Disposable glass catheter for Gastroesophageal pH-metry

The “Jubileum” probe is a disposable probe for measuring gastroesophageal pH with a glass sensor
DM “Jubileum” is a nasogastric catheter that is introduced nasally up to the esophagus. It remains in place, measuring the values of the esophageal pH, for a duration of 24 hours.

The DM “Jubileum” is connected via a LEMO or 8-pin PLUG connection cable to a digital datalogger that stores the pH-metric data

The DM “Jubileum” is a CE marked product and is sold in sealed disposable blisters made of medical and PVC paper.

The single-use product is supplied in boxes of 10 pieces each.

The connection cable is reusable and is sold separately in sealed blisters made of the same materials as the probe blister. It is sold in single units

INTENDED USE AND RISK CLASS

The “Jubileum” gastroesophageal pH-metry catheters produced by Microbioprobe and Telemedicine s.r.l. are intended for clinical use aimed at the diagnosis of esophageal reflux disease and dysfunction of esophageal function. The catheter under examination is, as mentioned, a naso-gastric tube that is introduced nasally into the esophagus.
The Jubileum glass disposable pH-metry catheters are of two types:
1) “Jubileum 1.8”. This catheter has only one measuring point located on the tip of this. Its REF code is php 180
2) “Jubileum 2.2”. This catheter has two measurement points. The first is positioned on the tip while the second is positioned at three distances from the first which are respectively 5, 10 or 15 cm.
To identify the three different provisions, a suffix is ​​added to the name of the catheter 5, 10 or 15 depending on whether the distance between the two measuring points is 5, 10 or 15cm. So we will have the catheter “Jubileum 2.2-5”, “Jubileum 2.2-10” and “Jubileum 2.2-15”. Its REF code is php220-5, php220-10 and php220-15 respectively.

Both types of pH-metry catheters “Jubileum” are made to allow easy introduction of DM which is of a naso-gastric type. For this purpose, a biocompatible material is used for both, with a flexibility suitable for its correct introduction.
The difference between the two types of catheters consists exclusively in the presence of one or two channels of pH measurement.
This difference naturally involves different steps to be achieved during catheter production.

The DM in question must be used by specialized medical or paramedical personnel who are identified by the clinical-diagnostic structure.

The class of risk of such catheters falls into class IIa or, according to Annex IX of Directive 93/42 / EEC, invasive devices in natural orifices; (class IIa)
The classification assigned to the DM as belonging to class IIa is consistent with the assessments made by the company. The DM “Jubileum” produced by Microbioprobe, in fact, is a single-use, short-term, invasive, non-active catheter.
These characteristics include the DM under analysis in class IIa according to the classification rules set out in Annex IX.
According to the definition of the classification criteria, the DM results to be:

Short term; intended to be used as a rule for a continuous duration of less than 30 days (see 1.1, Annex IX)
Invasive; device that partially or completely penetrates the body through a body orifice (ref 1.2, Annex IX)

Inactive; is not dependent, for its operation, from a source of electricity or other energy, different from that generated directly by the human body (ref 1.4, all.IX)

Turning to the classifications, rule 5 regarding invasive devices places our DM in class IIa since it is intended for short-term use (ref.2.1 rule 5).