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K Number
K993888
Device Name
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
Manufacturer
A & D ENGINEERING, INC.
Date Cleared
1999-12-20

(34 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.

Device Description

Digital Blood Pressure Monitors

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report detailing acceptance criteria and performance data. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available within this document.

The letter explicitly states: "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... to legally marketed predicate devices..." This indicates that the device's clearance is based on its substantial equivalence to existing devices, rather than a detailed clinical study with the specified metrics.

The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies.
  6. Results of standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The "Indications for Use" section (Image 2) merely describes the intended use of the device: "to be used by end users who are eighteen (18) years and older at home and doctor/nurse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC & UA-779T uses the oscillometric method to conduct the measurement." This is not a performance metric or acceptance criterion.

§ 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).