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 5.3 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Description

The Wrist Blood Pressure Monitor Model BP4350 ("BP4350") is a battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) home use. BP4350 is designed for wrist circumference ranging from 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an integral controllable Piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 40 to 180 beats/min.

The device also detects the appearance of irregular heartbeats during the blood pressure measurement process, which 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, a "HIGH" indication appears if the blood pressure recorded is greater than 130/80 based on the AHA/ACC High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017.

In addition, the device includes an Advanced Positioning Sensor (APS) feature known as the Heart Zone Indicator, which aids the user in determining 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 (integral to the device) to measure the angle of the arm in relation to the table. The APS feature is similar to the predicate device.

The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. 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 blood pressure and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP4350 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, BP4350 does not connect with other collateral devices.

AI/ML Overview

The provided text describes the 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP4350. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven device.

Therefore, much of the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details cannot be extracted from this document as it is not an AI/ML device and the study described is a traditional clinical validation for a blood pressure monitor.

However, I can extract the information relevant to a traditional medical device clinical validation study as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document refers to the acceptance criteria implicitly by stating adherence to the ANSI/AAMI/ISO 81060-2:2013 standard for non-invasive sphygmomanometers. This standard dictates the accuracy requirements for blood pressure monitors.

Acceptance Criteria (from ANSI/AAMI/ISO 81060-2:2013, implied)	Reported Device Performance
Blood Pressure Accuracy: Mean difference (device - reference) ≤ ±5 mmHg. Standard deviation of difference ≤ 8 mmHg. (These are the primary statistical requirements of the standard)	"The results demonstrated that BP4350 performed equivalently to the auscultation method and is in conformance with ANSI/AAMI/ISO 81060-2:2013." (Specific numerical results are not provided in this summary, but conformance implies meeting the standard's criteria).
Pulse Rate Accuracy: Within ±5% of reading (stated as a specification in comparison table)	"Accuracy of pulse rate is ±5% in both devices." (Implies the proposed device meets this).
Irregular Heartbeat Detection: The device detects and gives a warning signal when two or more heartbeat intervals differ by greater than 25% from the average heartbeat rhythm.	"The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings." (Functionality confirmed, but specific performance metrics for this feature like sensitivity/specificity are not provided in this summary).
AHA/ACC Hypertension Indicator Threshold: "HIGH" indication if BP > 130/80 mmHg.	"a 'HIGH' indication appears if the blood pressure recorded is greater than 130/80 based on the AHA/ACC High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017." (Functionality confirmed).

2. Sample sized used for the test set and the data provenance

Sample Size: The document does not explicitly state the exact sample size (number of subjects) used for the clinical investigation. ANSI/AAMI/ISO 81060-2:2013 typically requires a minimum of 85 subjects for full validation.
Data Provenance: Not specified in the provided text (e.g., country of origin). The study was a "clinical investigation" which implies it was prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth was established by "trained medical staff" using an "auscultation method" with a "calibrated sphygmomanometer."
The exact number of experts and their specific qualifications (e.g., medical doctors, nurses, with how much experience) are not detailed in this summary. The ANSI/AAMI/ISO 81060-2:2013 standard often requires multiple observers to mitigate bias.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for the clinical investigation results. For blood pressure validation, direct comparison to reference measurements from trained observers is the primary method, and the standard outlines protocols for this.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This study is for a blood pressure monitor, not an AI/ML-driven diagnostic device that relies on human readers interpreting images with or without AI assistance. The device directly measures blood pressure.

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

This is a standalone device that provides direct blood pressure readings. Its performance is measured independently against a reference standard (auscultation). So, in a sense, its "standalone" performance is what was evaluated. There is no "human-in-the-loop" interaction in the measurement process itself that would alter the device's reading.

7. The type of ground truth used

The ground truth was established by expert auscultation (manual blood pressure measurement by trained medical staff) using a calibrated sphygmomanometer. This is the gold standard for clinical validation of automated blood pressure devices.

8. The sample size for the training set

Not applicable. This device is a traditional blood pressure monitor, not an AI/ML device that requires a "training set" in the machine learning sense. Its design and algorithm are based on established oscillometric principles and engineering, not on learning from a large dataset.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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November 8, 2018

Omron Healthcare, Inc. % Ron Warren Senior Director, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110

Re: K182166

Trade/Device Name: Wrist Blood Pressure Monitor Model BP4350 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 9, 2018 Received: August 10, 2018

Dear Ron 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 vou, 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

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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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.

Image /page/1/Picture/7 description: The image shows the text "Shawn W. Forrest - A" in a simple, sans-serif font. The text is arranged vertically, with "Shawn W. Forrest -" on the first line and "A" on the second line. The background is plain white.

le. 0.9.2342.19200300.100.1.1=136

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182166

Device Name

Wrist Blood Pressure Monitor Model BP4350

Indications for Use (Describe)

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) SUMMARY

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: August 8, 2018

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Wrist Blood Pressure Monitor Model BP4350

Generic/Common Name:

Noninvasive blood pressure measurement system

Classification:

Class II per 21 CFR§870.1130

Product Code:

DXN

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PREDICATE DEVICE(S) [807.92(a)(3)]

The Wrist Blood Pressure Monitor Model BP4350 is substantially equivalent to the Omron BP652N (HEM-6300-Z) with APS Noninvasive Blood Pressure Measurement System (K142917).

DEVICE DESCRIPTION [807.92(a)(4)]

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INDICATIONS FOR USE [807.92(a)(5)]

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 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

The proposed BP4350 has similar technological characteristics as compared to the predicate BP652N device. Both devices are intended for home use and employ the oscillometric method for measuring blood pressure and pulse rate. Both devices have the same cuff pressure range of 0 to 299mmHg and pulse rate range of 40 to 180 beats/min. Both devices are intended for a wrist circumference range of 5.24 - 8.5 inches (13.5 -21.5cm). The accuracy of pressure reading is ±3mmHg for both devices, and accuracy of pulse rate is ±5% in both devices. There are minor differences between BP4350 and BP652N in functional features, such as new hypertension threshold (per new AHA guideline) for the hypertension indicator function, the Morning Averages feature, and the Cuff Wrap Guide. However, these last two features are included on previously cleared Omron blood pressure monitors, Model HEM-780N3 and HEM-6131, and these two devices are identified as reference devices in the Substantial Equivalence summary table below.

SUBSTANTIAL EQUIVALENCE

The proposed Indications for Use for BP4350 is substantially equivalent to the Indications for Use for the predicate device. Comparative testing demonstrated that the proposed device is equivalent to the predicate device with regard to measurement reproducibility of blood pressure and pulse rate 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. In addition, the differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, BP4350 is substantially equivalent to the predicate BP652N device as described in the Substantial Equivalence Summary, Table 5.1.

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Y

SUMMAR













510(k)

	Table 5.1: Substantial Equivalence Summary Table
	Proposed Device	Primary Predicate Device	Reference Device	Reference Device	SE Assessment to Predicate Device
Model Number	BP4350(HEM-6232T-Z)	BP652N(HEM-6300-Z)	HEM-780N3	HEM-6131	--
K number	--	K142917	K061822	K131742	--
CFR Classification	§870.1130	§870.1130	§870.1130	§870.1130	Identical
Class I/II/III	II	II	II	II	Identical
Product Code	DXN	DXN	DXN	DXN	Identical
Indications for Use	The device is a digital monitorintended for use in measuringblood pressure and pulse rate inadult patient population with wristcircumference ranging from5.3 inches to 8.5 inches (13.5cm to21.5cm).The device detects the appearanceof irregular heartbeats duringmeasurement and gives a warningsignal with readings.	The device is a digital monitorintended for use in measuringblood pressure and pulse rate inadult patient population with wristcircumference ranging from5 1/4 inches to 8 1/2 inches (13.5cmto 21.5cm).The device detects the appearanceof irregular heartbeats duringmeasurement and gives a warningsignal with readings.	The device is a digital monitorintended for use in measuringblood pressure and pulse rate inadult patient population with armcircumference ranging from9 inches to 17 inches (22cm to42cm).The device detects the appearanceof irregular heartbeats duringmeasurement and gives a warningsignal with readings.	The device is a digital monitorintended for use in measuringblood pressure and pulse rate inadult patient population with wristcircumference ranging from5 1/4 inches to 8 1/2 inches (13.5cmto 21.5cm).The device detects the appearanceof irregular heartbeats duringmeasurement and gives a warningsignal with readings.	Identical
Environment of Use	Home	Home	Home	Home	Identical
Patient Population	Adults	Adults	Adults	Adults	K182166Identical
Specifications
Measurement Method /Principal of Operation	Cuff oscillometric method.Identical to both predicates	Cuff oscillometric method.Identical to both predicates	Cuff oscillometric method	Cuff oscillometric method	Identical
Measurement Range	Cuff pressure range 0 to 299mmHgPulse Rate: 40 to 180 beats/min.	Pressure: 0 to 299mmHgPulse Rate: 40 to 180 beats/min.	Cuff pressure range 0 to 294mmHgPulse Rate: 40 to 180 beats/min.	Cuff pressure range 0 to 299mmHgPulse Rate: 40 to 180 beats/min.	Identical
Pressure Sensor	Semiconductor pressure sensor.	Semiconductor pressure sensor.	Capacitive pressure sensor	Semiconductor pressure sensor.	Identical
Applicable Cuff(Wrist Circumference)	13.5-21.5cm	13.5-21.5cm	22-42cm	13.5 - 21.5cm	Identical
Accuracy of PressureIndicator	Within +3mmHg	Within +3mmHg or 2% of reading	Within +3mmHg or 2% of reading	Within +3mmHg or 2% of reading	Identical
Accuracy of Pulse Rate	Within ±5% of reading	Within ±5% of reading	Within ±5% of reading	Within ±5% of reading	Identical
Inflation Method	Automatic inflation withpiezoelectric pump	Automatic inflation withpiezoelectric pump	Automatic inflation withpiezoelectric pump	Automatic inflation withpiezoelectric pump	Identical
Deflation Method	Automatic rapid deflation valve	Automatic rapid deflation valve	Automatic rapid deflation valve	Automatic rapid deflation valve	Identical
Display	LCD digital display	LCD digital display	LCD digital display	LCD digital display	Identical
Power Source	2 "AAA" batteries	2 "AAA" batteries	4 "AA" batteries	2 "AAA" batteries	Identical
Operating Conditions	10 to 40°C (50 to 104°F) 15 to90% RH (non-condensing) 800 to1060hPa	10 to 40°C (50 to 104°F) 15 to85%RH	10 to 40°C (50 to 104°F)30 to 85% RH	10 to 40°C (50 to 104°F)30 to 85%RH	Similar(Slightly changedto comply withIEC60601 1)
Table 5.1: Substantial Equivalence Table – Regulatory Information (cont.)
Storage Conditions	-20 to 60°C (-4 to 140°F)10 to 90% RH (non-condensing)	-20 to 60°C10 to 95%RH	-20 to 60°C (-4 to 140°F)10 to 90% RH (non-condensing)	-20 to 60°C (-4 to 140°F)10 to 95%RH (non-condensing)
Dimensions (mm)	91mm (W) x 13.4mm (D) ×63.4mm (H)	89mm (W) x 13mm (D) × 61mm(H)	131mm (W) x 155mm (D) x 84mm(H)	Approx. 78mm (W) x 21mm (D) x60mm (H) (without the wrist cuff)	Similar(Slightly changedto comply withIEC60601-1)
Weight	Approx. 90g (3.2 oz) (not includingbattery)	Approx. 80g (2 7/8 oz) (notincluding battery)	Approx. 420g (14.9 oz) (notincluding battery)	Approx. 101g (not includingbattery)	Similar, withproposed devicehaving slightlylargerdimensions
Features					Similar
Irregular Heart BeatDetection	Yes	Yes	Yes	Yes	Identical
Body MovementDetection	Yes	Yes	Yes	Yes	Identical
Heart Zone Indicator	Yes	Yes(Cleared with the name AdvancedPositioning System)	No	Yes	Identical(Exactly samespecification forpredicate is usedfor new device
Hypertension Indicator	Yes(Use 130/80 with "High" symbolbased on published 2017 AHAguideline)	Yes(Used 135/85 standard with bloodpressure level indicator)	No	Yes(Used 135/85 standard with bloodpressure level indicator)	Similar(Only thresholdis changed)
Morning Averages	Yes	No	Yes	No	Cleared underK061822 (Exactlysamespecification forK061822 is usedfor new device)
Cuff Wrap Guide	Yes	No	No	Yes	Cleared underK131742(HEM-6131)(Specification isidentical withK131742)

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510(k) SUMMARY

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PERFORMANCE DATA [807.92(b)]

All necessary bench and clinical testing was conducted on the Wrist Blood Pressure Monitor Model BP4350 to support a determination of substantial equivalence to the predicate device.

Nonclinical Testing Summary [807.92(b)(1)]:

The nonclinical, bench testing included:

. Comparative testing against the predicate BP652N
. Performance verification testing to confirm acceptable performance of device features and functions
Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents as may be required in home use environment

Other nonclinical safety testing included:

Biocompatibility testing of patient-contacting materials per ISO 10993-1 ● requirements
Evaluation of relevant electrical safety, electromagnetic compatibility and ● electrostatic discharge requirements per IEC60601 and 80601 requirements 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 the Wrist Blood Pressure Monitor Model BP4350 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Wrist Blood Pressure Monitor Model BP4350 does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse rate in a home use environment when compared to the predicate device.

Clinical Testing Summary [807.92(b)(2)]:

A clinical investigation was conducted with the objective of validating the accuracy of blood pressure measurements by BP4350 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 guideline per

ANSI/AAMI/ISO 81060-2:2013 Noninvasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type. The results demonstrated that BP4350 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 BP4350, it is concluded that the proposed device is safe and effective, and performs as safely and effectively as the legally marketed BP652N predicate device.

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510(k) SUMMARY

SUMMARY

BP4350 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 and the performance characteristics related to blood pressure 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 device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed BP4350 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).