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Electromechanical Arm For A Transcranial Magnetic Stimulation System

Page Type
Product Code
Definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
Physical State
A mechanical or electromechanical arm with or without a cart, a tracking system, software, 3D camera, coil adoption kit with or without its mechanical adaptor and a contact sensor.
Technical Method
A tracking system measures the position and orientation of the patient’s head and the software uses the measurements provided by the tracking system to move the robotic arm and position the coil. A contact sensor allows the software to measure amount of contact applied by the coil onto the head to prevent unexpected collisions.
Target Area
Head
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5805
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5805 Repetitive transcranial magnetic stimulation system

§ 882.5805 Repetitive transcranial magnetic stimulation system.

(a) Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

(b) Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

[76 FR 44491, July 26, 2011]

Electromechanical Arm For A Transcranial Magnetic Stimulation System

Page Type
Product Code
Definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
Physical State
A mechanical or electromechanical arm with or without a cart, a tracking system, software, 3D camera, coil adoption kit with or without its mechanical adaptor and a contact sensor.
Technical Method
A tracking system measures the position and orientation of the patient’s head and the software uses the measurements provided by the tracking system to move the robotic arm and position the coil. A contact sensor allows the software to measure amount of contact applied by the coil onto the head to prevent unexpected collisions.
Target Area
Head
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5805
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5805 Repetitive transcranial magnetic stimulation system

§ 882.5805 Repetitive transcranial magnetic stimulation system.

(a) Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

(b) Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

[76 FR 44491, July 26, 2011]