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K Number
K014141
Device Name
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
Manufacturer
DIGIBIO TECHNOLOGY CORP.
Date Cleared
2002-09-13

(270 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

DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the DIGIBIO Digital Blood Pressure Monitor Model D11. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

This document is primarily an FDA clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines the regulation number, product code, and indications for use, but typically 510(k) summaries do not include the in-depth technical and clinical study details you're looking for.

To answer your questions, I would need access to the actual 510(k) submission document itself, or a clinical study report specific to the DIGIBIO Digital Blood Pressure Monitor Model D11. These documents would contain information on:

  • Acceptance Criteria: Often based on standards like ISO 81060-2 for non-invasive sphygmomanometers.
  • Device Performance: Data from verification and validation studies.
  • Sample Sizes: For both training and test sets.
  • Data Provenance: Details about the clinical trials.
  • Ground Truth Establishment: How reference measurements were obtained (e.g., expert-manual readings, invasive measurements for blood pressure).
  • Expert Qualifications: If applicable for human expert-based ground truth.
  • Adjudication Method: If multiple experts were involved.
  • MRMC or Standalone Studies: For AI/algorithm-based devices, which this blood pressure monitor is not.

Since the provided text does not contain this information, I cannot generate the table or answer the specific questions.

What the provided document does tell us:

  • Device Name: DIGIBIO Digital Blood Pressure Monitor Model D11
  • Indications For Use: Non-invasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.
  • Regulatory Classification: Class II (two)
  • Product Code: DXN
  • Regulation Number: 21 CFR 870.1130 (Non-invasive Blood Pressure Measurement System)
  • Regulatory Pathway: 510(k) premarket notification (substantial equivalence)
  • Use Environment: Over-The-Counter Use (indicated by "X" next to "Over-The-Counter Use")

If you have access to the actual 510(k) submission (often available through the FDA public database if you search for K014141), or a related clinical study report, I would be happy to analyze that information to answer your questions.

§ 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).