T65 (9016E061-)

The T65 is a figure-of-eight transcranial magnetic stimulation (TMS) coil designed to treat Major Depressive Disorder in adults who have failed prior antidepressant medication. It delivers magnetic pulses to the left dorsolateral prefrontal cortex and is used as part of the MagVenture TMS Therapy System by licensed physicians in clinical settings.

The T65 is a redesign of the predicate Cool-B65 coil, incorporating the motor threshold (MT) determination capability previously found only in the C-B60 coil. Key enhancements include an integrated intensity control wheel, built-in trigger button with LED status indicator, reduced weight (1.42 kg vs. 1.8 kg), and strain relief mechanisms. Both coils use active liquid cooling and are figure-of-eight shaped with identical treatment protocols and magnetic field characteristics within ±5% tolerance.

IEC 60601-1 (general safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), ISO 13485:2016 (quality management), and ISO 14971:2019 (risk management). The device was tested per FDA's Class II Special Controls Guidance Document for rTMS Systems.

The T65 maintains identical intended use, indications, treatment protocols, target anatomy, and user population as the predicate Cool-B65. Magnetic field characteristics are within ±5% of the predicate. The added intensity wheel is functionally equivalent to the C-B60 coil (a predicate device) and does not raise different safety/effectiveness questions. Weight reduction and ergonomic enhancements do not affect clinical function. All materials are shared with the predicate or pose no biocompatibility concerns. Therefore, the devices share the same technological characteristics and intended use.