(141 days)
The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The Rapid2 Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The Rapid2 Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
This document (K162935) is a 510(k) premarket notification for a modification to an existing device, the Magstim Rapid2 Therapy System. The modification involves the introduction of a new optional handheld remote coil (D70mm MT Remote Coil) for determining the motor threshold level. It is important to note that this document is not a clinical study proving the device meets primary efficacy acceptance criteria for Major Depressive Disorder (MDD) treatment. Instead, it demonstrates substantial equivalence to a previously cleared predicate device (K143531) for this specific modification.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the traditional sense of clinical efficacy endpoints or performance goals for MDD treatment. Instead, it relies on demonstrating that the modified device (with the new coil) maintains parity in safety and technical performance with the predicate device. The "performance" reported is primarily in the form of non-clinical testing results and a comparison of technical specifications.
| Criteria | Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (with D70mm MT Remote Coil) |
|---|---|---|
| Intended Use/Indications for Use | Remain the same as the predicate device (treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode). | Identical to the predicate device. |
| Technological Characteristics & Principles of Operation | Should not introduce new questions of safety or effectiveness compared to the predicate. | The document states "does not change the intended use and indications for use nor does it change the technological characteristics and principles of operation." Table 1 shows very similar (or identical where applicable) specifications. |
| Electrical Safety | Compliant with IEC 60601-1 (Ed. 3.1.). | Demonstrated compliance with IEC 60601-1 (Ed. 3.1.). |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 (2007). | Demonstrated compliance with IEC 60601-1-2 (2007). |
| Environmental Testing | Compliant with IEC 60601-1. | Demonstrated compliance with IEC 60601-1. |
| Biocompatibility | Both coils (Air Film Coil and D70mm MT Remote Coil) meet ISO 10993-1 (2009) standards. | Demonstrated compliance with ISO 10993-1 (2009) for both coils. |
| Magnetic Field Characteristics | Consistent with predicate device and FDA guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". | Maximum output amplitude, frequency range, pulse train duration range, inter-train interval range, maximum trains per session, and maximum pulses per session are identical to the predicate. Magnetic field strength and gradient also compared and shown to be similar. |
| Software Verification & Validation | Software performs as intended and in accordance with specifications (for a "moderate" level of concern). | Software verification and validation testing completed, demonstrating performance as intended. Basic software capabilities related to treatment administration are unchanged. |
| Risk Management | Identified and evaluated risks in compliance with ISO14971, with acceptable or addressed risks. | Risks identified and evaluated per ISO14971, with risks determined acceptable or addressed. |
| Safety and Effectiveness Comparability (Overall) | As safe and effective as the predicate device. | Performance data demonstrate that the Rapid Therapy System is "as safe and effective as the predicate" with the new coil. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not describe a clinical "test set" in the context of patient data for efficacy or safety comparisons. The testing described is non-clinical for technical specifications (electrical, EMC, environmental, biocompatibility, magnetic field characteristics, and software). Therefore, patient sample sizes are not applicable to the scope of this 510(k) submission.
- Data Provenance: The data provenance is primarily from non-clinical laboratory testing conducted by the manufacturer (Magstim Company Limited) in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as the document describes non-clinical testing for device specifications and substantial equivalence, not a clinical study requiring expert ground truth establishment for patient outcomes. "Ground truth" in this context would be engineering specifications and standards.
4. Adjudication Method for the Test Set
- This information is not applicable as the document describes non-clinical testing, not a clinical study that would typically involve adjudication of patient outcomes or image interpretations.
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
- No, an MRMC comparative effectiveness study was not done. This document pertains to a Repetitive Transcranial Magnetic Stimulation (rTMS) System, which is a therapeutic device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The Rapid2 Therapy System is a medical device for treatment delivery, not an algorithm, and it explicitly requires "prescription only under the supervision of a licensed physician" (human-in-the-loop for operation and treatment). The software mentioned is for device control and operation, not for standalone diagnostic performance.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical testing described would be the established international standards (IEC, ISO) for electrical safety, EMC, environmental performance, and biocompatibility, as well as the engineering specifications and design requirements of the device itself (e.g., magnetic field parameters, coil inductance, pulse width). The comparison to the predicate device's cleared specifications also serves as a form of "ground truth" for demonstrating equivalence.
8. The Sample Size for the Training Set
- This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. The software within the device is control software, verified and validated against its specifications, but not "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as #8. There is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Magstim Company Ltd. Kevyn Beard, Regulatory Affairs Manager Spring Gardens Whitland, SA34 0HR Carmarthenshire, GB
Re: K162935
Trade/Device Name: Rapid2 Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February 2, 2017 Received: February 6, 2017
Dear Kevyn Beard:
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 (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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, William J. Heetderks -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
Device Name
Rapid2 Therapy System
Indications for Use (Describe)
The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients The Rape failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 PRAStaff(@fda.hhs.gov
"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.
{3}------------------------------------------------
510(k) SUMMARY Magstim's Rapid2 Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Magstim Company Limited Spring Gardens, Whitland, Carmathenshire SA34 OHR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Kevyn Beard
Date Prepared: February 2, 2017
Name of Device
Magstim Rapid2 Therapy System
Common or Usual Name/
Repetitive Transcranial Magnetic Stimulation (rTMS) System
Classification
Repetitive Transcranial Magnetic Stimulation (rTMS) System
21 C.F.R. § 882.5805, Class II, product code OBP
Predicate Devices
Magstim Rapid2 Therapy System, The Magstim Company Limited. (K143531)
Device Description
The Rapid2 Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.
The Rapid2 Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The Rapid2 Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
The Rapid2 Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
{4}------------------------------------------------
Intended Use / Indications for Use
The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Technological Characteristics
The Rapid Therapy System is comprised of five principal components. These include:
-
- User Interface;
-
- Mainframe:
-
- Power supply;
-
- Air Film Coil;
-
- Optional D70mm MT Remote Coil
-
- Accessory coil stand
-
- Accessory footswitch and
-
- Accessory cables
The proposed change which is the subject of this 510(k), is to introduce a new optional hand held remote coil that is intended to be used for determining the motor threshold level.
The operator controls the Rapid2 Therapy System via the User Interface, using a graphic LCD panel with touchscreen technology. The operator instructions, given through the User Interface, direct the Rapid2 Stimulator mainframe in charging and discharging the device's high voltage discharge capacitor. The discharge is delivered to the patient via the stimulating coil. Motor threshold level can be determined using either the Air Film Coil or the optional D70mm MT Remote Coil. Treatment is delivered to the treatment area via the Air Film Coil, which is positioned above the treatment area. Positioning, and fixation, of the coil over the treatment area is accomplished using an accessory coil stand. The Rapid2 power supply provides power to charge the high voltage capacitor in the Rapid2 Stimulator.
Software documentation for a "moderate" level of concern has been provided.
Non-Clinical Testing
Electrical safety and electromagnetic compatibility ("EMC") testing was conducted on the system to demonstrate that the device is compliant with IEC 60601-1 (Ed. 3.1.) and IEC 60601-1-2 (2007). Environmental testing also demonstrated compliance with IEC 60601-1. The biocompatibility evaluation demonstrated that both coils meet ISO 10993-1 (2009) standards. In addition, magnetic field measurements and acoustic output measurements have been conducted to demonstrate safety and performance.
Software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of Rapid2 have been identified and evaluated in compliance with ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.
The non-clinical testing with the Rapid2 Therapy System included testing of the magnetic field characteristics of the system, as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems", was demonstrated under K143531
{5}------------------------------------------------
The addition of the optional D70mm MT Remote Coil to the Rapid2 Therapy System (predicate device) does not change the intended use and indications for use nor does it change the technological characteristics and principles of operation. The addition of the optional D70mm MT Remote Coil raises no new issues of safety or effectiveness.
Performance data demonstrate that the Rapid Therapy System is as safe and effective as the predicate.
The similarities and minor differences between the Air Film Coil and optional D70mm MT Remote Coil are described in the table below:
| Criteria | Rapid² System(Subject of this submission) | Rapid² Therapy System(Predicate System) | |
|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | |
| Device Name | Rapid² System | Rapid² System | |
| Clearance date | 08/05/2015 | ||
| 510(k) number | K143531 | ||
| Device code | OBP | OBP | |
| Intended Use/Indications for Use | The Rapid² Therapy System is indicated for thetreatment of Major Depressive Disorder in adultpatients who have failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. | The Rapid² Therapy System is indicated for thetreatment of Major Depressive Disorder in adultpatients who have failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. | |
| Treatment Protocol | |||
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | |
| Stimulus Frequency | 10 Hz | 10 Hz | |
| Stimulus Train duration | 4 sec | 4 sec | |
| Inter-train interval | 26 sec | 26 sec | |
| Number of trains | 75 | 75 | |
| Magnetic Pulses perSession | 3000 | 3000 | |
| Treatment SessionDuration | 37.5 min | 37.5 min | |
| Sessions/week | 5 | 5 | |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | |
| Area of brain to bestimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | |
| Applicator (Coil) Parameters | |||
| D70 MT Remote Coil(Optional for MTDetermination only) | Air Film Coil(Treatment Delivery andMT Determination) | ||
| Waveform | Biphasic | Biphasic | |
| Configuration | Figure 8 | Figure 8 | |
| Rapid2 System | Rapid2 Therapy System | ||
| Criteria | (Subject of this submission) | (Predicate System) | |
| Core Material | Air | Air | |
| Coil WindingParameters | Flat spiral winding9 turns/wing$1.75 \u00d7 6$ mm wire | Flat spiral winding19 turns/wing, 3 layers$1.0 \u00d7 3.5$ mm wire | |
| Inductance (nominal) | $15\u03bc$ H | $12\u03bc$ H | |
| Pulse Width | $330\u03bcs$ | $300\u03bcs$ | |
| Stimulator Output Parameters | |||
| Amplitude in SMT units(Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 | |
| Frequency range (Hz) | 0.1 - 30 | 0.1 - 30 | |
| Pulse train durationrange (sec) | 1 - 20 | 1 - 20 | |
| Inter-train interval range(sec) | 10 - 60 | 10 - 60 | |
| Maximum trains persession | ~ 140 | ~ 140 | |
| Maximum # of pulsesper session(cumulative exposure) | 5000 | 5000 | |
| Method for determiningMotor Threshold | • Place device over the left motor region• Determine patient sensitivity• Adjust coil position to identify region ofmaximal response in contra-lateralhand.• Reduce output amplitude to determinethreshold of stimulation | • Place device over the left motor region• Determine patient sensitivity• Adjust coil position to identify region ofmaximal response in contra-lateralhand.• Reduce output amplitude to determinethreshold of stimulation | |
| Method for determiningcoil treatment position | 5.5cm anterior to motor hotspot | 5.5cm anterior to motor hotspot | |
| Maximum outputamplitude (V/m) at adepth of 2cm below thecoil surface | 150 V/m | 150 V/m | |
| Maximum magnetic fieldstrength (T) at coilsurface | 1.0T | 1.0T | |
| Maximum magnetic fieldstrength (T) at a depthof 2cm | 0.4T | 0.4T | |
| Maximum magnetic fieldgradient (dB/dt) (kT/s) atcoil surface | 18 kT/s | 18 kT/s | |
| Maximum magnetic fieldgradient (dB/dt) (kT/s) ata depth of 2cm | 10 kT/s | 10 kT/s | |
| Magnetic field strengthgradient ratio | 1.8 | 1.8 |
Table 1: Substantial Equivalence Summary
{6}------------------------------------------------
The basic software capabilities related to treatment administration are unchanged from
the predicate device.
{7}------------------------------------------------
The Rapid Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (IEC 60601-1-2), with or without the optional D70mm MT Remote Coil.
Conclusions
In summary, the addition of the D70mm MT Remote Coil does not change the intended use and indications for use for the Rapid2 Therapy System, nor does it change the technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure. The addition of the optional D70mm MT Remote Coil raises no new issues of safety and effectiveness. Performance data demonstrate that the Rapid2 Therapy System is as safe and effective as the predicate.
Thus, the Rapid2 Therapy System, with the addition of the D70mm MT Remote Coil, is substantially equivalent to the predicate device.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.