Disposable catheter for esophageal and rectal manometry
The EU-CAT catheter is a single-use product for measuring esophageal and rectal pressure based on open-tip technology.
The EU-CAT catheter for esophageal manometry is a nasogastric catheter that is introduced nasally to the esophagus. The rectal one is introduced to the anal area up to the area of the rectum to be investigated.
It uses a new generation of biocompatible, hypoallergenic, non-toxic material.
The mechanical peculiarities of this plastic material consist in the possibility of easy modification during the working phase which allows to give the catheter characteristics of flexibility and softness more suited to the type of investigation it is intended for.
It also employs an innovative balloon for rectal analysis made of thermoplastic rubber which on the one hand is Latex free and on the other hand has better compliance features than conventional materials.
INTENDED USE AND RISK CLASS
The EU-CAT esophageal and rectal manometry catheters produced by Microbioprobe and Telemedicine s.r.l. they are intended for clinical use aimed at the diagnosis of esophageal reflux disease and dysfunctions of esophageal and rectal motility.
There are four types of open-tip “EU-CAT” esophageal and rectal manometry catheters.
Each type of catheter is then divided into a range of products that vary only for the configuration and arrangement of the measuring points.
Each catheter has been coded (see section 5) and the configuration of the catheter itself is shown on the labeling.
In the DM in question the measuring point is constituted by the hole on the external surface of the catheter stem that defines the point of the esophagus or of the rectum to be investigated.
These methods are standardized and have long been included in clinical protocols for diagnosing these diseases.
All types of “EU-CAT” manometry catheters are designed to allow easy introduction of DM which is of a naso-gastric or anorectal type. For this purpose, a biocompatible material is used for both, with a flexibility suitable for its correct introduction.
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 “EU-CAT” DM produced by Microbioprobe, in fact, is a single-use, temporary, 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:
1) Temporary; intended to be used normally for a continuous duration of less than 60 minutes (see 1.1, Annex IX)
2) Invasive; device that partially or completely penetrates the body through a body orifice (ref 1.2, Annex IX)
3) Not active; 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 concerning invasive devices places our DM in class IIa since it is intended for short-term use connected to an active device (ref.2.1 rule 5).