The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U with semiconductor pressure sensor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist.

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

The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic semiconductor pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market called the "oscillometric method". 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

The provided 510(k) summary for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U, focuses on demonstrating substantial equivalence to a predicate device (Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, K#040002) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the modified device. The key takeaway is that the clinical performance of the modified device is addressed by relying on the predicate device's compliance with the ANSI/AAMI SP10-2002 standard.

Here's an attempt to extract and synthesize the requested information based on the provided text, noting where information is not explicitly available for the modified device's clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Reference)
Compliance with ANSI/AAMI SP10-2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" for determining systolic and diastolic blood pressure and pulse rate (specifically, "All relevant sections were addressed and testing conducted").	The predicate device (Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1) met all relevant requirements of this standard. The modified device (BP3AX1-4U) is stated to also meet these requirements as clinical testing results were not affected by the changes to the modified device (which was the addition of a PC-link function).
Electrical, Mechanical and Environmental Performance Requirements (as outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND).	The Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP3AX1-4U met all relevant requirements of the conducted tests (Reliability Tests - Storage, Operating, Vibration, Drop, Life; EMC Test; PC-link software BPA Test).

Note: The document explicitly states: "Repeat testing was not performed for the modified device, as clinical testing results were not affected by the changes to the modified device." This means the reported clinical performance refers to the predicate device's performance against the ANSI/AAMI SP10-2002 standard. Specific numerical performance metrics (e.g., mean difference, standard deviation) for blood pressure accuracy as per the AAMI standard are not provided in this summary for either the predicate or the modified device.

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

Sample Size for Clinical Performance (Predicate Device): Not explicitly stated in the provided text for the clinical study that proved compliance with ANSI/AAMI SP10-2002.
Data Provenance: Not explicitly stated for any clinical study. The summary focuses on non-clinical and technical tests for the modified device, and refers to clinical testing performed on the predicate device.

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

For Clinical Performance (Predicate Device): Not specified in the provided text. The ANSI/AAMI SP10 standard typically involves comparison against mercury sphygmomanometry performed by trained observers, but the number and qualifications of these observers are not detailed here.
For Non-Clinical Tests (Modified Device): No experts were involved in establishing ground truth for the non-clinical and technical tests (reliability, EMC, PC-link software).

4. Adjudication Method for the Test Set

For Clinical Performance (Predicate Device): Not specified. Standard practice for AAMI SP10 validation involves specific procedures for comparing automated readings against auscultatory readings, often involving multiple observers, but the adjudication method (e.g., 2+1, 3+1) is not explicitly detailed.
For Non-Clinical Tests (Modified Device): Not applicable. These tests are objective pass/fail based on engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed. This type of study is not relevant to a blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool for interpretation by human readers.

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

Yes, in essence. The blood pressure monitor itself is a standalone device that provides measurements via its internal algorithm. The "oscillometric method" is an algorithm. The clinical testing of the predicate device against the ANSI/AAMI SP10-2002 standard essentially represents a standalone performance evaluation of the device's algorithm against a recognized standard reference method (auscultatory measurement).

7. The Type of Ground Truth Used

For Clinical Performance (Predicate Device): The ground truth for blood pressure measurement against the ANSI/AAMI SP10-2002 standard would typically be auscultatory blood pressure measurements performed by trained observers using mercury sphygmomanometers. This is generally considered an "expert consensus" or "reference standard" method in this context.
For Non-Clinical Tests (Modified Device): The ground truths were engineering specifications and functional requirements (e.g., successful data transfer for PC-link).

8. The Sample Size for the Training Set

Not applicable / Not specified. The device uses the "oscillometric method," which is a well-known, established algorithm, not typically "trained" in the sense of modern machine learning models with large datasets. If there were any algorithmic refinements based on data, the size of that data is not mentioned in the summary.

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

Not applicable / Not specified. As noted above, the "oscillometric method" is a long-established technique. The summary does not describe a machine learning training process.

Summary

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K061403
P 1\3

JUN 1 4 2006

Exhibit #1

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 510(k) number is:

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland

Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland

Date Summary Prepared: May 18, 2006

Contact: Mr. Gerhard Frick

2. Name of the Device:

Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U

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

Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, K#040002.

4. Device Description:

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ട. Intended Use:

Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist.

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. Wrist 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. They use semiconductor pressure sensor instead of capacitive pressure sensor to translate the pressure variations to electrical signals that can be interpreted by an integrating circuit. Moreover both devices have a MAM function.

The difference between BP3AX1-4U and the predicate device is the addition of a PC function. 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.

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 BP3AX1-4U 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 StorageTest
b. Reliability Test - Operating Test

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Reliability Test Vibration Test ﻥ
d. Reliability Test Drop Test
e. Reliability Test Life Test
f. EMC Test
g. PC-link software BPA 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 the Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP3AX1-4U tested met all relevant requirements of the aforementioned tests.

061403 3 3

8. Discussion of Clinical Tests Performed:

ANSI/AAMI SP10-2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" testing was performed on our predicate device. All relevant sections were addressed and testing conducted. The BP3AX1-4U 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".

10. Conclusions:

We have demonstrated that the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U, is as safe and effective as our predicate, the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 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.

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2006

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

Re: K061403

Trade Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AXI-4U Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN Dated: May 18, 2006 Received: May 19, 2006

Dear Ms. Goldstein-Falk

This letter corrects our substantially equivalent letter of June 14, 2006.

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 (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 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.

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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 requirements of the Free any 1 outs with all the Act's requirements, including, but not I coord agencies: - 1 ou nnd listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practice rollicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section This locer will and w your will be 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), If you court opening at (240) 276-0120. Also, please note the preparation entitled, "Misbranding by reference to premarket notification" (21CFR Part 16 guallon chittion, "Miboranang of a virtuation on your responsibilities under the Act 807.27). Touring obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit# B

Indications for Use

Page	1 of 1
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510(k) Number (if known):	K061403
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Device Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U

Indications For Use:

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/ummmma

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).