(119 days)
Not Found
No
The summary describes a computerized, electromechanical device for magnetic stimulation and does not mention AI or ML capabilities.
Yes
The device is indicated for the "treatment of Major Depressive Disorder" and "used for patient treatment by prescription".
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosing it.
No
The device description explicitly states it is a "computerized, electromechanical medical device" that "produces and delivers non-invasive, magnetic stimulation," indicating it includes significant hardware components beyond just software.
Based on the provided information, the HORIZON™ TMS 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. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description clearly states it's an electromechanical medical device that produces and delivers magnetic stimulation. It does not mention any interaction with biological specimens.
- Mechanism of Action: The device works by inducing electrical currents in the brain using magnetic fields, a physical process, not by analyzing biological samples.
Therefore, the HORIZON™ TMS 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™ 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 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, prefrontal cortex, Left Dorsolateral Prefrontal Cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
prescription only under the supervision of a licensed physician. It can be used in both inpatient 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 test data demonstrates that the HORIZON® TMS Therapy System is as safe and effective as the HORIZON® Therapy System (K171051).
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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August 3, 2018
Magstim Company Ltd. Tom Campbell Regulatory Affairs Manager Spring Gardens Whitland, Camarthenshire Wales, UK SA34 0HR
Re: K180907
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: July 2, 2018 Received: July 5, 2018
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/cdrh/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
1
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 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 mediation-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).
Sincerelv.
Image /page/1/Picture/6 description: The image shows the name "Pamela D. Scott -S" in a large, bold font on the left side. On the right side, there is a digital signature block that reads "Digitally signed by Pamela D. Scott -S" followed by a DN string and a date. The date is "2018.08.03 18:58:54-04'00'".
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
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Indications for Use
510(k) Number (if known) K180907
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) |
|---|
| ------------------------------------------------- |
| Residential Use (Part 21 CFR 601 Subpart D) OTC Cosmetic Use (21 CFR 331) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | |||
| Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | ||||||||
| Residential Use (Part 21 CFR 601 Subpart D) | Residential Use (Part 21 CFR 601 Subpart D) | |||||||||
| Residential Use (Part 21 CFR 601 Subpart D) | ||||||||||
| OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | ||||||||
| OTC Cosmetic Use (21 CFR 331) | OTC Cosmetic Use (21 CFR 331) | |||||||||
| OTC Cosmetic Use (21 CFR 331) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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 0HR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Tom Campbell
Date Prepared: July 30, 2018
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 Devices
HORIZON® Therapy System, The Magstim Company Limited. (K171051) (Primary Predicate) NeuroStar TMS Therapy System, Neuronetics, Inc. (K160703) (Secondary Predicate) Neurosoft TMS, TeleEMG, LLC. (K173441) (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 settings, including physicians' offices, clinics, and hospitals.
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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® Trolley;
- 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.
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 EN 60601-1-2 (2007). Environmental testing also demonstrated compliance with IEC 60601-1.
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EN 60601-1-2 (2007) is not an FDA recognized standard and hence a justification of its equivalence to the appropriate FDA recognized standard for its acceptance has been provided.
The biocompatibility evaluation demonstrated that the stimulation 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® TMS 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.
As required by FDA's Guidance Document titled "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems", non-clinical testing of the HORIZON® TMS Therapy System included testing of the magnetic field characteristics of the system. The results of this testing demonstrate that the magnetic field characteristics of the HORIZON® TMS Therapy System is substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).
Substantial Equivalence
The HORIZON® TMS Therapy System is substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).
The HORIZON® TMS Therapy System and the primary predicate device (K171051) have identical intended use and indications for use, equivalent principles of operation, as well as the same key technological characteristics.
The technological difference between the HORIZON® TMS Therapy System and the HORIZON® Therapy System (K171051), includes the addition of the HORIZON® E-z Cool Coil, HORIZON® E-z Cart and HORIZON® E-z Arm. These changes raise no new issues of safety or effectiveness. Performance data demonstrates that the HORIZON® TMS Therapy System is as safe and effective as the primary predicate device.
The design of the HORIZON® TMS Therapy System is substantially equivalent to the design of the primary predicate device (K171051), 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 principles of operation of the HORIZON® TMS Therapy System is equivalent to the HORIZON® Therapy System (K171051). The modification to the device allows a range of inter-train intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which allows a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes. The change to this output stimulation parameter is identical to the secondary predicate device, the NeuroStar TMS Therapy System (K160703).
Transcranial magnetic stimulation is enabled in the HORIZON® TMS Therapy System and in the HORIZON® Therapy System (K171051), as both have the same key system
6
components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure is the same in both the HORIZON® TMS Therapy System and the HORIZON® Therapy System (K171051), consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters.
The basic software capabilities related to treatment administration are the same as the primary predicate, the HORIZON® Therapy System (K171051). A notable difference is that the arbitrary upper limit imposed by software for the maximum number of pulses per session (cumulative exposure) has been increased from 6000 to 60,000 in the HORIZON® TMS Therapy System. This is supported by TeleEMG, LLC's Neurosoft TMS (K173441) that is capable of delivering a maximum of 72,000.
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 HORIZON® Therapy System (Primary Predicate), the NeuroStar TMS Therapy System (Secondary Predicate) and the Neurosoft TMS (Secondary Predicate) are described in Table 1.
Conclusions
In summary, the intended use and indications for use for the HORIZON® TMS Therapy System and primary predicate device, The HORIZON® Therapy System (K171051) are identical.
Furthermore, the key technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure are substantially equivalent.
Non-clinical test data demonstrates that the HORIZON® TMS Therapy System is as safe and effective as the HORIZON® Therapy System (K171051).
Thus, the HORIZON® TMS Therapy System is considered substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).
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Table 1: Substantial Equivalence Summary
| Criteria | HORIZON® TMS Therapy System
(Subject of this submission) | HORIZON® Therapy
System
(K171051)
(Primary Predicate) | NeuroStar TMS
Therapy System
(K160703)
(Secondary
Predicate) | Neurosoft TMS
(K173441)
(Secondary Predicate) | Sessions/week | 5 | | 5 | | 5 | 5 | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------|---------------------------|----------------------------------------|----------------------------|----------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Neuronetics Inc. | TeleEMG, LLC | Treatment Schedule | 5 daily sessions for 6 weeks | | 5 daily sessions for 6 weeks | | 5 daily sessions for 6
weeks | 5 daily sessions for 6
weeks | |
| Device Name | HORIZON® Therapy System | HORIZON® Therapy System | NeuroStar TMS
Therapy System | Neurosoft TMS | Area of brain to be
stimulated | Left Dorsolateral Prefrontal Cortex | | Left Dorsolateral Prefrontal
Cortex | | Left Dorsolateral
Prefrontal Cortex | Left Dorsolateral
Prefrontal Cortex | |
| Clearance date | | 09/13/2017 | 06/10/2016 | 12/13/2017 | | HORIZON®
MT Remote
Coil | HORIZON®
E-z Cool Coil | HORIZON®
AFC | HORIZON®
MT Remote Coil | HORIZON®
AFC | NeuroStar Stimulating
Coil | FEC-02-100-C, AFEC-
02-100-C
FEC-02-100 (optional),
AFEC-02-100 (optional) |
| 510(k) number | | K171051 | K160703 | K173441 | Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Device code | OBP | OBP | OBP | OBP | Core Material | Air | Air | Air | Air | Air | Ferromagnetic core | Air |
| 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 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 NeuroStar 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 Neurosoft TMS 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. | Pulse Width | 330μs | 340μs | 300μs | 330μs | 300μs | 185μs | 280μs |
| Magnetic Field
Intensity | 120% of the MT | 120% of the MT | 120% of the MT | 120% of the MT | Amplitude in SMT units
(Standard Motor Threshold) | 0.28 - 1.9 | | 0.28 - 1.9 | | 0.22 - 1.6 | | FEC-02-100-C 0-1.89
AFEC-02-100-C 0-2.38
FEC-02-100 0-1.92
AFEC-02-100 0-2.33 |
| Stimulus Frequency | 10 Hz | 10 Hz | 10 Hz | 10 Hz | Frequency range (Hz)
at 100% | | 1 - 20 | | 1 - 20 | | 0.1-30 | 0.1-30 (stand-alone)
0.1-100 (with PC) |
| Stimulus Train duration | 4 sec | 4 sec | 4 sec | 4 sec | Pulse train duration
range (sec) | | 0.1 - 600 | | 0.1 - 600 | | 1-20 | 0.5 - 100 |
| Inter-train interval | 11-26 sec | 26 sec | 11-26 sec | 11-26 sec | Inter-train interval range
(sec) | | 1 - 540 | | 1 - 540 | | 10-60 | 0 - 300 |
| Number of trains | 75 | 75 | 75 | 75 | Maximum # of pulses
per session
(cumulative exposure) | | 60000 | | 6000 | | 5000 | 72000 (Stand-alone) =
2400 s [max session]
*30Hz
240000 (with PC) =
2400 s [max session] *
100Hz |
| Magnetic Pulses per
Session | 3000 | 3000 | 3000 | 3000 | Maximum output
amplitude (V/m) at a
depth of 2cm below the
coil surface | | 150 V/m | | 150 V/m | | 135V/m nominal | Not disclosed by
Manufacturer |
| Treatment Session
Duration | 18.8 min-37.5 min | 37.5 min | 18.8 min – 37.5 min | 18.8 min-37.5 min | | | | | | | | |
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