Omron Model BP7900 Blood Pressure Monitor + EKG

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 1, 2021 Omron Healthcare, Inc. % Kit Cariquitan Chief Regulatory Officer Experien Group 224 Airport Parkway Suite 250 San Jose, California 95110 Re: K202228 Trade/Device Name: Omron Model BP7900 Blood Pressure Monitor + EKG Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN. DXH. DPS. ODA Dated: February 26, 2021 Received: March 2, 2021 Dear Kit Cariquitan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202228 Device Name Omron Model BP7900 Blood Pressure Monitor + EKG #### Indications for Use (Describe) The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously. The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Notification K_________________ ### GENERAL INFORMATION [807.92(a)(1)] ### Applicant: Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: 847-247-5626 Fax: 847-680-6269 ### Correspondent: Kit Cariquitan Chief Regulatory Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Date Prepared: August 06, 2020 ### DEVICE INFORMATION [807.92(A)(2)] Classification: 21 CFR 870.1130, Noninvasive blood pressure measurement system ### Product Code: DXN, System, Measurement, Blood-Pressure, Non-Invasive DXH, Transmitters and Receivers, Electrocardiograph, Telephone DPS, Electrocardiograph QDA, Electrocardiograph Software for Over-The-Counter Use #### Trade/Proprietary Name: Omron Model BP7900 Blood Pressure Monitor + EKG #### Generic/Common Name: Noninvasive Blood Pressure Monitor and Electrocardiograph ### PREDICATE DEVICE(S) [807.92(A)(3)] The Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and AliveCor, Inc. KardiaMobile System (K191406). {4}------------------------------------------------ ### DEVICE DESCRIPTION [807.92(A)(4)] The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use. The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm, respectively. Other than the difference in circumference, the two cuffs function in the same manner. The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron Connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared software of the AliveCor, Inc. KardiaMobile System (K191406) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user. In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archive and review by the user. {5}------------------------------------------------ ### INDICATIONS FOR USE [807.92(a)(5)] The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously. The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] The proposed BP7900 incorporates a software update to the cleared BP7900 primary predicate device (K182579), with no change in principles of operation, hardware components, or key specifications; to bring the proposed device's onboarding procedure for accessing ECG functionalities in alignment with the secondary predicate, the AliveCor KardiaMobile System (K191406). The proposed device is substantially equivalent to both predicate devices with regard to intended use, product labeling, anatomical sites, patient population, performance testing, technological characteristics, and safety characteristics. With respect to technological characteristics, there are no differences between the proposed and primary predicate devices with respect to the key functionalities blood pressure measurement, ECG recording, or ECG analysis. The main difference between the devices, which prompted this 510(k) submission, is a change in the onboarding procedure to access the ECG features. The "unlock overread" restriction has been removed for the first use of the product. This change matches the proposed device's first-use onboarding procedure for accessing ECG functionalities with that of the secondary predicate device. Omron has conducted software testing to demonstrate that the updated onboarding procedure, which is identical to that of the secondary predicate device, has been successfully implemented in the updated software. The removal of the unlock overread restriction for first ECG use does not introduce any new risks or significantly modify existing risks, nor does it remove mitigations of risk as compared with the predicate device. This technological difference therefore does not raise different questions of safety or effectiveness from the predicate devices and supports that the proposed device is substantially equivalent to both predicate devices. Table 1 presents a tabular substantial equivalence comparison between the proposed device and both predicate devices. {6}------------------------------------------------ | | Proposed Device:<br>Omron Healthcare, Inc. | Primary Predicate:<br>Omron Healthcare, Inc. | Secondary Predicate:<br>AliveCor, Inc. | SE Assessment to | |-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Omron BP7900 Blood Pressure<br>Monitor + EKG | Omron BP7900 Blood Pressure<br>Monitor + EKG<br>(K182579) | KardiaMobile System<br>(K191406) | Predicate Devices | | CFR Classification | 21 CFR§870.1130, Noninvasive blood<br>pressure measurement system. | 21 CFR§870.1130, Noninvasive blood<br>pressure measurement system. | 21 CFR§870.2920, Telephone<br>electrocardiograph transmitter and<br>receiver. | Same. Unchanged from the cleared<br>predicate device. | | Regulatory Class | II | II | II | Same. Unchanged from the cleared<br>predicate device. | | Product Codes | DXN - Noninvasive blood pressure<br>measurement<br>DXH - Telephone electrocardiograph<br>transmitter and receiver<br>DPS - Electrocardiograph<br>QDA - Electrocardiograph Software<br>for Over-The-Counter Use | DXN - Noninvasive blood pressure<br>measurement<br>DXH - Telephone electrocardiograph<br>transmitter and receiver<br>DPS - Electrocardiograph | DXH - Telephone electrocardiograph<br>transmitter and receiver<br>DPS - Electrocardiograph<br>QDA - Electrocardiograph Software<br>for Over-The-Counter Use | Product codes include those for<br>predicates. | | Indications for Use | The device is intended to measure<br>blood pressure only, electrocardiogram<br>(ECG) only or blood pressure and ECG<br>simultaneously.<br>The device is a digital monitor<br>intended for use in measuring blood<br>pressure and pulse rate in adult<br>population.<br>The device is intended to record, store,<br>and transfer single-channel<br>electrocardiogram (ECG) rhythms. The<br>device also displays ECG rhythms and<br>the output of ECG analysis including<br>detecting the presence of atrial<br>fibrillation, bradycardia, tachycardia<br>and normal sinus rhythm, and others.<br>The device is intended for use by<br>healthcare professionals, patients with<br>known or suspected heart conditions,<br>and health-conscious individuals. The<br>device has not been tested and it is not<br>intended for pediatric use. | The device is intended to measure blood<br>pressure only, electrocardiogram (ECG)<br>only or blood pressure and ECG<br>simultaneously.<br>The device is a digital monitor intended<br>for use in measuring blood pressure and<br>pulse rate in adult population.<br>The device is intended to record, store,<br>and transfer single-channel<br>electrocardiogram (ECG) rhythms. The<br>device also displays ECG rhythms and<br>detects the presence of atrial fibrillation,<br>bradycardia, tachycardia and normal<br>sinus rhythm (when prescribed or used<br>under the care of a physician). The<br>device is intended for use by healthcare<br>professionals, patients with known or<br>suspected heart<br>conditions, and health-conscious<br>individuals. The device has not been<br>tested and it is not intended for pediatric<br>use. | The KardiaMobile System is intended<br>to record, store and transfer single-<br>channel electrocardiogram (ECG)<br>rhythms.<br>The KardiaMobile System also<br>displays ECG rhythms and output of<br>ECG analysis from AliveCor's<br>KardiaAI platform including detecting<br>the presence of normal sinus rhythm,<br>atrial fibrillation, bradycardia,<br>tachycardia, and others. The<br>KardiaMobile System is intended for<br>use by healthcare professionals,<br>patients with known or suspected heart<br>conditions and health conscious<br>individuals. The device has not been<br>tested and is not intended for pediatric<br>use. | Similar. The Intended Use of the<br>proposed device is the same as the<br>predicate device.<br>The wording of the Indications for<br>Use statement with respect to ECG<br>analysis has been updated to reflect<br>the updated onboarding procedure<br>which is consistent with that of the<br>secondary predicate device. | | Environment of Use | Home Use | Home Use | Home Use | Same as both predicate devices. | | | Proposed Device:<br>Omron Healthcare, Inc.<br>Omron BP7900 Blood Pressure<br>Monitor + EKG | Primary Predicate:<br>Omron Healthcare, Inc.<br>Omron BP7900 Blood Pressure<br>Monitor + EKG<br>(K182579) | Secondary Predicate:<br>AliveCor, Inc.<br>KardiaMobile System<br>(K191406) | SE Assessment to<br>Predicate Devices | | Type of Use | OTC: blood pressure features and ECG<br>recording, display, and analysis | OTC: blood pressure features and ECG<br>recording<br>Rx: overread unlock restriction for ECG<br>display and analysis features | OTC: ECG recording, display, and<br>analysis | Same as the primary predicate<br>device for blood pressure features<br>and ECG recording. Same as the<br>secondary predicate device for ECG<br>display and analysis.<br>As the "overread unlock" restriction<br>has been removed from the proposed<br>device for the ECG functionalities,<br>as is consistent with the secondary<br>predicate device; the proposed<br>device is no longer indicated as a Rx<br>(prescription use) device. | | Patient Population | Adults | Adults | Adult (non-pediatric) | Same as both predicate devices.<br>Unchanged from the cleared<br>predicate device. | | Key Contraindications/<br>Warnings/Precautions | Contraindicated against use in<br>ambulatory environments and aircraft. | Contraindicated against use in<br>ambulatory environments and aircraft. | There are no known contraindications. | Same as both predicate devices.<br>Unchanged from the cleared<br>predicate device. | | Single Use | No | No | No | Same as both predicate devices.<br>Unchanged from the cleared<br>predicate device. | | Sterility | External contacting device, nonsterile | External contacting device, nonsterile | External contacting device, nonsterile | Same as both predicate devices.<br>Unchanged from the cleared<br>predicate device. | | Specifications/Features | | | | | | Measurement Method /<br>Principal of Operation | BP measurement:<br>Cuff oscillometric method<br>ECG recording:<br>User completes circuit with skin<br>contact and hardware transmits audio<br>signal to MCP to convert and display<br>ECG | BP measurement:<br>Cuff oscillometric method<br>ECG recording:<br>User completes circuit with skin contact<br>and hardware transmits audio signal to<br>MCP to convert and display ECG | User completes circuit with skin<br>contact and hardware transmits audio<br>signal to MCP to convert and display<br>ECG | Same as primary predicate. No<br>change from cleared BP7900<br>device. | | | Proposed Device:<br>Omron Healthcare, Inc.<br>Omron BP7900 Blood Pressure<br>Monitor + EKG | Primary Predicate:<br>Omron Healthcare, Inc.<br>Omron BP7900 Blood Pressure<br>Monitor + EKG<br>(K182579) | Secondary Predicate:<br>AliveCor, Inc.<br>KardiaMobile System<br>(K191406) | SE Assessment to<br>Predicate Devices | | Measurement Range | BP measurement:<br>Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180 beats/min.<br>ECG recording:<br>Pulse Rate: 30 to 300 beats/min. | BP measurement:<br>Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180 beats/min.<br>ECG recording:<br>Pulse Rate: 30 to 300 beats/min. | Pulse Rate: 30 to 300 beats/min. | Same as primary predicate. No<br>change from cleared BP7900 device. | | Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | None | Same as primary predicate. No<br>change from cleared BP7900 device. | | Applicable cuff<br>(Arm Circumference) | 17-22cm (HEM-CS24-B)<br>22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24-B)<br>22-42cm (HEM-RML31-B) | None | Same as primary predicate. No<br>change from cleared BP7900 device. | | Accuracy of pressure<br>indicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading | None | Same as primary predicate. No<br>change from cleared BP7900 device. | | Accuracy of pulse rate | Within 5% of reading | Within 5% of reading | Unknown | Same as primary predicate. No<br>change from cleared BP7900 device. | | Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump | None | Same as primary predicate. No<br>change from cleared BP7900 device. | | Deflation Method | Automatic pressure release valve | Automatic pressure release valve…