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 6 inches to 8 inches (15.0 cm to 20.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Description

The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a battery- powered automatic non-invasive blood pressure system intended for home use. The device is powered by a rechargeable lithium-polymer battery. There is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff 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 pressure range is 0 to 299mmHg and the pulse rate range is 30 to 199 beats/min.

HEM-6400T-Z is intended for use in adult patient population with wrist circumference ranging from 6 inches to 8 inches (15.0 cm to 20.5 cm). The device also detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. In addition, the device includes 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. It makes this determination based on the reading of an accelerometer (to measure the angle of the arm in relation to the table) integral to the device. The APS feature is similar to the predicate device. The operation of the device is intended for home use. 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 BP and pulse measurement cycle, and charging the batteries as needed. As an optional feature, the user can also pair the HEM-6400T-Z 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-6400T-Z does not connect with other collateral devices.

AI/ML Overview

The document relates to the 510(k) premarket notification for the Omron HEM-6400T-Z Wrist Blood Pressure Monitor. The primary study presented is a clinical investigation to validate the accuracy of blood pressure measurements.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Standard)	Reported Device Performance (Omron HEM-6400T-Z)
Blood Pressure Accuracy	Within ±3mmHg	Performed equivalently to the auscultation method (details of deviation not explicitly provided, but compliance with standard expected)
Pulse Rate Accuracy	Within ±5% of reading	Not explicitly stated in the clinical testing summary, but "Performance characteristics related to BP measurement and pulse rate are comparable between the two devices" implies it meets the predicate's ±5% criteria.
Measurement Method	Cuff oscillometric method	Cuff oscillometric method
Cuff Pressure Range	0 to 299mmHg	0 to 299mmHg
Pulse Rate Range	30 to 199 beats/min	30 to 199 beats/min (predicate was 40 to 180 beats/min, but this difference was deemed not to impact safety or effectiveness)
Wrist Circumference	6 to 8 inches (15.0 cm to 20.5 cm)	6 to 8 inches (15.0 cm to 20.5 cm) (predicate accommodated 13.5cm to 21.5cm, difference deemed minor)
Irregular Heartbeat Detection	Yes	Yes
Body Movement Detection	Yes	Yes
Biocompatibility	ISO 10993-1 requirements	Met ISO 10993-1 requirements
Electrical Safety, EMC, ESD	Relevant standards	Met relevant standards
Software Verification & Validation	Relevant standards	Performed

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

Sample Size (Clinical Investigation): Not explicitly stated in the provided text. The document mentions "A clinical investigation was conducted," but does not specify the number of subjects.
Data Provenance: Not specified. The document does not indicate the country of origin or whether the study was retrospective or prospective, though general clinical investigations for device validation are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated. The ground truth was established using an "auscultation method using a calibrated sphygmomanometer by trained medical staff."
Qualifications of Experts: Referred to as "trained medical staff." Specific qualifications (e.g., physician, nurse, years of experience, specialty) are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The description mentions "auscultation method using a calibrated sphygmomanometer by trained medical staff," implying direct measurement as the ground truth, rather than an adjudication process between multiple independent readings or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a clinical investigation validating the device's accuracy against a recognized measurement method, not assessing human reader improvement with or without AI assistance.
Effect Size: Not applicable, as no MRMC study was performed.

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

Standalone Performance: Yes, the clinical investigation described is a standalone performance study. It validated the accuracy of the Omron HEM-6400T-Z (an automated device operating on its own) against an auscultation method. There is no human-in-the-loop component for the device's measurement function itself; the "human" aspect is purely for establishing ground truth.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus from "trained medical staff" using the auscultation method with a calibrated sphygmomanometer. This is a direct measurement by trained human operators, serving as the clinical gold standard for blood pressure measurement in many validation studies.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. Wrist blood pressure monitors like the Omron HEM-6400T-Z typically use established algorithms based on oscillometric principles, which are not "trained" in the machine learning sense on a dataset but rather designed and calibrated. The document does not mention any machine learning or AI training processes that would require a training set.

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

Training Set Ground Truth: Not applicable, as there is no mention of a training set or machine learning/AI training process for this device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 21, 2017

Omron Healthcare, Inc. % Ronald S. Warren Senior Director, Regulatory Affairs Experien Group LLC 224 Airport Parkway Suite 250 San Jose, CA 95110 US

Re: K163045

Trade/Device Name: Omron HEM-6400T-Z 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: January 20, 2017 Received: January 23, 2017

Dear Ronald S. 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. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K163045
Device Name	Omron HEM-6400T-Z 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 6 inches to 8 inches (15.0 cm to 20.5 cm).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)
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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

Contact Person:

Ronald S. Warren Senior Director, 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: October 27, 2016

DEVICE INFORMATION

Trade Name:

Omron HEM-6400T-Z Wrist Blood Pressure Monitor

Generic/Common Name:

Noninvasive blood pressure measurement system

Classification:

Class II per 21CFR§870.1130

Product Code:

DXN

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PREDICATE DEVICE(S)

The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is substantially equivalent to the Omron BP652N (HEM-6300-Z) with APS (K142917).

DEVICE DESCRIPTION

INDICATIONS FOR USE

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

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The proposed HEM-6400T-Z has similar technological characteristics as compared to the predicate BP652N device. Both devices are intended for home use and employ the cuff oscillometric method for measuring blood pressure and pulse rate from the wrist. Both devices have the same cuff pressure range of 0 to 299mmHg. The pulse rate range is similar between the two devices with a range of 30 to 199 beats/min for HEM-6400T-Z and range of 40 to 180 beats/min for the predicate BP652N. The devices accommodate similar sized wrists. HEM-6400T-Z is intended for a wrist circumference of 6 to 8 inches (15.0 cm to 20.5 cm) while the BP652N is intended for a wrist circumference of 5.25 to 8.5 inches (13.5 cm to 21.5 cm). 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. In addition, both devices include an 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.

There are minor differences between HEM-6400T-Z and BP652N but these do not raise different questions of safety or effectiveness. The HEM-6400T-Z uses a rechargeable lithium-polymer battery as the power source, whereas BP652N uses 2 "AAA" batteries. On the device display, HEM-6400T-Z adds time and date as compared to BP652N display, and the HEM-6400T-Z control buttons have been updated for user convenience. Specifically, the HEM-6400T-Z has a secondary "mini display" on the bottom of the device which also serves as the start/stop button. During the BP measurement, this mini display cycles through a display of systolic pressure, diastolic pressure, and then pulse rate. At the conclusion of the BP measurement, the mini display goes blank and the final results are shown on the main display screen on the top of the device. The BP652N only has a single display screen and start/stop button located on the top of the device. The HEM-6400T-Z wrist cuff main components include an elastomer strap, air bag and metal buckle, while the BP652N wrist cuff main components are a cloth bag, air bag, and hookand-loop strap (aka Velcro). See Table 5.1 for a summary of the comparison between the proposed device and the predicate device.

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Feature	Proposed DeviceOmron HEM-6400T-ZK	Predicate DeviceOmron BP652NK142917	Analysis of TechnologicalDifferences
Classification-Regulation	21 CFR§870.1130,Noninvasive bloodpressuremeasurementsystem.	21 CFR§870.1130,Noninvasive bloodpressuremeasurement system.	No difference. Proposed device andpredicate device have the samemedical device classificationnumber
Classification -Product Code	DXN - Noninvasiveblood pressuremeasurement	DXN - Noninvasiveblood pressuremeasurement	No difference. Proposed device andpredicate device have the samemedical device product code
Indications forUse	The device is adigital monitorintended for use inmeasuring bloodpressure and pulserate in adult patientpopulation withwrist circumferenceranging from 6inches to 8 inches(15.0 cm to 20.5cm).The device detectsthe appearance ofirregular heartbeatsduring measurementand gives a warningsignal with readings.	The device is adigital monitorintended for use inmeasuring bloodpressure and pulserate in adult patientpopulation with wristcircumferenceranging from 5 1/4inches to 8 1/2inches (13.5cut to21.5 cm). The devicedetects theappearance ofirregular heartbeatsduring measurementand gives a warningsignal with readings.	No difference of intended purpose.The proposed indication for use isthe same as the cleared indicationfor use of the predicate device. Thewrist circumference is slightlydifferent between the two devices,but this difference does not affectsafety or effectiveness.
Environment ofUse	Home Use	Home Use	No difference. The proposeddevice and predicate device havethe same environment of use.
Patient Population	Adults	Adults	No difference. Intended for samepopulation.
Contraindications/Warnings/Precautions	There are no knowncontraindications.	There are no knowncontraindications.	No difference. Proposed deviceand predicate device have noknown contraindications
Single Use	No	No	No difference. Proposed andpredicate devices are durablemedical equipment intended formultiple uses
Sterility	External contactingdevice, nonsterile	External contactingdevice, nonsterile	No difference. Proposed andpredicate device are providednonsterile
Label Information	Labeled for OTC(Home Use)	Labeled for OTC(Home Use)	No difference, Label informationprovided as required by US medicaldevice regulations for home use.
Feature	Proposed DeviceOmron HEM-6400T-ZK	Predicate DeviceOmron BP652NK142917	Analysis of TechnologicalDifferences
Specifications/Features
Measurementmethod/Principleof operation	Cuff oscillometricmethod	Cuff oscillometricmethod	No difference
Measurementrange	Pressure: 0 to299mmHgPulse Rate: 30 to 199beats/min.	Pressure: 0 to299mmHgPulse Rate: 40 to 180beats/min.	This minor difference in pulse raterange does not impact safety andeffectiveness of the device.
Pressure senor	Semiconductorpressure sensor	Semiconductorpressure sensor	No difference
Applicable cuff(WristCircumference)	15.0 to 20.5cm	13.5 to 21.5cm	This minor difference does notimpact safety and effectiveness ofthe device.
Accuracy ofpressureindicator	Within ±3mmHg	Within ±3mmHg or2% of reading	There is no difference in theaccuracy range based on mmHgscale
Accuracy ofpulse rate	Within ±5 % ofreading	Within ±5 % ofreading	No difference
Inflation method	Automatic inflationwith piezoelectricpump	Automatic inflationby piezoelectric pump	No difference
Deflationmethod	Automatic rapiddeflation valve	Automatic rapiddeflation valve	No difference
Display	Organicelectroluminescentdisplay	LCD digital display	Similar. Both devices providedigital display of BP and pulse.
Power source	Rechargeablelithium-polymerbattery	Two (2) "AAA"batteries	HEM-6400T-Z includesrechargeable battery for userconvenience and reducedenvironmental impact
Operatingconditions	5 to 40 °C (41 to 104°F)15 to 85 %RH (non-condensing)800 to 1060 hPa	10 to 40 °C (50 to104 °F)15 to 85 %RH	Similar. HEM-6400T-Z operatingconditions specified to comply withIEC60601-1 requirements.
Charging/Datatransmissionconditions	10 to 35 °C (+50 to95 °F)15 to 85 %RH(non-condensing)	NA	HEM-6400T-Z has specific batterycharging conditions for recharginglithium-ion battery.
Storageconditions	-20 to 40 °C (-4 to104 °F)10 to 90 %RH(non-condensing)	-20 to 60 °C (-4 to140 °F)10 to 95 %RH	Similar. HEM-6400T-Z has specificstorage conditions since lithium-ionbattery requires specific storageconditions.
Transportingconditions	-20 to 60 °C (-4 to140 °F)10 to 90 %RH(non-condensing)	-20 to 60 °C (-4 to140 °F)10 to 95 %RH	Similar. HEM-6400T-Z has specifictransporting conditions sincelithium-ion battery requires specifictransporting conditions.
Feature	Proposed DeviceOmron HEM-6400T-ZK	Predicate DeviceOmron BP652NK142917	Analysis of TechnologicalDifferences
Dimensions(mm)	54 (W) × 63 (D) × 16(H) mm	89 (W) × 61 (D) × 13(H) mm	Similar. HEM-6400T-Z has smallerdimensions for added conveniencein home use.
Weight	Approx. 110g (3 7/8oz.)(including batteries)	Approx. 80g (2 7/8oz.)(not includingbatteries)	This minor difference does notimpact safety and effectiveness ofthe device.
Irregular HeartBeat Feature	Yes	Yes	No difference
Body movementdetection	Yes	Yes	No difference
Hypertensionindicator	No	Yes	Hypertension Indicator not includedin HEM-6400T-Z. Device notintended to make diagnosis ofhypertension. Instruction Manualincludes statement that only aphysician is qualified to diagnoseand treat high blood pressure.
Advancedpositioningsensor (APS)	Yes	Yes	No difference
Technology/Features Comparison
Power supply	Regulates powervoltage regardless ofbattery voltage.	Regulates powervoltage regardless ofbattery voltage.	No difference
Microprocessor	• determines bloodpressure and pulserate• controls the pump,the valve, and thedisplay• detects switchoperations• storesmeasurement results• manages date andtime	• determines bloodpressure and pulserate• controls the pump,the valve, and thedisplay• detects switchoperations• stores measurementresults• manages date andtime	No difference
Pressure sensor	Semiconductorpressure sensor.	Semiconductorpressure sensor	No difference
Rapid exhaustValve	Active electroniccontrol valve thatperforms cuff airbleeding and release	Active electroniccontrol valve thatperforms cuff airbleeding and release	No difference
Inflation source	Piezoelectric pump	Piezoelectric pump	No difference
Feature	Proposed DeviceOmron HEM-6400T-ZK	Predicate DeviceOmron BP652NK142917	Analysis of TechnologicalDifferences
Display	Organicelectroluminescentdisplay• current cuffpressure• systolic bloodpressure• diastolic bloodpressure• pulse rate• error messages• time and date• latest results inthe memory	LCD (Liquid CrystalDisplay) displays;• current cuffpressure• systolic bloodpressure• diastolic bloodpressure• pulse rate• error messages• measurementresults in thememory	Different technology for digitaldisplay. Similar informationdisplayed.
Controls	• START/STOPButton• Connection Button• Memory• Home Button	• START/STOPButton• Date/Time settingButton• Up/Down Button• User ID SelectionsButton	Similar. Minor differences relate touser convenience.
Cuff	Wrist Cuff,Composed ofelastomer belt, airbag and metal buckle	Wrist Cuff,Composed of clothbag, air bag andhook-and-loopfastener	Similar. Difference in method toapply device to wrist was evaluatedin usability study and foundacceptable.
Materials	Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance	Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance	No difference

Table 5.1: Substantial Equivalence Table

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Table 5.1: Substantial Equivalence Table (cont.)

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Table 5.1: Substantial Equivalence Table (cont.)

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Tablo 5 1: Substantial Equivolonco Tablo (cont )

SUBSTANTIAL EQUIVALENCE

The indications for use statement for HEM-6400T-Z is identical to that of the predicate BP652N. Comparison testing demonstrated that the proposed device is equivalent to the predicate device with regard to measurement of blood pressure in a pulse wave generator test. Minor differences in technological features relate to convenience considerations for home use but do not impact safety or performance of blood pressure or pulse rate measurements. These minor differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, HEM-6400T-Z is substantially equivalent to the predicate BP652N device.

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PERFORMANCE DATA [807.92(b)]

All necessary bench and clinical testing was conducted on HEM-6400T-Z to support a determination of substantial equivalence to the predicate device.

Nonclinical Testing Summary:

The nonclinical, bench testing included:

Comparative blood pressure and pulse rate testing to the predicate device
Performance verification testing of HEM-6400T-Z to confirm acceptable performance of device features and functions
Cleaning verification testing to confirm device retains its performance when cuff is exposed to surfactants as may be experienced in home use environment
Usability testing with a representative population of study participants in a ● simulated home use environment

Other nonclinical safety testing included:

. Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
. Electrical safety, electromagnetic compatibility, and electrostatic discharge testing
Software verification and validation

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of HEM-6400T-Z meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that HEM-6400T-Z does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse in a home use environment when compared to the predicate device.

Clinical Testing Summary:

A clinical investigation was conducted with the objective of validating the accuracy of blood pressure measurements by HEM-6400T-Z based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. The results demonstrated that HEM-6400T-Z performed equivalently to the auscultation method.

Conclusions

Based on the results from the nonclinical and clinical tests performed in support of HEM-6400T-Z, it is concluded that that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate device.

Summarv

HEM-6400T-Z and BP652N are designed for the measurement of blood pressure, pulse rate and detection of irregular pulses in adult population for home use. These devices have the same indications for use. Performance characteristics related to BP measurement and pulse rate are comparable between the two devices. The minor differences in labeling and technological characteristics between the proposed device and the predicate devices have been evaluated and determined to not raise any different issues of safety or effectiveness. As such, the proposed HEM-6400T-Z is substantially equivalent to the predicate device.

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).