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510(k) Data Aggregation
(160 days)
Ultimate rTMS for OCD (M-series)
The Ultimate rTMS for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder(OCD).
The Ultimate rTMS 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 prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.
Area of the brain to be simulated for ODC treatment is the Dorsomedial Prefrontal Cortex.
The provided FDA 510(k) clearance letter and summary for the "Ultimate rTMS for OCD (M-series)" device focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance characteristics, rather than a clinical study evaluating the device's efficacy in treating OCD. Therefore, it does not contain the detailed information about clinical acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth for test/training sets) that would typically be found in a clinical trial report.
The document primarily shows that the new device's technical specifications and physical/magnetic properties are comparable to a previously cleared device. It asserts that the proposed device does not introduce new safety concerns and has equivalent performance characteristics based on bench testing.
Here's an attempt to answer the questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the submission:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device (MagVenture TMS Therapy system K193006) through close matching of technological characteristics and non-clinical performance (bench testing) according to FDA guidance. The "reported device performance" are the measured values for the Ultimate rTMS for OCD (M-series) in comparison to the predicate.
| Criteria (Implicit Acceptance based on Predicate Equivalence) | Proposed Device Ultimate rTMS for OCD Performance (Reported) | Predicate Device MagVenture TMS Therapy system (K193006) Performance (Reported) | Equivalence Comments (Context of Acceptance) |
|---|---|---|---|
| Intended Use | Treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) | Treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) | Identical |
| Treatment Protocol (Magnetic Field Intensity, Frequency, Train/Inter-train duration, Pulses/Session, Session Duration, Sessions/week, Treatment Schedule, Area of brain to be stimulated) | All match predicate values | All specified | Identical |
| Coil Configuration | Double-cone coil | Double-cone coil | Identical |
| Coil Materials of Construction | Copper tubing (GIS-C1100), Polycarbonate (Covestro Makrolon PC 2805) | Copper tubing (unknown), Polycarbonate (unknown) | Equivalent, no additional concerns for safety and effectiveness. |
| Core material | Air core | Air core | Identical |
| Cooling | Liquid cooling | Liquid cooling | Identical |
| Coil for MT determination | Used for both MT determination and treatment. | Used for both MT determination and treatment. | Identical |
| Number of Turns/Wing | 8 (Upper: 4, Lower: 4) | 7 (Upper: 4, Lower: 3) | Equivalent (See Note A for explanation). |
| Inner/Outer Diameter of Winding | Inner: 50 mm, Outer: 105 mm | Inner: 67 mm, Outer: 95 mm | Equivalent (See Note A for explanation). |
| Amplitude in SMT units | 0-2.22 SMT (45% intensity → 1 SMT) | 0-2.38 SMT (42% intensity → 1 SMT) | Comparable, within variations seen across cleared TMS devices (See Note B). |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Identical |
| Active pulse width (μs) | Measured: 308.6 (spec: 300 ±5%) | Measured: 302.2 (spec: 290 ±5%) | Equivalent, compensated by MT settings (See Note C). |
| Max magnetic field strength 3 cm from coil (T) | At 25%: 0.147; 50%: 0.225; 75%: 0.297; 100%: 0.380 | At 25%: 0.119; 50%: 0.212; 75%: 0.301; 100%: 0.391 | Equivalent, narrow range, similar slope and intercept. Compensated by MT settings (See Note D). |
| Max initial dB/dt (kT/s) near coil surface (z=0 cm) | 21.4 | 21.9 | Sufficiently close, compensated by MT settings (See Note E). |
| Max initial dB/dt (kT/s) 3 cm from coil surface (z=3 cm) | 7.73 | 8.12 | Sufficiently close, compensated by MT settings (See Note E). |
| Coil temperature exceed auto-disable | 40°C (104°F) | 41°C (106°F) | Slightly enhanced safety for proposed device. |
| Frequency range (Hz) | 0.1 - 100 | 0.1 - 30 or 0.1 - 100 (model dependent) | Differences in overall capabilities, but both encompass recommended OCD treatment parameters. |
| Pulse train duration range (s) | Up to 2000 pulses in train | Up to 1000 pulses in train | Differences in overall capabilities, but both encompass recommended OCD treatment parameters. |
| Inter-train interval range (s) | 0-60s | 0-120s | Differences in overall capabilities, but both encompass recommended OCD treatment parameters. |
| Maximum trains per session | 250 | 500 | Differences in overall capabilities, but both encompass recommended OCD treatment parameters. |
| Maximum number of pulses per session | 500,000 | 500,000 | Identical maximum. |
| Electrical safety | Complies with IEC 60601-1, IEC 60601-1-2 | Complies with IEC 60601-1, IEC 60601-1-2 | N/A |
| ISO Standards met | ISO 13485:2016, ISO 14971 | ISO 13485:2016 | N/A |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. The submission is based on non-clinical (bench) testing of the device's physical and magnetic characteristics rather than a clinical test set of patients.
- Data provenance: Not applicable. The data arises from engineering measurements and comparative bench testing of the physical device components (coils, stimulator output).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for clinical efficacy or diagnosis using patient data is not established in this non-clinical submission.
- Qualifications of experts: Not applicable. Engineering and technical experts would have conducted and verified the bench tests.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This was a non-clinical (bench) testing comparison, not a clinical study requiring adjudication of patient outcomes or diagnoses.
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
- MRMC study: No. This is not an AI-assisted diagnostic or therapeutic device that involves human "readers" or image interpretation. It is a TMS system for direct treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a medical device, not a software algorithm in the context of interpretation. Its "standalone" performance is assessed by its physical and magnetic output characteristics in bench tests.
7. The type of ground truth used
- Type of ground truth: The "ground truth" in this context is the measured physical and electromagnetic properties of the new Ultimate rTMS device compared to the established properties of the predicate MagVenture TMS Therapy system, as well as adherence to recognized safety standards (IEC, ISO). The substantial equivalence is built upon the premise that if the new device behaves physically like the predicate, and the predicate is known to be safe and effective, then the new device is also considered safe and effective for the stated indications.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is a conventional medical device whose performance is characterized by its engineering specifications and bench test results. It does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable (as above).
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