(237 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 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 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.
The Omron Model BP7900 Blood Pressure Monitor + EKG received 510(k) clearance based on its substantial equivalence to two predicate devices: the Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and the AliveCor, Inc. KardiaMobile System (K191406). The primary change in the proposed device is a software update to the onboarding procedure for accessing ECG functionalities, aligning it with the secondary predicate.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent, meaning its performance for key functionalities (blood pressure measurement, ECG recording, and ECG analysis) is expected to be as safe and effective as the predicate devices. The document explicitly states: "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 acceptance criteria are implicitly tied to the performance specifications of the predicate devices, particularly the primary predicate (K182579) which the proposed device largely mirrors in hardware and core functionality.
| Feature | Acceptance Criteria (based on predicate K182579) | Reported Device Performance (proposed BP7900) |
|---|---|---|
| Blood Pressure Monitoring | ||
| BP measurement method | Cuff oscillometric method | Cuff oscillometric method |
| Pressure measuring range | 0 to 299mmHg | 0 to 299mmHg |
| Pulse Rate measuring range | 40 to 180 beats/min | 40 to 180 beats/min |
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor |
| Applicable cuff (Arm Circumference) | 17-22cm (HEM-CS24-B), 22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24-B), 22-42cm (HEM-RML31-B) |
| Accuracy of pressure indicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading |
| Accuracy of pulse rate | Within 5% of reading | Within 5% of reading |
| Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump |
| Deflation Method | Automatic pressure release valve | Automatic pressure release valve |
| Display | LCD digital display on device and Smartphone | LCD digital display on device and Smartphone display |
| Body Movement Detection | Yes, for BP measurement | Yes, for BP measurement |
| Communications (BP) | Bluetooth | Bluetooth |
| Memory Capacity (BP) | 90 BP readings in internal memory | 90 BP readings in internal memory |
| Microprocessor (BP) | Determines BP/pulse rate, controls pump/valve/display, detects switch operations, stores results, manages date/time | Determines BP/pulse rate, controls pump/valve/display, detects switch operations, stores results, manages date/time |
| Rapid Exhaust/Deflation Valve | Active electronic control valve | Active electronic control valve |
| Inflation Source | DC rolling diaphragm pump | DC rolling diaphragm pump |
| Controls | START/STOP Button, Connection Button | START/STOP Button, Connection Button |
| Anatomical site (BP) | Upper arm | Upper arm |
| ECG Monitoring | ||
| ECG analysis | Provided by KardiaAI platform (K181823) | Provided by KardiaAI platform (K181823) |
| ECG Detectors (outputs) | Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, Unclassified, Unreadable | Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, Unclassified, Unreadable |
| ECG recording pulse rate range | 30 to 300 beats/min | 30 to 300 beats/min |
| Communications (ECG) | Ultrasonic Acoustics acquired by phone | Ultrasonic Acoustics acquired by phone |
| Data Acquisition for ECG: Frequency Response | 0.67 - 40Hz | 0.67 - 40Hz |
| Data Acquisition for ECG: ECG channels | Single Channel | Single Channel |
| Data Acquisition for ECG: Resolution | 16-bit | 16-bit |
| Data Acquisition for ECG: Sample Rate | 300 samples/second | 300 samples/second |
| Memory Capacity (ECG) | Essentially unlimited (due to app transmission) | Essentially unlimited (due to real-time transmission to MCP memory) |
| User Interface for ECG | Apple iOS-based or Google Android-based software | Apple iOS-based or Google Android-based software |
| Number of ECG Leads | Single lead, 4 electrodes (2 neutral) | Single lead, 4 electrodes (2 neutral) |
| Anatomical site (ECG) | Left hand fingers to right hand fingers | Left hand fingers to right hand fingers |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was conducted in support of this 510(k) Premarket Notification."
Therefore, there is no information regarding a test set sample size or data provenance (country of origin, retrospective/prospective). The clearance relies on substantial equivalence to predicate devices, supported by nonclinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was conducted for this specific 510(k) submission, there were no experts used to establish ground truth for a new test set. The ECG analysis relies on the cleared AliveCor KardiaAI platform (K181823), which would have had its own validation studies involving experts. However, details of those studies are not part of this document.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was created or evaluated for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was conducted or reported in this 510(k) submission for the proposed device. The device's clearance is based on its substantial equivalence to existing devices and the fact that the changes made (primarily software for onboarding) do not raise new questions of safety or effectiveness. The ECG analysis is performed by the previously cleared KardiaAI platform, which likely had its own validation studies, but those are not detailed here for the proposed device itself.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document does not detail any new standalone studies for the algorithms within the proposed device. The ECG analysis functionalities are provided by the "KardiaAI platform (K181823)," which was previously cleared. The blood pressure measurement is hardware-based (oscillometric method) with software analysis, and its performance is considered unchanged from the primary predicate. The nonclinical testing performed focused on verifying the software update related to onboarding procedures.
7. The Type of Ground Truth Used
For the current submission, no new ground truth was established as no new clinical studies were conducted. The device's performance is assumed to be equivalent to the predicate devices, which would have been validated against their respective ground truths (e.g., reference blood pressure measurements for the BP monitor, and expert-adjudicated ECGs for the KardiaMobile component).
8. The Sample Size for the Training Set
No information is provided regarding a training set for the proposed device, as no new clinical studies were conducted for this submission. The ECG analysis algorithms ("KardiaAI platform") had their own training sets, but details are not included here.
9. How the Ground Truth for the Training Set Was Established
Not applicable to this submission, as no new training set or ground truth establishment relevant to the device's clearance were detailed. The KardiaAI platform's previous clearance (K181823) would contain this information.
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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
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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
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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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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).
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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.
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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.
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| Proposed Device:Omron Healthcare, Inc. | Primary Predicate:Omron Healthcare, Inc. | Secondary Predicate:AliveCor, Inc. | SE Assessment to | |
|---|---|---|---|---|
| Omron BP7900 Blood PressureMonitor + EKG | Omron BP7900 Blood PressureMonitor + EKG(K182579) | KardiaMobile System(K191406) | Predicate Devices | |
| CFR Classification | 21 CFR§870.1130, Noninvasive bloodpressure measurement system. | 21 CFR§870.1130, Noninvasive bloodpressure measurement system. | 21 CFR§870.2920, Telephoneelectrocardiograph transmitter andreceiver. | Same. Unchanged from the clearedpredicate device. |
| Regulatory Class | II | II | II | Same. Unchanged from the clearedpredicate device. |
| Product Codes | DXN - Noninvasive blood pressuremeasurementDXH - Telephone electrocardiographtransmitter and receiverDPS - ElectrocardiographQDA - Electrocardiograph Softwarefor Over-The-Counter Use | DXN - Noninvasive blood pressuremeasurementDXH - Telephone electrocardiographtransmitter and receiverDPS - Electrocardiograph | DXH - Telephone electrocardiographtransmitter and receiverDPS - ElectrocardiographQDA - Electrocardiograph Softwarefor Over-The-Counter Use | Product codes include those forpredicates. |
| Indications for Use | The device is intended to measureblood pressure only, electrocardiogram(ECG) only or blood pressure and ECGsimultaneously.The device is a digital monitorintended for use in measuring bloodpressure and pulse rate in adultpopulation.The device is intended to record, store,and transfer single-channelelectrocardiogram (ECG) rhythms. Thedevice also displays ECG rhythms andthe output of ECG analysis includingdetecting the presence of atrialfibrillation, bradycardia, tachycardiaand normal sinus rhythm, and others.The device is intended for use byhealthcare professionals, patients withknown or suspected heart conditions,and health-conscious individuals. Thedevice has not been tested and it is notintended for pediatric use. | The device is intended to measure bloodpressure only, electrocardiogram (ECG)only or blood pressure and ECGsimultaneously.The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult population.The device is intended to record, store,and transfer single-channelelectrocardiogram (ECG) rhythms. Thedevice also displays ECG rhythms anddetects the presence of atrial fibrillation,bradycardia, tachycardia and normalsinus rhythm (when prescribed or usedunder the care of a physician). Thedevice is intended for use by healthcareprofessionals, patients with known orsuspected heartconditions, and health-consciousindividuals. The device has not beentested and it is not intended for pediatricuse. | The KardiaMobile System is intendedto record, store and transfer single-channel electrocardiogram (ECG)rhythms.The KardiaMobile System alsodisplays ECG rhythms and output ofECG analysis from AliveCor'sKardiaAI platform including detectingthe presence of normal sinus rhythm,atrial fibrillation, bradycardia,tachycardia, and others. TheKardiaMobile System is intended foruse by healthcare professionals,patients with known or suspected heartconditions and health consciousindividuals. The device has not beentested and is not intended for pediatricuse. | Similar. The Intended Use of theproposed device is the same as thepredicate device.The wording of the Indications forUse statement with respect to ECGanalysis has been updated to reflectthe updated onboarding procedurewhich is consistent with that of thesecondary predicate device. |
| Environment of Use | Home Use | Home Use | Home Use | Same as both predicate devices. |
| Proposed Device:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG | Primary Predicate:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG(K182579) | Secondary Predicate:AliveCor, Inc.KardiaMobile System(K191406) | SE Assessment toPredicate Devices | |
| Type of Use | OTC: blood pressure features and ECGrecording, display, and analysis | OTC: blood pressure features and ECGrecordingRx: overread unlock restriction for ECGdisplay and analysis features | OTC: ECG recording, display, andanalysis | Same as the primary predicatedevice for blood pressure featuresand ECG recording. Same as thesecondary predicate device for ECGdisplay and analysis.As the "overread unlock" restrictionhas been removed from the proposeddevice for the ECG functionalities,as is consistent with the secondarypredicate device; the proposeddevice 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 clearedpredicate device. |
| Key Contraindications/Warnings/Precautions | Contraindicated against use inambulatory environments and aircraft. | Contraindicated against use inambulatory environments and aircraft. | There are no known contraindications. | Same as both predicate devices.Unchanged from the clearedpredicate device. |
| Single Use | No | No | No | Same as both predicate devices.Unchanged from the clearedpredicate device. |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | External contacting device, nonsterile | Same as both predicate devices.Unchanged from the clearedpredicate device. |
| Specifications/Features | ||||
| Measurement Method /Principal of Operation | BP measurement:Cuff oscillometric methodECG recording:User completes circuit with skincontact and hardware transmits audiosignal to MCP to convert and displayECG | BP measurement:Cuff oscillometric methodECG recording:User completes circuit with skin contactand hardware transmits audio signal toMCP to convert and display ECG | User completes circuit with skincontact and hardware transmits audiosignal to MCP to convert and displayECG | Same as primary predicate. Nochange from cleared BP7900device. |
| Proposed Device:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG | Primary Predicate:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG(K182579) | Secondary Predicate:AliveCor, Inc.KardiaMobile System(K191406) | SE Assessment toPredicate Devices | |
| Measurement Range | BP measurement:Pressure: 0 to 299mmHgPulse Rate: 40 to 180 beats/min.ECG recording:Pulse Rate: 30 to 300 beats/min. | BP measurement:Pressure: 0 to 299mmHgPulse 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. Nochange from cleared BP7900 device. |
| Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | None | Same as primary predicate. Nochange 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. Nochange from cleared BP7900 device. |
| Accuracy of pressureindicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| Accuracy of pulse rate | Within 5% of reading | Within 5% of reading | Unknown | Same as primary predicate. Nochange from cleared BP7900 device. |
| Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| Deflation Method | Automatic pressure release valve | Automatic pressure release valve | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| Display | LCD digital display on device andSmartphone display | LCD digital display on device andSmartphone display | Smartphone display | Same as primary predicate. Nochange from cleared BP7900 device. |
| Power Source | 4 AA" batteries | 4 AA" batteries | 1 Lithium Manganese Dioxide CoinCells | Same as primary predicate. Nochange from cleared BP7900 device. |
| Operating Conditions | 10 to 40°C15 to 90% RH | 10 to 40°C15 to 90% RH | 10 to 40°C | Same as primary predicate. Nochange from cleared BP7900 device. |
| Storage Conditions | -20 to 60°C10 to 95% RH | -20 to 60°C10 to 95% RH | -20 to 60°C | Same as primary predicate. Nochange 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. Nochange from cleared BP7900device. |
| Weight | Approximately 21oz (600g)(not including batteries) | Approximately 21oz (600g)(not including batteries) | 40g | Same as primary predicate. Nochange from cleared BP7900device. |
| Proposed Device:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG | Primary Predicate:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG(K182579) | Secondary Predicate:AliveCor, Inc.KardiaMobile System(K191406) | SE Assessment toPredicate Devices | |
| ECG Detectors | Provided by KardiaAI platform(K181823): | Provided by KardiaAI platform(K181823): | Provided by KardiaAI platform(K181823): | Same as both predicate deviceswith 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 BP7900device. | |
| Body MovementDetection | Yes, for BP measurement | Yes, for BP measurement | No | Same as primary predicate. Nochange from cleared BP7900device. |
| Communications | BP measurement:BluetoothECG recording:Ultrasonic Acoustics acquired byphone | BP measurement:BluetoothECG recording:Ultrasonic Acoustics acquired by phone | Ultrasonic Acoustics acquired byphone | Same as primary predicate. Nochange from cleared BP7900 device. |
| Data Acquisition forECG recording:Frequency ResponseECG channelsResolutionSample Rate | 0.67 - 40HzSingle Channel16-bit300 samples/second | 0.67 - 40HzSingle Channel16-bit300 samples/second | 0.5 - 40HzSingle Channel16-bit300 samples/second | Same as primary predicate. Nochange from cleared BP7900 device. |
| Memory Capacity | BP measurement:90 BP readings can be stored in theinternal memoryECG recording:Essentially unlimited due to real-timetransmission to MCP memory (size ofECG file is miniscule – kilobytescompared to device memory capacity -gigabytes) | BP measurement:90 BP readings can be stored in theinternal memoryECG recording:Essentially unlimited due to real-timetransmission to MCP memory (size ofECG file is miniscule - kilobytescompared to device memory capacity -gigabytes) | Essentially unlimited due to real-timetransmission to MCP memory (size ofECG file is miniscule - kilobytescompared to device memory capacity -gigabytes) | Same as primary predicate. Nochange from cleared BP7900 device. |
| Technology/Features | ||||
| Power Supply | Regulates power voltage regardless ofbattery voltage. | Regulates power voltage regardless ofbattery voltage. | Regulates power voltage regardless ofbattery voltage. | Same as primary predicate. Nochange from cleared BP7900 device. |
| Proposed Device:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG | Primary Predicate:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG(K182579) | Secondary Predicate:AliveCor, Inc.KardiaMobile System(K191406) | SE Assessment toPredicate Devices | |
| Microprocessor | BP measurement:• Determines blood pressure andpulse rate• Controls the pump, the valve, andthe display• Detects switch operations• Stores measurement results• Manages date and timeECG recording:None. ECG rhythm is analyzed byAliveCor engine. | BP measurement:• Determines blood pressure and pulserate• Controls the pump, the valve, andthe display• Detects switch operations• Stores measurement results• Manages date and timeECG recording:None. ECG rhythm is analyzed byAliveCor engine. | None(ECG rhythm is analyzed by AliveCorengine) | Same as primary predicate. Nochange from cleared BP7900 device. |
| Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| RapidExhaust/DeflationValve | Active electronic control valve thatperforms cuff air bleeding and release | Active electronic control valve thatperforms cuff air bleeding and release | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| Inflation Source | DC rolling diaphragm pump | DC rolling diaphragm pump | None | Same as primary predicate. Nochange from cleared BP7900 device. |
| Display | 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 / PossibleAtrial Fibrillation / Bradycardia /Tachycardia Unclassified /Unreadable)• Past ECG recording in the memory• Some other user convenientinformation | BP measurement:LCD displays;• Current cuff pressure• Systolic blood pressure• Diastolic blood pressure• Pulse rate• Error messagesECG recording:Smartphone (App) displays;• ECG rhythm• ECG detectors (Normal / PossibleAtrial Fibrillation / Bradycardia /Tachycardia Unclassified /Unreadable)• Past ECG recording in the memory• Some other user convenientinformation | Smartphone (App) displays;• ECG rhythm• ECG detectors (Normal / PossibleAtrial Fibrillation / Bradycardia /Tachycardia Unclassified /Unreadable)• Past ECG recording in the memory• Some other user convenientinformation | BP measurement:Same as primary predicate. Nochange from cleared BP7900 device.ECG recording:Same as both predicate devices withrespect to types of informationdisplayed. The specific contentdisplayed to the user within thesoftware (e.g., on-screen text anduser interface) has been updatedfrom the primary predicate device tobe consistent with that of thesecondary predicate device. |
| Proposed Device:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG | Primary Predicate:Omron Healthcare, Inc.Omron BP7900 Blood PressureMonitor + EKG(K182579) | Secondary Predicate:AliveCor, Inc.KardiaMobile System(K191406) | SE Assessment toPredicate Devices | |
| Controls | • START/STOP Button• Connection Button | • START/STOP Button• Connection Button | None (When electrode is held by usersit starts recording) | Same as primary predicate. Nochange from cleared BP7900 device |
| Number of ECG Leads | Single lead, 4 electrodes (2 neutralelectrodes) | Single lead, 4 electrodes (2 neutralelectrodes) | Single Lead, 2 electrodes | Same as primary predicate. Nochange from cleared BP7900 device |
| Anatomical sites | BP measurement:Upper armECG recording:Left hand fingers to right hand fingers | BP measurement:Upper armECG recording:Left hand fingers to right hand fingers | Left hand fingers to right hand fingers | Same as primary predicate. Nochange from cleared BP7900 device |
| User Interface for ECGrecording: | Same as primary predicate. Nochange 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 cuffhave been tested in accordance withISO 10993 and FDA guidance | Patient contact materials of the cuffhave been tested in accordance withISO 10993 and FDA guidance | Patient contact materials of the cuffhave been tested in accordance withISO 10993 and FDA guidance | Same as primary predicate. Nochange from cleared BP7900 device |
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Table 1: Substantial Equivalence Comparison (Cont.)
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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.
§ 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).