescriptionUse) | Labeled for both OTC (HomeUse) and Rx (PrescriptionUse) | Same as predicates and referencedevice. |
| Specifications/Features | Measurement Method /Principal of Operation | ||||
| BP measurement:Cuff oscillometric methodECG recording:User completes circuit withskin contact and hardwaretransmits audio signal to MCPto convert and display ECG | Cuff oscillometric methodUser completes circuit withskin contact and hardwaretransmits audio signal to MCPto convert and display ECG | - An interface that providestools to process and analyzeECGs through variousalgorithms- The automated proprietaryECG algorithms providesupportive information forECG diagnosis. The librarycan be accessed by directlyconnecting to the KardiaAI'sApplication ProgrammingInterface | BP measurement:Same as HEM-7311.ECG recording:Same as Heart Monitor. The minordifferences in orientation of thesensors and additional noise sensorsdo not raise different questions ofsafety or effectiveness. Bradycardiaand Tachycardia detection same asreference device. | ||
| Measurement Range | BP measurement:Pressure: 0 to 299mmHgPulse Rate: 40 to 180beats/min. | Pressure: 0 to 299mmHgPulse Rate: 40 to 180beats/min.ECG recording:Pulse Rate: 30 to 300beats/min. | Pulse Rate: 30 to 300beats/min. | n/a | BP measurement:Same as HEM-7311.ECG recording:Same as Heart Monitor. |
| Pressure Sensor | Semiconductor pressuresensor | Semiconductor pressuresensor | 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 haschanged from HEM-7311 cuffs inorder to comply with the ISOstandards (ISO 80369-1/-5) for small-bore connector. The diameter of plugand connector are increased inaccordance with hazard analysis.This change does not raise differentquestions of safety or effectiveness. |
| Accuracy of pressureindicator | Within ±3mmHg or 2% ofreading | Within ±3mmHg or 2% ofreading | 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 byelectric pump | Automatic inflation byelectric pump | None | n/a | Same as HEM-7311. |
| Deflation Method | |||||
| Display | Automatic pressure release valveLCD digital display on device and Smartphone display | Automatic pressure release valveLCD 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°C15 to 90% RH | 10 to 40°C15 to 90% RH | n/a | 10 to 40°C | Same as HEM-7311. |
| Storage Conditions | -20 to 60°C10 to 95% RH | -20 to 60°C10 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 | YesECG 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 |
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| Provides an average of 3 measurements | Multiple Users | Communications | Data Acquisition for ECG recording: | ||
|---|---|---|---|---|---|
| No | No | BP measurement:BluetoothECG 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 - 40HzSingle Channel16-bit300 samples/second | 0.5 - 40HzSingle Channel16-bit300 samples/second |
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| 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 timeECG 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. |
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| P. W |
|---|
| the program and should the count11 |
| 721 |
| 1411 |
| Display | Controls | Number of ECG Leads | Anatomical sites | User Interface for ECGrecording: | |||||
|---|---|---|---|---|---|---|---|---|---|
| BP measurement:LCD (Liquid Crystal Display) displays:• current cuff pressure• systolic blood pressure• diastolic blood pressure• pulse rate• error messagesECG 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 armECG 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 ButtonNone | Single Lead, 2 electrodes | n/aLeft 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 affectfundamental ECG recording functionor raise different questions of safetyor effectiveness. |
| Smartphone (App) displays;• ECG rhythmECG 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 Universalmodule | ||
| 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 ofthe cuff have been tested inaccordance with ISO 10993and FDA guidance | Patient contact materialsof the cuff have been tested inaccordance with ISO 10993and FDA guidance | Patient contact materials ofthe cuff have been tested inaccordance with ISO 10993and 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. |
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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.
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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.
§ 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).