Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

K250286 · The Magstim Company Limited · QPL · Jul 3, 2025 · Neurology

Device Facts

• Record ID: K250286
• Device Name: Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
• Applicant: The Magstim Company Limited
• Product Code: QPL · Neurology
• Decision Date: Jul 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Rapid² Magnetic Stimulators are computerized, electromechanical systems delivering focused magnetic pulses to stimulate peripheral nerves for pain relief. Used in hospitals and pain management clinics by clinicians. System comprises a stimulating unit, power supply, user interface, and various stimulating coils (circular or butterfly). Operation involves selecting a pre-defined, non-modifiable pain therapy protocol (13-minute session, 0.5Hz repetition rate, 400 pulses). The device monitors coil temperature via dual sensors, automatically disabling at 40°C. Output is controlled via an LCD capacitive touchscreen. The magnetic pulses induce electric fields in tissue to modulate nerve activity. Benefits include non-invasive pain management for chronic conditions. Healthcare providers use the interface to initiate therapy; output affects clinical decision-making by providing a non-pharmacological pain intervention. Safety features include acoustic protection requirements (earplugs) and automated thermal cut-offs.

Clinical Evidence

Bench testing only. Performance data included electrical, mechanical, and thermal safety testing (IEC 60601-1 Ed 3.2), electromagnetic compatibility (IEC 60601-1-2 Ed 4.1), and software verification/validation (IEC 62304). Biocompatibility testing (ISO 10993) confirmed safety of applied parts. Output characteristics (electric/magnetic field distribution, dB/dt, linearity) were quantitatively characterized and compared to the predicate. No clinical trial data presented.

Technological Characteristics

Electromechanical magnetic stimulator. Materials: Stimulator (PUR, stainless/galvanized steel), Coils (PC, PUR, copper windings). Energy: Electromagnetic pulses (Biphasic/Biphasic Burst). Connectivity: Standalone system with LCD capacitive touchscreen. Thermal safety: Dual sensors, 40°C auto-disable. Standards: IEC 60601-1 (Ed 3.2), IEC 60601-1-2 (Ed 4.1), IEC 60601-1-8, ISO 10993, ISO 14971. Sterilization: Non-sterile.

Indications for Use

Indicated for patients 18 years or older suffering from chronic intractable, post-traumatic, or post-surgical pain requiring peripheral nerve stimulation.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 3, 2025

The Magstim Company Limited
Daniel Gregory
Principal Systems Engineer
Spring Gardens, Whitland
Carmarthenshire, SA34 0HR
United Kingdom

Re: K250286
Trade/Device Name: Rapid² Magnetic Stimulators (Magstim Rapid², Magstim Super Rapid², Magstim Super Rapid² Plus¹)
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: QPL
Dated: June 11, 2025
Received: June 11, 2025

Dear Daniel Gregory:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}

K250286 - Daniel Gregory
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

{2}

K250286 - Daniel Gregory
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Amber T. Ballard -S

Amber Ballard, PhD
Assistant Director
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250286 | |
| Device Name Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | |
| Indications for Use (Describe) 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. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

{4}

1

# 510(k) Summary

# K250286

## Manufacturer and 510(k) Owner

The Magstim Company Limited

Spring Gardens, Whitland, Carmarthenshire SA34 0HR, United Kingdom

Phone: [phone]

Facsimile: [phone]

Contact Person: Daniel Gregory, Principal Systems Engineer

Email: [e-mail]

Date Prepared: July 3, 2025

## Device Information

Proprietary Name/Trade Name: Rapid² Magnetic Stimulators (Magstim Rapid², Magstim Super Rapid², Magstim Super Rapid² Plus¹)

Common Name: Electromagnetic Stimulator, Pain Relief

Regulation Number: 21 CFR 882.5890

Regulation Name: Transcutaneous electrical nerve stimulator for pain relief

Class: Class II

Product Code: QPL

Review Panel: Physical Medicine

## Predicate Device

The Rapid² Magnetic Stimulators (K250286) are substantially equivalent to the following predicate:

| 510(k) Number | Predicate Device Name / Manufacturer | Regulation / Product Code |
| --- | --- | --- |
| K230014 | Device Name: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption. | 21 CFR 882.5890
QPL |
| | Manufacturer: Tonica Elektronik A/S. | |

{5}

2

# Device Description

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.

# Indications for Use

The Rapid² Magnetic Stimulators are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

{6}

# Comparison of Technological Characteristics

Table 1: Substantial Equivalence Summary

| | Rapid2 Magnetic Stimulators (Subject Device) | MagVenture Pain Therapy (Predicate Device) | Evaluation of Differences |
| --- | --- | --- | --- |
| Manufacturer | Magstim Company Limited | Tonica Elektronik A/S | |
| Device Name | Rapid2 Magnetic Stimulators | MagVenture Pain Therapy | |
| Device Configurations | Rapid2, Super Rapid2, Super Rapid2 Plus1 | MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | |
| 510(k) number(s) | K250286 | K230014 | |
| Device regulation and product code | 21 CFR 882.5890 QPL | 21 CFR 882.5890 QPL | Identical |
| Indications for Use | Rapid2 Magnetic Stimulators are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. | The MagVenture Pain Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. | Identical |
| 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 |

{7}

| | Rapid2 Magnetic Stimulators (Subject Device) | MagVenture Pain Therapy (Predicate Device) | Evaluation of Differences |
| --- | --- | --- | --- |
| 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 as the predicate device. |
| 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 when compared to the predicate device. Refer to SE Note 1 |
| Pulse Width | Biphasic (300-425 μs) | Biphasic (280-320 μs) | Pulse width range is similar when compared to predicate. Refer to SE Note 2 |
| Pulse Mode | Standard | Standard | Same pulse mode as the predicate |
| Maximum Output Power | Rapid2: 100% at 15Hz/pps Super Rapid2: 100% at 25Hz/pps Super Rapid2 Plus1: 100% at 41Hz/pps | 100% at 15Hz/pps | Substantially equivalent maximum output to predicate device. Refer to SE Note 1 |
| Waveform | Biphasic, Biphasic Burst | MagPro R30: Biphasic MagPro R30 with MagOption: Biphasic, Monophasic MagPro X100: Biphasic, Biphasic Burst, Monophasic MagPro X100 with MagOption: Biphasic, Halfsine, Biphasic Burst, Monophasic | Substantially equivalent – waveform produced by subject device is within the range available in the predicate device. |

{8}

| Criteria | Rapid^{2} Magnetic Stimulators
(Subject Device) | MagVenture Pain Therapy
(Predicate Device) | Evaluation of Differences |
| --- | --- | --- | --- |
| Maximum Coil Temperature | 40°C | 43°C | both subject and predicate devices automatically disable if max. temperature is reached. |
| Peak Magnetic Field at Coil Surface (T) | 1.0-1.5T | 1.15-2.6T | Substantially equivalent – peak field produced is a subset of the predicate device.
*Refer to SE Note 2* |
| Peak Magnetic Field Gradient dB/dt at coil center, 20mm distance from the coil surface | 9-12kT/s | 9-24kT/s | Substantially Equivalent – Peak Rate of Change at 20mm is subset of the predicate device.
*Refer to SE Note 2* |
| Software or Firmware Control | Yes | Yes | Identical |
| Power Source | Power Supply via dedicated power supply modules each using a separate input mains line cord.
Power Supply: 115/230/240V ~50/60Hz | Power Supply via Isolation Transformer
Power Supply: 120V~ 50/60Hz | 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 |
| Housing Material Construction | Stimulator: PUR, Stainless/Galvanized Steel
Coils: PC, PUR | Stimulator: Aluminum, Aluzinc
Coils: PVC, ABS, PA, POM | Similar |
| Applied Parts | Magnetic Coils:
3190-00 Double 70mm Remote (K051864)
3192-00 90mm Remote (K051864) | Magnetic Coils:
MC-140-II (K061645)
MCF-140 (K061645) | Substantially equivalent coil range to predicate.
*Refer to SE Note 2* |

{9}

| Criteria | Rapid^{2} Magnetic Stimulators
(Subject Device) | MagVenture Pain Therapy
(Predicate Device) | Evaluation of Differences |
| --- | --- | --- | --- |
| | 3193-00 90mm Standard (K051864)
3910-00 Double 70mm Air Film Coil (K080499)
4102-00 D70^{2} (K130403)
4150-00 D70 Alpha Coil (New)
4170-00 D70 Alpha Coated Flat Coil (New)
4189-00 D60 Alpha Coated Branding Iron Coil (New)
4190-00 D60 Alpha Coated Flat Coil (New)
4510-00 D70 Alpha Coated Branding Iron Coil (New) | RT-120-II (K061645)
MMC-90 (K061645)
MCF-125 (K071821)
Cool-B65 (K071821)
Cool-125 (K071821) | |
| Applied Part Area | Butterfly Coils (3190-00, 3910-00, 4102-00, 4150-00, 4170-00, 4189-00, 4190-00, 4510-00):
152mm – 191mm

Circular Coils (3192-00, 3193-00):
124.5mm | Butterfly Coils: 150mm

Circular Coils: 110-126mm

Special Coils: 160x80 mm | Substantially equivalent.

Refer to 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 | Same – just newer edition of the standard. |
| Mechanical Safety | Complies with IEC 60601-1 Ed. 3.2 | Complies with IEC 60601-1 Ed. 3.1 | Same – just newer edition of the standard. |
| Thermal Safety | Complies with IEC 60601-1 Ed. 3.2 | Complies with IEC 60601-1 Ed. 3.1 | Same – just newer edition of the standard. |
| Radiation Safety | No radiation generated. | No radiation generated. | Same. |

{10}

| | Rapid² Magnetic Stimulators
(Subject Device) | MagVenture Pain Therapy
(Predicate Device) | Evaluation of Differences |
| --- | --- | --- | --- |
| Biocompatibility | Complies with the following parts of the ISO 10993 series:
ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | Complies with ISO 10993 | Same as predicate. |
| Standards | Company Complies with ISO 13485
Device Complies with IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 and IEC 62366-1 | Company Complies with EN ISO 13485 | Same/Equivalent standards met as the predicate device. |

## Substantial Equivalence Note/Discussion Point 1 – Comparing Repetition Rate and Power Capabilities of the Subject and Predicate Devices:

Relevant Characteristics from SE Table – Device Configurations, Maximum Repetition Rate, Maximum Output Power

The pulse frequencies of 0.1-50Hz and 0.1-100Hz as well as the maximum repetition rates of 100Hz (pps) are similar to the predicate device. The difference from the subject device compared to the predicate device is the maximum frequency that can be delivered at maximum machine output. This does not raise any differing questions of safety or effectiveness as:

1. The subject device states that the treatment parameter is 0.5Hz within the instructions for use, as well as being the default options provided on the system user interface. The recommended pain therapy protocol is provided by default on the system and cannot be modified, overwritten or deleted by a user.

a. Three to four treatments over two months and maintenance therapy every 6 to 8 weeks is recommended.
b. Treatment Level: Individually estimated (% of maximum machine output).
c. Repetition Rate: 0.5Hz/PPS
d. Pulse per Train: 10
e. Number of Trains: 40
f. Number of Pulses: 400
g. Inter-Train Interval: 2s
h. Treatment Time: 13min

2. Both the instructions for use and User Interface provide statements where parameters are displayed that Treatment parameters (e.g., repetition rate, pulses per train, number of trains, number of pulses, inter train interval, treatment time) that are not included in the treatment protocol have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

## Substantial Equivalence Note/Discussion Point 2 – Comparing Magnetic Coils between the Subject and Predicate Devices:

Relevant Characteristics from SE Table – Pulse Width, Peak Magnetic Field at Coil Surface, Peak Magnetic

{11}

Field Gradient at 20mm from Coil Center, Applied Parts/Applied Parts Area

The subject device has equivalent coils which have slightly different characteristics compared to the predicate device. These characteristics slightly alter the magnetic field spatial distribution. This does not raise any differing questions of safety or effectiveness as:

1. The subject device nominal peak magnetic field outputs of the subject device (1.0T – 1.5T) have different maximum values to that of the predicate device (1.15T – 2.6T). This does not raise any differing questions of safety and effectiveness because the subject device has a smaller peak over a longer period, compared to the predicate device which has a larger peak over a shorter period.

2. As demonstrated by the performance data within this submission, the coil E-Field decay, linearity of output as well as electric & magnetic field spatial distributions are very similar and would produce equivalent effects at 0-2cm from the coil surface.

3. The subject device has the same type of coil configurations as the predicate device, which are circular and butterfly coils.

4. The construction of the coils of the subject device matches the predicate device as described in K230014 – A copper winding element encapsulated in a plastic housing.

5. Finally, the pulses produced by the subject device are all Biphasic waveforms equivalent to the predicate device. Some pulse widths of coils of the subject device (300ms – 425ms) do exceed that of the predicate device (280ms – 320ms) but no differing questions of safety or effectiveness are raised as the higher pulse widths and lower peak magnetic field of the subject device result in an equivalent level of energy delivered into the tissue as the lower pulse widths and higher peak magnetic field of the predicate device.

Summary of Non-Clinical Testing

Non-clinical testing was performed to demonstrate the subject Rapid² Magnetic Stimulators raise no differing questions of safety or effectiveness when compared to the predicate device cleared under K230014.

Electrical, Mechanical & Thermal safety was performed on all device configurations (Standard Rapid², Super Rapid² and Super Rapid² Plus¹) and demonstrated compliance to the IEC, ANSI/AAMI, CAN/CSA and BS EN variants of 60601-1 (Ed. 3.2). The proposed device configurations were assessed for operating under both 115V and 230V/240V (Split Phase) at 60Hz mains power supply. Additionally, in house thermal testing was performed to demonstrate that in representative conditions, the systems and their compatible coils could successfully deliver the recommended pain therapy protocol with no overheating or compromising of safety. In addition to 60601-1, the device was also assessed to the collateral standard for alarm systems and complies with 60601-1-8.

Electromagnetic Compatibility was assessed, and the subject device was found to be compliant to the requirements of IEC 60601-1-2 (Ed. 4.1) The test report and certification of conformance show that the emissions and immunity testing performed per CISPR 11, IEC 61000-3 and IEC 61000-4, respectively, resulted in passing results. This standard provides an adequate level of electromagnetic compatibility according to the risk assessment and essential performance of the proposed device.

Software Verification and Validation was performed in accordance with 62304 to ensure the software systems do not contribute to any unacceptable risk. Software was verified using methods such as 'Open Box' testing where fault scenarios were generated and backup hardware measures were verified to ensure no unacceptable risk. A risk management process in compliance with ISO 14971:2019 was used to perform risk management activities and control risk. Risk management and software development also included

8

{12}

security assessment utilizing AAMI TIR57. Security risk was assessed and controlled as appropriate based on the intended use environment and the functions of the device. Further, the software was validated as part of the Human Factors and Usability Engineering process.

Device biocompatibility was assured via application of the ISO 10993 series of standards. The applied parts of the system that are regularly in contact with the operator and patient (stimulating coils) use suitable biocompatible materials. Testing has been performed on the applied part materials commensurate to the risk and use of the device including Skin Irritation, Cytotoxicity and Skin Sensitization testing.

Acoustics testing was performed as part of the 60601-1 type testing, as well as separately in-house to ensure the device does not reach any excessive or unacceptable noise levels. The results demonstrate a substantially equivalent level of acoustic output. As stated in the Labeling (Operating Manual/Instructions for Use) the patient must always wear earplugs or similar hearing protection devices with a rating of 30dB of noise reduction when being treated with Rapid² Magnetic Stimulators.

Finally, device output characteristics was quantitatively characterized for each of the compatible applicating coils described within this submission. The method for testing was informed by methods of evaluation used for Transcranial Magnetic Stimulators - specifically following guidance from "Repetitive Transcranial Magnetic Stimulation (rTMS) Systems – Class II Special Controls Guidance for Industry and FDA Staff" – July 26, 2011.

For each of the sample coils:

1. an electric field distribution plot was created in a volume of 20cm * 20cm * 3cm.
2. Magnetic field distribution plots were created in a volume of 20cm * 20cm * 4cm, plotting both the Magnetic Flux Density and the dB/dt (Magnetic Field Rate of Change).

This resulted in the following characteristics and values being obtained:

1. Peak Magnetic Field Strength (T) at Coil Surface
2. Peak Magnetic Field Strength (T) at 2cm from Coil Surface
3. Peak Magnetic Field Gradient (dB/dt, kT/s) at Coil Surface
4. Peak Magnetic Field Gradient (dB/dt, kT/s) at 2cm from Coil Surface
5. Output Waveform Oscilloscope Traces
6. Electric Field Spatial Distribution Plots for each Sample Coil in a 20cm * 20cm * 3cm region with 5mm resolution
7. Magnetic Flux Density and dB/dt Plots for each Sample Coil in a 20cm * 20cm * 4cm region with 2cm resolution
8. Electric Field Decay as a Function of Distance from the Coil Surface.
9. Linearity of Output

The above non-clinical testing resulted in a comprehensive collection of data that demonstrates substantially equivalence between the subject device and the predicate device for the stimulation of peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain.

## Conclusion

In conclusion, the Rapid² Magnetic Stimulators can be deemed to be as safe and effective as the predicate

{13}

device cleared under K230014 for the proposed indications for use and no new or differing questions of safety or effectiveness are raised. Therefore, it can be determined that the proposed Rapid² Magnetic Stimulators are substantially equivalent to the predicate device.

10