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K Number
K040899
Device Name
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
Manufacturer
MEDEX, INC.
Date Cleared
2004-04-30

(24 days)

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

The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:

  • in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
  • in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
  • in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
  • in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
  • inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.

The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Medex, Incorporated regarding their Medex 3000 Series MRI Syringe Infusion Pump. This document does not include information about acceptance criteria or a study that proves the device meets those criteria.

The letter confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the device.

Therefore, I cannot provide the requested information based on the input text. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with/without AI assistance.
  6. Information about a standalone (algorithm only) performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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).