HEM-6410T-ZL Wrist Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. April 17. 2019 Omron Healthcare, Inc. % Ronald Warren Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose. California 95110 Re: K190693 Trade/Device Name: HEM-6410T-ZL Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 15, 2019 Received: March 18, 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 {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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/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. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### 510(k) Notification K190693 ### GENERAL INFORMATION [807.92(a)(1)] ### Applicant: Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 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 15, 2019 ### DEVICE INFORMATION [807.92(A)(2)] Classification: Class II per 21CFR§870.1130 Product Code: DXN Trade Name: Omron HEM-6410T-ZL Wrist Blood Pressure Monitor ### Generic/Common Name: Noninvasive blood pressure measurement system ### PREDICATE DEVICE(S) [807.92(A)(3)] The Omron HEM-6410T-ZL Wrist Blood Pressure Monitor is substantially equivalent to the Omron HEM-6410T-ZM (K182481). ### DEVICE DESCRIPTION [807.92(A)(4)] The Omron HEM-6410T-ZL Wrist Blood Pressure Monitor ("HEM-6410T-ZL") is a battery-powered, automatic, non-invasive blood pressure system intended for home use. HEM-6410T-ZL is intended for use in adult patient population with wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.50cm). The device is powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform {3}------------------------------------------------ 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 can measure pressure range from 0 to 299mmHg, and the pulse rate range from 40 to 180 beats/min. The blood pressure reading is displayed in "red" color if the blood pressure recorded is equal to or greater than 130/80 based on the American Heart Association (AHA)/ American College of Cardiology (ACC) High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The device also detects the appearance of irregular heartbeats during the blood pressurement process. An irregular rhythm is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings. In addition, the device includes an Advanced Positioning Sensor (APS), known as the Heart Zone Indicator, which aids the user to determine if the wrist cuff is at the correct height in relation to the heart. This determination is based on the reading of an accelerometer (integral to the device) to measure the angle of the arm. The APS feature is identical to that of the predicate device. The operation of the device is intended for home use. Additional functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and charging the battery as needed. As an optional feature, the user can also pair the HEM-6410T-ZL to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6410T-ZL does not connect with other collateral devices. ### INDICATIONS FOR USE [807.92(a)(5)] Aside from change in wrist circumference, the proposed indications for use is the same indications for use as the predicate device HEM-6140T-ZM (K182481) as follows: The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. {4}------------------------------------------------ ### SUBSTANTIAL EQUIVALENCE The proposed HEM-6410T-ZL device has the same intended use as the predicate HEM-6410T-ZM device. Both devices are intended for home use and employ the cuff oscillometric method for measuring blood pressure and pulse rate from the wrist. Additionally, the proposed HEM-6410T-ZL device has identical technological characteristics as compared to the predicate HEM-6410T-ZM device. Both devices have the same cuff pressure range of 0 to 299mmHg. The pulse rate range is the same for the two devices with a range of 40 to 180 beats/min. The accuracy of pressure reading is ±3mmHg for both devices, and accuracy of pulse rate is ±5% in both devices. Both devices include detection of irregular heartbeats and give a warning signal with readings. Both devices give an error message when body movement is detected during BP measurement. Also, both devices include an Advanced Positioning Sensor (APS) as an aid to the user to determine if the wrist cuff is at the correct height in relation to the heart. Both devices utilize a piezoelectric pump for wrist cuff inflation. Both the proposed device and the predicate device employ a semiconductor pressure sensor and utilize an active electronic control valve that performs cuff air bleeding and release. The devices have identical design features and user interface. There are two (2) minor differences in technical specifications in HEM-6410T-ZL as compared to HEM-6410T-ZM. Both minor design modifications of the HEM-6410T-ZL relate to the addition of a larger sized wrist strap ("Large") to accommodate wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.5cm) as a line extension of the previously cleared HEM-6410T-ZM which has a "Medium" sized wrist strap for adults with wrist circumference ranging from 6.3 inches to 7.5 inches (16.0cm to 19.0cm). To accommodate the change in wrist strap size, the proposed device has a slightly larger inflatable cuff and a minor change of the algorithm parameters used to calculate diastolic and systolic blood pressure. The design modifications outlined in this Special 510(k) premarket notification do not affect the intended use. indications for use or alter the fundamental scientific technology of the device as detailed in the comparison table below. Based on these comparisons and completed testing, the proposed HEM-6410T-ZL device is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. The minor differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the proposed HEM-6410T-ZL is substantially equivalent to the predicate device. {5}------------------------------------------------ | | Substantial Equivalence Comparison Table: | | | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Proposed Device<br>Omron HEM-6410T-ZL<br>K190693 | Predicate Device<br>Omron HEM-6410T-ZM<br>K182481 | Analysis of Technological<br>Differences | | Classification -<br>Regulation | 21CFR§870.1130,<br>Noninvasive blood pressure<br>measurement system. | 21CFR§870.1130,<br>Noninvasive blood pressure<br>measurement system. | Same | | Classification -<br>Product Code | DXN - Noninvasive blood<br>pressure measurement | DXN - Noninvasive blood<br>pressure measurement | Same | | Indications for Use | The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate<br>in adult patient population<br>with wrist circumference<br>ranging from 7.1 to 8.5 inches<br>(18.0cm to 21.5cm).<br>The device detects the<br>appearance of irregular<br>heartbeats during<br>measurement and gives a<br>warning signal with readings. | The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate<br>in adult patient population<br>with wrist circumference<br>ranging from 6.3 to 7.5 inches<br>(16.0cm to 19.0cm).<br>The device detects the<br>appearance of irregular<br>heartbeats during<br>measurement and gives a<br>warning signal with readings. | Minor change to wrist strap<br>size to allow use on larger<br>sized wrists. | | Environment of Use | Home Use | Home Use | Same | | Patient Population | Adults | Adults | Same | | Contraindications/<br>Warnings/ Precautions | There are two (2)<br>contraindications:<br>The monitor is contraindicated<br>for use in ambulatory<br>environments<br>The monitor is contraindicated<br>in aircraft | There are two (2)<br>contraindications:<br>The monitor is contraindicated<br>for use in ambulatory<br>environments<br>The monitor is contraindicated<br>in aircraft | Same | | Single Use | No | No | Same | | Sterility | External contacting device,<br>nonsterile | External contacting device,<br>nonsterile | Same | | Label Information | Labeled for OTC (Home Use) | Labeled for OTC (Home Use) | Same | | Specifications/Features | | | | | Measurement method/<br>Principle of operation | Cuff oscillometric method | Cuff oscillometric method | Same | | Measurement range | Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180<br>beats/min. | Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180<br>beats/min. | Same | | Pressure senor | Semiconductor pressure<br>sensor | Semiconductor pressure<br>sensor | Same | | Applicable cuff<br>(Wrist Circumference) | 18.0 to 21.5cm | 16.0 to 19.0cm | Minor change to wrist strap<br>size to allow use on larger<br>sized wrists. Does not impact<br>safety or effectiveness of the<br>device. | | Accuracy of pressure<br>indicator | Within ±3mmHg | Within ±3mmHg | Same | | Accuracy of pulse rate | Within ±5% of reading | Within ±5% of reading | Same | | Inflation method | Automatic inflation with<br>piezoelectric pump | Automatic inflation with<br>piezoelectric pump | Same | | Deflation method | Automatic rapid deflation<br>valve | Automatic rapid deflation<br>valve | Same | | Display | Transreflective memory-in-<br>pixel LCD | Transreflective memory-in-<br>pixel LCD | Same | | Power source | Rechargeable lithium-polymer<br>battery | Rechargeable lithium-polymer<br>battery | Same | | Operating conditions | 5 to 40°C (41 to 104°F)<br>15 to 85% RH<br>(non-condensing)<br>800 to 1060hPa | 5 to 40°C (41 to 104°F)<br>15 to 90% RH<br>(non-condensing)<br>800 to 1060hPa | Same | | Charging/Data<br>transmission<br>conditions | 10 to 35°C (+50 to 95°F)<br>15 to 90% RH<br>(non-condensing) | 10 to 35°C (+50 to 95°F)<br>15 to 90% RH<br>(non-condensing) | Same | | Storage conditions | -20 to 40°C (-4 to 104°F)<br>10 to 90% RH<br>(non-condensing) | -20 to 40°C (-4 to 104°F)<br>10 to 90% RH<br>(non-condensing) | Same | | Transporting<br>conditions | -20 to 60°C (-4 to 140°F)<br>10 to 90% RH<br>(non-condensing) | -20 to 60°C (-4 to 140°F)<br>10 to 90% RH<br>(non-condensing) | Same | | Dimensions (mm) | Case diameter: 48mm<br>Case thickness: 14mm<br>Band width: 30mm | Case diameter: 48mm<br>Case thickness: 14mm<br>Band width: 30mm | Same | | Weight | Approx. 120g (4.2oz.)<br>(including batteries) | Approx. 115g (4.1oz.)<br>(including batteries) | Slightly heavier due to larger<br>strap. This minor difference<br>does not impact safety and<br>effectiveness of the device. | | Irregular Heart Beat<br>Feature | Yes | Yes | Same | | Body movement<br>detection | Yes | Yes | Same | | Hypertension indicator | Yes | Yes | Same | | Advanced positioning<br>sensor (APS) | Yes | Yes | Same | | Substantial Equivalence Comparison Table (Cont.): | | | | | Technology/Features Comparison | | | | | Power supply | Regulates power voltage<br>regardless of battery | Regulates power voltage<br>regardless of battery | Same | | Microprocessor | Determines blood pressure<br>and pulse<br>Controls the pump, valve and<br>display<br>Detects switch operations<br>Stores measurement results<br>Manages date and time | Determines blood pressure<br>and pulse<br>Controls the pump, valve and<br>display<br>Detects switch operations<br>Stores measurement results<br>Manages date and time | Same | | Pressure sensor | Semiconductor pressure<br>sensor | Semiconductor pressure<br>sensor | Same | | Rapid exhaust valve | Active electronic control<br>valve that performs cuff air<br>bleeding and release | Active electronic control<br>valve that performs cuff air<br>bleeding and release | Same | | Deflation valve | No | No | Same | | Inflation source | piezoelectric | piezoelectric | Same | | Display Type and<br>Parameters | Transreflective memory-in-<br>pixel LCD<br>Current cuff pressure<br>Systolic blood pressure<br>Diastolic blood pressure<br>Pulse rate<br>Error messages<br>Time and date<br>Latest results in the memory | Transreflective memory-in-<br>pixel LCD<br>Current cuff pressure<br>Systolic blood pressure<br>Diastolic blood pressure<br>Pulse rate<br>Error messages<br>Time and date<br>Latest results in the memory | Same | | Controls | Start/Stop Button<br>Forward Button<br>Home Button | Start/Stop Button<br>Forward Button<br>Home Button | Same | | Cuff | Wrist Cuff, composed of<br>elastomer belt, air bag and<br>metal buckle | Wrist Cuff, composed of<br>elastomer belt, air bag and<br>metal buckle | Only the air bag length is<br>extended to support larger<br>wrist circumference.<br>Materials and structure of the<br>air bag are not changed. The<br>elastomer belt and buckle are<br>the same. | | Materials | Patient contact materials of<br>the cuff have been tested in<br>accordance with ISO 10993<br>and FDA guidance | Patient contact materials of<br>the cuff have been tested in<br>accordance with ISO 10993<br>and FDA guidance | Same materials and same<br>manufacturing process. | ### Substantial Equivalence Comparison Table: {6}------------------------------------------------ ### Substantial Equivalence Comparison Table (Cont.): {7}------------------------------------------------ # Substantial Equivalence Comparison Table (Cont.): {8}------------------------------------------------ ### PERFORMANCE DATA [807.92(b)] ### Nonclinical Testing Summary [807.92(b)(1)]: 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 predicate device were employed for this proposed device. To support the minor changes, additional performance testing, software verification and validation was performed to confirm the minor change in algorithm parameters used to calculate blood pressure resulted in comparable readings as compared to the predicate device. ### Clinical Testing Summary [807.92(b)(2)]: Clinical validation of the HEM-6410T-ZL was conducted using the same methodology and test strategy used for the predicate device. The study assessed the accuracy of blood pressure measurements by HEM-6410T-ZL 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 HEM- 6410T-ZL performed equivalently to the auscultation method and is in conformance with ANSI/AAMI/ISO 81060-2:2013. ### CONCLUSIONS [807.92(b)(3)] Based on the results from the nonclinical and clinical tests performed in support of HEM-6410T-ZL, it is concluded that the proposed device performs as safely and effectively as the legally marketed predicate device. ### SUMMARY The proposed HEM-6410T-ZL device, and the predicate HEM-6410T-ZM device are both designed for the measurement of blood pressure (BP), pulse rate 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 and pulse rate. The minor differences in wrist strap size and minor software algorithm modifications have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed HEM-6410T-ZL device is substantially equivalent to the predicate device. {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190693 Device Name Omron HEM-6410T-ZL Wrist Blood Pressure Monitor Indications for Use (Describe) The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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