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The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media and central venous pressure monitoring.

When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.

The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial catheter intended to provide the means for infusion of solutions, measuring pressure, delivering contrast media and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.

The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5 French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for the distal; medial and proximal exit at the ports. The catheter is manufactured from a base material of barium sulfate-filled polyurethane. Barium sulfate makes the material more radiopaque. Carbon, silver, and platinum are added to the base material. The silver and platinum render the polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial agent is silver, which is ionized and electrochemically released from the inside and outside surfaces of the catheter material into the lumens and subcutaneous space. The Oligon polymer technology provides antimicrobial protection on both the inside and outside of the catheter.

With the use of the Oligon material, the catheter has demonstrated significant antimicrobial activity, within 48 hours after inoculation, against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa, Candida glabrata, and VRE (Enterococcus faecium)

The provided text describes the 510(k) summary for the PreSep Oligon Oximetry Catheter (K160645). However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document discusses:

• The device's trade name, regulation, and classification.
• Indications for Use, which are for hemodynamic monitoring, blood sampling, infusion, continuous oxygen saturation monitoring, pressure injection of contrast media, and central venous pressure monitoring for short-term use (<30 days).
• A comparison to predicate devices, noting the specific difference being an indication expansion to include pressure injection of contrast media and MR Safe labeling.
• Functional and safety testing performed: blood oxygenation, tensile, fatigue, flow rate, tip buckling, radiopacity, pressure, silver release, and MRI testing.

There is no mention of:

• Acceptance criteria in a quantitative sense with reported performance values.
• Sample sizes for test sets (beyond the generic list of functional tests).
• Data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML context.
• Training set details.

This document pertains to a physical medical device (catheter) and its substantial equivalence to a predicate device, focusing on its physical and functional properties, not an AI/ML software device. Therefore, it cannot be used to answer the prompt's specific requirements geared towards AI/ML device validation.

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