LIFESOURCE MODELS UA-787, UA 787PC, UA-787T by A & D ENGINEERING, INC.

Measuring systolic and diastolic blood pressure and pulse rate in adult patients (18 years Mcasuring Systeme and Charlerse office. The arm circumference should be between 5.1" and 17.7" (13 cm to 45 cm).

Device Description

Not Found

AI/ML Overview

This FDA premarket notification (510(k)) filing for the LifeSource Models UA-787, UA-787PC, and UA-787T Digital Blood Pressure Monitors does not include detailed information about specific acceptance criteria, a comprehensive study report, or the methodology for establishing ground truth as typically requested for AI/ML device evaluations.

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device under the 510(k) pathway, rather than providing a detailed technical performance study against pre-defined acceptance criteria with specific statistical measures.

Therefore, many of the requested details cannot be extracted directly from the provided text. However, based on the nature of a blood pressure monitor and standard validation practices, we can infer some general information or state that the specific details are not provided.

Here's an attempt to answer the questions based on the available information and general knowledge of medical device approvals:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. For a blood pressure monitor, typical performance acceptance criteria would relate to accuracy (e.g., standard deviation of difference, mean difference) and precision when compared to a reference measurement method (e.g., auscultatory method). Standards like ISO 81060-2 are commonly used for validating automated sphygmomanometers.
Reported Device Performance: Not explicitly detailed in the provided text. The document states the device measures "systolic and diastolic blood pressure and pulse rate." Performance data, such as accuracy statistics (mean difference, standard deviation), are not provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text. Clinical validation studies for blood pressure monitors typically involve a specific number of subjects (e.g., AAMI/ISO standards recommend at least 85 subjects).
Data Provenance: Not specified in the provided text. It's highly likely such studies would be prospective clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Ground Truth Experts: Not specified. For blood pressure monitors, the "ground truth" is typically established by trained human observers using the auscultatory method with a mercury sphygmomanometer, often performed by at least two independent observers. Their qualifications would typically involve specific training in blood pressure measurement according to relevant clinical standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not specified. If multiple human observers are used for ground truth, an adjudication method (e.g., averaging, or a third expert if discrepancies arise) would typically be employed.

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 study is not applicable as this is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. This device does not involve "human readers" in the context of interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, this is inherently a "standalone" device. Its performance is the algorithm's performance (i.e., the device's measurement) compared to a reference method. The document implicitly supports that a standalone performance evaluation was conducted as part of the substantial equivalence claim, but the details of that evaluation are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Inferred to be a comparison to a reference measurement method, most commonly the auscultatory method performed by trained human observers using a mercury sphygmomanometer, which could be considered a form of "expert measurement" or "expert consensus" on the reference values.

8. The sample size for the training set

Training Set Sample Size: Not applicable/not specified. This device likely uses traditional algorithms and calibration procedures rather than AI/ML requiring a distinct "training set" in the context of machine learning. If it used statistical models, the data used for developing those models would not typically be called a "training set" in the same way as for deep learning.

9. How the ground truth for the training set was established

Training Set Ground Truth: Not applicable/not specified, for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the shape of a bird or wing-like structure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

JUL 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A & D Engineering, Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth meeting, PA 19462

Re: K012013

Trade Name: LifeSource Models UA-787, UA-787PC, and UA-787T Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: DXN Dated: June 27, 2001 Received: June 28, 2001

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 stired in the 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). 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 provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( reading your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Mr. Robert Mosenkis

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothloated. THE I Drive 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 and 11 you active specific and in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your respect 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,

toello

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: A&D Medical LifeSource UA-787, UA-787PC, & UA-787T Digital Blood Pressure Monitors

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number	K012013

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).