The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) 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 one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

Device Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) 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 resistive 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>>, << SCREEN>> and << ROUTINE>> measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data:

This submission (K101275) is for a modified device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS). The manufacturer largely relies on previous clearances for its predicate devices (K082357 and K080337) to demonstrate substantial equivalence, particularly by asserting that the relevant clinical accuracy and AF detection functionalities are identical. This means detailed new clinical study data for this specific device is not provided in this summary, but rather referenced from previous submissions.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (from referenced predicate devices)	Reported Device Performance (from referenced predicate devices)
Blood Pressure Detection Accuracy	Compliance with ANSI/AAMI SP10 (standard for BP monitors)	"Identical to our predicate device Model WatchBP Office (Twin200) [K082357]." The previous device met ANSI/AAMI SP10.
Atrial Fibrillation (AF) Detection	Not explicitly stated, but implied to be sufficient for a warning signal	"Identical to what is utilized in our predicate device Model BP3MQ1-2D [K080337]." The previous device achieved intended AF detection.
Electrical, Mechanical, Environmental Performance	Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND	All relevant requirements met; no design characteristics violated the guidance or resulted in safety hazards.
Software Validation	Moderate level of concern designation in accordance with FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"	Validation conducted in accordance with the guidance.

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

Blood Pressure Accuracy: The original clinical test report for the predicate device Model WatchBP Office (Twin200), K082357, would contain this information. This current submission does not provide new sample size data for blood pressure accuracy validation as it claims identity to the predicate. The provenance of that original data is not stated in this summary.
Atrial Fibrillation (AF) Detection: The original clinical test report for the predicate device Model BP3MQ1-2D, K080337, would contain this information. This current submission does not provide new sample size data for AF detection validation as it claims identity to the predicate. The provenance of that original data is not stated in this summary.

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

This information would be found in the original clinical test reports for the predicate devices (K082357 for BP accuracy and K080337 for AF detection), which are not provided in this summary. The summary simply states that these reports are "applicable" to the subject device.

4. Adjudication Method for the Test Set

Again, this information would be detailed in the original clinical test reports for the predicate devices (K082357 and K080337), which are not included in this summary.

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

No, an MRMC comparative effectiveness study was not done or reported in this summary. For a blood pressure monitor and AF detection, the primary clinical validation typically involves comparing the device's readings against a gold standard (e.g., auscultation by trained observers) rather than assessing human reader improvement with AI assistance. The device functions as a standalone diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The clinical validation for blood pressure accuracy (referenced to K082357) and AF detection (referenced to K080337) represents standalone performance. These devices provide readings and AF warnings without requiring a human-in-the-loop to interpret the raw signals. The device itself is the "algorithm only" in this context, providing a direct output.

7. Type of Ground Truth Used

For Blood Pressure: The ground truth for oscillometric blood pressure monitors, when validated against standards like ANSI/AAMI SP10, typically involves simultaneous auscultatory measurements performed by trained human observers using a mercury sphygmomanometer, often in a double-blinded fashion.
For Atrial Fibrillation Detection: The ground truth for AF detection (referenced to K080337) would typically involve simultaneous Electrocardiogram (ECG) recordings interpreted by electrophysiologists or cardiologists.

8. Sample Size for the Training Set

The summary does not provide information on the training set sample size. This submission is for a device based on an established oscillometric method and AF detection algorithm (from predicate devices). Such algorithms are typically developed and refined using substantial datasets, but the details of those development datasets (including sizes) are not part of this 510(k) summary, which focuses on validation.

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

Similar to point 8, the summary does not provide details on how the ground truth for the training set was established. This information would pertain to the development of the underlying algorithms, not their validation for substantial equivalence. The validation ground truth (as per point 7) is what's relevant to this submission.

Summary

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K101275
P1/3

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:

MAY 2 8 2010

Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: April 28, 2010

Contact: Mr. Gerhard Frick

2. Name of the Device:

Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS)

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

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (Twin200), K082357, Microlife Intellectual Property GmbH.
b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D, K080337, Microlife Intellectual Property GmbH.

4. Device Description:

The device has << AUSCULTATION>>. << SCREEN>> and << ROUTINE>> measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc.

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K101275
p2/3

Image /page/1/Picture/1 description: The image shows a simple line drawing of a rectangular prism. The prism is oriented diagonally, with one of its corners pointing towards the upper left of the frame. The lines are dashed, giving the impression of a sketch or outline. The background is plain white.

The << AUSCULTATION>> mode is selected for blood pressure measurement of patients to confirm if a patient is suitable for the oscillometric method.

The <> mode is selected to complete a fully-automated triple measurements on both arms according to recommended ESH/AHA blood pressure measurement protocols for a patient's first office visit.

The << ROUTINE>> mode is selected to perform an automated duplicate measurements on the preferred arm for prompt and accurate office measurements.

5. Intended Use:

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) is a device intended to measure the systolic and diastolic blood pressure, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

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

The subject modified device, Model WatchBP Office AFIB (TWIN200 AFS) and our predicate device, Model WatchBP Office (Twin200), 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 deflation pressures are transferred via tubing to one (or two) sensor(s).

The sole differences between the two models are the measurement mode names, sensor type and additional features such as atrial fibrillation detection function. However, the differences do not affect the accuracy and normal use of this device.

The atrial fibrillation detection function is the same with what is used in our predicate device Model BP3MQ1-2D, 510(k) cleared under K080337.

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

Testing information demonstrating safety and effectiveness of the subject modified Microlife Upper Arm Automatic Digital Blood Pressure Monitor. Model WatchBP Office AFIB (TWIN200 AFS) 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 Storage test
b. Reliability Test Operating test
c. Reliability Test Vibration test

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ರ. Reliability Test - Drop test
e. Reliability Test - Life test
f. EMC Test

None of our 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 subject modified device tested, Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

Clinical Validation Concerning the Compliance of ANSI/AAMI SP10: a)
The subject modified device, Model WatchBP Office AFIB (TWIN200 AFS), is from the technical point of view, identical to our predicate device Model WatchBP Office (Twin200). The differences between these devices do not affect the clinical accuracy in terms of blood pressure detection. Based on Microlife's risk analysis and internal clinical test and simulator test report, repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required. The clinical test report included in our Model WatchBP Office (Twin200), K082357, is applicable to our subject modified device, WatchBP Office AFIB (TWIN200 AFS).
Clinical Evaluation Concerning Atrial Fibrillation (AF) Detection: b)
The atrial fibrillation detection technique utilized in the subject modified device Model WatchBP Office AFIB (TWIN200 AFS), is from the technical point of view, identical to what is utilized in our predicate device Model BP3MQ1-2D. The clinical test report included in our Model BP3MQ1-2D, K080337, is applicable to our subject modified WatchBP Office AFIB (TWIN200 AFS).

9. Software information:

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

10. Conclusions:

We have demonstrated that there are no significant differences between the subject modified Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) and our predicate devices, Model WatchBP Office (Twin200) and Model BP3MQ1-2D, in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and the ANSI/AAMI Voluntary Standard, SP10: 2008.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

MAY 2 8 2010

Re: K101275

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: May 3, 2010 Received: May 6, 2010

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, Trug, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,
W. West.

3 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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Ki01275

Exhibit B

Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS)

Indications For Use:

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

Prescription Use X (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)

W.W.W.S.T.

Division of Cardiovascular Device

510(k) Number K101275

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).