(156 days)
Not Found
No
The summary describes a standard Transcranial Magnetic Stimulation (TMS) system and does not mention any AI or ML components in its description, intended use, or performance testing.
Yes
The device is indicated for the "treatment of Major Depressive Disorder" and is described as a "non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder."
No
Explanation: The device is described as a "Therapy System" indicated for "treatment of Major Depressive Disorder." Its function is to "produce and deliver non-invasive, magnetic stimulation" for "cortical stimulation." These descriptions clearly indicate a therapeutic, rather than diagnostic, function.
No
The device description explicitly states that the HORIZON™ Therapy System is an integrated system consisting of a combination of hardware, software, and accessories, and it is a computerized, electromechanical medical device.
Based on the provided information, the HORIZON™ Therapy System is not an In Vitro Diagnostic (IVD) device.
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 description clearly states it's a "computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation." This describes a physical device used for treatment, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the HORIZON™ 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 HORIZON™ 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)
OBP
Device Description
The HORIZON™ 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 HORIZON™ 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 HORIZON™ 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 HORIZON™ 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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, acoustic output measurements have been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.
The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of HORIZON™ Therapy System 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 magnetic field characteristics of the system are identical to the predicate device, therefore equivalent safety and performance is assured. Consequently, no additional testing of the magnetic field characteristics of the system is necessary to meet the requirement of FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" in order to demonstrate safety and performance.
In summary, performance testing demonstrates that the HORIZON™ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
Magstim Company Ltd. Tom Campbell Regulatory Affairs Officer Spring Gardens Whitland, SA34 0HR Gb
Re: K171051/S002
Trade/Device Name: HORIZON Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: May 23, 2017 Received: August 10, 2017
Dear Tom Campbell:
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 device
1
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.
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 (DICE) 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 (DICE) 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 2017.09.13 08:48:43 -04'00'
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
510(k) Number (if known)
Device Name
HORIZON™ Therapy System
Indications for Use (Describe)
The HORIZON™ 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)
Z 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 HORIZON™ Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Magstim Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 OHR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Tom Campbell
Date Prepared: August 29, 2017
Name of Device
HORIZON™ 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 and K162935)
Device Description
The HORIZON™ 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 HORIZON™ 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 HORIZON™ 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.
4
The HORIZON™ 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 HORIZON™ 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 HORIZON™ Therapy System is comprised of five principal components. These include:
-
- HORIZON™ User Interface;
-
- HORIZON™ Mainframe;
-
- HORIZON™ Power supply:
-
- HORIZON™ Air Film Coil;
-
- HORIZON™ MT Remote Coil;
-
- Accessory HORIZON™ Cart;
-
- Accessory Coil Holding Mechanism;
-
- Accessory Footswitch;
-
- Accessory Cables: and
-
- Accessory TMS Patient Caps.
The operator controls the HORIZON™ Therapy System via the HORIZON™ User Interface, using a graphic LCD panel with touchscreen technology. The operator instructions, given through the HORIZON™ User Interface, direct the HORIZON™ 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 the HORIZON™ MT Remote Coil. Treatment is delivered to the treatment area via the HORIZON™ 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 Holding Mechanism. The HORIZON™ Power Supply provides power to charge the high voltage capacitor in the HORIZON™ Mainframe.
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, acoustic output measurements have been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.
The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of HORIZON™ Therapy System have been identified and evaluated in compliance with
5
ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.
As demonstrated in Section XIV and Appendix 03 the coil head geometry of both the HORIZON™ Air Film Coil and HORIZON™ MT Remote Coil are identical to the predicate devices, the Air Film Coil and D70mm MT Remote Coil, cleared under K143531 and K162935. For this reason, the magnetic field characteristics of the system are identical to the predicate device, therefore equivalent safety and performance is assured. Consequently, no additional testing of the magnetic field characteristics of the system is necessary to meet the requirement of FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" in order to demonstrate safety and performance.
In summary, performance testing demonstrates that the HORIZON™ Therapy System is as safe and effective as the predicate.
Substantial Equivalence
The HORIZON™ Therapy System has the same intended use and indications for use, the same principles of operation, as well as the same key technological characteristics as the predicate device.
The design of the HORIZON™ Therapy System is substantially equivalent to the design of the predicate, 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.
The modifications from the predicate device include increased thermal performance and reliability of the mainframe and power supply and a new coil to mainframe connector to improve reliability and usability.
Transcranial magnetic stimulation is enabled in the HORIZON™ Therapy System and in the Rapid² Therapy System, as both have the same key system components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure is the same in both the HORIZON™ Therapy System and the Rapid² Therapy System consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters. The similarities and minor differences between the HORIZON™ Therapy System and the Rapid2 Therapy System are described in Table 1.
6
Table 1: Substantial Equivalence Summary
| Criteria | HORIZON™ Therapy System
(Subject of this submission) | Rapid² Therapy System | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | | |
| Device Name | HORIZON™ Therapy System | Rapid² Therapy System | | |
| Clearance date | | 2017/03/10 | | |
| 510(k) number | | K143531 and K162935 | | |
| Device code | OBP | OBP | | |
| Intended Use/ Indications
for Use | The HORIZON™ 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 | | |
| MT Determination Coil Parameters | | | | |
| | HORIZON™ MT Remote Coil
Part #: 4990-00 | D70 MT Remote Coil
Part #: 4949-00 | | |
| Waveform | Biphasic | Biphasic | | |
| Configuration | Figure 8 | Figure 8 | | |
| Core Material | Air | Air | | |
| Coil Winding Parameters | Flat spiral winding
9 turns/wing
1.75 × 6mm wire
Magstim Part #: 3303-01 | Flat spiral winding
9 turns/wing
1.75 × 6mm wire
Magstim Part #: 3303-01 | | |
7
| Criteria | HORIZON TM Therapy System
(Subject of this submission) | Rapid2 Therapy System |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Inductance (nominal) | 15μH | 15μH |
| Pulse Width | 330μs | 330μs |
| Coil Connector | Harting Han-Eco Connector | Trident Ringlock Circular Connector |
| | Treatment Delivery Coil Parameters | |
| | HORIZON TM Air Film Coil
Part #: 4980-00 | Air Film Coil
Part #: 3910-00 |
| Waveform | Biphasic | Biphasic |
| Configuration | Figure 8 | Figure 8 |
| Core Material | Air | Air |
| Coil Winding Parameters | Flat spiral winding
19 turns/wing, 3 lyrs
1.0 x 3.5mm wire
Magstim Part #: 0056-01 | Flat spiral winding
19 turns/wing, 3 lyrs
1.0 x 3.5mm wire
Magstim Part #: 0056-01 |
| Inductance (nominal) | 12μH | 12μH |
| Pulse Width | 300μs | 300μs |
| Coil Connector | Harting Han-Eco Connector | Trident Ringlock Circular Connector |
| | Stimulator Output Parameters | |
| Amplitude in SMT units
(Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 |
| Frequency range (Hz) at
100% | 1 - 20 | 1 - 11 |
| Pulse train duration range
(sec) | 0.1 - 600 | 0.1 - 600 |
| Inter-train interval range
(sec) | 1 - 540 | 1 - 540 |
| Maximum trains per
session | 1 - 999 | 1 - 999 |
| Maximum # of pulses per
session
(cumulative exposure) | 6000 | 65000 |
| 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 | 5.5cm anterior to motor hotspot | 5.5cm anterior to motor hotspot |
| Criteria | HORIZON™ Therapy System
(Subject of this submission) | Rapid2 Therapy System |
| 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 |
8
The basic software capabilities related to treatment administration are the same as the predicate device.
The HORIZON™ Therapy System meets 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 HORIZON™ Therapy System and the Rapid² Therapy System are identical. Furthermore, the key technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure are the same. Non-clinical test data demonstrates that the HORIZON™ Therapy System is as safe and effective as the predicate.
Thus, the HORIZON™ Therapy System is substantially equivalent to the Rapid? Therapy System.