(329 days)
BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The BTL-99-OC is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-99-OC consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm. The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.
The provided text is a 510(k) summary for the BTL-99-OC device, which is a transcranial magnetic stimulation (TMS) system intended as an adjunct treatment for Obsessive-Compulsive Disorder (OCD). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MagVenture TMS Therapy system - K193006) and a reference device (BTL-995-rTMS - K212723), rather than presenting a performance study with specific acceptance criteria and detailed findings from a clinical trial.
Therefore, the document does NOT contain the information needed to fill out a table of acceptance criteria and reported device performance based on clinical study outcomes, nor does it detail a study structure that includes sample sizes for test sets, data provenance, expert consultation for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The provided text mostly describes:
- The device's intended use and technical characteristics.
- Comparisons of the BTL-99-OC with its predicate and reference devices, primarily focusing on physical and electrical parameters (e.g., magnetic field intensity, coil parameters, electrical safety compliance) to establish technical substantial equivalence.
- Compliance with electrical safety, software lifecycle, and risk management standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971).
- Bench testing results comparing induced fields in a phantom head, showing values are substantially equivalent within a certain range.
In summary, there is no information in the provided document about a clinical study that proves the device meets specific acceptance criteria related to its clinical efficacy or performance in diagnosing/treating OCD. The substantial equivalence is argued based on technological similarities and adherence to safety standards.
Therefore, I cannot populate the requested table or describe the study details as they are not present in this 510(k) summary.
§ 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.