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Transcranial Magnetic Stimulation System For Smoking Cessation

Page Type
Product Code
Definition
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Physical State
Repetitive transcranial magnetic stimulation system
Technical Method
Applies transcranial pulsed magnetic stimulation to the cortex of the brain
Target Area
Prefrontal cortex of the brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5802
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions

§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

(a) Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Magnetic pulse output testing;

(ii) Magnetic and electrical field testing;

(iii) Testing of the safety features built into the device; and

(iv) Testing of the sound levels patients are exposed to during device use.

(5) The physician and patient labeling must include the following:

(i) The risks and benefits associated with use of the device;

(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and

(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.

[84 FR 9230, Mar. 14, 2019]

Transcranial Magnetic Stimulation System For Smoking Cessation

Page Type
Product Code
Definition
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Physical State
Repetitive transcranial magnetic stimulation system
Technical Method
Applies transcranial pulsed magnetic stimulation to the cortex of the brain
Target Area
Prefrontal cortex of the brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5802
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions

§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

(a) Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Magnetic pulse output testing;

(ii) Magnetic and electrical field testing;

(iii) Testing of the safety features built into the device; and

(iv) Testing of the sound levels patients are exposed to during device use.

(5) The physician and patient labeling must include the following:

(i) The risks and benefits associated with use of the device;

(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and

(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.

[84 FR 9230, Mar. 14, 2019]