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510(k) Data Aggregation
(153 days)
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.
The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics.
Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations:
- Rapid2
- Super Rapid2
- Super Rapid2 Plus1
All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.).
All Rapid2 Magnetic Stimulators are composed from the following main components:
- Stimulating Unit & Power Supply
- User Interface
- Stimulating Coil
- System and Stimulating Coil Cart and Holding Arm
Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.
The provided document is an FDA 510(k) Clearance Letter for the Rapid2 Magnetic Stimulators. It does NOT contain information about a study proving the device meets acceptance criteria related to its performance in pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of technical characteristics, safety standards compliance, and physical properties.
The document does not describe an AI/ML-driven device, nor does it present results from a clinical study with patients or human readers using AI. The acceptance criteria and performance metrics described are related to physical and electrical characteristics of the magnetic stimulator, not diagnostic accuracy or clinical effectiveness in a traditional sense of "performance" as one might expect for an AI diagnostic device.
Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type) cannot be answered based on the provided text, as they pertain to clinical or AI/ML performance evaluation, which is not the subject of this 510(k) summary.
However, I can extract information related to the technical acceptance criteria and how they align with the device's measured performance as described in the summary:
Acceptance Criteria and Device Performance (Based on Technical and Safety Equivalence)
The acceptance criteria for the Rapid2 Magnetic Stimulators are primarily based on demonstrating substantial equivalence to the predicate device (MagVenture Pain Therapy) in terms of technical characteristics, safety, and effectiveness for the stated indications for use. The "performance" reported is adherence to these characteristics and safety standards.
| Acceptance Criteria Category/Characteristic | Subject Device Performance (Rapid2 Magnetic Stimulators) | Predicate Device Performance (MagVenture Pain Therapy) | Evaluation / Proof of Meeting Criteria |
|---|---|---|---|
| Indications for Use | Stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. | Stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. | Identical. Meets criteria by having the same intended use. |
| Anatomical Sites | Any area, such as hand, arm, waist, buttock, thigh, calf, back and lower back etc. | Any area, such as hand, arm, waist, buttock, thigh, calf, back and lower back etc. | Identical. |
| Treatment Facilities | Hospitals & Clinics | Hospitals & Clinics | Identical. |
| Treatment Time | 13 minutes per session (800 seconds) | 13 minutes per session (800 seconds) | Identical. |
| Pulse Frequency | Rapid2: 0.1 – 50 Hz (pps); Super Rapid2 and Super Rapid2 Plus1: 0.1 – 100 Hz (pps) | MagPro R30 & MagPro R30 with MagOption: 0.1 – 30 Hz (pps); MagPro X100 & MagPro X100 with MagOption: 0.1 – 100 Hz (pps) | Similar range. Subject device's range covers or extends slightly beyond predicate, but the recommended protocol (0.5Hz) is well within both. |
| Pulse Amplitude | 0 – 100% | 0 – 100% | Identical. |
| On-cycle duty period | 2-800 Seconds (0.5 Hz and up to 400 pulses) | 2-800 Seconds (0.5 Hz and up to 400 pulses) | Identical. |
| Off-cycle rest period | N/A | N/A | Identical. |
| Maximum Repetition Rate | Rapid2: 50Hz; Super Rapid2: 100Hz; Super Rapid2 Plus1: 100Hz | MagPro R30 & MagPro R30 with MagOption: 30 pulses per second; MagPro X100 & MagPro X100 with MagOption: 100 pulses per second | Upper limit identical compared to predicate. Substantial equivalence demonstrated despite differences in how maximum output is achieved (explained in "SE Note 1"). |
| Pulse Width | Biphasic (300-425 µs) | Biphasic (280-320 µs) | Similar range. Differences deemed not to raise new safety/effectiveness questions due to compensating factors (see "SE Note 2"). |
| Pulse Mode | Standard | Standard | Same. |
| Temperature Control | Automatic disable at 40°C; includes air-cooled coil; UI communication of over-temperature. | Automatic disable at 43°C. | Comparable/Better. Subject device has a lower cutoff and additional cooling/reporting features. |
| Peak Magnetic Field at Coil Surface | 1.0-1.5T | 1.15-2.6T | Substantially equivalent. Subject device is a subset of the predicate's range. Differences explained in "SE Note 2" as not raising new safety/effectiveness concerns. |
| Peak Magnetic Field Gradient (dB/dt) at 20mm from Coil Center | 9-12kT/s | 9-24kT/s | Substantially equivalent. Subject device is a subset of the predicate's range. Differences explained in "SE Note 2" as not raising new safety/effectiveness concerns. |
| Waveform | Biphasic, Biphasic Burst | Biphasic, Monophasic, Biphasic Burst, Halfsine (combinations vary by predicate configuration) | Substantially equivalent. Subject device's waveform is within the range available in the predicate. |
| Software/Firmware Control | Yes | Yes | Identical. Verified per IEC 62304. |
| Power Supply Type | Power Supply via dedicated power supply modules each using a separate input mains line cord. | Power Supply via Isolation Transformer. | Similar. |
| Power Consumption | 230/240V Systems – 3000VA peak per input; 115V Systems – 2300VA peak per input | Maximum 2700VA | Similar. |
| User Interface | LCD Capacitive Touchscreen | LED Display | Similar. A difference in display technology, but performs the same function. |
| Housing Material Construction | Stimulator: PUR, Stainless/Galvanized Steel; Coils: PC, PUR | Stimulator: Aluminum, Aluzinc; Coils: PVC, ABS, PA, POM | Similar. Different specific materials but serve the same function. |
| Applied Parts (Coils) | Various, including previously cleared (K051864, K080499, K130403) and new coils (4150-00, 4170-00, 4189-00, 4190-00, 4510-00). | Various, all previously cleared. | Substantially equivalent coil range. New coils are evaluated for safety and function to be equivalent (see "SE Note 2"). |
| Applied Part Area | Butterfly Coils: 152mm – 191mm; Circular Coils: 124.5mm | Butterfly Coils: 150mm; Circular Coils: 110-126mm; Special Coils: 160x80 mm | Substantially equivalent. (see "SE Note 2"). |
| Sterilization | Non-sterile when used. | Non-sterile when used. | Identical. |
| Electrical Safety | Complies with IEC 60601-1 Ed. 3.2 | Complies with IEC 60601-1 Ed. 3.1 | Meets/Exceeds. Complies with a newer edition of the standard. |
| Mechanical Safety | Complies with IEC 60601-1 Ed. 3.2 | Complies with IEC 60601-1 Ed. 3.1 | Meets/Exceeds. Complies with a newer edition of the standard. |
| Thermal Safety | Complies with IEC 60601-1 Ed. 3.2 | Complies with IEC 60601-1 Ed. 3.1 | Meets/Exceeds. Complies with a newer edition of the standard. |
| Radiation Safety | No radiation generated. | No radiation generated. | Same. |
| Biocompatibility | Complies with ISO 10993-1, -5, -10; materials tested for Skin Irritation, Cytotoxicity, Skin Sensitization. | Complies with ISO 10993. | Same/Exceeds. Detailed compliance with relevant parts of the standard. |
| Standards Compliance | ISO 13485 (company); IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62366-1 (device). | EN ISO 13485 (company). | Same/Equivalent. Device-specific standards compliance indicated. |
| Acoustics | Tested per 60601-1 type testing and in-house, demonstrating substantially equivalent acoustic output. Labeling requires earplugs (30dB noise reduction). | (Not specified beyond "similar") | Comparable. Demonstrated and mitigated with user instructions. |
| E-Field Decay & Linearity of Output | Performance data showed "very similar" E-Field decay, linearity, and electric/magnetic field spatial distributions. | (Not explicitly detailed, but implied to be baseline for comparison) | Comparable. Results demonstrate equivalent effects at 0-2cm from coil surface. |
Regarding the specific questions that cannot be answered from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable or provided. The "test set" here refers to non-clinical testing of device characteristics, not a clinical study on patients or data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would implicitly be engineering specifications, laboratory measurements, and standard compliance testing, not expert clinical assessment of patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. No adjudication process detailed for establishing technical specifications.
- 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 is not an AI/ML device, nor is it a diagnostic device being evaluated for reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance evaluation is based on engineering specifications, direct physical measurements (e.g., of magnetic fields, temperatures, electrical properties), and compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993).
- The sample size for the training set: Not applicable or provided. This device does not use a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable or provided.
In summary, the provided document details the 510(k) clearance process for a non-AI/ML magnetic stimulator for pain relief. The "acceptance criteria" and "performance" are framed around demonstrating substantial technical and safety equivalence to a legally marketed predicate device, rather than clinical efficacy data from patient studies or AI algorithm performance metrics.
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