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K Number
K955849
Device Name
DIB INFUSOR
Manufacturer
NOVACON CORP.
Date Cleared
1996-08-05

(222 days)

Product Code
MEB
Regulation Number
880.5725
Type
Traditional
Panel
HO
Reference & Predicate Devices
K930404
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the DIB Infusor is similar to that of other legally marketed elastomeric infusion pumps.

Device Description

The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.

AI/ML Overview

It is not possible to extract the requested information from the provided text. The document "K955849" describes a medical device called the "DIB Infusor" and its intended use, manufacturing, and prior testing/clinical experience. However, it does not contain the specific details about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested.

The provided text discusses:

  • Standards and Intended Use: States the DIB Infusor uses biocompatible materials and will conform to the AMMI Draft Infusion Device Standard. Its intended use is similar to other legally marketed elastomeric infusion pumps.
  • Manufacturing and Testing Procedures: Mentions manufacturing in a clean room, GMP regulations, and 100% testing of silicone balloons to an internal pressure.
  • Prior In-Vitro Tests and Clinical Experience: Lists several studies and clinical uses, but these documents are only referenced as "attached" and their content is not provided.

To answer your request, detailed study reports with acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications would be needed. This information is not present in the given "SUMMARY of SAFETY and EFFECTIVENESS" document.

§ 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).