The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.

The device can be used in connection with your personal computer (PC) running the WatchBP 03 software .The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

Device Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP 03 (BP3MZ1-1) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscuitatory method but uses an electronic 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 has << AMBULATORY >>. << HOME >> and << CASUAL >> measurement modes and has a medication record function. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP O3 software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

AI/ML Overview

The provided text describes a 510(k) submission for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1). This submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study for the new device. The key argument for equivalence in terms of blood pressure measurement accuracy is that the new device uses the identical measurement algorithm and program codes as the previously cleared predicate device, Model WatchBP Home (BP3MX1-1).

Therefore, the acceptance criteria and study information reference the standard applied to the predicate device because the accuracy of the new device is asserted to be the same due to identical core technology for measurement.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary primarily references adherence to the ANSI/AAMI SP10: 2002 standard for blood pressure monitors. The document explicitly states that the WatchBP O3 (BP3MZ1-1) met all relevant requirements of this standard, as applicable to our modified device. As the core measurement technology is identical to the predicate, the performance is implicitly equivalent to the predicate's performance against this standard. Specific numerical performance data for the WatchBP O3 (BP3MZ1-1) itself is not provided, rather it relies on the predicate's established performance.

Acceptance Criteria (from ANSI/AAMI SP10: 2002)	Reported Device Performance (WatchBP O3 via predicate)
Section 5.2.2 - Individual Differences
The difference between the device reading and the reference standard reading for each subject shall be within ±5 mmHg.	Not explicitly stated for WatchBP O3, but implies meeting this criterion as it "met all relevant requirements" of AAMI SP10 through its predicate.
Section 5.2.3 - Overall Mean Difference
The mean difference between the device reading and the reference standard reading for the entire clinical population shall be within ±5 mmHg.	Not explicitly stated for WatchBP O3, but implies meeting this criterion as it "met all relevant requirements" of AAMI SP10 through its predicate.
Section 5.2.4 - Standard Deviation of Differences
The standard deviation of the differences between the device reading and the reference standard reading for the entire clinical population shall be less than or equal to 8 mmHg.	Not explicitly stated for WatchBP O3, but implies meeting this criterion as it "met all relevant requirements" of AAMI SP10 through its predicate.
Other relevant sections of ANSI/AAMI SP10: 2002 (e.g., cuff requirements, display accuracy, alarm functionality, etc.)	"Met all relevant requirements of this standard, as applicable to our modified device."

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

Sample Size for Test Set: Not explicitly stated for the WatchBP O3 (BP3MZ1-1) clinical testing. The submission states that "Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject WatchBP O3 (BP3MZ1-1) device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device." This implies reliance on the clinical data for the predicate device, Model WatchBP Home (BP3MX1-1), which would have undergone testing according to this standard. ANSI/AAMI SP10 typically requires a minimum of 85 subjects for validation.
Data Provenance: Not specified in the provided text, as the focus is on the claim of identical performance to a previously cleared device. If the predicate's study was used, its provenance would apply.

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

Number of Experts: Not specified. For AAMI SP10 validation, ground truth is typically established by trained human observers using a mercury sphygmomanometer, often with two or more observers simultaneously to reduce bias, but their "expert" status is primarily based on training rather than specific years of experience in the way a radiologist's experience might be cited.
Qualifications of Experts: Not specified. Standard practice for AAMI SP10 validation involves trained observers (often nurses or other medical professionals) following a strict protocol for auscultatory measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified directly for the device, as clinical testing was deemed unnecessary due to identical core technology. For AAMI SP10 validation, if multiple ground truth observers are used, their readings are typically averaged or differences adjudicated according to the standard's protocol for comparing to the automated device. The standard aims for high inter-observer agreement.

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

No, an MRMC comparative effectiveness study was not done. This type of study comparing human readers with and without AI assistance is not relevant for a blood pressure monitor, which is a standalone measurement device rather than an AI diagnostic aid for human interpretation.

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

Yes, a standalone study was effectively done for the predicate device, which forms the basis for the current device's performance claim. The "oscillometric method" described is an algorithm-only measurement that does not require human intervention during the measurement process to determine systolic and diastolic blood pressure. The WatchBP O3 (BP3MZ1-1) is stated to have the "measurement algorithm and its program codes... unchanged" from the predicate, implying its standalone performance is identical to the predicate device's standalone performance, which met the ANSI/AAMI SP10: 2002 standard.

7. The Type of Ground Truth Used

Expert Consensus (Auscultation): For blood pressure monitors, the gold standard (ground truth) is typically human auscultatory measurement using a mercury sphygmomanometer, often performed by multiple trained observers, from which an "expert consensus" or averaged reading is derived. This is the method prescribed by ANSI/AAMI SP10.

8. The Sample Size for the Training Set

Not applicable / Not specified. Blood pressure monitors using the oscillometric method are often developed using a combination of engineering principles, signal processing, and empirical data, but there isn't a "training set" in the machine learning sense as would be relevant for an AI algorithm that learns complex patterns from labeled data. The algorithm is based on a well-established physiological principle rather than being "trained" on a dataset in the modern AI paradigm.

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

Not applicable. See explanation for #8. The "ground truth" during the development of traditional oscillometric algorithms would involve physiological understanding and calibration against known reference methods, but not a "training set" with ground truth in the AI sense.

Summary

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K082881
P1/3

Exhibit#1

510(k) SUMMARY

NOV 2 4 2008

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

Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: September, 26, 2008

Contact: Gerhard Frick

2. Name of the Device:

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1)

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

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1), K073198, Microlife Intellectual Property GmbH. b. Welch Allyn ABPM 6100, K021756, Welch Allyn Inc.

4. Device Description:

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The <> mode is selected for fully programmable 24-hour patient out-of-office blood pressure measurement. The device automatically takes measurements at fixed intervals programmed by the physician.

The <> mode is selected for patient home blood pressure measurement. The patient should carry out two sets of measurements on 7 consecutive working days (or normal week days). Then the patient returns to the physician's office with the subiect device for an evaluation of their home blood pressure measurement data.

The <> mode is selected to function like a regular blood pressure monitor - single measurements are automatically stored and can be reviewed by the physician at a later date.

5. Intended Use:

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

The modified device model WatchBP O3 (BP3MZ1-1) 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 is inflated automatically, deflation rate is controlled by one factory set exhaust valve and the deflation pressures are transferred via tubing to one sensor.

The major differences between the two models are the additional features such as an AMBULATORY measurement mode and medication record function. However. the differences do not affect the accuracy and normal use of this device.

AMBULATORY measurement mode is similar with what is used in predicate device Welch Allyn ABPM 6100, with 510(k) cleared number K021756.

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 03 (BP3MZ1-1) 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.

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K082881
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The following testing was conducted:

a. Reliability Test Storage test
b. Reliability Test Operating test
C. Reliability Test - Vibration test
d. Reliability Test Drop test
Reliability Test Life test e.
ﮩﺖ EMC Test
g. IEC 60601-1 Safety 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 O3 (BP3MZ1-1) tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The WatchBP O3 (BP3MZ1-1) met all relevant requirements of this standard, as applicable to our modified device.

The WatchBP O3 (BP3MZ1-1) is, from a technical point of view, identical to the predicate device, Model WatchBP Home (BP3MX1-1). Moreover, the measurement algorithm and its program codes of the WatchBP O3 (BP3MZ1-1) remain unchanged. The fundamental scientific technology of the modified WatchBP O3 (BP3MZ1-1) device is the same as the predicate WatchBP Home (BP3MX1-1) device. Therefore the performance of the WatchBP O3 (BP3MZ1-1) in terms of blood pressure measurement would be identical with performance of the predicate WatchBP Home (BP3MX1-1) device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject WatchBP O3 (BP3MZ1-1) device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.

ഗ് 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". In addition, since our device requires the use of off-the-shelf software to operate the PC-link function, we adhered to the FDA September 1999 document "Guidance for Off-The-Shelf Software Use in Medical Devices".

10. Conclusions:

We have demonstrated that there are no significant differences between the Microlife Upper Arm Automatic Digital Blood Pressure Monitor Model WatchBP O3 (BP3MZ1-1) and the predicate devices, Model WatchBP Home (BP3MX1-1) and the Welch Allyn ABPN (6100), in terms of safety and effectiveness based on electrical. mechanical and environmental test results per the FDA DCRND November 1993

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 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: K082881

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP 03 (BP3MZ1-1) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 26, 2008 Received: September 29, 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

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 Scction 510(k) promarket 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,

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

KO82 981 510(k) Number (if known): _

Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP 03 (BP3MZ1-1)

Indications For Use:

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1) is a device intended to measure the systelic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive orcillometric technique in which an inflatable cuff is wrapped around the upper arm.

The device can be used in connection with your personal computer (PC) running the WatchBP 03 software . The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

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)

N.R. Klein for B. Zuckerman

Page of

(Division Sign-Off) 11/24/05
Division of Cardiovascular Devices

KOAZBET 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).