The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches (22cm to 42cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Description

The Evolv Model BP7000 Upper Arm Blood Pressure Monitor ("BP7000") is a battery powered automatic non-invasive blood pressure system intended for home use. The device inflates a cuff with an integral controllable pump, then deflates the cuff via an electric valve. During inflation the 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 40 to 180 beats/min. BP7000 is intended to be used for arms ranging from 22 to 42cm in circumference. The cuff is not replaceable. The device also detects the appearance of irregular heartbeats during measurement. 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 arm cuff to the upper arm, powering on/off the system, starting or stopping the BP and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP7000 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, BP7000 does not connect with other collateral devices.

AI/ML Overview

The provided text describes the 510(k) submission for the Omron Evolv Model BP7000 Upper Arm Blood Pressure Monitor. This device is a non-invasive blood pressure measurement system, and the submission focuses on demonstrating its substantial equivalence to a predicate device (Omron HEM-7320) rather than proving performance against specific acceptance criteria for an AI/ML powered device.

Therefore, many of the requested details regarding AI/ML study methodologies (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this traditional medical device submission.

However, I can extract the relevant information regarding the device's performance and the clinical testing that was conducted.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Study for Omron Evolv Model BP7000 Upper Arm Blood Pressure Monitor

This submission demonstrates substantial equivalence of a traditional blood pressure monitor to a predicate device, not the performance of an AI/ML algorithm. As such, many of the requested AI/ML specific criteria are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device and meeting established industry standards for blood pressure monitors. The document mentions an accuracy claim for both the proposed and predicate devices.

Feature/Metric	Acceptance Criteria (Implied/Stated)	Reported Device Performance (BP7000)
Blood Pressure Accuracy	±3mmHg (Same as predicate device)	Confirmed (Comparison testing demonstrated equivalence to predicate; Clinical investigation found it performed equivalently to auscultation)
Pulse Rate Accuracy	±5% (Same as predicate device)	Confirmed (Comparison testing demonstrated equivalence to predicate)
Cuff Pressure Range	0 to 299mmHg (Same as predicate device)	0 to 299mmHg
Pulse Rate Range	40 to 180 beats/min (Same as predicate device)	40 to 180 beats/min
Arm Circumference Range	22cm to 42cm (Same as predicate device)	22cm to 42cm
Irregular Heartbeat Detection	Detects and gives warning signal (Same as predicate device)	Detects and gives warning signal
Equivalence to Predicate	Substantially equivalent in safety and effectiveness	Determined to be substantially equivalent (Based on nonclinical and clinical tests)
Cleaning Performance	Retains performance when cuff is exposed to surfactants	Confirmed by cleaning verification testing
Usability	Acceptable performance in simulated home use environment	Confirmed by usability testing
Biocompatibility	Compliant with ISO 10993-1 requirements	Confirmed by biocompatibility testing
Electrical Safety, EMC, ESD	Complies with relevant requirements	Confirmed by testing
Software Verification/Validation	Complies with relevant requirements	Confirmed by testing

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

Test Set Sample Size: The document does not explicitly state the exact sample size for the clinical investigation. It mentions "a clinical investigation" to validate accuracy. For non-clinical bench testing, it refers to "comparative blood pressure and pulse rate testing to the predicate device" and "performance verification testing," but no specific sample numbers are provided.
Data Provenance: Not explicitly stated regarding country of origin. The clinical investigation was for "validating the accuracy... as compared to an auscultation method." It does not specify if it was retrospective or prospective, but clinical investigations for device validation are typically prospective studies.

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

Number of Experts: Not explicitly stated. The clinical investigation compared the device's accuracy "to an auscultation method using a calibrated sphygmomanometer by trained medical staff."
Qualifications of Experts: "Trained medical staff." No further details on their specific qualifications or experience level (e.g., radiologist with X years of experience) are provided as this is not an imaging device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not stated. The comparison was to an auscultation method performed by medical staff, implying a direct comparison rather than an expert consensus adjudication process typically seen in image interpretation studies.

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

MRMC Study: Not applicable. This is a blood pressure monitor, not an AI-powered diagnostic tool requiring human reader studies.

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

Standalone Performance: The device itself performs the measurement and provides readings. The "clinical investigation" effectively evaluates its "standalone" performance against a reference standard (auscultation). The direct comparison was of the device's measured blood pressure values against the auscultation readings.

7. The Type of Ground Truth Used

Ground Truth: For the clinical investigation, the ground truth was based on the auscultation method using a calibrated sphygmomanometer performed by trained medical staff. This serves as the clinical reference standard.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a traditional blood pressure monitor, not an AI/ML algorithm that undergoes a distinct "training" phase with a specified dataset. Its internal algorithm for oscillometric measurement is pre-defined.

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

Ground Truth Establishment for Training Set: Not applicable. As stated above, this is not an AI/ML device in the context of "training data." The device's underlying algorithm for converting oscillometric data to blood pressure readings is based on established physiological principles and engineering design, not on a machine learning training process with a labeled dataset.

Summary

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

November 22, 2016

Omron Healthcare, Inc. % Ronald Warren Senior Director, Regulatory Affairs Experien Group 755 N. Mathilda Ave. Suite 100 Sunnyvale, California 94085

Re: K162092

Trade/Device Name: Evolv Model Bp7000 Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 11, 2016 Received: October 13, 2016

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. 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.

Sincerel

Mark Jellman
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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Indications for Use

510(k) Number (if known) K162092

Device Name Evolv Model BP7000 Upper Arm Blood Pressure Monitor

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY ...

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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OMRON EVOLV MODEL BP7000 UPPER ARM BLOOD PRESSURE MONITOR 510(k) SUMMARY

510(k) Notification K162092

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 7, 2016

DEVICE INFORMATION

Trade Name:

Evolv Model BP7000 Upper Arm Blood Pressure Monitor

Generic/Common Name:

Noninvasive blood pressure measurement system

Classification:

Class II per 21CFR870.1130

Product Code: DXN

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PREDICATE DEVICE(S)

The Evolv Model BP7000 Upper Arm Blood Pressure Monitor is substantially equivalent to the Omron HEM-7320 Noninvasive blood pressure measurement system (K133383).

DEVICE DESCRIPTION

BP7000 is intended to be used for arms ranging from 22 to 42cm in circumference. The cuff is not replaceable. The device also detects the appearance of irregular heartbeats during measurement. 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 arm cuff to the upper arm, powering on/off the system, starting or stopping the BP and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP7000 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, BP7000 does not connect with other collateral devices.

INDICATIONS FOR USE

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22cm to 42cm). 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

The proposed BP7000 has similar technological characteristics as compared to the predicate HEM-7320 device. Both devices are intended for home use and employ the cuff 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 is 40 to 180 beats/min. Both devices are intended for an arm circumference range of 22 to 42mm. The accuracy of pressure reading is ±3mmHg for both devices, and accuracy of pulse rate is ±5% in both devices. There are minor difference between BP7000 and HEM-7320 but these relate to convenience factors for home use. The cuff and display for BP7000 are provided in a one-piece configuration, while there is a separate cuff

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OMRON EVOLV MODEL BP7000 UPPER ARM BLOOD PRESSURE MONITOR 510(k) SUMMARY

and stand-alone desk top display for HEM-7320. BP7000 is battery powered while HEM-7320 is battery powered or AC powered. HEM-7320 has the option to store BP readings for up to two users. BP7000 stores data for one user. BP7000 has slightly smaller dimensions as weighs slightly less than HEM7320. HEM-7320 cuff can be deflated with automatic pressure release or controlled deflation settings. BP7000 cuff is deflated with automatic pressure release only.

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate device is substantially equivalent to the proposed indications for use for BP7000. 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. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, BP7000 is substantially equivalent to the predicate HEM-7320 device.

PERFORMANCE DATA [807.92(b)]

All necessary bench and clinical testing was conducted on BP7000 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 BP7000 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
o Software verification and validation

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of BP7000 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that BP7000 does not raise new questions of safety or effectiveness for measurement of blood pressure and pulse in a home use environment when compared to the predicate device.

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OMRON EVOLV MODEL BP7000 UPPER ARM BLOOD PRESSURE MONITOR 510(k) SUMMARY

Clinical Testing Summary:

A clinical investigation was conducted with the objective of validating the accuracy of blood pressure measurements by BP7000 based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. The results demonstrated that BP7000 performed equivalently to the auscultation method.

Conclusions

Based on the results from the nonclinical and clinical tests performed in support of BP7000, it is concluded that that the proposed device is safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.

SUMMARY

BP7000 and HEM-7320 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 new issues of safety or effectiveness. As such, the proposed BP7000 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).