The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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 Upper Arm Automatic Blood Pressure Monitor, Model BP3MC1- PC is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive 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 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 Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

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 BP3MC1-PC, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP10-2002 "National Standard for Manual. Electronic or Automated Sphygmanometers"	The BP3MC1-PC met all relevant requirements of this standard, as applicable to the modified device.

Note: The document explicitly states that "All relevant sections were addressed and testing conducted." and that the device "met all relevant requirements." However, specific numerical performance metrics (e.g., mean difference, standard deviation) for accuracy against the standard are not provided in this summary. The summary focuses on compliance with the standard rather than detailed performance numbers. Also, the document indicates that "Repeat testing was not performed for the modified device, as clinical testing results were not affected by the changes to the modified device."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "testing was conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'" and that "ANSI/AAMI SP10-2002" testing was performed. These standards typically specify patient recruitment and testing protocols, but the exact number of subjects or measurements is not provided in this summary.
Data Provenance: Not explicitly stated. It is implied that the clinical testing was conducted in a manner consistent with FDA and AAMI standards, which usually involve prospective studies for device validation. The country of origin is not mentioned.

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

This information is not provided in the document. For blood pressure monitors, ground truth often involves comparison with a reference method (e.g., auscultation by trained observers), but the specifics of who performed this or their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
Effect Size: Not applicable.

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

Yes, a standalone performance evaluation was performed. The device itself is an automated blood pressure monitor that uses an algorithm ("oscillometric method") to determine systolic and diastolic blood pressure and pulse rate. The clinical testing against ANSI/AAMI SP10-2002 evaluates the accuracy of this algorithm as embodied in the device.

7. The Type of Ground Truth Used

The ground truth used for clinical testing would typically be established by a reference method, most commonly auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated device, as per the ANSI/AAMI SP10 standard for non-invasive blood pressure monitors. This acts as the "gold standard" against which the oscillometric device's readings are compared. The document states the device's method is "similar to the auscultatory method."

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way for these types of oscillometric blood pressure devices as it would be for machine learning or AI models developed directly from data. The "training" for such a device involves the development and calibration of the oscillometric algorithm itself, which is based on established physiological principles and extensive prior engineering, rather than a distinct "training set" of patient data as understood in modern AI.

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

Not applicable in the context of a "training set" for a continually learning AI model. The oscillometric algorithm's development and internal validation would rely on established physiological models of cuff pressure changes in relation to arterial pressure, likely refined through engineering tests and initial clinical studies, rather than a dedicated "training set" with established ground truth listed in this type of summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text "Exhibit #1" in bold font on the bottom left. To the right of the text is the fraction "1/4" written in a handwritten style. The text and fraction are the only elements in the image. The background is white.

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 5I0(k) number is: K061471

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland

Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland

Date Summary Prepared: May 25, 2006

Contact: Mr. Gerhard Frick

2. Name of the Device:

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1- PC.

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

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3BT0-AP, K#041411.
b. Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP3BU1-5, K#021305.

Device Description: র্ব

{1}------------------------------------------------

ട്. Intended Use:

The Microlife Upper Arm Blood Pressure Monitor, Model BP3MC1-PC is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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 Device (Predicate Device):

Both devices use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. An upper arm cuff is inflated automatically; deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. Moreover both devices have a pulse irregular heartbeat detection (IHD) function.

However the difference between BP3MC1- PC and the predicate devices are as follows:

1. MAM function:

BP3MC1- PC contains a switchable average mode in which the device automatically repeats 3 individual measurements cycles, each with a rest time of 15 seconds in between. After that the average of these 3 individual measurements is calculated and shown on the display. By certain key operation the user can access the individual results of the measurements.

2. PC function:

{2}------------------------------------------------

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

Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model BP3MC1- PC 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. Moreover

The following testing was conducted:

a. Reliability Test Storage test
b. Reliability Test Operating test
Reliability Test Vibration test C.
d. Reliability Test Drop test
e. Reliability Test Life test
f. EMC Test
g. PC-Link Software BPA Test Report

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 the Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP3MC1- PC tested met all relevant requirements of the aforementioned tests.

Discussion of Clinical Tests Performed: 8.

ANSI/AAMI SP10-2002 "National Standard for Manual. Electronic or Automated Sphygmanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP3MC1-PC met all relevant requirements of this standard, as applicable to our modified device. Repeat testing was not performed for the modified device, as clinical testing results were not affected by the changes to the modified device.

9. Software information:

In keeping with current FDA policy on software level of concern, the modified device is consistent with a moderate level of concern. We provided software documentation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices ". Moreover, the subject device requires the use of off-the-shelf software to operate the PC-link function, and we met all required elements as outlined in FDA's "Off the Shelf Software Guidance Document".

{3}------------------------------------------------

4/4

10. Conclusions:

We have demonstrated that the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U, is as safe and effective as our predicate devices, the Microlife Wrist Watch Blood Pressure Monitor, Model BP3BTO-AP, and the Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP3BU1-5, based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and our "Risk Analysis", as supplied with this submission.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2006

Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K061471

Trade Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 16, 2006 Received: August 17, 2006

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{5}------------------------------------------------

Page 2 – Ms. Susan D. Goldstein-Falk

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B.Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Exhibit# B

Indications for Use

1 Page -

510(k) Number (if known): ___K061471

Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC

Indications For Use:

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC i he Microlic oppor Alm Ratom the systolic and diastolic blood pressure and pulse rate of is a dewoo intended to mag a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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 The device ban be assure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Ammerman

ivision Sign-Off) Division of Cardlovascular Devices 510(k) Number k

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).