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K Number
K955546
Device Name
PATIENT MONITOR MODEL 405P
Manufacturer
IVY BIOMEDICAL SYSTEMS, INC.
Date Cleared
1996-08-16

(255 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.

Device Description

The Model 405P physiological monitor is the same in function and operation as the F.D.A. approved Ivy Biomedical Systems Model 405T physiological monitor, with the following exceptions:

  • The replacement of the flat panel electrolumiesent display with a Liquid Crystal Display and LED's . for numerics
  • The deletion of the option to monitor Temperature. .
  • The deletion of the option to monitor invasive blood pressure. .
    The 405P monitors the following parameters: ECG, Heart Rate, Pulse Oximetry and Non-Invasive Blood Pressure.
AI/ML Overview

This document is a 510(k) Summary for the Ivy Biomedical Systems Model 405P physiological monitor, prepared on October 12, 1995. It states that the 405P model is substantially equivalent to the previously FDA-approved Model 405T, with a few exceptions.

Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance details, or ground truth establishment.

The document discusses the substantial equivalence of the 405P to the 405T model, highlighting the following differences:

  • Replacement of the electroluminescent display with a Liquid Crystal Display (LCD) and LEDs for numerics.
  • Deletion of the option to monitor Temperature.
  • Deletion of the option to monitor invasive blood pressure.

The summary asserts that these changes "have no adverse effect on the safety or effectiveness of the device when used as labeled."

The 405P monitors ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure, targeting use in Emergency Rooms, Surgery, Recovery Rooms, Intensive Care, and surgical applications for both adult and neonate patients.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and device performance or details about the study, as this information is not present in the provided text.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).