The Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist.

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Device Description

Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irreqular heart beat symbol " is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X.

Based on the provided document, the device did not undergo specific clinical testing for its overall accuracy and performance for this particular submission (K141083). Instead, the submission relies on the "substantial equivalence" principle to predicate devices. Therefore, direct acceptance criteria and study data for this specific model as if it were a novel device are not present in the given text.

The document claims that the device's measurement algorithm and program codes from a predicate device (BP3BS1-3C) remain unchanged, and therefore its performance in terms of blood pressure measurement would be identical. This means the clinical performance data would refer to those predicate devices, not the BP3NU1-4X directly.

However, I can extract information relevant to the type of testing and standards that would typically apply to such a device, and how the manufacturer justifies not conducting new clinical trials for this specific model.

Acceptance Criteria and Study for Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X

Important Note: The provided document states that no new clinical testing was necessary for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X because its fundamental scientific technology, measurement algorithm, and program codes are identical to a predicate device (Model BP3BS1-3C). Therefore, the "reported device performance" in the table below reflects the performance expected based on the predicate device, or general expectations for such devices, rather than new, specific performance data for Model BP3NU1-4X itself.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Expected Performance (from relevant standards or predicate device)	Reported Device Performance (as justified in the submission)
Blood Pressure Measurement Accuracy	In accordance with ANSI/AAMI SP10: 2008 & AAMI / ANSI / IEC 80601-2-30:2009 for oscillometric blood pressure monitors (e.g., mean difference and standard deviation between device and reference measurements within specified limits).	Stated to be "identical with performance of the predicate device BP3BS1-3C" due to identical measurement algorithm and program codes. The predicate device would have demonstrated compliance with ANSI/AAMI SP10 standards.
Pulse Rate Measurement Accuracy	As per relevant standards for oscillometric blood pressure monitors.	Expected to be identical to the predicate device BP3BS1-3C.
Irregular Heartbeat Detection (IHD)	Ability to detect and provide a warning signal for irregular heartbeats.	Device "detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected."
Electrical Safety & EMC	Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and relevant EMC standards.	"Met all relevant requirements of the aforementioned tests" (EMC Test was conducted).
Mechanical & Environmental Performance	Withstanding specified storage, operating, vibration, drop, and life tests.	"Met all relevant requirements of the aforementioned tests" (Storage, Operating, Vibration, Drop, Life tests were conducted).
Software Validation	Compliance with FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern).	"Software validation was conducted in accordance with a moderate level of concern designation."

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

Clinical Performance Test Set: No new clinical test set was used for the BP3NU1-4X device itself, specifically for blood pressure measurement accuracy. The justification for substantial equivalence is based on the performance of a predicate device (BP3BS1-3C). The document does not specify the sample size or data provenance for the original clinical studies performed on the predicate device.
Non-Clinical Testing: The non-clinical tests (reliability, EMC) were conducted on the BP3NU1-4X device. The sample sizes for these engineering tests are not specified but are typically sufficient to demonstrate compliance with the respective standards.

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

Not applicable for the BP3NU1-4X directly, as new clinical testing was not performed. For the predicate device, clinical validation (e.g., against ANSI/AAMI SP10) would typically involve qualified clinicians taking reference measurements (e.g., auscultatory readings by trained observers) to establish ground truth. The document does not provide details on these experts for the predicate testing.

4. Adjudication method for the test set

Not applicable as new clinical testing was not performed for the BP3NU1-4X. In a typical clinical validation for a blood pressure monitor, multiple trained observers often take reference readings, and their agreement (or specific adjudication rules) would be used to establish the validated ground truth.

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

Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader intervention.

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

Yes, implicitly. The blood pressure measurement algorithm operates autonomously without human intervention during measurement. The justification for substantial equivalence relies on the standalone performance of this algorithm, which remains "unchanged" from the predicate device. The accuracy testing required by standards like ANSI/AAMI SP10 is a standalone performance evaluation of the device's measurement capabilities against a reference standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the blood pressure accuracy (referencing the predicate device's clinical validation), the ground truth would typically be established by simultaneous auscultatory measurements performed by trained human observers using a mercury sphygmomanometer or another validated reference device, following standardized protocols (e.g., specified by ANSI/AAMI SP10).
For non-clinical tests, ground truth is the specified engineering requirement or standard for the test (e.g., specific voltage levels for EMC, impact force for drop tests).

8. The sample size for the training set

Not applicable. This device is likely using a fixed algorithm based on established oscillometric principles, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" or development of the algorithm would have occurred during the initial design of the oscillometric method, likely incorporating physiological models and experimental data, but this is not disclosed as a separate dataset in this submission.

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

Not applicable for the same reasons as (8). Any data used for the development of the oscillometric algorithm would have been associated with reference measurements (e.g., auscultatory) to optimize the algorithm's accuracy, but this is part of the fundamental technology development, not a separate "training set" for an AI model in this context.

Summary

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

August 22, 2014

Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc., 55 Northern Boulevard, Suite 200 Great Neck, NY 11021

Re: K141083

Trade/Device Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 24, 2014 Received: July 25, 2014

Dear Ms. Goldstein-Falk:

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. Isting 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

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Page 2 - Ms. Susan D. Goldstein-Falk

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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.

Sincerelv vours

Mitchell Stein

forBram 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)

K141083

Device Name

Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X

Indications for Use (Describe)

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: K141083 .

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: April 25, 2014

Mr. Gerhard Frick Contact: Vice President of Technical and Service Microlife Intellectual Property GmbH. Switzerland Tel: +41 79 216 0070 E-Mail: gerhard.frick@microlife.ch

2. Name of the Device:

Mircolife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X

Regulation Number: 21 CFR Part 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Requlatory Class: II Product Code: DXN

3. Information for the 510(k) Cleared Device (Predicate Device):

a. Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C, K092456, Microlife Intellectual Property GmbH.

b. Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P, K120430, Microlife Intellectual Property GmbH

4. Device Description:

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5. Intended Use:

The Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist.

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

The subject BP3NU1-4X and the predicate device model BP3BS1-3C, use the same oscillometric method with the same fundamental scientific technology to determine the systolic and diastolic blood pressure and pulse rate. Wrist cuff is inflated automatically by pump and the pressures are transferred via tubing to a sensor in these two units.

They differ by the traffic light function, Blood Pressure Analyzer Software version, and MAM function. The traffic light function and MAM function are added to the subject device. But those differences do not affect the accuracy and normal use of this device because they use the same fundamental scientific technology . Therefore repeated clinical test in accordance with the standard ANSI/AAMI SP10 is not necessary, please refer to "Clinical Declaration of Identity" in EXHIBIT #9a.

The subject BP3NU1-4X and the predicate BP3MO1-3P both has traffic light function. And the traffic light function has no impact on the clinical accuracy in terms of blood pressure detection.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.

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The following testing was conducted:

a. Reliability Test Storage test
b. Reliability Test Operating test
c. Reliability Test Vibration test
d. Reliability Test Drop test
e. Reliability Test Life test
EMC Test ﺖ

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

The subject device Model BP3NU1-4X is from the technical point of view, identical to the predicate blood pressure monitor. Moreover, the measurement algorithm and its program codes of BP3BS1-3C remain unchanged. The fundamental scientific technology of the modified BP3BS1-3C device is the same as the predicate device BP3NU1-4X. Therefore the performance of the BP3NU1-4X in terms of blood pressure measurement would be identical with performance of the predicate device BP3BS1-3C. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject device BP3NU1-4X is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.

9. Software information:

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

10. Conclusions:

We have demonstrated that there are no significant differences between the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X and the predicate devices, Model BP3BS1-3C and Model BP3MO1-3P, in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and the ANSI/AAMI Voluntary Standard, SP10: 2008, AAMI / ANSI / IEC 80601-2-30:2009.

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).