(276 days)
The Apollo 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 Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).
The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (Apollo TMS Therapy System K243539) |
|---|---|
| Intended Use Equivalence: Identical intended use as predicate devices. | The Apollo 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). This matches the intended use of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171) for OCD, and the secondary predicate (Apollo TMS Therapy System K232639) for MDD. |
| OCD Treatment Stimulation Parameters Equivalence: Identical brain area, intensity (100% leg MT), frequency (20 Hz), pulse train duration (2 sec), inter-train interval (20 sec), trains per session (50), max no. of pulses (2000), and treatment schedule (5 daily sessions for 5 weeks, 4 daily sessions for 1 week) as the primary predicate device. | Area of brain to be stimulated: DMPFC (Identical to predicate) Stimulation intensity: 100 % of leg MT (Identical to predicate) Stimulation frequency: 20 Hz (Identical to predicate) Pulse train duration: 2 sec (Identical to predicate) Inter-train interval: 20 sec (Identical to predicate) Trains per session: 50 (Identical to predicate) Max no. of pulses: 2000 (Identical to predicate) Treatment schedule: 5 daily sessions for 5 weeks, 4 daily sessions for 1 week (Identical to predicate) |
| Consistent Intensity of Individual Stimuli during OCD Protocol: The intensity of each stimulus during the OCD protocol is equal and kept constant throughout the delivery of the full treatment. | Successfully demonstrated for the subject device. |
| Safety Temperature Limits Adherence: Remaining within recognized safety temperature limits at maximum output. | Remaining within recognized safety temperature limits. (Identical to predicates) |
| Electrical Safety: Conformance to IEC 60601-1. | Conforms to IEC 60601-1. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2. | Conforms to IEC 60601-1-2. |
| Usability: Conformance to IEC 60601-1-6. | Conforms to IEC 60601-1-6. |
| Software Life Cycle Processes: Conformance to IEC 62304 and FDA guidance for software. | Software verification and validation testing conducted and documented in accordance with IEC 62304 and internal quality procedures. Software documentation considered "basic documentation" (supported by Special Controls Guidance "rTMS Class II"). |
| Risk Management: Application of ISO 14971 and IEC 62304 throughout the product development lifecycle with no new hazards/harms compared to predicates. | Risk assessment applied. Results indicate no new hazards, harms, or safety risks introduced when compared to the predicate devices. |
| Output Stimulation Parameters: Adequately similar output stimulation parameters (amplitude, pulse width, frequency, pulse train duration, ITI range, max # of pulses per session) to enable substantial equivalence determination. | Detailed comparison provided in the summary. While pulse width differs, the output stimulation is considered "adequately similar" to the primary predicate for OCD treatment. Other parameters within acceptable ranges or directly comparable. |
| Stimulation Coil Parameters: Similar coil configuration (figure-of-eight), output waveform (biphasic), E-Field at 1.0 SMT (130 V/m). | All identical to predicates. |
| Coil Positioning System: Comparable in function and method to predicate devices. | Integrated into Head-and-Neck-Support System (HANS), Landmark-Aided Coil Placement, TMS Cap for standardized 10-20-EEG Positioning with Coil Positioning Arm. Considered comparable or improved over predicate. |
2. Sample size used for the test set and the data provenance
The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.
The "study" relies on:
- Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
- Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
- Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.
4. Adjudication method for the test set
This information is not applicable as there was no clinical test set requiring expert 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
This information is not applicable. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.
7. The type of ground truth used
For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.
For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.
8. The sample size for the training set
This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
FDA 510(k) Clearance Letter - Apollo TMS Therapy System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 18, 2025
MAG & More GmbH
Juliane Rieß
Regulatory Affairs Manager
Machtlfinger Straße 13
Munich, 81379
Germany
Re: K243539
Trade/Device Name: Apollo TMS Therapy System
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP, QCI
Dated: July 4, 2025
Received: July 16, 2025
Dear Juliane Rieß:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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K243539 - Juliane Rieß
Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K243539 - Juliane Rieß
Page 3
Sincerely,
JAY R. GUPTA -S
For Pamela 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243539
Device Name
Apollo TMS Therapy System
Indications for Use (Describe)
The Apollo 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 5
510(k) Summary Apollo TMS Therapy System
510(k) Summary
Page 1 of 9
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
510(k) Owner:
MAG & More GmbH
Machtlfinger Straße 13
81379 Munich, Germany
Phone: +49 (0)89 998 292 300
Fax: +49 (0)89 998 292 330
Primary Contact: Juliane Rieß
Date Prepared: 04-Jul-2025
Proprietary Name: Apollo TMS Therapy System
Common/Usual Name: Repetitive Transcranial Magnetic Stimulation (rTMS) System
Classification: 21 CFR 882.5805, class II, product code OBP and QCI
Predicate Device:
Intended Use
The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder (MDD) 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).
Device Description and Function
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
Page 6
510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 2 of 9
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).
Performance Standards
The Apollo TMS Therapy System conforms to the following recognized consensus standards:
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62304 Medical device software - Software life cycle processes
Further Applicable Standards
The Apollo TMS Therapy System complies with applicable requirements of the following additional standards:
- ISO 14971 Medical devices - Application of risk management to medical devices
- ISO 15223 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
- IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Non-Clinical and Clinical Performance Data
Apollo TMS Therapy System and its technological characteristics remain identical to that cleared within the prior Apollo TMS Therapy System clearance (K232639).
The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff." Non-clinical performance testing was performed according to the standards listed above or leveraged from prior clearances of the device (K180313 and K232639) if unchanged, including electrical safety, electromagnetic compatibility and biocompatibility testing.
Page 7
510(k) Summary Apollo TMS Therapy System
The proposed changes for the subject device for the adjunctive treatment of OCD are limited to updates to the Indications for Use (IFU) and the Stimware application software, in addition to necessary labeling changes. These changes have been made to enable the safe and effective treatment of patients with OCD and do not introduce any new safety or effectiveness considerations.
To establish substantial equivalence between the predicate device and the subject device comparative performance testing was carried out. The data provided in this submission, such as the comparison of the electric and magnetic field output of the device, demonstrate that expanding the indications to include the adjunct treatment of obsessive-compulsive disorder (OCD) in adult patients does not raise any different questions regarding safety and effectiveness. Further performance testing was carried out to demonstrate that the Apollo TMS Therapy System can reliably and safely deliver the OCD protocol while remaining within recognized safety temperature limits. This verification is based on well-established methods using the recognized international standard IEC 60601-1 and the test protocol and data already used in K180313 and K232639.
Additional verification testing has demonstrated that the intensity of each stimulus during the OCD protocol is equal and kept constant throughout the delivery of the full treatment. This was successfully demonstrated for the subject device and therefore, is substantially equivalent to the primary predicate HORIZON® 3.0 TMS Therapy System (cleared in K222171). Clinical performance data was not required to demonstrate safety and effectiveness of the OCD treatment.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documented in accordance with IEC 62304 and internal quality procedures already used in K180313 and K232639.
The documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software documentation for this device is considered as "basic documentation" (supported by Special Controls Guidance "rTMS Class II"), since a failure or flaw of any device software function(s) could not present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.
Risk Management
Risk assessment is applied throughout the product development lifecycle process in accordance with the recognized consensus standards ISO 14971 and IEC 62304. The results of the comprehensive risk analysis for the device indicate that there are no new hazards, harms, or safety risks introduced when compared to the predicate devices.
510(k) Summary Page 3 of 9
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510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 4 of 9
Substantial Equivalence
The Apollo TMS Therapy System is substantially equivalent to its predicate devices, the HORIZON® 3.0 TMS Therapy System (K222171) and Apollo TMS Therapy System (K232639). The intended use and indications for use for the Apollo TMS Therapy System and predicate devices are identical.
The Apollo TMS Therapy System and the secondary predicate device have identical system components, consisting of a main unit (available in two variants 918001 Apollo and 918010 Apollo Light) including the stimulator, a stimulation coil, a coil positioning system, and the application software. The basic operational procedure is identical consisting of system setup, patient preparation, coil positioning, determination of patient's motor threshold, and administration of treatment at predefined treatment stimulation parameters.
Treatment effectiveness depends on the applied treatment protocol. The OCD protocol of the subject device Apollo TMS Therapy System is identical to that of the primary predicate device HORIZON® 3.0 TMS Therapy System cleared in K222171. The equal and constant intensity of individual stimuli being delivered was successfully demonstrated for the subject device throughout the full OCD treatment. Additionally, although the waveform characteristics (e.g., pulse width) differ, the output stimulation of the system are adequately similar to determine the subject device is substantially equivalent to the primary predicate HORIZON® 3.0 TMS Therapy System (K222171) in terms of OCD treatment.
Conclusions
The indication for use, the target population, the treatment procedure, and the treatment spot for OCD are all identical for the Apollo TMS Therapy System and the predicate device HORIZON® 3.0 TMS Therapy System (K222171). The MDD treatment of the subject device was already cleared in K232639 and remains unaltered.
The OCD treatment parameters are identical to those of the primary predicate device HORIZON® 3.0 TMS Therapy System (K222171). Non-clinical performance testing has demonstrated that the technological characteristics of the subject device are substantially equivalent to the predicate devices. Additional verification testing has demonstrated that the intensity of individual stimuli during the OCD protocol is equal and kept constant throughout the delivery of the full treatment with the Apollo TMS Therapy System. This provides a consistent treatment dose when treating patients with the Apollo TMS Therapy System. This demonstrates that the Apollo TMS Therapy System is as safe and effective for use in adjunctive treatment of obsessive-compulsive disorder as the primary predicate device.
All identified differences between the subject device Apollo TMS Therapy System and its predicate devices are minor and without any impact on safety or effectiveness. The subject device Apollo TMS Therapy System does not introduce any new safety considerations.
Therefore, the Apollo TMS Therapy System is substantially equivalent to its predicate devices HORIZON® TMS Therapy System (K222171) and Apollo TMS Therapy System (K232639).
Page 9
510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 5 of 9
Substantial Equivalence Comparison
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| 510(k) number | N/A | K222171 | K232639 |
| Device trade name | Apollo TMS Therapy System | HORIZON® 3.0 TMS Therapy System | Apollo TMS Therapy System |
| 510(k) submitter | MAG & More GmbHMachtlfinger Straße 1381379 Munich, Germany | Magstim Company LimitedSpring Gardens, Whitland,CarmarthenshireSA34 OHR, United Kingdom | MAG & More GmbHMachtlfinger Straße 1381379 Munich, Germany |
| Indications for use | The Apollo 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). | 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 Apollo 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 code | OBP, QCI | OBP, QCI | OBP |
| Classification | 21 CFR 882.5805 | 21 CFR 882.5805 | 21 CFR 882.5805 |
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510(k) Summary Apollo TMS Therapy System
Substantial Equivalence Comparison
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| OCD Treatment Stimulation Parameters | |||
| Area of brain to be stimulated | DMPFC | DMPFC | - |
| Stimulation intensity | 100 % of leg MT | 100 % of leg MT | - |
| Stimulation frequency | 20 Hz | 20 Hz | - |
| Pulse train duration | 2 sec | 2 sec | - |
| Inter-train interval | 20 sec | 20 sec | - |
| Trains per session | 50 | 50 | - |
| Max no. of pulses | 2000 | 2000 | - |
| Treatment schedule | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week | - |
| Standard MDD Treatment Stimulation Parameters | |||
| Area of brain to be stimulated | Left DLPFC | Left DLPFC | Left DLPFC |
| Stimulation intensity | 120% of MT | 120% of MT | 120% of MT |
| Stimulation frequency | 10 Hz | 10 Hz | 10 Hz |
510(k) Summary Page 6 of 9
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510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 7 of 9
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| Pulse train duration | 4 sec | 4 sec | 4 sec |
| Inter-train interval | 11 – 26 sec | 11 – 26 sec | 11 – 26 sec |
| Trains per session | 75 | 75 | 75 |
| Max no. of pulses | 3,000 | 3,000 | 3,000 |
| Treatment schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks |
| iTBS Treatment Stimulation Parameters | |||
| Area of brain to be stimulated | Left DLPFC | Left DLPFC | Left DLPFC |
| Stimulation intensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Repetition rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) |
| Train duration | 2 sec | 2 sec | 2 sec |
| Inter-train interval | 8 sec | 8 sec | 8 sec |
| Burst pulses | 3 | 3 | 3 |
| Bursts | 200 | 200 | 200 |
| Inter pulse interval | 20 ms | 20 ms | 20 ms |
| Number of trains | 20 | 20 | 20 |
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510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 8 of 9
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| Number of pulses per session | 600 | 600 | 600 |
| Treatment session duration | 3.09 min | 3.09 min | 3.09 min |
| Sessions/week | 5 | 5 | 5 |
| Treatment schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks |
| Output Stimulation Parameters | |||
| Amplitude in SMT units (/SMT: standard motor-threshold) | 0 – 2.0 SMT | 0.28 - 1.9 SMT | 0 – 2.0 SMT |
| Pulse width (± accuracy) | pCool coils: 162 µsaCool coils: 163 µs | HORIZON® MT Remote Coil: 330µsHORIZON® 3.0 E-z Cool Coil: 340 µs | pCool coils: 162 µsaCool coils: 163 µs |
| Frequency (± accuracy) | 1-100 Hz (± 2%) | 1 – 20 Hz | 30-100 Hz (± 2%) (iTBS) |
| Pulse train duration (sec) | 0.04 - 2000 | 0.1 - 600 | 0.04 - 2000 |
| ITI range (sec) | 1 - 65 | 1 - 540 | 1 - 65 |
| Max # of pulses per session | 75,000 | 60,000 | 75,000 |
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510(k) Summary Apollo TMS Therapy System
510(k) Summary Page 9 of 9
| Characteristic | Subject Device | Predicate Device | Secondary Predicate |
|---|---|---|---|
| Stimulation Coil Parameters | |||
| Configuration | figure-of-eight coil | figure-of-eight coil | figure-of-eight coil |
| Output waveform | biphasic | biphasic | biphasic |
| E-Field at 1.0 SMT | 130 V/m | 130 V/m | 130 V/m |
| Surface temperature at max output | Remaining within recognized safety temperature limits | Remaining within recognized safety temperature limits | Remaining within recognized safety temperature limits |
| Coil Positioning System | Integrated into Head-and-Neck-Support System (HANS), Landmark-Aided Coil PlacementTMS Cap for standardized 10-20-EEG Positioning with Coil Positioning Arm | TMS Patient Caps | Integrated into Head-and-Neck-Support System (HANS), Landmark-Aided Coil PlacementTMS Cap for standardized 10-20-EEG Positioning with Coil Positioning Arm |
§ 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.