The Microlife Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) 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 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.

Device Description

Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3(BP W100) is designed to measure the 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 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 irregular heart beat symbol " irregular heart beat signal has been detected.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100), based on the provided text:

Acceptance Criteria and Device Performance:

The document explicitly states that the device's performance is compared to its predicate device (BP3BU1) and other models (BP3BT0-AP) based on non-clinical and clinical testing. Crucially, the application for this model (BP3MK1-3) argues that no new clinical testing is required because the measurement algorithm and program codes are unchanged from the predicate device and the fundamental scientific technology is the same. Therefore, the device meets the acceptance criteria by being demonstrated as equivalent to an already cleared device that met the ANSI/AAMI SP10-2002 standard.

Acceptance Criteria (Met by Predicate Device)	Reported Device Performance
ANSI/AAMI SP10-2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" (All relevant sections addressed and tested for predicate)	Clinical performance remains unchanged from predicate device BP3BU1. (No new clinical data presented for this specific device model due to equivalence claim).
Electrical, Mechanical, and Environmental Performance Requirements (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions")	Device (BP3MK1-3) met all relevant requirements of: Reliability Tests (Storage, Operating, Vibration, Drop, Life) and EMC Test.
Equivalence to Predicate Device (BP3BU1) in terms of safety and effectiveness	Demonstrated no difference between BP3MK1-3 and BP3BU1 based on non-clinical test results.

Study Details:

Since the submission claims substantial equivalence to a predicate device (BP3BU1) and states that "anther clinical test for the modified device, BP3MK1-3(BP W100) is not required" due to unchanged algorithms and technology, the following details pertain to the implication of that claim rather than direct studies for this specific device model. The document does not provide details of the original clinical study for the predicate device BP3BU1 beyond mentioning compliance with ANSI/AAMI SP10-2002.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either non-clinical (reliability, EMC) or clinical (from predicate) tests.
- Data Provenance: Not specified for the predicate device's clinical testing. The non-clinical tests (reliability, EMC) for the BP3MK1-3 were conducted by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided for the predicate device's clinical testing, nor is it relevant for the non-clinical tests conducted for the BP3MK1-3.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided for the predicate device's clinical testing.
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 is a blood pressure monitor, not an AI-assisted diagnostic imaging device for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The core functionality of the device is to measure blood pressure using an oscillometric method, which is an algorithm-only measurement. The document states the "measurement algorithm and the program codes of the BP3MK1-3(BP W100) remain unchanged." This implies standalone performance was measured for the predicate and is assumed for this device. Specific performance metrics (accuracy, precision) are not detailed but are implied to meet the ANSI/AAMI SP10-2002 standard.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors seeking compliance with standards like ANSI/AAMI SP10, the "ground truth" typically involves simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often double-blinded, which serves as the "reference method." This would have been the case for the predicate device's clinical testing.
The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that uses a "training set" in the conventional sense. The "training" of the device refers to its design and calibration based on known physiological principles and validated algorithms.
How the ground truth for the training set was established:
- Not applicable (see point 7).

Summary

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DEC 20 2007

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.

173348 The assigned 510(k) number is:_

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland

Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: June 8, 2007

Name of the Device: 2.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3(BP W100)

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

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1, K#001182. Pls refer to Exhibit#2 for 510(K) summary of BP3BU1 Microlife Upper Arm Blood Pressure Monitor, Model BP3BT0-AP, K#041411.Pls refer to Exhibit#3 for 510(K) summary of BP3BT0-AP.

4. Device Description:

The device detects the appearance of irregular heartbeat during measurement and

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Exhibit#1-1

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the irregular heart beat symbol " irregular heart beat signal has been detected.

5. Intended Use:

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

Pls also refer to the "Indications for use" statement, which is attached as Exhibti#B.

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

The modified model BP3MK1-3(BP W100) has the same intended of use and is similar in terms of design to our original 510(K) cleared device, model BP3BU1.

The model BP3MK1-3(BP W100) and the model BP3BU1 are identical in functionality and performance. The solely differences between these two models are the additional features such as irregular heartbeat detection function, alarm function However, the difference does not affect the accuracy and normal use of this device. Pls refer to Exhibt#4.

Irreqular heartbeat detection technology is same as what is used in Microlife Automatic upper arm blood pressure monitor; model BP3BT0-AP, with 510(K) cleared number k#041411. Pls refer to Exhibit#3 for the summary of BP3BT0-AP.

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 BP3MK1-3(BP W100) 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:

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Exhibit#1-2

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Reliability Test Storage test a.
Reliability Test Operating test ﻗ
Reliability Test Vibration test ﻦ
Reliability Test Drop test ರ
Reliability Test Life test e.
EMC Test f.

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 BP3MK1-3(BP W100) tested met all relevant requirements of the aforementioned tests.

Discussion of Clinical Tests Performed: 8.

Relevant tests in accordance with ANSI/AAMI SP10-2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" had been performed in the cleared device, BP3MK1-3(BP W100). All relevant sections were addressed and tested. Since the measurement algorithm and the program codes of the BP3MK1-3(BP W100) remain unchanged and the fundamental scientific technology of the modified device is the same as that of the 510(k) cleared device, BP3BU1. Clinical performance of the modified device will remain unchanged; therefore anther clinical test for the modified device, BP3MK1-3(BP W100) is not required. Please refer to the Exhibit#10 for a copy of this signed statement by a company designated individual.

9. Conclusions:

It has been demonstrated that there is no difference between the Microlife Wrist Watch Blood Pressure Monitor Model BP3MK1-3(BP W100) and the predicate model BP3BU1 in terms of safety and effectiveness based on electrical, mechanical and environmental test results. the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and the ANSI/AAMI Voluntary Standard, SP10-2002 test results.

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Exhibit#1-3

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

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

Re: K073398

Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 30, 2007 Received: December 3, 2007

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.

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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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. .

B/Sommer 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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Exhibit B

Indications for Use

510(k) Number (if known):

K073398

Device Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)

Indications For Use:

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

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)

Bhumanna

COS

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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).