Wrist Blood Pressure Monitor Model BP4350

K182166 · Omron Healthcare, Inc. · DXN · Nov 8, 2018 · Cardiovascular

Device Facts

• Record ID: K182166
• Device Name: Wrist Blood Pressure Monitor Model BP4350
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 Story

Battery-powered, automatic, wrist-worn oscillometric blood pressure monitor for OTC home use. Input: pulse waveform data captured during cuff inflation via piezoelectric pump. Processing: software analyzes waveform to determine systolic/diastolic pressure and pulse rate; detects irregular heartbeats (intervals differing >25% from average); utilizes accelerometer-based Heart Zone Indicator to ensure correct wrist-to-heart height. Output: LCD display of BP, pulse, irregular heartbeat symbol, and 'HIGH' indicator (if >130/80 mmHg). Optional smartphone app 'Omron connect' provides trend graphs; no diagnostic/medical decision-making function. Benefits: enables home monitoring of BP and pulse, facilitating hypertension management.

Clinical Evidence

Clinical investigation conducted per ANSI/AAMI/ISO 81060-2:2013. Accuracy of BP4350 oscillometric measurements validated against auscultation method using calibrated sphygmomanometer by trained medical staff. Results demonstrated equivalence to auscultation and conformance with standard requirements.

Technological Characteristics

Oscillometric measurement; semiconductor pressure sensor; piezoelectric pump; automatic rapid deflation valve. Wrist circumference 13.5-21.5cm. Powered by 2 AAA batteries. Features: Heart Zone Indicator (accelerometer), irregular heartbeat detection, hypertension indicator, Bluetooth connectivity for optional app. Biocompatibility per ISO 10993-1; electrical safety/EMC per IEC60601/80601.

Indications for Use

Indicated for adult patients with wrist circumference 13.5cm to 21.5cm for measurement of blood pressure and pulse rate; includes irregular heartbeat detection.

Regulatory Classification

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.

Predicate Devices

• Omron BP652N (HEM-6300-Z) with APS Noninvasive Blood Pressure Measurement System (K142917)

Reference Devices

• HEM-780N3 (K061822)
• HEM-6131 (K131742)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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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### 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: [phone] FAX: [phone]

### Contact Person:

Ronald S. Warren Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] FAX: [phone]

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)]

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.

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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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| | Table 5.1: Substantial Equivalence Summary Table | | | | |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | Proposed Device | Primary Predicate Device | Reference Device | Reference Device | SE Assessment to Predicate Device |
| Model Number | BP4350<br>(HEM-6232T-Z) | BP652N<br>(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 monitor<br>intended for use in measuring<br>blood pressure and pulse rate in<br>adult patient population with wrist<br>circumference ranging from<br>5.3 inches to 8.5 inches (13.5cm to<br>21.5cm).<br>The device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a warning<br>signal with readings. | The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate in<br>adult patient population with wrist<br>circumference ranging from<br>5 1/4 inches to 8 1/2 inches (13.5cm<br>to 21.5cm).<br>The device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a warning<br>signal with readings. | The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate in<br>adult patient population with arm<br>circumference ranging from<br>9 inches to 17 inches (22cm to<br>42cm).<br>The device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a warning<br>signal with readings. | The device is a digital monitor<br>intended for use in measuring<br>blood pressure and pulse rate in<br>adult patient population with wrist<br>circumference ranging from<br>5 1/4 inches to 8 1/2 inches (13.5cm<br>to 21.5cm).<br>The device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a warning<br>signal with readings. | Identical |
| Environment of Use | Home | Home | Home | Home | Identical |
| Patient Population | Adults | Adults | Adults | Adults | K182166<br>Identical |
| Specifications | | | | | |
| Measurement Method /<br>Principal of Operation | Cuff oscillometric method.<br>Identical to both predicates | Cuff oscillometric method.<br>Identical to both predicates | Cuff oscillometric method | Cuff oscillometric method | Identical |
| Measurement Range | Cuff pressure range 0 to 299mmHg<br>Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299mmHg<br>Pulse Rate: 40 to 180 beats/min. | Cuff pressure range 0 to 294mmHg<br>Pulse Rate: 40 to 180 beats/min. | Cuff pressure range 0 to 299mmHg<br>Pulse Rate: 40 to 180 beats/min. | Identical |
| Pressure Sensor | Semiconductor pressure sensor. | Semiconductor pressure sensor. | Capacitive pressure sensor | Semiconductor pressure sensor. | Identical |
| Applicable Cuff<br>(Wrist Circumference) | 13.5-21.5cm | 13.5-21.5cm | 22-42cm | 13.5 - 21.5cm | Identical |
| Accuracy of Pressure<br>Indicator | 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 with<br>piezoelectric pump | Automatic inflation with<br>piezoelectric pump | Automatic inflation with<br>piezoelectric pump | Automatic inflation with<br>piezoelectric 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 to<br>90% RH (non-condensing) 800 to<br>1060hPa | 10 to 40°C (50 to 104°F) 15 to<br>85%RH | 10 to 40°C (50 to 104°F)<br>30 to 85% RH | 10 to 40°C (50 to 104°F)<br>30 to 85%RH | Similar<br>(Slightly changed<br>to comply with<br>IEC60601 1) |
| Table 5.1: Substantial Equivalence Table – Regulatory Information (cont.) | | | | | |
| Storage Conditions | -20 to 60°C (-4 to 140°F)<br>10 to 90% RH (non-condensing) | -20 to 60°C<br>10 to 95%RH | -20 to 60°C (-4 to 140°F)<br>10 to 90% RH (non-condensing) | -20 to 60°C (-4 to 140°F)<br>10 to 95%RH (non-condensing) | |
| Dimensions (mm) | 91mm (W) x 13.4mm (D) ×<br>63.4mm (H) | 89mm (W) x 13mm (D) × 61mm<br>(H) | 131mm (W) x 155mm (D) x 84mm<br>(H) | Approx. 78mm (W) x 21mm (D) x<br>60mm (H) (without the wrist cuff) | Similar<br>(Slightly changed<br>to comply with<br>IEC60601-1) |
| Weight | Approx. 90g (3.2 oz) (not including<br>battery) | Approx. 80g (2 7/8 oz) (not<br>including battery) | Approx. 420g (14.9 oz) (not<br>including battery) | Approx. 101g (not including<br>battery) | Similar, with<br>proposed device<br>having slightly<br>larger<br>dimensions |
| Features | | | | | Similar |
| Irregular Heart Beat<br>Detection | Yes | Yes | Yes | Yes | Identical |
| Body Movement<br>Detection | Yes | Yes | Yes | Yes | Identical |
| Heart Zone Indicator | Yes | Yes<br>(Cleared with the name Advanced<br>Positioning System) | No | Yes | Identical<br>(Exactly same<br>specification for<br>predicate is used<br>for new device |
| Hypertension Indicator | Yes<br>(Use 130/80 with "High" symbol<br>based on published 2017 AHA<br>guideline) | Yes<br>(Used 135/85 standard with blood<br>pressure level indicator) | No | Yes<br>(Used 135/85 standard with blood<br>pressure level indicator) | Similar<br>(Only threshold<br>is changed) |
| Morning Averages | Yes | No | Yes | No | Cleared under<br>K061822 (Exactly<br>same<br>specification for<br>K061822 is used<br>for new device) |
| Cuff Wrap Guide | Yes | No | No | Yes | Cleared under<br>K131742<br>(HEM-6131)<br>(Specification is<br>identical with<br>K131742) |

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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.