Hi Laudie3,
I am not aware of a straight-forward HC definition of accessory, but this might help.
HC guidance on Guidance on the Risk-based Classification has a definition of a medical device that includes an "accessory":
"DEVICE (Food and Drugs Act) - means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in
(a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
(b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
(c) diagnosing pregnancy in human beings or animals,
(d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
(e) preventing conception in human beings or animals;"
HC guidance on Classification of Products at the (Medical) Device-Drug Interface says this about accessory:
"A product considered to be an accessory to a device may itself be classified as a device under the “device” definition. A device accessory is distinguished by its intended purpose/associated claim(s) to enable or support the intended use of the primary device. For example, a gel used as a lubricant to assist in the insertion and use of a probe would be considered a device accessory. Moreover, a liquid solution intended to disinfect or sterilize a medical device could also be considered an accessory to that device."
The HC perception of accessory seems similar to that of the European MDR:
"accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)"
Shimon