Small Sterilized Battery Operated Light - Is this a medical Device?

K

Ktrna

#1
A small sterilized battery operated light (like a reading light) intended for use in minimum invasive surgery or low light surgery to provide light while preparing, reading syringe labels, loading/unloading needle drivers, scalpel blades and preparing specimens.
 
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somashekar

Staff member
Super Moderator
#2
From ISO13485 definition:
medical device:
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
 diagnosis, prevention, monitoring, treatment or alleviation of disease, (NO, for the light)
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (NO, for the light)
 investigation, replacement, modification, or support of the anatomy or of a physiological process, (NO, for the light)
 supporting or sustaining life, (NO, no for the light ... or perhaps ...?)
 control of conception, (NO, for the light)
 disinfection of medical devices, (NO, for the light)
 providing information for medical purposes by means of in vitro examination of specimens derived from the human body, (NO, for the light)
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

I feel its a NO for all the points of the above definition. Hence Small Sterilized Battery Operated Light is not a medical device ...

The key point is "intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of "

So if the manufacturer of the light wants to term it as a medical device saying that it is supporting or sustaining life in its own right, then he can, and based on his further risk assessment, he can be also sterilize it as you have mentioned.
In which case it will become a single use light and must be disposed after one use ?
 
Last edited:
K

Ktrna

#3
Thanks for the reply. What had me wondering is what I read on the FDA website. Would this small light would fall under this category?


Subpart E--Surgical Devices
Sec. 878.4580 Surgical lamp. (a)Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
(b)Classification. Class II.
 
M

MIREGMGR

#4
If I understand the product's function correctly, it is to be physically operated by one of the sterile personnel within the sterile field, in proximity to the patient, likely during a sterile invasive procedure. Given that, it's obviously a medical device per FDA. Its use qualifies as diagnostic or therapeutic. It doesn't create the diagnostic or therapeutic effect by itself, any more than the surgical table does; but it has to be there for the overall procedure to work.

It's very difficult to convince the FDA that any product that's used directly by sterile personnel within a sterile field during a procedure is not a medical device, and I wouldn't recommend trying...especially if you want to be able to get the product through US Customs.

In my view, it's obviously a medical device per MDD definition, using a similar analysis. Ditto for the Canadian, Australian and New Zealand rules. I don't know about Japan.
 
M

MIREGMGR

#5
As to FDA classification, as you may know most devices under 878.4580 are large overhead mounted lights. Your need is to identify a predicate device first, then determine what classification and regulation were applied to that predicate device.

If your device in fact is novel, you'll have to discuss with FDA whether they'll allow you to use an overhead surgical light as a predicate, or instead require you to follow some other regulatory path.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
If I understand the product's function correctly, it is to be physically operated by one of the sterile personnel within the sterile field, in proximity to the patient, likely during a sterile invasive procedure. Given that, it's obviously a medical device per FDA. Its use qualifies as diagnostic or therapeutic. It doesn't create the diagnostic or therapeutic effect by itself, any more than the surgical table does; but it has to be there for the overall procedure to work.

It's very difficult to convince the FDA that any product that's used directly by sterile personnel within a sterile field during a procedure is not a medical device, and I wouldn't recommend trying...especially if you want to be able to get the product through US Customs.

In my view, it's obviously a medical device per MDD definition, using a similar analysis. Ditto for the Canadian, Australian and New Zealand rules. I don't know about Japan.
I very much agree. With regards to EC, Australia etc. regulation, I would say this light would fall under the definition of an accessory to a medical device (or devices), because it's probably intended to enable those other devices to achieve their intended purpose. Under the MDD etc. accessories are regulated similarly to medical devices.
 
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