The UA-767BT 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-767BT memory. UA-767BT 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. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UA-767BT 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).

Device Description

The A&D Medical UA-767BT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UA-767BT 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 are determined by oscillometric method. The deflation rate is controlled by a preset 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 are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the A&D Medical UA-767BT Digital Blood Pressure Monitor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (SP-10 Section)	Description	Reported Device Performance
4.1.1	General requirements	Conformed
4.1.2.1	Device labeling	Conformed
4.1.2.2	Outer container labeling	Conformed
4.1.3	Information manual	Conformed
4.1.4.1	Component replacement information	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 resistance	Conformed
4.2.4.1	Voltage range	Conformed
4.2.4.2	Life (durability)	Conformed
4.3.1.1	Maximum cuff pressure	Conformed
4.3.1.2	Cuff deflation rate	Conformed
4.3.2	Electrical safety	Conformed
4.3.3	Conductive components safety	Conformed
4.4.1	Pressure indicator accuracy	Conformed
4.4.2	Overall system efficacy (measurement accuracy)	Conformed
4.4.2.1	Auscultatory method as the reference standard (for overall system efficacy)	Conformed
4.4.2.2	Intra-arterial method as the reference standard	Not applicable
4.4.3	Battery-powered devices requirements	Conformed
4.5	Requirements for devices with manual inflation systems	Conformed

Note: The document explicitly states, "UA-767BT is not clinically tested." Instead, it relies on demonstrating conformance to the NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance." The performance reported is "Conformed" for each section, indicating the device met the requirements outlined in the standard for non-invasive blood pressure monitors.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided document. The document refers to conformance to AAMI SP-10 tests, which typically involve a specified number of subjects and measurements, but these details are not provided here.
Data Provenance: Not explicitly stated. The tests are described as conforming to the AAMI SP-10 standard, which implies a standardized testing methodology. However, details about the location or specifics of the test data (e.g., country of origin, retrospective/prospective) are not included.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not explicitly stated. For the "Overall system efficacy" (4.4.2) and "Auscultatory method as the reference standard" (4.4.2.1) criteria, the AAMI SP-10 standard typically requires measurements to be taken by trained observers (experts) using a reference method. However, the exact number and qualifications of these observers are not detailed in this submission.
Qualifications of Experts: Not explicitly stated. For the auscultatory method, the experts would typically be trained clinicians (e.g., physicians, nurses) proficient in taking manual blood pressure measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. In AAMI SP-10 testing, when multiple observers are used for the auscultatory reference, there are usually methods for reconciling differences in their readings (e.g., averaging, discarding outliers, or requiring consensus). However, this document does not describe the specific adjudication method used.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers or interpretation of medical images/data in a way that would necessitate such a study. The product is a direct measurement device rather than an interpretive aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the device's performance was evaluated in a standalone manner. The entire testing listed in the table under "DEVICE TESTING" refers to the performance of the UA-767BT device itself, measuring its accuracy and conformance to the AAMI SP-10 standard without human intervention in the measurement process (other than operating the device as intended for a non-invasive blood pressure monitor). The key statements are: "UA-767BT is not clinically tested" and "It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This indicates technical performance validation against a standard, not a human-in-the-loop study.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The ground truth for the device's accuracy (specifically for blood pressure measurements) was established through the auscultatory method as the reference standard (SP-10 Section 4.4.2.1). This method involves trained human observers using a stethoscope and sphygmomanometer to manually determine systolic and diastolic blood pressure, which is considered the gold standard for non-invasive blood pressure measurement against which automated devices are compared.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Its function is based on oscillometric principles and pre-programmed algorithms, not a learning model developed from a data set. The document states it uses "identical software codes and pressure detection related hardware as the predicate devices."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning. The device's underlying algorithms are based on established oscillometric principles and inherited from a predicate device, which would have undergone its own validation based on the auscultatory method as ground truth.

Summary

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MAY 1 9 2004

Attachment (D) 510(k) Summary

1. DATE PREPARED

February 10, 2004

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@aandmedical.com

3. DEVICE NAME

Proprietary Name:	A&D Medical UA-767BT Digital Blood Pressure Monitor
Common/Usual Name:	Blood Pressure Monitor
Classification name:	Non-invasive blood pressure measurement System21 CFR 870-1130, Class II, 74DXN.

DEVICE DESCRIPTION AND INTENDED USE 4.

The A&D Medical UA-767BT 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

6. TECHNOLOGICAL CHARACTERISTECS

UA-767BT 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 are determined by oscillometric method. The deflation rate is controlled by a preset

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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 are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.

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. UA-767BT is not clinically tested. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.

SP-10	Section Title	Test Results &Comments
Section #
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 manualinflation systems	Conformed

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Image /page/2/Picture/2 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" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines resembling a bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

A&D Engineering, Inc. c/o Mr Jerry Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95025

Re: K040371

Trade Name: UA-767BT 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: May 05, 2004 Received: May 06, 2004

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 prodicate 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 - Mr. Jerry Wang

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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International 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 vours,

Neil Rf Ogden
Bram D. Zuckerman, M.D. for

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment (B) Indications for Use Statement

510(k) Number (if known): __ K04037 |

Device Name: A&D Medical UA-767BT Digital Blood Pressure Monitors

Indications for Use:

Nielko Ogl for DDR
(Division Sign Off)

of Cardiovascular Devi

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).