(147 days)
Not Found
No
The document describes a Transcranial Magnetic Stimulation (TMS) system. While it is a computerized system with software, there is no mention of AI, ML, or any related terms or concepts in the provided text. The performance studies focus on safety and basic device characteristics, not algorithmic performance metrics typically associated with AI/ML.
Yes
The device is used for the "treatment of Major Depressive Disorder" by inducing electrical currents to specific regions of the cerebral cortex, directly addressing a health condition.
No
The device description clearly states it is for "treatment of Major Depressive Disorder" and is "for patient treatment." It describes how it produces and delivers stimulation to induce electrical currents. There is no mention of diagnosing conditions.
No
The device description explicitly states that the Rapid Therapy System is an integrated system consisting of a combination of hardware, software, and accessories, and describes it as a computerized, electromechanical medical device that produces and delivers magnetic stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Rapid2 Therapy System is described as a device that delivers non-invasive magnetic stimulation to the cerebral cortex. It is a treatment device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for the treatment of Major Depressive Disorder, not for the diagnosis of it.
Therefore, the Rapid2 Therapy System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
OPB
Device Description
The Rapid 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 Rapid" 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 Rapid-Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.
The Rapid Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cerebral cortex, prefrontal cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed physician; inpatient settings, including physicians' offices, clinics, and hospitals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 to demonstrate that the device is compliant with IEC 60601-1 (2ªª & 3ª ed.) and IEC 60601-1-2 (2007).
Environmental testing also demonstrated compliance with IEC 60601-1.
The biocompatibility evaluation demonstrated that the coil meets ISO 10993-1 (2009) standards.
Magnetic field plots, and acoustic output measurements were also 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.
Output Waveform measurement: The output waveform produced by the biphasic figure 8 coil was measured using a calibrated search coil connected to an oscilloscope.
Electric Field Spatial Distribution modeling: The electric field distribution was modeled using a finite element method on a homogeneous sphere with a radius of 8.5cm.
Magnetic Field Strength Gradient measurement: The magnetic field strength was measured in a relevant volume above the stimulating coils using a calibrated search coil connected to an oscilloscope.
Cooling System Test: The temperature on the patient surface was measured over successive treatment sessions in order to evaluate the effectiveness of the cooling system at a higher than normal ambient temperature to ensure safe operation.
Key results: The performance tests demonstrate that the Rapid2 Therapy System may be safely and effectively used for treatment of Major Depressive Disorder.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping profiles facing right, with a design element resembling a wing or ribbon extending from the first profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Magstim Company Limited C/O Janice Hogan Partner, Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
Re: K143531
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: OPB Dated: April 10, 2015 Received: April 10, 2015
Dear Ms. Hogan:
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. Isting 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Felipe Aquel - S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Type of Use (Select one or both, as applicable)
区 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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510(k) SUMMARY Magstim's Rapid2 Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Maqstim Company Limited Spring Gardens, Whitland, Carmathenshire SA34 OHR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Charles Hounsell
Date Prepared: December 11, 2014
Name of Device
Magstim Rapid- 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
NeuroStar TMS Therapy System, Neuronetics, Inc. (K133408)
Device Description
The Rapid 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 Rapid" 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 Rapid-Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.
4
The Rapid Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Intended Use / Indications for Use
The Rapid 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 Rapid2 Therapy System is comprised of five principal components. These include:
-
- User Interface;
-
- Mainframe;
-
- Power supply;
-
- Air Film Coil;
-
- Coil Stand
-
- Accessory footswitch and
-
- Accessory cables
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 Rapid Stimulator mainframe in charging and discharging the device's high voltage discharge capacitor. The discharge 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 the Coil Stand. The Rapid 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 to demonstrate that the device is compliant with IEC 60601-1 (2ªª & 3ª ed.) and IEC 60601-1-2 Environmental testing also demonstrated compliance with IEC 60601-1. The (2007). biocompatibility evaluation demonstrated that the coil meets ISO 10993-1 (2009) standards. In addition, magnetic field plots, and acoustic output measurements were also 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 quidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems", as follows:
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Output Waveform .
The output waveform produced by the biphasic figure 8 coil was measured using a calibrated search coil connected to an oscilloscope. This way the waveform could be quantified in three directions as well as in time.
Electric Field Spatial Distribution .
The electric field distribution was modeled using a finite element method on a homogeneous sphere with a radius of 8.5cm. This allows a quantification of the depth (d1/2) and spread (S1/2) of the field.
Magnetic Field Strength Gradient .
The magnetic field strength was measured in a relevant volume above the stimulating coils using a calibrated search coil connected to an oscilloscope. This way the magnetic field strength could be quantified in three directions as well as its magnitude.
. Cooling System Test
The temperature on the patient surface was measured over successive treatment sessions in order to evaluate the effectiveness of the cooling system at a higher than normal ambient temperature to ensure safe operation.
The performance tests demonstrate that the Rapid2 Therapy System may be safely and effectively used for treatment of Major Depressive Disorder.
Substantial Equivalence
The Rapid Therapy System has the same intended use and indications for use as the predicate device, as well as similar technological characteristics and principles of operation. The minor technological differences between the Rapid2 Therapy System and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Rapid- Therapy System is as safe and effective as the predicate.
The design of the Rapid- Therapy System is similar to the design of the NeuroStar TMS Therapy System, as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.
Transcranial magnetic stimulation is enabled in the Rapid2 Therapy System and in the NeuroStar TMS Therapy System, as both devices have the same system components, consisting of a mobile cart or console, an electromagnetic coil, a positioning arm, a TMS stimulator, and software. The basic operational procedure is the same in both the Rapid Therapy System and in the NeuroStar TMS Therapy System consisting of system setup, patient preparation, determination of patient's motor threshold, coil position, and administration of treatment at predefined treatment stimulation parameters. The similarities and minor differences between the Rapid² Therapy System and the NeuroStar TMS Therapy System are described in the table below:
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Table 1: Substantial Equivalence Summary
| Criteria | Rapid² Therapy System | NeuroStar TMS Therapy System |
|---|---|---|
| Magnetic Field | ||
| Intensity | 120% of the MT | 120% of the MT |
| Frequency | 10 Hz | 10 Hz |
| 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/wk | 5 | 5 |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks |
| Area of brain to be | ||
| stimulated | Frontal Cortex | Frontal Cortex |
| Applicator | ||
| Configuration | ||
| Core Material | Biphasic Figure 8 Coil | |
| Air | Biphasic Figure 8 Coil | |
| Ferromagnetic | ||
| Coil Parameters | Area = 33000mm² | |
| Flat spiral winding | ||
| WC = 1.75 mm × 6 mm | ||
| N = 3x19 turns/wing x 2 wings | Area = 13000mm² | |
| Stranded rectangular windings | ||
| Wire wrapped around cross-section of the core | ||
| N = 5 turns/wing (stranded) | ||
| Machine Output | ||
| Parameters: Amplitude | ||
| in Standard Motor | ||
| Threshold (SMT) units | ||
| Pulse width (usec) | ||
| Frequency range (Hz) | ||
| Pulse train duration | ||
| range (sec) | ||
| Inter-train interval | ||
| range (sec) | 0.28 - 1.9 | |
| 300 | ||
| 0.1 - 30 | ||
| 1 - 20 | ||
| 10 - 60 | 0.22 - 1.6 | |
| 185 | ||
| 0.1 - 30 | ||
| 1 - 20 | ||
| 10 - 60 | ||
| Criteria | Rapid2 Therapy System | NeuroStar TMS Therapy System |
| Maximum trains per | ||
| session | ~ 140 | ~ 140 |
| Maximum # of pulses | ||
| per session | ||
| (cumulative exposure) | 5000 | 5000 |
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The basic software capabilities related to treatment administration are the same in the Rapid2 Therapy System and in the NeuroStar TMS Therapy System.
Both the Rapid Therapy System and in the NeuroStar TMS Therapy System meet the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (IEC 60601-1-2).
Conclusions
In summary, the intended use and indications for use for the Rapid2 Therapy System and in the NeuroStar TMS Therapy System are identical. Furthermore, the key technological characteristics of the Rapid2 Therapy System and in the NeuroStar TMS Therapy System, including basic design, mechanism of action, components, specifications, and treatment procedure, are similar. Performance testing demonstrates that the minor differences do not impact safety or effectiveness.
Thus, the Rapid2 Therapy System is substantially equivalent to the NeuroStar TMS Therapy System predicate device.