(55 days)
No
The document describes a standard oscillometric blood pressure monitor with irregular heartbeat detection and data transfer capabilities. There is no mention of AI, ML, or any advanced algorithms that would suggest their use. The performance studies rely on equivalence to a predicate device using the same algorithm, which is described as a "well-known technique" (oscillometric method).
No
The device is described as a monitor that measures blood pressure and heart rate; it does not mention any therapeutic function.
Yes
The device is intended to measure systolic and diastolic blood pressure and pulse rate, and it also detects the appearance of irregular heartbeat, which are all diagnostic functions.
No
The device description clearly states it is a physical blood pressure monitor that uses an inflatable cuff and pressure sensors to measure blood pressure, indicating it is a hardware device with accompanying software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B, measures blood pressure and pulse rate using a non-invasive technique (oscillometric method) by wrapping a cuff around the upper arm. This is a measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate of an adult individual using a non-invasive technique.
- Device Description: The description reinforces the non-invasive nature of the measurement.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual by using a non-invasive oscillometric technique in which an 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.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
Product codes
DXN
Device Description
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B 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".
The device detects the appearance of irregular heartbeat during measurement, and the symbol " device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
single upper arm
Indicated Patient Age Range
adult individual
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Testing information demonstrating safety and effectiveness of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B 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 National and International Standards were utilized for testing the subject device:
-
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 1988 A1:1991 A21995
-
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 3:2007-03
-
- AAMI/ANSI SP10 Manual, electronic, or automated sphygmomanometers 2002 (R) 2008, 2002 A1:2003
-
- EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements 1995: Amendment 2, 2009
-
- EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. 1997: Amendment 2, 2009
-
- ISO 14971 Medical devices Application of risk management o medical devices. 2007
-
- AAMI/ANSI/ISO 10993-1-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 2010
-
- AAMI/ANSI/ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity, 2009
-
- AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for Irritation and skin sensitization, 2010
-
- AAMI/ANSI/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013
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 BP3NF1-2B tested met all relevant requirements of the aforementioned tests.
- AAMI/ANSI/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013
Clinical Tests:
Clinical Validation Concerning the Compliance of ANSI/AAMI ISO 81060-2: The subject device Model BP3NF1-2B is from the technical point of view. identical to the predicate blood pressure monitor BP3MC1-PC. Moreover, the measurement algorithm and its program codes of BP3MC1-PC remain unchanged. The fundamental scientific technology of the modified BP3NF1-2B device is the same as the predicate device BP3MC1-PC. Therefore the performance of the BP3NF1-2B in terms of blood pressure measurement would be identical with performance of the predicate device BP3MC1-PC. Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/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 symbol featuring three human profiles arranged in a row, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Microlife Intellectual Property Gmbh, Switzerland % Ms. Susan Goldstein-Falk Official Correspondent for Microlife Intellectual Property Gmbh mdi Consultants, Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021
K151869 Re:
Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 6, 2015 Received: July 9, 2015
Dear Ms. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
for Bram 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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B
Indications for Use (Describe)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual by using a non-invasive oscillometric technique in which an 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.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperw ork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperw ork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
The assigned 5l0(k) number is:
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: July 2, 2015
Mr. Gerhard Frick Contact: 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 BP3NF1-2B
Regulation Number: 21 CFR Part 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN
3. Information for the 510(k) Cleared Device (Predicate Device):
- a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471, Microlife Intellectual Property GmbH.
- b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (Twin200), K082357, Microlife Intellectual Property GmbH.
4. Device Description:
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B 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".
5
The device detects the appearance of irregular heartbeat during measurement,
and the symbol " device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC
via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
5. Indications for Use:
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B 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 which an 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.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
6. Comparison to the 510(k) Cleared Device (Predicate Device):
The modified device model BP3NF1-2B and the predicate device model BP3MC1-PC 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.
They differ by Bluetooth function. The subject device BP3NF1-2B is added the function of transferring the memory data to the smart phone via Bluetooth. However, this function is only a way to transfer the data and will not affect the clinical accuracy.
Although the cuff used with the subject BP3NF1-2B is changed to WRR conical cuff, it is the same with the one cleared in BP3AP1-3E, which was cleared in K111652.
The modified device model BP3NF1-2B uses the same oscillometric method as the predicate device WatchBP Office (Twin200). The have the function of transferring
6
the memory data via Bluetooth. Based upon the aforementioned information, the two devices are substantially equivalent.
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 BP3NF1-2B 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 to prove safety and effectiveness as well as substantial equivalence to the predicate devices:
The following National and International Standards were utilized for testing the subject device:
-
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 1988 A1:1991 A21995
-
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 3:2007-03
-
- AAMI/ANSI SP10 Manual, electronic, or automated sphygmomanometers 2002 (R) 2008, 2002 A1:2003
-
- EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements 1995: Amendment 2, 2009
-
- EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. 1997: Amendment 2, 2009
-
- ISO 14971 Medical devices Application of risk management o medical devices. 2007
-
- AAMI/ANSI/ISO 10993-1-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 2010
-
- AAMI/ANSI/ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity, 2009
7
K151869
-
- AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part
-
- Tests for Irritation and skin sensitization, 2010
-
- AAMI/ANSI/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013
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 BP3NF1-2B tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
Clinical Validation Concerning the Compliance of ANSI/AAMI ISO 81060-2: The subject device Model BP3NF1-2B is from the technical point of view. identical to the predicate blood pressure monitor BP3MC1-PC. Moreover, the measurement algorithm and its program codes of BP3MC1-PC remain unchanged. The fundamental scientific technology of the modified BP3NF1-2B device is the same as the predicate device BP3MC1-PC. Therefore the performance of the BP3NF1-2B in terms of blood pressure measurement would be identical with performance of the predicate device BP3MC1-PC. Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.
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". In addition, since our device requires the use of off-the-shelf software to operate the PClink function, we adhered to the FDA September 1999 document "Guidance for Off-The-Shelf Software Use in Medical Devices".
10. Conclusions:
Conclusions drawn from the non-clinical and clinical tests demonstrate that the subject device is as safe, effective, and performs as well as the predicate device.