(141 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electromechanical and magnetic stimulation technology.
Yes
The device is indicated for the "treatment of Major Depressive Disorder" and delivers "magnetic stimulation," which falls under the definition of a therapeutic device.
No
The device is indicated for the "treatment of Major Depressive Disorder," and its description details a method of "cortical stimulation" for therapeutic purposes, not for diagnosing.
No
The device description explicitly states that the Rapid2 Therapy System is an "integrated system consisting of a combination of hardware, software, and accessories," and it is described as a "computerized, electromechanical medical device." The performance studies also include testing of hardware components like electrical safety, EMC, environmental testing, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder by applying magnetic stimulation to the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states it's a system that produces and delivers magnetic stimulation to the cerebral cortex. This is an external, non-invasive treatment method.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is a therapeutic device that uses Transcranial Magnetic Stimulation (TMS) for the treatment of a neurological condition.
N/A
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.
Product codes
OBP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex, Left Dorsolateral Prefrontal Cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed physician; inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Results: Performance data demonstrate that the Rapid Therapy System is as safe and effective as the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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 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 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. | |
| 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 per
Session | 3000 | 3000 | |
| Treatment Session
Duration | 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 be
stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | |
| Applicator (Coil) Parameters | | | |
| | D70 MT Remote Coil
(Optional for MT
Determination only) | Air Film Coil
(Treatment Delivery and
MT 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 Winding
Parameters | Flat spiral winding
9 turns/wing
$1.75 \u00d7 6$ mm wire | | Flat spiral winding
19 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 duration
range (sec) | 1 - 20 | | 1 - 20 |
| Inter-train interval range
(sec) | 10 - 60 | | 10 - 60 |
| Maximum trains per
session | ~ 140 | | ~ 140 |
| Maximum # of pulses
per session
(cumulative exposure) | 5000 | | 5000 |
| Method for determining
Motor Threshold | • Place device over the left motor region
• Determine patient sensitivity
• Adjust coil position to identify region of
maximal response in contra-lateral
hand.
• Reduce output amplitude to determine
threshold of stimulation | | • Place device over the left motor region
• Determine patient sensitivity
• Adjust coil position to identify region of
maximal response in contra-lateral
hand.
• Reduce output amplitude to determine
threshold of stimulation |
| Method for determining
coil treatment position | 5.5cm anterior to motor hotspot | | 5.5cm anterior to motor hotspot |
| Maximum output
amplitude (V/m) at a
depth of 2cm below the
coil surface | 150 V/m | | 150 V/m |
| Maximum magnetic field
strength (T) at coil
surface | 1.0T | | 1.0T |
| Maximum magnetic field
strength (T) at a depth
of 2cm | 0.4T | | 0.4T |
| Maximum magnetic field
gradient (dB/dt) (kT/s) at
coil surface | 18 kT/s | | 18 kT/s |
| Maximum magnetic field
gradient (dB/dt) (kT/s) at
a depth of 2cm | 10 kT/s | | 10 kT/s |
| Magnetic field strength
gradient 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.