Is the device an invasive device with respect to body orifices?

 
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A body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Is the invasive device (not surgically invasive) with respect to body orifices, intended for connection to a class IIa, class IIb or class III active device?

 
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A body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Is the invasive device with respect to body orifices, intended for connection to a non-active device OR a class I active device?

 
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A body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

In this case, what of the intended duration of use?

 
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DURATION OF USE

 

Transient means normally intended for continuous use for less than 60 minutes.

 

Short term means normally intended for continuous use for between 60 minutes and 30 days.

 

Long term means normally intended for continuous use for more than 30 days.

Is the device intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity?

 
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The pharynx is the throat; the musculomembranous cavity, about 5 inches (12.5 cm) long, behind the nasal cavities, mouth, and larynx, communicating with them and with the esophagus. It includes many individual structures and may be divided into three areas:

Is the device intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane?

 
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The pharynx is the throat; the musculomembranous cavity, about 5 inches (12.5 cm) long, behind the nasal cavities, mouth, and larynx, communicating with them and with the esophagus. It includes many individual structures and may be divided into three areas: