Cataract surgery is a procedure to remove natural but damaged cloudy lenses or cataracts from the eye to improve vision. To successfully conduct the Phacoemulsification surgery generally an ultrasonic device is used.
Intended use: The device is used to emulsify the cataract by ultrasonic vibrations of a Phaco tip or needle that is inserted into the anterior chamber of the eye. Through irrigation of BSS and aspiration of emulsified lens pieces in a fluidic circuit, the devices remove the cataract progressively. The surgery duration will come under the transient classification of fewer than 60 minutes. The product also integrates a vitrectomy cutter and a diathermy probe for coagulation to halt bleeding.
I need to be sure about the MDR classification but in all probability, it may be coming under class IIb as applicable to ‘surgical ultrasound devices. Please give a justifiable answer.
5 thoughts on “Phaco Emulsification Device”
As per EU MDR 2017/745, Annexure VIII Classification Rules, Chapter III, Rule 9 for Active device, Phaco Emulsification device is classified as IIb.
Justification as per MDR 2017/745 – All active therapeutic devices intended to administer or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy are classified in Class IIb.
Phacoemulsification devices are intended for the emulsification and removal of cataracts, hence
they are classified as Class IIb active medical devices, under Rule 12 of Annexure VIII of EU MDR 2017/745.
The Rule 12 states that,
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
As per the intended purpose, the phacoemulsification device is not “intended” to administer or exchange energy, so we can rule out rule 9.
I agree with what Mr. Manoj has mentioned. The phacoemulsification device is intended to emulsify the cataract and removal of it which falls in accordance with rule 12, and the risk class is IIb as the procedure is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application.
From your explanation, I think it is a Phacoemulsification system. The system works basically by 3 steps irrigation, aspiration, and ultrasound. As it is considered a system, it has two or more combinations of products. So, the classification also would be based on that.
Phacoemulsification/ vitrectomy system generator is classified as IIb based on rule 9 and Phacoemulsification/vitrectomy system (includes Phaco Probe), can be classified as class IIb based on rule 12. Thus, when it is considered as Phacoemulsification/ vitrectomy system generator (which consists both the generator and system) the strictest rule and sub-rule resulting in the higher classification shall apply. You can consider the higher classification as Class IIb.
The surgical ultrasound machine is used for the imaging for diagnosing and monitoring, that helps in the treatment. Hence the intended use of the surgical ultrasound machine and the phaco emulsification system is different, however both comes under the class IIb with former under rule 9 and latter under rule 12.
As per the Annex VIII chapter II, clause 3.1 the application of the rule should be according to the intended purpose of the device. The intended use of the phaco emulsifier is to emulsify the cataract and remove it from the eyes. The ultrasonic hand piece is used to emulsify but the ultimate aim is to remove the cataract which is moreover comes under rule 12. The MDR requirements are based rather on the classification of the device than on the classification rule. So class IIb is more important than the rule which it applies. Also if several rules are possible to apply then it is relevant to apply the more strictest rule to classify the device under higher class.