(101 days)
The UA-767PBT is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767PBT memory. UA-767PBT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, PC, a modem, or a printer. UA-767PBT uses the oscillometric method to conduct the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
The A&D Medical UA-767PBT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
UA-767PBT uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures arc determined by oscillometric method. The deflation rate is controlled by a presct mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the blue "START" button. The measurement results arc displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point. UA-767PBT measures blood pressure and pulse rate even when an irregular heartbeat occurs.
Acceptance Criteria and Study for A&D Medical UA-767PBT Digital Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI SP-10 Section #) | Section Title | Reported Device Performance |
|---|---|---|
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-arterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual inflation systems | Conformed |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set of patients or readings. However, it indicates that the device's performance was evaluated against the NIST/AAMI SP-10 standard. This standard specifies requirements for non-invasive automated sphygmomanometers, which typically involve a certain number of subjects and measurements to demonstrate accuracy. Without further details of the specific test report, the exact sample size for the clinical validation cannot be determined from this summary.
The data provenance is not explicitly stated in terms of country of origin. The study is described as meeting the AAMI SP-10 standard, which is an American national standard. The nature of the study (retrospective or prospective) is also not specified, but AAMI SP-10 typically involves prospective clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the auscultatory method was used as the reference standard (ground truth) for evaluating the device's overall system efficacy (Section 4.4.2.1 of AAMI SP-10). The AAMI SP-10 standard generally requires trained human observers (e.g., medical professionals) to perform the auscultatory measurements simultaneously with the automated device.
However, the specific number of experts and their individual qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this 510(k) summary. The standard usually mandates that these observers are blinded to the device's readings and are rigorously trained in the auscultatory method.
4. Adjudication Method for the Test Set
The document does not explicitly state an "adjudication method" in the context of expert consensus or disagreement. For the auscultatory method as a reference standard, the AAMI SP-10 standard often involves a technique where two or more trained observers simultaneously measure blood pressure using a mercury sphygmomanometer, and their readings must agree within a certain tolerance. If they disagree, a third observer might be involved, or the reading might be discarded. However, the specific "2+1, 3+1, none" adjudication detail is not provided in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and therefore no effect size of human reader improvement with AI assistance is reported. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The assessment of the A&D Medical UA-767PBT digital blood pressure monitor according to the NIST/AAMI SP-10 standard evaluates the device's accuracy in measuring blood pressure and pulse rate directly. This is an assessment of the algorithm and hardware performance without a human in the loop for interpretation or decision-making beyond operating the device. The device's oscillometric method is an automated algorithm.
7. The Type of Ground Truth Used
The type of ground truth used for evaluating the overall system efficacy (accuracy) was the auscultatory method (as specified in AAMI SP-10 Section 4.4.2.1). This method is considered the clinical reference standard for non-invasive blood pressure measurement and is performed by trained medical professionals using a stethoscope and a mercury sphygmomanometer.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. Blood pressure monitors like this typically utilize established oscillometric algorithms that may have been developed and refined over many years using large datasets, but the 510(k) summary focuses on the validation of the specific device against recognized standards, rather than detailing the development of the underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
Since information about a "training set" is not provided, the method for establishing its ground truth is also not described in this document.
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Attachment (D) 510(k) Summary
DATE PREPARED 1.
February 4, 2005
2. SPONSOR INFORMATION
A&D Engineering, Inc. Mr. Jerry Wang 1555 McCandless Drive, Milpitas, CA 95035 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang(a)andmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D Medical UA-767PBT Digital Blood PressureMonitor |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System21 CFR 870-1130, Class II, 74DXN. |
4. DEVICE DESCRIPTION AND INTENDED USE
The A&D Medical UA-767PBT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
5. PREDICATE DEVCIE
It is substantially equivalent to the following device:
A&D UA-767PC, FDA 510(k) K982481. Issued on Jan. 13, 1999 A&D UA-767BT, FDA 510(k) K040371. Issued on May 19, 2004 A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002
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TECHNOLOGICAL CHARACTERISTECS 6.
UA-767PBT uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures arc determined by oscillometric method. The deflation rate is controlled by a presct mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the blue "START" button. The measurement results arc displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point. UA-767PBT measures blood pressure and pulse rate even when an irregular heartbeat occurs.
DEVICE TESTING 7.
A&D Medical UA-767BT digital blood pressure monitor meets NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". Please refer to the table below for the list of AAMI SP-10 tests. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.
| SP-10Section # | Section Title | Test Results &Comments |
|---|---|---|
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-aeterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual inflation systems | Conformed |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A&D Engineering, Inc. c/o Mr Jerry Wang Director of Engincering & OA 1555 McCandless Drive Milpitas, CA 95025
Re: K043217
Trade Name: UA-767PBT Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 04, 2005 Received: February 07, 2005
Dear Mr. Wang:
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 adultcration.
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, RDAAway publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Jerry Wang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DTC issual.es sour device complies with other requirements of the Act that FDA has made a decemmandions administered by other Federal agencies. You must of any rederal statutes and regulations and limited to: registration and listing (21 comply with an the rive s requirements, on the manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients over device as described in your Section 510(k) I mis letter will anow you to organ manage of your device of your device to a legally premarket notineation: "The PDF intentigstification 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 If you desire specific at 100 is 100 (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Come of Commarket notification" (21CFR Part 807.97) you may obtain. INflouranding of reference to prour responsibilities under the Act may be obtained from the Other general mionmation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B.Zimmerman, MD
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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Indications for Use
510(K) Number (if known): K043217
Device Name: A&D Medical UA-767PBT Digital Blood Pressure Monitors
Indications For Use:
The UA-767PBT is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767PBT memory. UA-767PBT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, PC, a modem, or a printer. UA-767PBT uses the oscillometric method to conduct the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-
(21 C)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummen
Offision Sign-Off) Division of Cardiovascular Devices 510(k) Number Kost 201
Page 1 of |
x
§ 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).