(86 days)
K#041411
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and irregular heartbeat detection using established techniques, with no mention of AI or ML.
No.
The device is intended to measure blood pressure and pulse rate and detect irregular heartbeat, which are diagnostic/monitoring functions, not therapeutic interventions.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressure and pulse rate, and it detects irregular heartbeats, which are all diagnostic indicators of a person's health status.
No
The device description explicitly mentions an inflatable cuff, an electronic capacitive pressure sensor, and a physical monitor that connects to a PC via cable, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Microlife Automatic Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using an oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it measures 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 using an inflatable cuff on the upper arm.
Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Microlife Automatic Blood Pressure Monitor, Model BP 3AC1-1 P C i s a d evice intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the 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.
Product codes
DXN
Device Description
Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) 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 detects the appearance of irregular heartbeat during measurement, and the arrhythmia symbol " 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.
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
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 BP3AC1-1 PC 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 tests were conducted accordingly:
- a. Reliability Test - Storage test
- Reliability Test Operation test b.
- Reliability Test Vibration test C.
- d. Reliability Test - Drop test
- Reliability Test Life test e.
- f. EMC Test
- PC-link software BPA version 3.1.6 test report.
None of the tests demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It is then concluded that the Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC, meets all relevant requirements of the aforementioned tests.
Clinical performance of the modified device will remain unchanged; therefore anther clinical test for the modified device, BP3AC1-1PC is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#041411
Reference Device(s)
Not Found
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
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: K ص8666068
Submitter's Identification: 1.
JUN - 9 2006
Microlife Intellectual Property GmbH, Switzerland
Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: January 11, 2006
2. Name of the Device:
Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC.
3. Information for the 510(k) Cleared Device (Predicate Device):
Microlife Automatic Blood Pressure Monitor, Model BP3BT0-AP, K#041411.
4. Device Description:
Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) 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 detects the appearance of irregular heartbeat during measurement, and the arrhythmia symbol " 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.
Exhibit #1-1
page 1 of 4
1
5. Intended Use:
The Microlife Automatic Blood Pressure Monitor, Model BP 3AC1-1 PC, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the 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.
Comparison to the 510(k) Cleared Device (Predicate Device): 6.
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 by a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. Moreover, both devices have irregular heart beat detection function.
The differences between BP3AC1-1 PC and the predicate device are described as the following:
1.1. Average Mode function (MAM function):
BP3AC1-1 PC contains a switchable average mode in which the device automatically repeats 3 individual measurements cycles. After that, the average of these 3 individual measurements is calculated and also be shown on the display.
1.2. PC-link function:
BP3AC1-1 PC 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 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
Exhibit #1-2
Page 2 of 4
2
monitor. After transferred to computer, the memory data can then be saved in the personal computer memory.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC 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 tests were conducted accordingly:
- a. Reliability Test - Storage test
- Reliability Test Operation test b.
- Reliability Test Vibration test C.
- d. Reliability Test - Drop test
- Reliability Test Life test e.
- f. EMC Test
- PC-link software BPA version 3.1.6 test report ದ.
None of the tests demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It is then concluded that the Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC, meets all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
Clinical performance of the modified device will remain unchanged; therefore anther clinical test for the modified device, BP3AC1-1PC is not required.
9. Conclusions:
We have demonstrated that the Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1 PC, is as safe and effective as the predicate device, the Microlife Automatic Blood Pressure Monitor, Model BP 3BT0-AP based on electrical,
Exhibit #1-3
page 3 of 4
3
mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and, the ANSI/AAMI Voluntary Standard, SP10-2002 testing results.
page 404
Exhibit #1-4
and and the country of the county of
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4
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2006
Microlife Intellectual Property c/o Mr. Tzu-Wei Li Center for Measurement Standards/ Industrial Technology Research Institute Bldg 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu, Taiwan 30042 R.O.C. R.O.C.
Re: K060686
Trade/ Name: Microlife Automatic Blood Pressure Monitor, Mode BP3AC1-PC Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Measurement System, Non-invasive Regulatory Class: II (two) Product Code: DXN Dated: March 6 and May 17, 2006 Received: March 15 and May 23, 2006
Dear Mr. Li:
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.
5
Page 2 - Mr. Tzu-Wei Li
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 or any I 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) rms leket notification. The FDA finding of substantial equivalence of your device to a legally premated 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,
B. Gimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use Form
Page 1 of 1
510(k) Number (if known):_
Device Name: Microlife Automatic Blood Pressure Monitor , Model BP3AC1-1PC Indications for Use:
The Microlife Automatic Blood Pressure Monitor, Model BP 3 AC1-1 P C i s a d evice intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use _ X (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.B. Commemor