(17 days)
The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irreqular heart beat signal has been detected.
This document describes the 510(k) submission for the Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50). The primary claim of substantial equivalence is based on its similarity to a previously cleared device, Model BP2BI0, with the addition of an irregular heartbeat detection function inherited from another cleared device, Model BP3BT0-AP.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it refers to compliance with a recognized standard, ANSI/AAMI SP10: 2002 "National Standard for Noninvasive Sphygmomanometers".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Blood Pressure Measurement) | "Relevant tests in accordance with ANSI/AAMI SP10: 2002 'National Standard for Noninvasive Sphygmomanometers' had been performed in the Manufacturer, Electric, Automatic, Sphygmomanometers and were addressed and tested." |
| Safety and Effectiveness (General) | "Electrical, mechanical and environmental test results, the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', and the ANSI/AAMI Voluntary Standard, SP10: 2002 test results." |
| Irregular Heartbeat Detection | Functionality described as "same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411." |
2. Sample Size for Test Set and Data Provenance
The document states:
"Since the cleared device, BP2BI0, and the program codes of the BP3MR1-H(BP A50) remain unchanged and the fundamental scientific technology of the modified device is the same as the 510(k) cleared device, BP2BI0. Clinical performance of the modified device will remain unchanged; therefore another clinical test for the modified device, BP3MR1-H(BP A50) is not required."
This indicates that no new clinical test set was used for the BP3MR1-H(BP A50) to demonstrate its blood pressure measurement accuracy. The clinical performance is inferred from the predicate device (BP2BI0). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a new test set for the BP3MR1-H(BP A50) device is not provided.
For the irregular heartbeat detection feature, it is stated that the technology is the "same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411." To understand the sample size and data provenance for the irregular heartbeat detection, one would need to refer to Exhibit#3, which contains the 510(k) summary for BP3BT0-AP. This information is not available in the provided text.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not provided. If an ANSI/AAMI SP10 study was performed for the predicate device (BP2BI0), it would typically involve trained observers (likely clinicians or medical professionals) taking reference measurements, but the specifics are not detailed here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.
4. Adjudication Method for Test Set
Since no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not applicable/provided. For studies adhering to ANSI/AAMI SP10, there are specific requirements for agreement between observers, which implicitly involves a form of "adjudication" if discrepancies arise, but the details are not given here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted, as the device is a standalone blood pressure monitor and does not involve human readers interpreting its output in a comparative AI-assisted vs. non-AI-assisted scenario. Therefore, not applicable, and no effect size for human readers with/without AI assistance is provided.
6. Standalone Performance Study
A standalone performance evaluation (algorithm only without human-in-the-loop) for blood pressure measurement accuracy was implied to have been conducted for the predicate device (BP2BI0) in accordance with ANSI/AAMI SP10: 2002. The current device's performance is asserted to be unchanged due to identical programming and fundamental technology.
A standalone performance evaluation for the irregular heartbeat detection feature was likely conducted for the predicate device BP3BT0-AP, as the technology is stated to be derived from it. The specifics are not provided in the given text but would be in the 510(k) for BP3BT0-AP.
7. Type of Ground Truth Used
For blood pressure measurement accuracy, the ground truth for studies adhering to ANSI/AAMI SP10 typically involves simultaneous auscultatory measurements performed by trained observers using a mercury manometer or a validated reference device. This is a form of expert consensus/reference measurement.
For irregular heartbeat detection, the ground truth for the BP3BT0-AP (from which this device's technology is derived) would typically involve a gold standard like electrocardiogram (ECG) recordings. This implies outcomes data/reference standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning, as this is a traditional medical device (oscillometric blood pressure monitor) and not explicitly an AI/ML-driven device in the modern sense. The "program codes" for the BP3MR1-H(BP A50) are stated to be "unchanged" from the predicate BP2BI0, implying that any underlying algorithms were developed and "trained" (or validated) as part of the predicate device's clearance. Therefore, a specific training set size for this device is not provided or explicitly applicable in the context of its submission strategy.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, the concept of a "training set" with distinct ground truth establishment for this device is not directly applicable given the submission strategy of substantial equivalence to a predicate. The underlying algorithms for the core oscillometric measurement and irregular heartbeat detection would have been developed and validated using relevant physiological data (e.g., simultaneous auscultatory readings or ECGs) in accordance with recognized standards for the predicate devices. The specifics of how this ground truth was established for the predicate devices are not detailed in the provided text.
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Exhibit#1
510(K) SUMMARY
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. KO ? 3397
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland
Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: April 28, 2007
2. Name of the Device:
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50)
Information for the 510(k) Cleared Device (Predicate Device): 3.
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP2BI0, K#970139. Pis refer to Exhibit#2 for 510(K) summary of BP2Bl0. Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP3BT0-AP, K#041411.Pls refer to Exhibit#3 for 510(K) summary of BP3BT0-AP.
Device Description: 4.
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 detects the appearance of irregular heartbeat during measurement and
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Exhibit#1-1
DEC 2 0 2007
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the irregular heart beat symbol " irreqular heart beat signal has been detected.
5. Intended Use:
The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Pls also refer to the "Indications for Use" statement, which is attached as Exhibit#B.
Comparison to the 510(k) Cleared Device (Predicate Device): ે.
The modified model BP3MR1-H(BP A50) has the same intended of use and is similar in terms of design to our original 510(K) cleared device, model BP2BI0.
The model BP3MR1-H(BP A50) and the model BP2Bl0 are identical in functionality and performance. The solely differences between these two models are the additional features such as irregular heartbeat detection function. However, the difference does not affect the accuracy and normal use of this device. Pls refer to Exhibit#4.
Irregular heartbeat detection technology is same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411. Pls refer to Exhibit#3 for the summary of BP3BT0-AP.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 equirements.
The following testing was conducted:
- a. Reliability Test Storage test
- b. Reliability Test Operating test
- Reliability Test Vibration test C.
- d. Reliability Test Drop test
- e. Reliability Test Life test
fase 2 of 3
Exhibit#1-2
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- f. EMC 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 Manual Blood Pressure Monitor, Model our concludion that millers.it be all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
Relevant tests in accordance with ANSI/AAMI SP10: 2002 "National Standard for Nelevant tests in accordance will Sphygmomanometers" had been performed in the Manufi, Eloctionio of Automations were addressed and tested. Since the cleared device, of 2Dio. And the program codes of the BP3MR1-H(BP A50) remain modouromont aligon with the fundamental scientific technology of the modified device is the anonangod and the 110(k) cleared device, BP2Bl0. Clinical performance of the modified device will remain unchanged; therefore another clinical test for the modified device, BP3MR1-H(BP A50) is not required. Please refer to the Exhibit#10 for a copy of this signed statement by a company designated individual.
g. Conclusions:
It has been demonstrated that there is no difference between the Microlife Upper Arm Manual Blood Pressure Monitor Model BP3MR1-H(BP A50) and the predicate model BP2B10 in terms of safety and effectiveness based on electrical, mechanical and environmental test results, the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and the ANSI/AAMI Voluntary Standard, SP10: 2002 test results.
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Exhibit#1-3
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
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: K073397
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 30, 2007 Received: December 3, 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. Iisting 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 that I Dr has intatutes and regulations administered by other Federal agencies. You must or uny I outral 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,
Blymmima for
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
510(k) Number (if know
510(k) Number (if known): K073367
Device Name: Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50)
Indications For Use:
The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) 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 detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
· rescription 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)
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Bhumima
Division Sign-Off Division of Cardiovascular Devices 510(k) N
§ 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).