The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Office (Twin200) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a noninvasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).

The device can be used in connection with your personal computer (PC) running the WatchBP Office software .The memory data can be transferred to the PC by connecting the monitor with the PC via bluetooth.

Device Description

Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Office (Twin200) is designed to measure systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two electronic 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, pulse pressure (PP) and mean arterial pressure (MAP), which is a well - known technique in the market called the "oscillometric method".

The device has << AUSCULTATION>>, << 1st VISIT>> and << FOLLOW-UP>> measurement modes and has inflation pressure setting function, measurement intervals setting function etc. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP Office software. The memory data can be transferred to the PC by connecting the monitor with the PC via bluetooth.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
AAMI/ANSI SP-10 standard clinical testing requirements	The device met all applicable requirements of the standard.

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

The document does not explicitly state the sample size used for the AAMI/ANSI SP-10 clinical testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the testing was performed.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the AAMI/ANSI SP-10 clinical testing. This standard typically involves comparison against a reference method (often auscultatory measurements by trained observers), but specific details are not present.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For AAMI/ANSI SP-10, the "ground truth" standard is usually applied via a predefined protocol for comparison to the device's readings, rather than a separate adjudication process in the traditional sense of reaching consensus on diagnoses.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the AAMI/ANSI SP-10 standard clinical testing is inherently a standalone performance study. It evaluates the accuracy of the automated device (algorithm only, without human-in-the-loop influence during the measurement process) against a reference standard.

7. The Type of Ground Truth Used

The ground truth used for the AAMI/ANSI SP-10 clinical testing would be a reference measurement, typically obtained via auscultatory methods by trained observers, as specified by the AAMI/ANSI SP-10 standard for validating automated blood pressure monitors. This is a form of expert-derived reference data.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" sample size. For a blood pressure monitor utilizing an "oscillometric method," the underlying algorithms are typically developed and validated over time using extensive physiological data, but the submission package primarily focuses on the clinical validation against a recognized standard (AAMI/ANSI SP-10) rather than the specific details of algorithm training data.

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

Given that the document does not discuss a separate training set, it also doesn't detail how ground truth would have been established for it. The "oscillometric method" is a well-known technique, implying that its fundamental principles and calibration data are established through extensive physiological research and engineering practices, rather than a single, explicitly defined "training set" with ground truth in the context of this 510(k) summary.

Summary

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OCT 2 9 2008

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:

Submitter's Identification: 1.

Microlife Intellectual Property GmbH, Switzerland

Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: June 12, 2008

2. Name of the Device:

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (Twin200)

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

a. Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home

(BP3MX1-1), K073198, Microlife Intellectual Property GmbH.

b. VP-2000/1000, K013434, Colin Corporation.

4. Device Description:

The device has << AUSCULTATION>>. << 1st VISIT>> and << FOLLOW-UP>> measurement modes and has inflation pressure setting function, measurement intervals setting function etc. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP Office software. The memory data can be transferred to the PC by connecting the monitor with the PC via bluetooth.

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K082357
P2/3

The <> mode is selected for blood pressure measurement of patients with arrhythmia, and, in need, to confirm if a patient is suitable for the oscillometric method using a digital blood pressure monitor. The subject device in this mode serves only as a pressure gauge. No oscillometric measurements will be taken and a mental note must be made of the systolic and diastolic values.

The <<1st VISIT>> mode is selected to complete a fully-automated three consecutive measurements on both arms simultaneously, the result of these three measurements are averaged to produce the 18 visit blood pressure measurement. This mode is helpful to determine the preferred measurement arm and reveal other cardiovascular risks for a patient's first office visit.

The <> mode is selected to complete a fully-automated three consecutive measurements on the preferred arm, the result of these three measurements are averaged to produce the follow-up visit blood pressure measurement.

5. Intended Use:

The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Office (Twin200) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).

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

The modified device model WatchBP Office (Twin200) and the predicate device model WatchBP Home (BP3MX1-1) use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff(s) is (are) inflated automatically, deflation rate is controlled by one (or two) factory set exhaust valve(s) and the defiation pressures are transferred via tubing to one (or two) sensor(s).

The solely differences between the two models are the additional features such as measuring location (single-arm or dual-arm), PP & MAP automatically calculation function. However, the differences do not affect the accuracy and normal use of this device.

Measuring on dual-arm and PP & MAP automatically calculation function are similar with what are used in predicate device VP-2000/1000, with 510(k) cleared number K013434.

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

Testing information demonstrating safety and effectiveness of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (Twin200) in

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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
Reliability Test Operating test b.
Reliability Test Vibration test ပဲ
Reliability Test Drop test ರ
Reliability Test Life test e.
f. EMC Test
IEC 60601-1 Safety Test g.
Bluetooth Test h.
i. FCC 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 WatchBP Office (Twin200) tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

AAMI/ANSI SP-10 standard clinical testing was performed and the device met all applicable requirements of the standard.

g. Software information:

The subject device's software documentation is consistent with a moderate level of concern. We provided software documentation in accordance with the FDA's November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. " Moreover, our device requires the use of off-the-shelf software to operate the PC-link function and we have tested our OTC software in accordance with the FDA September 1999 document "Off-The-Shelf Software Use in Medical Device".

10. Conclusions:

We have demonstrated that there are no significant differences between the Microlife Upper Arm Automatic Digital Blood Pressure Monitor Model WatchBP Office (Twin200) and the predicate devices in terms of safety and effectiveness based on electrical, mechanical and environmental test results and the ANSI/AAMI Voluntary Standard, SP10: 2002 test results.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2008

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

Re: K082357

Trade/Device Name: Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Office (Twin200) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 15, 2008 Received: August 18, 2008

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. 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

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Page 2 - Ms. Susan D. Goldstein-Falk

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,

er 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

Page _ of

510(k) Number (if known): ____________________

Device Name: Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Office (Twin200)

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
10/28/08

ular Device

510(k) Number

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).