The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.

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

The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

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 Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert 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 can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

The device detects the appearance of irregular heartbeat during measurement, and the symbol " " "is displayed after the measurement. In addition, the device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Standard/Protocol)	Reported Device Performance
Blood Pressure Accuracy (Systolic & Diastolic)	ANSI/AAMI/ISO 81060-2:2009 validation criteria (and AAMI SP10 protocol)	Satisfied the validation criterion of the AAMI SP10 protocol.
Accuracy in Pregnant Patients (including preeclampsia)	ANSI/AAMI/ISO 81060-2:2009 protocol	Device "can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia."
Irregular Heartbeat Detection	(No specific numerical criterion provided, just detection functionality)	Detects the appearance of irregular heartbeat and displays a symbol/warning.
Electrical, Mechanical, Environmental Performance	FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND	Met all relevant requirements of the aforementioned tests (Reliability, EMC, IEC 60601-1 Safety).
Software Validation	FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern) and FDA September 1999 "Guidance for Off-The-Shelf Software Use in Medical Devices"	Software validation conducted in accordance with these guidances.

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

The document mentions clinical validation reports but does not explicitly state the sample size used for the clinical test set.

Sample Size (Test Set): Not explicitly stated in the provided text for the clinical validation or other tests.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical validation report," implying prospective clinical testing.

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

This information is not provided in the text. The document refers to the ANSI/AAMI/ISO 81060-2:2009 and AAMI SP10 protocols for blood pressure measurement validation, which typically involve a specific number of observers (experts) for reference measurements. However, the exact number and qualifications of these experts are not detailed in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the text. The AAMI protocols typically have specific requirements for how reference measurements are compared and adjudicated, but the summary does not elaborate on this for this specific study.

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

There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. This device is an automatic digital blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool.

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

Yes, the primary clinical testing described is a standalone validation of the device's accuracy in measuring blood pressure and detecting irregular heartbeats, according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This protocol evaluates the device's performance without human interpretation or assistance beyond the typical operation of a blood pressure monitor.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the blood pressure accuracy validation, the ground truth would be established through reference measurements taken by trained observers using a calibrated sphygmomanometer (or similar reference method) according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This often involves simultaneous or nearly simultaneous measurements with the test device and a highly accurate reference method. For "irregular heartbeat detection," the ground truth would likely be established by a physician's or cardiologist's diagnosis using an ECG or other standard diagnostic methods.

8. The Sample Size for the Training Set

This device is based on the "oscillometric method," which is a well-known and established technique for blood pressure measurement. While software is involved in analyzing the signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern sense (i.e., for deep learning or AI). The software algorithm is described as using the "well-known oscillometric method." Therefore, the concept of a separate "training set" for an AI model, as typically understood, does not apply in this context.

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

As explained under point 8, the concept of a "training set" for an AI model with a distinct ground truth establishment method is not applicable to this device. The oscillometric method itself is based on established physiological principles and signal analysis techniques, not a data-driven machine learning training process described in the document.

Summary

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K140572

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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: K 140572

Submitter's Identification: 1.

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

Date Summary Prepared: May 15, 2014

Contact: Mr. Gerhard Frick 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:

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R)

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

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

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471, Microlife Intellectual Property GmbH.

b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1), K073198, Microlife Intellectual Property GmbH.

Device Description: 4.

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and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

5. Intended Use:

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

The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

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

The modified subject device model BP3MW1-4X(R) and the predicate device model BP3MC1-PC use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically, deflation rate is controlled by one factory set exhaust valve and the deflation pressures are transferred via tubing to one (or two) sensor(s).

They differ by the early preeclampsia function. AM/PM average function and the operating button. The button of the predicate device is a traditional button, and the buttons of the subject device are touch pad "buttons" which operate similarly to traditional buttons, but require only a light touch of the finger to operate.

Although the cuff used with the subject BP3MW1-4X(R) is changed to a WRR conical cuff, it is the same cuff as cleared in BP3AP1-3E. K111652. The subject device now includes an early pre-eclampsia function. validated according to the ANSI/AAMI/ISO 81060-2:2009 protocol. The

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addition of the early pre-eclampsia function to the subject device does not affect the accuracy and normal use. The other differences also do not affect the accuracy and normal use of this device based on the clinical declaration of identity and clinical testing comparing different functions.

The modified device model BP3MW1-4X(R) uses the same oscillometric method as the predicate device WatchBP Home(BP3MX1-1). The have the same AM/PM average function. Based upon the aforementioned information, the two devices are substantially equivalent.

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

Testing information demonstrating substantial equivalence to the predicate device and safety and effectiveness of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) 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.

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
f. EMC Test
g. IEC 60601-1 Safety Test

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 Upper Arm Automatic Digital Blood Pressure Monitor. Model BP3MW1-4X(R) tested met all relevant requirements of the aforementioned tests.

Discussion of Clinical Tests Performed: 8.

Included in the submission was a clinical validation report of an automated Microlife blood pressure measurement device used during pregnancy and preeclampsia according to the ANSI/AAMI/ISO 81060-2:2009 protocol. The test results satisfied the validation criterion of the AAMI SP10 protocol.

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". In addition, since our device requires the use of off-the-shelf software to operate the PC-link function, we adhered to the FDA September 1999 document "Guidance for Off-The-Shelf Software Use in Medical Devices".

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10. Conclusions:

We have demonstrated that there are no significant differences between the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-

4X(R) and the predicate devices, Model BP3MC1-PC and Model WatchBP Home(BP3MX1-1), 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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July 2, 2014

Microlife Intellectual Property Gmbh, Switzerland % Susan Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021

K140572 Re:

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (Model BP3MW1-4X (R)) Regulation Number: 21 CFR 870.1130 Regulation Name: Auto-Inflation Oscillometric Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: May 19, 2014 Received: May 21, 2014

Dear Susan 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, 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

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Page 2 - Susan Goldstein-Falk

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours,

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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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K140572

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drun Administration

Indications for Use

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

510(k) Number (if known) K140572

Device Name

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R)

Indications for Use (Describe)

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

The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

2 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) (Signeture)

FDA 2014.07.02
05 -04'00'

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

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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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

BC Bebine Berriner (20) +40-6740

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).