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K Number
K963136
Device Name
PACER MODEL 100 INFUSION CONTROLLER
Manufacturer
HEALTH WATCH, INC.
Date Cleared
1997-10-10

(423 days)

Product Code
LDR
Regulation Number
880.5725
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pacer Model 100 Infusion Controller is indicated for use in:

    1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36" of water) is not required.
    1. The delivery of intravenous drugs where positive pressure (above 36" of water) is not required.
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacer Model 100 Infusion Controller." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).