(112 days)
No
The document describes a standard oscillometric blood pressure monitor and does not mention AI or ML in its description, intended use, or performance studies. The technology described is based on analyzing electrical signals from pressure sensors, which is a well-established, non-AI/ML technique.
No
The device is intended to measure blood pressure and pulse rate, and detect irregular heartbeats, but it does not provide treatment or therapy.
Yes
The device is described as "intended to measure the systolic and diastolic blood pressure, pulse rate" and "detects the appearance of irregular heartbeat during measurement". Monitoring blood pressure and detecting irregular heartbeats are diagnostic functions.
No
The device is described as a "Microlife Upper Arm Automatic Digital Blood Pressure Monitor" and utilizes physical components like an inflatable cuff and pressure sensors to measure blood pressure. While it includes software for data transfer and analysis, it is fundamentally a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that this device measures blood pressure and pulse rate using a non-invasive oscillometric technique on the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is for measuring blood pressure and pulse rate in adults at home. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B, is a medical device for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults on the upper arm at home.
Product codes
DXN
Device Description
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW 1-4B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. 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, which is a well - known technique in the market called the "oscillometric method". This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The device detects the appearance of irreqular heartbeat during measurement.
and the symbol " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The patient's level of blood pressure is determined in the circulatory center of the brain and adjusts to a variety of situations through feedback from the nervous system. To adjust blood pressure, the strength and frequency of the heart (pulse), as well as the width of circulatory blood vessels is altered. Blood vessel width is affected by fine muscles in he blood vessel walls.
The patient's level of arterial blood pressure changes periodically during heart activity. During the "blood ejection" (Systole), the value is highest (systolic blood pressure value). At the end of the heart's "rest period" (Diastole), pressure is lowest (diastolic blood pressure value).Blood pressure values must lie within certain normal ranges in order to prevent particular diseases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
adults on the upper arm at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Microlife Intellectual Property Gmbh % Susan Goldstein-Falk Official Correspondent For Microlife Intellectual Property Gmbh Mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K153077
Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 11, 2016 Received: January 13, 2016
Dear Susan 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Sincerely vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153077
Device Name
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
Indications for Use (Describe)
The Microlife Upper Arm Automatic Dizital Blood Pressure Monitor. Model BP3MW1-4B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults on the upper arm at home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
The assigned 5l0(k) number is: K153077
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: February 12, 2016
Contact: Mr. Gerhard Frick Vice President of Technical and Service Microlife Intellectual Property GmbH, Switzerland Tel: +41 79 216 0070 E-Mail: gerhard.frick@microlife.ch
2. Name of the Device:
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
Regulation Number: 21 CFR Part 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN
Information for the 510(k) Cleared Device (Predicate Device): 3.
- a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R), K140572, Microlife Intellectual Property GmbH.
- b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B, K151869, Microlife Intellectual Property GmbH.
Device Description: 4.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW 1-4B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure
4
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, which is a well - known technique in the market called the "oscillometric method". This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The device detects the appearance of irreqular heartbeat during measurement.
and the symbol " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The patient's level of blood pressure is determined in the circulatory center of the brain and adjusts to a variety of situations through feedback from the nervous system. To adjust blood pressure, the strength and frequency of the heart (pulse), as well as the width of circulatory blood vessels is altered. Blood vessel width is affected by fine muscles in he blood vessel walls.
The patient's level of arterial blood pressure changes periodically during heart activity. During the "blood ejection" (Systole), the value is highest (systolic blood pressure value). At the end of the heart's "rest period" (Diastole), pressure is lowest (diastolic blood pressure value).Blood pressure values must lie within certain normal ranges in order to prevent particular diseases.
| Category | Systolic
(mmHg) | Diastolic
(mmHg) |
|----------------------|--------------------|---------------------|
| Normal |