(156 days)
Not Found
No
The document describes a computerized, electromechanical device for transcranial magnetic stimulation and does not mention AI or ML in its description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of Major Depressive Disorder" and uses "magnetic stimulation... to induce electrical currents directed at spatially discrete regions of the cerebral cortex" for "cortical stimulation," which directly serves a therapeutic purpose.
No
The device is described as a "non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder," indicating its purpose is therapeutic rather than diagnostic.
No
The device description explicitly states that the HORIZON® TMS 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, the HORIZON® TMS Therapy System 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 HORIZON® TMS Therapy System is described as a device that delivers non-invasive magnetic stimulation to the cerebral cortex. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for the treatment of Major Depressive Disorder, which is a therapeutic application, not a diagnostic one based on in vitro testing.
Therefore, the HORIZON® TMS Therapy System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HORIZON TMS 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® TMS 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® TMS 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® TMS 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® TMS 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
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 Performance Testing:
The non-clinical performance testing of the HORIZON® TMS Therapy System including electrical safety, electromagnetic compatibility, biocompatibility, human factors and magnetic field characteristics has been tested as required and cleared by the FDA earlier in K180907.
Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment. As stated by the primary predicate device (K173620), the clinical performance of iTBS is dependent on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.
This demonstrates that the HORIZON® TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.
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.
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March 15, 2019
Magstim Company Ltd. Tom Campbell Regulatory Manager Spring Gardens, Whitland, Carmarthenshire SA34 OHR. United Kingdom
Re: K182853
Trade/Device Name: HORIZON TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February 5, 2019 Received: February 11, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott -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
Indications for Use
510(k) Number (if known) K182853
Device Name HORIZON TMS Therapy System
Indications for Use (Describe)
The HORIZON TMS 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) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) SUMMARY Magstim's HORIZON®TMS 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: March 15, 2019
Name of Device
HORIZON® TMS 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 Device
Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S. (K173620) (Primary Predicate)
HORIZON® TMS Therapy System, The Magstim Company Limited. (K180907) (Secondary Predicate)
Device Description
The HORIZON® TMS 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® TMS 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® TMS 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® TMS 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® TMS 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® TMS Therapy System is comprised of the following components:
-
- HORIZON® Stimulator
- a. HORIZON® User Interface;
- b. HORIZON® Mainframe;
- c. HORIZON® Power Supply;
- d. Accessory Cables;
- e. Accessory Footswitch.
-
- Coil for MT Determination
- a. HORIZON® MT Remote Coil.
-
- Coil(s) for Treatment
- a. HORIZON® AFC:
- b. HORIZON® E-z Cool Coil.
-
- Accessory Cart(s) and Coil Holding Mechanism(s)
- a. Magstim®Trollev:
- b. Magstim® Coil Stand(s);
- c. HORIZON® E-z Cart;
- d. HORIZON® E-z Arm.
-
- Accessory Marking Apparatus
- a. TMS Patient Caps.
The operator controls the HORIZON® TMS 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 either the HORIZON® AFC or the HORIZON® E-z Cool Coil, which is positioned above the treatment area. Positioning, and fixation, of the coil over the treatment area is accomplished using the Coil Holding Mechanism(s). The HORIZON® Power Supply provides power to charge the high voltage capacitor in the HORIZON® Mainframe.
Non-Clinical Performance Testing
The non-clinical performance testing of the HORIZON® TMS Therapy System including electrical safety, electromagnetic compatibility, biocompatibility, human factors and magnetic field characteristics has been tested as required and cleared by the FDA earlier in K180907.
5
Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment. As stated by the primary predicate device (K173620), the clinical performance of iTBS is dependent on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.
This demonstrates that the HORIZON® TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.
Substantial Equivalence
The HORIZON® TMS Therapy System is substantially equivalent to its predicate devices, the HORIZON® TMS Therapy System (K180907) and the Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620).
The intended use and indications for use for the HORIZON® TMS Therapy System and the secondary predicate device, the HORIZON® TMS Therapy System (K180907) are identical.
The key technological characteristics including basic design, mechanism of action, specifications are also identical for both the HORIZON® TMS Therapy System and the secondary predicate device (K180907).
The principles of operation of the HORIZON® TMS Therapy System is equivalent to the secondary predicate device, the HORIZON® TMS Therapy System (K180907). The only change to the HORIZON® TMS Therapy System is a modification to the labelling to include a recommendation for an additional treatment protocol known as iTBS. This treatment protocol, is identical to the treatment protocol recommended by the primary predicate device, the Maq Vita TMS Therapy System w/Theta Burst Stimulation (K173620). The design of the HORIZON® TMS Therapy System is unchanged from that previously cleared under K180907.
Transcranial magnetic stimulation is enabled in the HORIZON® TMS Therapy System and in the predicate devices, as all have the same key system components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters is unchanged in the HORIZON® TMS Therapy System to that cleared earlier in (K180907).
The basic software capabilities related to treatment administration are the same as the secondary predicate (K180907)
The HORIZON® TMS Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (EN 60601-1-2).
The similarities and minor differences between the HORIZON® TMS Therapy System, the Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620) (Primary Predicate) and the HORIZON® TMS Therapy System (K180907) (Secondary Predicate) are described in Table 1.
6
Conclusions
In summary, the intended use and indications for use for the HORIZON® TMS Therapy System and the secondary predicate device, the HORIZON® TMS Therapy System (K180907) are identical.
Furthermore, the key technological characteristics including basic design, mechanism of action, specifications are also identical for both the HORIZON® TMS Therapy System and the secondary predicate device (K180907).
The principles of operation, including the method for determining coil position, the treatment procedure and the relevant protocol parameters are substantially equivalent to the predicate devices.
Non-clinical performance testing has demonstrated that the change to the HORIZON® TMS Therapy System labelling to add a recommendation for an additional treatment protocol known as iTBS, raises no new issues of safety or effectiveness. Furthermore, the intended use, as described in the labeling, has not changed as a result of this modification.
Thus, the HORIZON® TMS Therapy System is considered to be substantially equivalent.
7
Table 1: Substantial Equivalence Summary
| Criteria | HORIZON® TMS Therapy System
(Subject of this submission) | Mag Vita TMS Therapy System
w/Theta Burst Stimulation
(K173620)
(Primary Predicate) | HORIZON® TMS Therapy System
(K180907)
(Secondary Predicate) | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Magstim Company Limited | Tonica Elektronik A/S | Magstim Company Limited | |
| Device Name | HORIZON® TMS Therapy System | Mag Vita TMS Therapy System
w/Theta Burst Stimulation | HORIZON® TMS Therapy System | |
| Clearance date | | 08/14/2018 | 08/03/2018 | |
| 510(k) number | | K173620 | K180907 | |
| Device code | OBP | OBP | OBP | |
| Intended Use/
Indications for Use | The HORIZON® TMS 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 Mag Vita TMS Therapy System w/Theta
Burst Stimulation is indicated for the
treatment of Major Depressive Disorder in
adult patients who have failed to receive
satisfactory improvement from prior
antidepressant medication in the current
episode. | The HORIZON® TMS 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. | |
| | Standard 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 | 11-26 sec | - | 11-26 sec | |
| Number of trains | 75 | - | 75 | |
| Magnetic Pulses per
Session | 3000 | - | 3000 | |
| Treatment Session
Duration | 18.8 min–37.5 min | - | 18.8 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 | |
| iTBS Treatment Protocol | | | | |
| Stimulation Intensity | 120% of the MT | 120% of the MT | - | |
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | - | |
| Train Duration | 2 sec | 2 sec | - | |
| Inter-train Interval | 8 sec | 8 sec | - | |
| Burst Pulses | 3 | 3 | - | |
| Bursts | 200 | 200 | - | |
| Inter Pulse interval | 20 msec | 20 msec | - | |
| Number of trains | 20 | 20 | - | |
| Number of Pulses per
Session | 600 | 600 | - | |
| Treatment Session
Duration | 3.09 min | 3.09 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 | - | |
8
9
| | HORIZON®
MT Remote
Coil | HORIZON®
E-z Cool Coil | HORIZON®
AFC | Cool-B70 Coil | HORIZON®
MT Remote
Coil | HORIZON®
E-z Cool Coil | HORIZON®
AFC | |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------|-------------------------------------------------|---------------------------------------------|-------------------------------------------|---------------------------------------------------|-------------------------------------------------|--|
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Core Material | Air | Air | Air | Air | Air | Air | Air | |
| Shape | Figure-of-
eight | Figure-of-
eight | Figure-of-
eight | Figure-of-eight | Figure-of-
eight | Figure-of-
eight | Figure-of-
eight | |
| Coil Winding
Configuration
Inner Diameter (ID)
Outer Diameter (OD)
Winding Height (H)
Number of Windings (NW) | ID: 55mm
OD: 92mm
H: 6mm
NW: 2x9 | ID: 37.5mm
OD: 97mm
H: 11mm
NW: 2x(3x23) | ID: 43mm
OD: 92mm
H: 11mm
NW: 2x(3x19) | ID: 23mm
OD: 96mm
H: 12mm
NW: 2x11 | ID: 55mm
OD: 92mm
H: 6mm
NW: 2x9 | ID: 37.5mm
OD: 97mm
H: 11mm
NW: 2x(3x23) | ID: 43mm
OD: 92mm
H: 11mm
NW: 2x(3x19) | |
| Pulse Width | 330μs | 340μs | 300μs | 280μs | 330μs | 340μs | 300μs | |
| Amplitude in SMT
units
(Standard Motor Threshold) | | 0.28 - 1.9 | | 0 - 1.7 | | 0.28 - 1.9 | | |
| Frequency range (Hz)
at 100% | 1 - 20 | | | | 1 - 20 | | | |