The Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U 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.

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 BP3BU1-4U 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 text describes a 510(k) premarket notification for a blood pressure monitor and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML-based medical devices or comparative effectiveness studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical and some clinical aspects, but not in the way an AI-based device's performance would be evaluated.

However, based on the information provided, here's an attempt to extract and infer relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the ANSI/AAMI SP10-2002 National Standard for Manual, Electronic or Automated Sphygmomanometers. This standard would define the acceptance criteria for blood pressure measurement accuracy. While the specific numerical criteria are not detailed in the provided text, typically these standards involve criteria for mean difference and standard deviation between the test device and a reference measurement.

Acceptance Criteria (Inferred from ANSI/AAMI SP10-2002)	Reported Device Performance
Mean difference between device and reference for systolic blood pressure (SBP) ≤ 5 mmHg	"BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported)
Standard deviation of difference between device and reference for SBP ≤ 8 mmHg	"BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported)
Mean difference between device and reference for diastolic blood pressure (DBP) ≤ 5 mmHg	"BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported)
Standard deviation of difference between device and reference for DBP ≤ 8 mmHg	"BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported)

Important Note: The document 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 performance data provided is for the predicate device (BP3BU1-5), not the new device (BP3BU1-4U), and the assumption is that the modification (addition of PC-link function) did not impact the clinical performance related to blood pressure measurement accuracy.

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

Test Set Sample Size: Not explicitly stated for the clinical evaluation. The document only mentions that the predicate device (Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-5) underwent testing according to ANSI/AAMI SP10-2002. Standards like ANSI/AAMI SP10 typically require a minimum number of subjects (e.g., 85 subjects for validation).
Data Provenance: Not specified (e.g., country of origin). The study for the predicate device would have been prospective to adhere to the ANSI/AAMI standard.

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

Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard for blood pressure monitor validation typically requires at least two independent trained observers to perform auscultatory reference measurements.
Qualifications of Experts: Not specified in the document, but for compliance with ANSI/AAMI SP10, these would be clinical professionals (e.g., physicians, nurses, or trained technicians) who are proficient in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly detailed. For ANSI/AAMI SP10, if multiple observers are used, their readings are compared, and specific protocols are followed to handle discrepancies (e.g., averaging their readings if within a certain threshold, or rereading if outside the threshold). This isn't a typical "adjudication" in the sense of consensus for image interpretation, but rather a methodology for obtaining a reliable reference measurement.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, the concept of a human reader improving with AI vs. without AI assistance is not applicable here.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the predicate device. The clinical testing according to ANSI/AAMI SP10-2002 is a standalone performance study of the device's accuracy in measuring blood pressure compared to a reference standard. The document states, "The BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device," indicating that the predicate device's standalone performance satisfied the standard.

7. Type of Ground Truth Used:

Expert Consensus of Auscultatory Measurements. For blood pressure monitors, the ground truth (reference method) is typically obtained through skilled clinical professionals performing auscultatory measurements using a mercury sphygmomanometer (or an appropriately validated non-mercury reference device) simultaneously or sequentially with the test device, following standardized protocols outlined in ANSI/AAMI SP10.

8. Sample Size for the Training Set:

Not Applicable / Not Provided. This device uses the "oscillometric method," which is a well-known technique. While it involves a software algorithm, the document does not suggest an AI/ML model that requires a "training set" in the modern sense (i.e., for supervised learning with data-driven model training). The algorithm is described as a "well known technique," implying a predetermined, fixed algorithm rather than one developed through machine learning.

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

Not Applicable. As explained above, there's no indication of a machine learning "training set" in the conventional sense for this device. The algorithm likely relies on established physiological principles and signal processing techniques for oscillometric blood pressure determination.

Summary

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

JUN 2 9 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 5l0(k) number is:

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland

Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland

Date Summary Prepared: June 2, 2006

Contact: Mr. Gerhard Frick

2. Name of the Device:

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U

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

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-5, K#040002.

4. Device Description:

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

5. Intended Use:

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U 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 BP3BU1-4U 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 BP3BU1-4U 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
Reliability Test Operating Test ﻗ

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

Reliability Test Vibration Test C.
d. Reliability Test Drop Test
e. Reliability Test Life Test
EMC Test ﻨﻬﺎ
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 BP3BU1-4U 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 Sphygmomanometers" testing was performed on our predicate device. All relevant sections were addressed and testing conducted. The BP3BU1-4U 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 BP3BU1-4U, is as safe and effective as our predicate, the Microlife Wrist Watch 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.

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

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

Re: K061558

Trade Name: Microlife Wrist Watch Blood Pressure Monitor Model BP3BU1-4U Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 2, 2006 Received: June 5, 2005

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 Amendinnis, 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. Iisting 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. Exist exass it (opedia controls) of Crass in (rWA).).
he found in the Cash of Existing major regulations affecting your device ca 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): good manufacturing practice requirements as set

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

Page 2 – Ms. Goldstein-Falk

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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Blymmumoufa

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

Enclosure

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

Exhibit# B

Indications for Use

Page 1 of

510(k) Number (if known): _ K061558

Device Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U

Indications For Use:

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 tragaferred 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)

nisice Sign-Off
Avision of Cardiovascular Devices
510(K) Number A161558

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).