(59 days)
BP3BT0-A
No
The description focuses on the oscillometric method and standard electrical/mechanical testing, with no mention of AI or ML algorithms. The software is described as a simple PC link for data transfer.
No.
The device is intended to measure blood pressure and pulse rate, not to treat or cure any medical condition. It's a diagnostic/monitoring device.
Yes
The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess and monitor a person's health status. While it doesn't provide a diagnosis itself, the data it collects is diagnostic in nature, providing information that medical professionals can use to diagnose or manage conditions.
No
The device description clearly states it is a physical blood pressure monitor with an inflatable cuff, pressure sensor, and the ability to connect to a PC for data transfer. While it includes software (WatchBP 1.0), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic and diastolic blood pressure and pulse rate using a non-invasive technique on the upper arm. This is a physiological measurement, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the non-invasive nature of the measurement using an inflatable cuff and oscillometric technique. It describes the sensor converting pressure changes to electrical signals, which is a physical measurement process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This blood pressure monitor measures a physiological parameter directly from the body.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1) 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 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC
Product codes
DXN
Device Description
Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home is designed to measure the systolic and diastolic blood pressure and 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 auscultatory method but uses an electronic capacitive 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 and measurement mode. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
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 individual
Intended User / Care Setting
Not Found
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)
Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model WatchBP Home 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 support this subject submission:
- a. Reliability Test Storage test
- b. Reliability Test Operating test
- c. Reliability Test Vibration test
- d. Reliability Test Drop test
- e. Reliability Test Life test
- EMC Test f.
- g. PC-link software WatchBP 1.0 test report
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 the Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home tested met all relevant requirements of the aforementioned tests.
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 Home met all relevant requirements of this standard, as applicable to our modified device.
The WatchBP Home is, from a technical point of view, identical to the predicate device, Model BP3BT0-A. Moreover, the measurement algorithm and its program codes of the WatchBP Home remain unchanged. The fundamental scientific technology of the modified WatchBP Home device is the same as the predicate BP3BT0-A device. Therefore the performance of the WatchBP Home in terms of blood pressure measurement would be identical with performance of the predicate BP3BT0-A device. Repeat clinical testing in accordance with AAMI Standard SP-10 for the subject WatchBP Home device 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)
K#060686
Reference Device(s)
BP3BT0-A
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
510(K) SUMMARY
JAN 11 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:_K0731 98
Submitter's Identification: 1.
Microlife Intellectual Property GmbH, Switzerland
Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: October 30, 2007
2. Name of the Device:
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1).
Information for the 510(k) Cleared Device (Predicate Device): 3.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3AC1-1 PC, K#060686.
Device Description: 4.
Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home is designed to measure the systolic and diastolic blood pressure and 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 auscultatory method but uses an electronic capacitive 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 and measurement mode. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
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5. Intended Use:
The Microlife upper arm Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive 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 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
6. Comparison to the 510(k) Cleared Device (Predicate Device):
Both devices use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. An upper arm cuff is inflated automatically; deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. Moreover both devices can be used in connection with PC. The memory data can be transferred to the PC by connection the monitor via cable with the PC.
The differences between the subject WatchBP Home (BP3MX1-1) and the predicate device (BP3AC1-1 PC) are as follows:
1. Irregular heartbeat detection function:
The predicate device, BP3AC1-1 PC, has the irregular heartbeat detection function, while the subject device, the WatchBP Home (BP3MX1-1) does not have this function.
2. Measurement mode:
BP3AC1-1PC contains a switchable average mode in which the device automatically repeats 3 individual measurements cycles, each with a rest time of 15 seconds in between. After that the average of these 3 individual measurements is calculated and shown on the display. By certain key operation the user can access the individual results of the measurements.
WatchBP Home contains a switchable and mode.
In mode , the device allows for only two blood pressure measurements to be taken in the morning (6-9am) and another two in the evening (6-9pm), each with a rest time of 60 seconds in between. After completing seven days, the device displays a symbol suggesting that the patient should consult his/her doctor. Pressing the memory button on the device displays the average of all measurements after discarding those of the first day.
In mode, the device functions like a normal blood pressure monitor single measurements are automatically stored up to 250 measurements and can
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be evaluated by a doctor.
3. Blood Pressure Analyzer Software:
The two devices can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer software. The memory data can be transferred to the PC by connecting the blood pressure monitor to personal computer via USB cable. All the memory data can be transferred to the connected computer through USB cable and be shown on the computer monitor. After transferred to computer, the memory data can then be saved in the personal computer memory. Different software is employed for the predicate and subject devices.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model WatchBP Home 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 support this subject submission:
- a. Reliability Test Storage test
- b. Reliability Test Operating test
- c. Reliability Test Vibration test
- d. Reliability Test Drop test
- e. Reliability Test Life test
- EMC Test f.
- g. PC-link software WatchBP 1.0 test report
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 the Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home 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 Home met all relevant requirements of this standard, as applicable to our modified device.
The WatchBP Home is, from a technical point of view, identical to the predicate device, Model BP3BT0-A. Moreover, the measurement algorithm and its program
3
codes of the WatchBP Home remain unchanged. The fundamental scientific technology of the modified WatchBP Home device is the same as the predicate BP3BT0-A device. Therefore the performance of the WatchBP Home in terms of blood pressure measurement would be identical with performance of the predicate BP3BT0-A device. Repeat clinical testing in accordance with AAMI Standard SP-10 for the subject WatchBP Home device 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 the subject device requires the use of an offthe-shelf software to operate the PC-link function, we adhered to the September 1999 FDA document, "Guidance for Off-the-Shelf Software Use in Medical Devices".
10. Conclusions:
We have demonstrated that there are no significant differences between the subject device, the Microlife Automatic Blood Pressure Monitor, Model WatchBP Home and the predicate Model BP3AC1-1 PC 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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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
JAN 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Microlife Intellectual Property GmbH c/o Ms. Susan Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
Re: K073198
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBPHome (BP3MX1-1) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 9, 2007 Received: November 13, 2007
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.
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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); 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,
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit#B
Indications for Use
510(k) Number (if known):
2073198
Device Name: Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1)
Indications For Use:
The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1) 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 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC
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)
B. Bimonana
(Division/Lot)
(Division Sign-Off) Division of Cardiovascular 510(k) Number
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