Fluorescent Video System risk class

[Barbora]

Hello all,

I wonder if the fluorescent endoscopic video system is still class I?

Thank you for your answers.

 

[dgrainger]

When was it class I?

 

[Barbora]

So can you please help me which risk class the device belongs to? Fluorescent edoscopic video system - for the imaging the fluorescent dye indocyanine green, light source with the near infrared light and a UHD camera is used.

 

[dgrainger]

Would be at least Class IIa. What body part are you imaging and how will it be done surgically or via body orifice?

MDCG 2021- 24 gives some examples

Rule 5:​

"Endoscopes using a light source in the visible spectrum" as Class IIa​

Rule 6​

"Neuro-endoscopes" - Class III​

Rule 10​

"Active devices intended for diagnosis and monitoring are classified as class IIa: if they are intended to supply energy which will be absorbed by the human body"​

​

 

[Barbora]

The applications would be various - gynaecology procedures (laparoscopic procedures/uterine or cervical cancer procedures/identifiying metastatic diseased lymph nodes), endometriosis procedures (bowel endometriosis surgery/visualization of vascularization of rectal wall), cholecystectomy (cholangiography, biliary duct visualization and perfusion assessment) or colorectal surgery.

The type of surgery would also determine whether it should be performed surgically or through a body orifice.

I have been told that this video system can be classified as risk class I, as it can function on its own without the fluorescent dye applied.

 

[dgrainger]

You need to look at the rules that may apply to your device and all the use cases you are considering.

• Is it for transient or short term use or both? (short term is >60 min) - may bring in Rule 7
• Is it invasive or surgically invasive or both? - you say both - Rule 5 and 6
• Is the infra red part of the device or connected to it?
• Is it specifically for use in direct contact with CCS or CNS? - sounds like not.
• Is it an Active devices intended for diagnosis - sounds like it is. - Rule 10

You then need to select the highest that applies to your device.

 

[Barbora]

This was very helpful, thank you!