(176 days)
The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.
Horizon® 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 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. ("TMS").
The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 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.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
The provided text describes a 510(k) premarket notification for the Magstim Horizon 3.0 TMS Therapy System, seeking substantial equivalence to existing devices for the treatment of Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD).
However, the document does not contain the results of a study designed to directly prove the device meets specific acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and limited non-clinical testing.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available from the provided text in the way they would be for an AI/ML diagnostic or prognostic device.
Here's an analysis based on the available information:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The device, Magstim Horizon 3.0 TMS Therapy System, is a medical device for therapeutic intervention (Transcranial Magnetic Stimulation), not a diagnostic or prognostic device that typically has performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness.
The "study" referenced for performance is primarily non-clinical testing and reliance on prior FDA clearances and published literature for predicate devices to support the extension of indications for use.
1. A table of acceptance criteria and the reported device performance:
Since the device is a therapeutic system and not a diagnostic one, the acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are centered on demonstrating that the proposed changes (primarily for OCD treatment indication) do not raise new questions of safety or effectiveness compared to predicate devices, and that the device can reliably deliver the therapy.
| Acceptance Criteria (Demonstrated Equivalence Aspects) | Reported Device Performance (Summary from Submission) |
|---|---|
| Software Functionality & Safety (OCD Protocol) | Software verification & validation according to IEC 62304 and company quality procedures, considered a well-established method. |
| System Therapeutic Delivery (OCD Protocol) | Performance verification confirmed reliable and safe delivery of the OCD protocol at maximum output within recognized safety temperature limits, referencing recognized standards and prior protocols (FR Recognition Number 19-46, K182853). |
| Equivalence of Magnetic Field Profiles (OCD Protocol) | Finite Element Method (FEM) and statistical analysis modeling in COMSOL showed induced E-field profiles of Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy coil are equivalent, with an average difference of ±5% at distances of 1 to 4 cm from the coil surface. This aligns with FDA guidance for rTMS systems. |
| Human Factors Testing (User Interface & Coil Positioning) | Human Factors testing performed according to HE 75 and IEC 62366, demonstrating that representative TMS users could appropriately position the coil and follow the treatment definition protocol with low variability after brief training. |
| Electrical, Mechanical Safety, EMC, Alarm Systems, Biocompatibility | Previous data from K211389 submission remains valid; no new testing was deemed necessary. |
| Clinical Efficacy (Indirect through Predicate Equivalence) | Magstim figure-of-eight stimulating coils were previously determined substantially equivalent to NeuroStar coils for MDD (K143531). A retrospective open-label study (Oliveira-Maia, Garcia-Guarniz, et al.) concluded no statistically significant differences in outcomes between Magstim and NeuroStar treated patients for depression, suggesting equivalent antidepressant efficacy. This supports the extension of indications to OCD based on coil equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Software Verification & Validation: The sample size for testing specific software functions or modules is not explicitly stated, but it would involve testing different use cases and parameter configurations. The data provenance is internal to the manufacturer's testing processes.
- Performance Verification of Therapeutic Delivery: Not specified as a typical patient "test set." Verification involves testing the device under various operational conditions.
- FEM Modeling: This is a computational simulation, not a physical test set with human subjects.
- Human Factors Testing: The sample size of "representative TMS users" is not explicitly stated. The provenance is likely internal testing data.
- Clinical Efficacy (Retrospective Study): The retrospective open-label study referenced (Oliveira-Maia, Garcia-Guarniz, et al.) is external scientific literature, not a study specifically conducted for this 510(k). The sample size for this study is not provided in the snippet, nor is the country of origin. It is a retrospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable in the context of this 510(k) submission, as it focuses on device safety and functional equivalence for a therapeutic system, not on establishing ground truth for diagnostic classifications by expert consensus. The "ground truth" for the device's function is its ability to reliably and safely deliver magnetic stimulation as intended, which is verified through engineering tests and adherence to standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is typically used in studies where human readers independently evaluate data and their findings require reconciliation to establish a ground truth. The non-clinical tests and simulations for the TMS system don't involve this type of adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a therapeutic system, not a diagnostic or AI-assisted interpretation tool where "human readers" would be involved in interpreting cases with or without AI assistance. The retrospective clinical study referenced in the submission is a comparative efficacy study of two different TMS devices, not an MRMC study involving AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself is a clinical tool used by a human operator (licensed physician). There is no "algorithm only" performance for a therapeutic TMS system. The software and hardware perform specific functions, but the overall therapy involves human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Software V&V: Ground truth is defined by specified software requirements and expected outputs.
- Performance Verification: Ground truth is defined by recognized safety limits and therapeutic delivery specifications (e.g., maximum output, temperature limits) as per international standards.
- FEM Modeling: Ground truth is derived from the physics principles governing electromagnetic fields and computational models, validated against known physical laws and prior successful device models.
- Human Factors: Ground truth relates to user comprehension, ability to perform tasks, and low variability in coil positioning, assessed against defined human factors engineering principles and successful task completion.
For the claim of substantial equivalence for clinical efficacy:
- Prior Equivalency Determination (K143531): FDA's prior determination of substantial equivalence for MDD treatment implies an acceptance of equivalent clinical outcomes based on comparative data.
- Retrospective Open-Label Study: The ground truth for this study would be patient outcomes (e.g., reduction in depression symptoms) as measured by clinical scales, which is a form of outcomes data.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that undergoes a "training phase" on a dataset in the conventional sense. The development of the device follows engineering design, verification, and validation principles.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this medical device's development or regulatory submission.
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January 13, 2023
Magstim Company Ltd Tom Campbell Corporate Director Regulatory Affairs Spring Gardens Whitland, Carmarthenshire SA340HR United Kingdom
Re: K222171
Trade/Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0. H3.0, Horizon 3.0 with StimGuide+ Regulation Number: 21 CFR 882.5805, 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: December 13, 2022 Received: December 14, 2022
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Digitally signed by Pamela D. Scott -S Date: 2023.01.13 22:31:45 -05'00'
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222171
Device Name Horizon 3.0 TMS Therapy System
Indications for Use (Describe)
Horizon 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are a dark blue color, except for a light blue circle above the "i". There is a small registered trademark symbol to the right of the word.
K222171 Traditional 510(k) SUMMARY Magstim's Horizon® 3.0 TMS Therapv System
Prepared according to the requirements outlined in 21 CFR 807.92
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, Corporate Director Regulatory Affairs
Date Prepared: August 31, 2022
Trade Name of Device
Horizon® 3.0 TMS Therapy System
Common or Usual Name
Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
Classification
21 C.F.R. § 882.5805, Class II, product code OBP 21 C.F.R. § 882.5802, Class II, product code QCI
Predicate Devices
K212289 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5802, QCI K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited (Secondary Predicate Device ), 21 C.F.R § 882.5805, OBP
K193006 MagVenture TMS Therapy, Tonica Elektronik A/S (Reference Predicate), 21 C.F.R ട്ട 882.5802, QCI
Device Description
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, maqnetic 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. ("TMS").
The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current
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episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 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.
Horizon® 3.0 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® 3.0 TMS Therapy System is intended to produce and deliver 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.
Horizon® 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Technological Characteristics
Horizon® 3.0 TMS Therapy System and its technological characteristics remain almost identical to that cleared within K211389.
The proposed changes to Horizon 3.0, for adjunctive treatment of OCD, are limited to updates to the IFU and software for user interface and treatment stimulation parameters. Both these changes are made to facilitate safe and effective treatment of patients with OCD and do not raise new or different questions of safety and effectiveness.
The coil positioning mechanism of action with Horizon 3.0 also remains unchanged with two options available dependent on Horizon 3.0 configuration. Horizon 3.0 with StimGuide+ offers the ability to locate and determine MT and the location of the treatment location with the use of stereotactic navigation, where standard Horizon 3.0 uses the conventional manual measurement approach.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
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Non-clinical Testing
Due to the minor nature of changes to the current Horizon 3.0 device, only a limited amount of non-clinical testing was necessary:
-
- Software verification & validation of the Horizon 3.0 software updates. The software modification was performed in accordance with IEC 62304 and the company's quality procedure, which is considered a well-established method via the utilization of a recognized international standard (FR Recognition Number 13-79) and the utilization of the development strategy used in the software development of the most recently cleared Horizon 3.0 device (K211389).
-
- Performance verification of the system therapeutic delivery. Testing was performed to verify that Horizon 3.0 could reliably and safely deliver the OCD protocol, at maximum output whilst remaining within recognized safety temperature limits. The verification protocol and test limits are well-established methods via utilization of a recognized international standard (FR Recognition Number 19-46) for the safety limits and K182853 for the verification protocol.
- a. In addition to OCD protocol performance testing, the subject device (Horizon 3.0) and the primary predicate device (NeuroStar) applicating coils were modeled in COMSOL and according to Finite Element Method (FEM) and statistical analysis, the induced E-field profiles are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface. The data provided is consistent with the FDA's quidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
-
- Human Factors testing of user interface and coil positioning mechanism was performed in accordance with HE 75 and IEC 62366 and the company's quality procedure, which is considered a well-established method via the utilization of a recognized international standard (FR Recognition Number 5-57 and 5-114) and the utilization of the validation strategies used in the development of the most recently cleared Horizon 3.0 device (K211389).
The testing performed is both described in the software section (Section XVIII) and performance testing section (Section XX).
No further testing for Electrical Safety, Mechanical Safety, Electromagnetic Compatibility, Alarm Systems and Biocompatibility was necessary as previous data submitted as part of K211389 premarket notification remains valid to demonstrate safety and effectiveness and support a determination of substantial equivalence. This is re-iterated in Sections XII, XIV, XVII and XIX.
Substantial Equivalence
Horizon 3.0 device changes are limited to updates to the IFU and software for user interface and treatment stimulation parameters. Both these changes are made to facilitate safe and effective treatment of patients with OCD and do not raise new or different questions of safety and effectiveness. Information on these changes can be found in the software section, Section XVIII.
Where the labelling has been updated, this has been performed appropriately to identify various contraindications and instructions relevant to the usage of the device for treatment of
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OCD as per special controls. Confirmed to be equivalent to that of the reference predicate (K193006), the well-established method used to update the labeling to extend the indication to include OCD does not raise new or different questions regarding safety and effectiveness. Labelling can be found in Section XV.
The focus component of both the subject device and the primary predicate device when considering the extension to the indication to include OCD is the stimulating coil.
Whilst the coil construction characteristics of the Ez Cool Coil and the NeuroStar Advanced Therapy are different, the magnetic field characteristics of the coils are equivalent which is pertinent to treatment delivery effectiveness. Earlier in K143531, the FDA determined that Magstim figure of eight stimulating coils are substantially equivalent to the NeuroStar Advanced Therapy System coil for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from medication in the current episode. This decision was later further substantiated in a retrospective open-label study titled "Comparative Efficacy of Repetitive Transcranial Magnetic Stimulation for Treatment of Depression Using 2 Different Stimulation Devices: A Retrospective Open-Label Study" where the authors Oliveira-Maia, Garcia-Guarniz, et al, conclude in that there was no statistically significant differences between outcomes in Magstim and NeuroStar treated patients which is suggestive of equivalent antidepressant efficacy between devices.1
To further substantiate this argument, the Horizon 3.0 Ez Cool Coil and the NeuroStar Advanced Therapy Coil were modeled in COMSOL and according to the finite element modelling (FEM) and statistical analysis, the induced E-field profiles by the Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy Coil are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface. The modeling method is based on well-established scientific methods, equivalent to those used to demonstrate equivalence for the reference predicate (K193006). For further information on the modelling, please refer to Section XX.
Coil positioning mechanism is identical to that of the Primary Predicate (K211389) where non-clinical testing according to international standard JEC 62366-1 (5-114) and HE 75 (5-57) has demonstrated that representative TMS users, after a brief training session, were able to appropriately position the coil for treatment, and follow the recommended treatment definition protocol with low variability between position. Human factors testing information can be found in Section XX.
Thus, in summary, as an adjunct for the treatment of OCD, the Horizon 3.0 figure of eight stimulating coil is considered equivalent to the NeuroStar Advanced Therapy System coil cleared by the FDA in K212289 and does not raise new or different questions of safety and effectiveness.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
Conclusion
1 (Garcia-Guarniz AL, Sinanis A, Pascual-Leone A, Press D. Comparative efficacy of repettive transcranial magnetic stimulation for treatment of depression using 2 different stimulation devices: A refrospective open-label study. J Clin Psychiatry 2016;77:e743.)
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In summary, the intended use and indications for use for Horizon 3.0 and it predicate devices are identical.
The minor modifications to Horizon 3.0 to extend the indications for use do not raise new or different questions regarding safety and effectiveness. Where non-clinical testing was performed, this was performed according to well established methods recognized either as an FDA recognized standard, FDA guidance document, scientific literature or via an approach previously accepted by the FDA.
Although the indications have been modified, the overall operating principles of TMS devices for stimulating the cerebral cortex remains the same. Regardless of indication, the same type of energy output is used and the same principles apply to determining a MT hotspot and positioning of the coil for delivery of brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex. The Physical State, Technical Method and Target Area for both OBP and QCI devices are equivalent in themselves.
Non-clinical test data collected via well-established methods demonstrates that Horizon 3.0 is as safe and effective as its predicate devices (K211389 and K212289).
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the Horizon 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
A tabular comparison of device characteristics can be found on the following page.
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| Criteria | Horizon 3.0 TMS Therapy System(Subject of this submission) | HORIZON 3.0 TMS Therapy System(K211389)(Secondary Predicate) | NeuroStar Advanced Therapy System(K212289)(Primary Predicate) | Magventure TMS Therapy System(K193006)(Reference Predicate) |
|---|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Neuronetics, Inc. | Tonica Elektronik A/S |
| Device Name | Horizon 3.0 TMS Therapy System | Horizon 3.0 TMS Therapy System | NeuroStar TMS Therapy System | Magventure TMS Therapy System |
| Clearance date | 09/14/2021 | 05/06/2022 | 08/09/2020 | |
| 510(k) number | K222171 | K211389 | K212289 | K193006 |
| Device code | OBP, QCI | OBP | QCI | QCI |
| Intended Indications Use/Use for | The Horizon 3.0 TMS Therapy System isindicated for the treatment of MajorDepressive Disorder in adult patients whohave failed to receive satisfactoryimprovement from prior antidepressantmedication in the current episode, as wellas an adjunct for the treatment of adultpatients suffering from Obsessive-Compulsive Disorder (OCD). | The Horizon 3.0 TMS TherapySystem is indicated for the treatmentof Major Depressive Disorder in adultpatients who have failed to receivesatisfactory improvement from priorantidepressant medication in thecurrent episode. | The NeuroStar AdvancedTherapy System is intended tobe used as an adjunct for thetreatment of adult patientssuffering from Obsessive-Compulsive Disorder (OCD). | The MagVenture TMS TherapySystem is intended to be usedas an adjunct for the treatmentof adult patients suffering fromObsessive-Compulsive Disorder(OCD). |
| OCD Treatment Protocol | ||||
| Magnetic Field Intensity | 100% of the MT | N/A | 100% of the MT | 100% of the MT |
| Stimulus Frequency | 20 Hz | N/A | 20 Hz | 20 Hz |
| Stimulus duration | 2 sec | N/A | 2 sec | 2 sec |
| Inter-train interval | 20 sec | N/A | 20 sec | 20 sec |
| Number of trains | 50 | N/A | 50 | 50 |
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| Magnetic Pulsesper Session | 2000 | N/A | 2000 | 2000 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TreatmentSession Duration | 18.3 min | N/A | 18.3 min | 18.0 min | Train Duration | 2 sec | 2 sec | N/A | N/A | N/A | N/A | N/A | N/A |
| Sessions/week | 5 | N/A | 5 | 5 | Inter-train Interval | 8 sec | 8 sec | N/A | N/A | N/A | N/A | N/A | N/A |
| TreatmentSchedule | 5 daily sessions for 5 weeks, 4 dailysessions for 1 week. | N/A | 5 daily sessions for 5 weeks,4 daily sessions for 1 week. | 5 daily sessions for 5 weeks,4 daily sessions for 1 week. | Burst Pulses | 3 | 3 | N/A | N/A | N/A | N/A | N/A | N/A |
| Area of brain to bestimulated | Dorsomedial Prefrontal Cortex | N/A | Dorsomedial PrefrontalCortex | Dorsomedial PrefrontalCortex | Bursts | 200 | 200 | N/A | N/A | N/A | N/A | N/A | N/A |
| Standard Treatment Protocol | Pulse Inter interval | 20 msec | 20 msec | N/A | N/A | N/A | N/A | N/A | N/A | ||||
| MagneticIntensity | 120% of the MT | 120% of the MT | N/A | N/A | Number of trains | 20 | 20 | N/A | N/A | N/A | N/A | N/A | N/A |
| StimulusFrequency | 10 Hz | 10 Hz | N/A | N/A | Number of Pulses per Session | 600 | 600 | N/A | N/A | N/A | N/A | N/A | N/A |
| Stimulusduration | 4 sec | 4 sec | N/A | N/A | Treatment Session Duration | 3.09 min | 3.09 min | N/A | N/A | N/A | N/A | N/A | N/A |
| Inter-train interval | 11-26 sec | 11-26 sec | N/A | N/A | Sessions/week | 5 | 5 | N/A | N/A | N/A | N/A | N/A | N/A |
| Number of trains | 75 | 75 | N/A | N/A | Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A | N/A | N/A | N/A | N/A | N/A |
| Magnetic Pulsesper Session | 3000 | 3000 | N/A | N/A | Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | N/A | N/A | N/A | N/A | N/A | N/A |
| TreatmentSession Duration | 18.8 min-37.5 min | 18.8 min-37.5 min | N/A | N/A | Horizon® MT Remote Coil | Horizon® 3.0 E-z Cool Coil | Horizon® 3.0 E-z Cool Coil (Nav) | Horizon® MT Remote Coil | Horizon® 3.0 E-z Cool Coil | Horizon® 3.0 E-z Cool Coil (Nav) | NeuroStar Stimulating Coil | Cool D-B80 | |
| Sessions/week | 5 | 5 | N/A | N/A | Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| TreatmentSchedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A | N/A | Core Material | Air | Air | Air | Air | Air | Air | Ferromagnetic Core | Air, Liquid Cooled |
| Area of brain to bestimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral PrefrontalCortex | N/A | N/A | Pulse Width | 330μς | 340μς | 340μς | 330μς | 340μς | 340μς | 180μς | 290μς |
| iTBS Treatment Protocol | Amplitude in SMT units (Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 | N/A | N/A | N/A | N/A | 0.22 - 2.08 | 0 - 1.9 | ||||
| StimulationIntensity | 120% of the MT | 120% of the MT | N/A | N/A | |||||||||
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | N/A | N/A |
{10}------------------------------------------------
{11}------------------------------------------------
| Frequency range (Hz) at 100% | Pulse train duration range (sec) | Inter-train interval range (sec) | Maximum # of pulses per session (cumulative exposure) | Maximum output amplitude (V/m) at a depth of 2cm below the coil surface | Maximum magnetic field strength (T) at coil surface | Maximum magnetic field strength (T) at a depth of 2cm | Maximum magnetic field gradient (dB/dt) (kT/s) at coil surface | Maximum magnetic field gradient (dB/dt) (kT/s) at a depth of 2cm |
|---|---|---|---|---|---|---|---|---|
| 1 - 20 | 0.1 - 600 | 1 - 540 | 60000 | 150 V/m | 1.0T | 0.4T | 18 kT/s | 10 kT/s |
| 1 - 20 | 0.1 - 600 | 1 - 540 | 60000 | 150 V/m | 1.0T | 0.4T | 18 kT/s | 10 kT/s |
| 0.1 - 30 | 1-20 | 10-60 | 5000 | 135 V/m nominal | 0.7T | 0.5T | 27 kT/s | 11 kT/s |
| 0.1 - 30 | Unknown | Unknown | Unknown | Unknown | 1.0T | Unknown | 31 kT/s | 11 kT/s |
{12}------------------------------------------------
| SystemConfiguration | CoilPrinciple for OCD | Horizon 3.0 | Horizon 3.0 withStimGuide+ | MT ResponsePrinciple for OCD | NeuroStar AdvancedTherapy System | MagVenture TMSTherapy System |
|---|---|---|---|---|---|---|
| Indirect targetingof treatmenttarget throughmeasureddistance anddirection (4cmanterior) from LegMT Hotspot.Measure derivedfrom statisticaldistance ofDMPFC/ACCfrom MT hotspot. | Indirect targetingof treatmenttarget throughmeasureddistance anddirection (4cm)from Leg MTHotspot usingstereotacticnavigation.Measure derivedfrom statisticaldistance ofDMPFC/ACCfrom MT hotspot. | N/A | Visual qualitative monitoring for APBresponse | Indirect targeting oftreatment target throughmeasured distance anddirection (4cm anterior) fromLeg MT Hotspot usingcontact sensing and headsupport system. Measurederived from statisticaldistance of DMPFC/ACCfrom MT hotspot. | Indirect targeting oftreatment target throughmeasured distance anddirection (4cm anterior) fromLeg MT Hotspot usingcontact sensing and headsupport system. Measurederived from statisticaldistance of DMPFC/ACCfrom MT hotspot. | |
| Coil Positioning and MT Determination Principle for MDD | CoilPrinciple for MDD | Horizon 3.0 | Horizon 3.0 withStimGuide+ | CoilPrinciple for MDD | NeuroStar AdvancedTherapy System | MagVenture TMSTherapy System |
| Indirect targetingof treatmenttarget throughmeasureddistance anddirection (5.5cm)from MT Hotspot.Measure derivedfrom statisticaldistance ofDLPFC from MThotspot. | Indirect targetingof treatmenttarget throughmeasureddistance anddirection (5.5cm)from MT Hotspotusingstereotacticnavigation.Measure derivedfrom statisticaldistance ofDLPFC from MT | N/A | N/A | N/A |
§ 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.