(326 days)
The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).
The CloudTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).
The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.
The CloudTMS for OCD consists of the following main components:
- . Mobile console
- Cooling unit .
- Extra power supply unit ●
- System software with GUI ●
- Treatment chair*
- Head support system*
- Coil DCC-03-125-C for both MT and treatment ●
- K8 Coil fixture
- K3 flexible arm coil positioning system ●
- Data Management System ●
- Trolley with casters .
- (* optional)
The acceptance criteria and study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Area | Acceptance Criteria (Primary Predicate Device K193006) | Reported Device Performance (CloudTMS for OCD) |
|---|---|---|
| Indications for use | Treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). | The CloudTMS for OCD system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). |
| Magnetic Field Intensity | 100% of the Leg MT (Leg Motor Threshold) | 100% of the Leg MT (Leg Motor Threshold) |
| Frequency | 20 Hz | 20 Hz |
| Train duration | 2 s | 2 s |
| Inter-train interval | 20 s | 20 s |
| Number of trains | 50 | 50 |
| Magnetic Pulses per Session | 2000 | 2000 |
| Treatment Session Duration | 18 min | 18 min |
| Sessions/wk | 5 | 5 |
| Treatment Schedule | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week |
| Area of brain to be stimulated | Dorsomedial Prefrontal Cortex | Dorsomedial Prefrontal Cortex |
| Waveform | Biphasic sinusoid | Biphasic sinusoid |
| Amplitude in Standard Motor Threshold (SMT) units | 0 - 1.9 SMT | 0 - 2.27 SMT (The new device indicates a slightly higher maximum amplitude, but the overall conclusion focuses on "substantially equivalent" magnetic field characteristics and recommended treatment parameters matching the predicate for OCD treatment). |
| Coil Configuration | Double-cone coil | Double-cone coil |
| Core material | Air core | Air core |
| Cooling | Liquid cooling | Liquid cooling |
| Coil for MT determination | Used for both MT determination and treatment. | Used for both MT determination and treatment. |
| Number of Turns/Wing | 7 (Upper layer N = 4 turns/wing; Lower layer N = 3 turns/wing) | 8 |
| Number of Wings | 2 | 2 |
| Number of Layers | 2 | 2 |
| Inner Diameter of Winding, mm | 67 | 96 |
| Outer Diameter of Winding, mm | 95 | 130 |
| Coil Temperature Disablement | 41 °C (106 °F) | 41 °C (106 °F) |
| Frequency range (Hz) | 0.1-30 or 0.1-100, depending on model | 0.1 - 30 (Stand-alone), 0.1 - 100 (with PC) |
| Pulse train duration range (s) | Rep Rate: 0.1 ...100Hz, Pulses in Train: 1,2,3,4 ... 1000, Train duration = Pulses in Train / Rep Rate | 0.5 - 100 |
| Inter-train interval range (s) | 1 – 120 | 0 - 300 |
| Maximum trains per session | 500 | 4800 (The document states 4800 is calculated based on max session time and min train/pause, allowing for more trains than the predicate's 500.) |
| Maximum # of pulses per session | 500,000 | 72000 (Stand-alone), 240000 (with PC) (The new device's number of pulses per session is lower than the predicate, but the overall treatment protocol for OCD matches). |
| Electrical Safety | Complies with IEC60601-1 v. 3.1, and IEC60601-1-2. | Complies with AAMI/ANSI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014 |
| ISO Standards met | Company complies with EN ISO 13485:2016. | Company complies with DIN EN ISO 13485:2016, ISO 10993-1:2018, ISO 14971:2019 |
Study Proving Device Meets Acceptance Criteria:
The provided document describes a non-clinical performance study to demonstrate substantial equivalence to a legally marketed predicate device (Tonica Electronik A/S, MagVenture TMS Therapy System for Treatment of OCD, K193006). The study primarily focused on comparing the technological characteristics of the new device (CloudTMS for OCD) with the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set of patient data was used. This was a non-clinical study focused on device characteristics and substantial equivalence, not a clinical trial with patient outcomes. Therefore, data provenance is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth was established by experts for a test set of patient data, as this was a non-clinical substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no external test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This was not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a medical device, not an algorithm, and the focus was on hardware and operational parameter equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this substantial equivalence application, the "ground truth" was the established and legally marketed predicate device (K193006) and its characterized technological parameters as specified in its FDA clearance. The new device's performance was compared against these established specifications.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
§ 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.