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K Number
K981576
Device Name
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
Manufacturer
HEWLETT-PACKARD GMBH
Date Cleared
1998-07-17

(74 days)

Product Code
MHX
Regulation Number
870.1025
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:

  • Can measure and display multiple physiological parameters' and a) waves' of one patient, and can generate alarms and printouts based on those measurements.
  • Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
      1. List of supported measurements
      • (a) ECG
      • (b) Respiration
      • Invasive blood pressure (c)
      • Non-invasive blood pressure (d)
      • SpO2 and Pleth (e)
      • Temperature (f)
Device Description

The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive pressure, and temperature. This [510(k)] modification adds a new feature (patient population) to the M3000A/M3046A Compact Portable Patient Monitor: the capability of monitoring neonatal patients is added to the noninvasive blood pressure measurement. The M3000A/M3046A Compact Portable Patient Monitor contains software.

AI/ML Overview

Based on the provided text, the document is a 510(k) summary and an FDA letter regarding a patient monitor, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information about acceptance criteria or a study proving the device meets them from this document.

The document states:

  • "The M3000A/M3046A Compact Portable Patient Monitor was fully validated."
  • "The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness, and intended use."

However, it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or details of a test set.
  3. Information on experts, ground truth establishment, or adjudication methods.
  4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement.
  5. A standalone algorithm performance study.
  6. The type of ground truth used (e.g., pathology, outcomes data).
  7. Training set sample size or how its ground truth was established.

This document is a regulatory approval notice, not the technical validation report itself.

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.