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.

Device Description

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 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.

AI/ML Overview

The provided text describes the OMRON HEM-6410T-ZL Wrist Blood Pressure Monitor and its clearance through a 510(k) premarket notification (K190693). The document primarily focuses on demonstrating substantial equivalence to a predicate device, the OMRON HEM-6410T-ZM (K182481). While it mentions clinical testing, it does not provide detailed acceptance criteria or extensive specifics about the study that proves the device meets these criteria in the way typically expected for an AI/ML medical device.

Therefore, many of the requested details, particularly regarding AI/ML-specific validation (e.g., sample sizes for training/test sets, data provenance, expert ground truth, MRMC studies, standalone performance), are not present in this document because this is a traditional medical device, not an AI/ML device.

The device in question is a non-invasive blood pressure measurement system that uses the oscillometric method. Its "software" analyzes pulse waveform data to determine blood pressure and pulse rate, and it detects irregular heartbeats. While it contains software, it is not described as an AI/ML-powered device in the sense of needing large, annotated datasets for training and sophisticated validation of AI model performance.

Below is an attempt to address the request based only on the information provided, with an acknowledgment of what is missing due to the nature of the device:

Acceptance Criteria and Device Performance for OMRON HEM-6410T-ZL Wrist Blood Pressure Monitor (K190693)

Based on the provided 510(k) submission, the device's performance is primarily assessed against the accuracy standards for blood pressure monitors and compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion (Acceptance Standard)	Device Performance (Reported Value)
Accuracy of Pressure Indicator	Within ±3mmHg
Accuracy of Pulse Rate	Within ±5% of reading
Measurement Range - Pressure	0 to 299mmHg
Measurement Range - Pulse Rate	40 to 180 beats/min.
Conformance to Standard	Conformance with ANSI/AAMI/ISO 81060-2:2013

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states that "Clinical validation of the HEM-6410T-ZL was conducted," but it does not specify the sample size (number of patients/subjects) used for this clinical testing.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the study was conducted in accordance with ANSI/AAMI/ISO 81060-2:2013. This standard typically requires prospective clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The ground truth for blood pressure measurement was established by "trained medical staff" using an "auscultation method" with a "calibrated sphygmomanometer."
The number of experts/medical staff is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here as it's a blood pressure device, not an imaging device).

4. Adjudication Method for the Test Set

The document implies a direct comparison of the device's readings against the auscultation method. It does not describe an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as is common in diagnostic AI/ML studies. The auscultation method itself serves as the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is not described as an AI-assisted diagnostic tool where human readers interpret outputs. It is a standalone measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The clinical validation directly assessed the device's performance (which includes its embedded algorithm) against the auscultation method. In essence, this is a form of "standalone" performance assessment of the device's measurement capabilities, as it's measuring blood pressure directly without human interpretive input beyond starting the measurement. However, it's not a standalone algorithm assessment in the way one would evaluate an AI model's output for an imaging device.

7. The Type of Ground Truth Used

The ground truth used was auscultation method measurements taken by trained medical staff using a calibrated sphygmomanometer. This is a recognized clinical reference standard for blood pressure measurement.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device. The document describes "algorithm parameters" being changed and validated, implying a modification to a traditional blood pressure measurement algorithm rather than a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided as there is no mention of a "training set" in the context of machine learning model development. The "ground truth" for validation was established via auscultation method.

Summary

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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

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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/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

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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)]

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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.

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 detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

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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.

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	Substantial Equivalence Comparison Table:
Feature	Proposed DeviceOmron HEM-6410T-ZLK190693	Predicate DeviceOmron HEM-6410T-ZMK182481	Analysis of TechnologicalDifferences
Classification -Regulation	21CFR§870.1130,Noninvasive blood pressuremeasurement system.	21CFR§870.1130,Noninvasive blood pressuremeasurement system.	Same
Classification -Product Code	DXN - Noninvasive bloodpressure measurement	DXN - Noninvasive bloodpressure measurement	Same
Indications for Use	The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient populationwith wrist circumferenceranging from 7.1 to 8.5 inches(18.0cm to 21.5cm).The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal with readings.	The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient populationwith wrist circumferenceranging from 6.3 to 7.5 inches(16.0cm to 19.0cm).The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal with readings.	Minor change to wrist strapsize to allow use on largersized wrists.
Environment of Use	Home Use	Home Use	Same
Patient Population	Adults	Adults	Same
Contraindications/Warnings/ Precautions	There are two (2)contraindications:The monitor is contraindicatedfor use in ambulatoryenvironmentsThe monitor is contraindicatedin aircraft	There are two (2)contraindications:The monitor is contraindicatedfor use in ambulatoryenvironmentsThe monitor is contraindicatedin aircraft	Same
Single Use	No	No	Same
Sterility	External contacting device,nonsterile	External contacting device,nonsterile	Same
Label Information	Labeled for OTC (Home Use)	Labeled for OTC (Home Use)	Same
Specifications/Features
Measurement method/Principle of operation	Cuff oscillometric method	Cuff oscillometric method	Same
Measurement range	Pressure: 0 to 299mmHgPulse Rate: 40 to 180beats/min.	Pressure: 0 to 299mmHgPulse Rate: 40 to 180beats/min.	Same
Pressure senor	Semiconductor pressuresensor	Semiconductor pressuresensor	Same
Applicable cuff(Wrist Circumference)	18.0 to 21.5cm	16.0 to 19.0cm	Minor change to wrist strapsize to allow use on largersized wrists. Does not impactsafety or effectiveness of thedevice.
Accuracy of pressureindicator	Within ±3mmHg	Within ±3mmHg	Same
Accuracy of pulse rate	Within ±5% of reading	Within ±5% of reading	Same
Inflation method	Automatic inflation withpiezoelectric pump	Automatic inflation withpiezoelectric pump	Same
Deflation method	Automatic rapid deflationvalve	Automatic rapid deflationvalve	Same
Display	Transreflective memory-in-pixel LCD	Transreflective memory-in-pixel LCD	Same
Power source	Rechargeable lithium-polymerbattery	Rechargeable lithium-polymerbattery	Same
Operating conditions	5 to 40°C (41 to 104°F)15 to 85% RH(non-condensing)800 to 1060hPa	5 to 40°C (41 to 104°F)15 to 90% RH(non-condensing)800 to 1060hPa	Same
Charging/Datatransmissionconditions	10 to 35°C (+50 to 95°F)15 to 90% RH(non-condensing)	10 to 35°C (+50 to 95°F)15 to 90% RH(non-condensing)	Same
Storage conditions	-20 to 40°C (-4 to 104°F)10 to 90% RH(non-condensing)	-20 to 40°C (-4 to 104°F)10 to 90% RH(non-condensing)	Same
Transportingconditions	-20 to 60°C (-4 to 140°F)10 to 90% RH(non-condensing)	-20 to 60°C (-4 to 140°F)10 to 90% RH(non-condensing)	Same
Dimensions (mm)	Case diameter: 48mmCase thickness: 14mmBand width: 30mm	Case diameter: 48mmCase thickness: 14mmBand width: 30mm	Same
Weight	Approx. 120g (4.2oz.)(including batteries)	Approx. 115g (4.1oz.)(including batteries)	Slightly heavier due to largerstrap. This minor differencedoes not impact safety andeffectiveness of the device.
Irregular Heart BeatFeature	Yes	Yes	Same
Body movementdetection	Yes	Yes	Same
Hypertension indicator	Yes	Yes	Same
Advanced positioningsensor (APS)	Yes	Yes	Same
Substantial Equivalence Comparison Table (Cont.):
Technology/Features Comparison
Power supply	Regulates power voltageregardless of battery	Regulates power voltageregardless of battery	Same
Microprocessor	Determines blood pressureand pulseControls the pump, valve anddisplayDetects switch operationsStores measurement resultsManages date and time	Determines blood pressureand pulseControls the pump, valve anddisplayDetects switch operationsStores measurement resultsManages date and time	Same
Pressure sensor	Semiconductor pressuresensor	Semiconductor pressuresensor	Same
Rapid exhaust valve	Active electronic controlvalve that performs cuff airbleeding and release	Active electronic controlvalve that performs cuff airbleeding and release	Same
Deflation valve	No	No	Same
Inflation source	piezoelectric	piezoelectric	Same
Display Type andParameters	Transreflective memory-in-pixel LCDCurrent cuff pressureSystolic blood pressureDiastolic blood pressurePulse rateError messagesTime and dateLatest results in the memory	Transreflective memory-in-pixel LCDCurrent cuff pressureSystolic blood pressureDiastolic blood pressurePulse rateError messagesTime and dateLatest results in the memory	Same
Controls	Start/Stop ButtonForward ButtonHome Button	Start/Stop ButtonForward ButtonHome Button	Same
Cuff	Wrist Cuff, composed ofelastomer belt, air bag andmetal buckle	Wrist Cuff, composed ofelastomer belt, air bag andmetal buckle	Only the air bag length isextended to support largerwrist circumference.Materials and structure of theair bag are not changed. Theelastomer belt and buckle arethe same.
Materials	Patient contact materials ofthe cuff have been tested inaccordance with ISO 10993and FDA guidance	Patient contact materials ofthe cuff have been tested inaccordance with ISO 10993and FDA guidance	Same materials and samemanufacturing process.

Substantial Equivalence Comparison Table:

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Substantial Equivalence Comparison Table (Cont.):

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Substantial Equivalence Comparison Table (Cont.):

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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.

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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 detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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).