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.

Device Description

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 of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The Apollo TMS Therapy System is comprised of four principal components: User Interface, Main Unit, Stimulation Coil, and Coil Positioning System. The operator controls the system via the User Interface. The Treatment and Data Management Software administrates the treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. The stimulation is applied via the Stimulation Coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system.

AI/ML Overview

The provided text is a 510(k) summary for the Apollo TMS Therapy System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a clinical study with detailed performance metrics.

Therefore, the document does not contain acceptance criteria and a study proving the device meets those criteria in the way one might expect for a new diagnostic or AI-driven interpretative device. Instead, it focuses on demonstrating substantial equivalence to existing, approved devices.

Here's an analysis based on your request, identifying what information is available and what is not:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly define "acceptance criteria" for performance in the typical sense of a new clinical trial. Instead, it demonstrates how the Apollo TMS Therapy System is substantially equivalent to predicate devices. The "performance" here is related to mirroring the characteristics and functionality of those predicates.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Apollo TMS Therapy System)
Indications for Use:
- Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.	- Met: Identical to predicate devices.
Treatment Stimulation Parameters:
- Area of brain to be stimulated: Left DLPFC	- Met: Left DLPFC
- Stimulation intensity: 120% of MT	- Met: 120% of MT
- Stimulation frequency: 10 Hz	- Met: 10 Hz
- Pulse train duration: 4 sec	- Met: 4 sec
- Inter-train interval: Similar to predicate	- Met: 11 – 26 sec
- Trains per session: 75	- Met: 75
- Max No. of Pulses: 3,000	- Met: 3,000
Output Stimulation Parameters:
- Amplitude in SMT units: Similar range to predicate	- Met: 0 – 2.0 SMT
- Pulse width (± accuracy): Similar to predicate	- Met: 167 μs (± 10%)
- Frequency (± accuracy): Similar to predicate	- Met: 0-100 Hz (± 2%)
Stimulation Coil Parameters:
- Configuration: Figure 8 Coil	- Met: Figure 8 Coil
- Core material: Similar to predicate	- Different but deemed equivalent: Air (Predicate: Iron Core or Air)
Coil Positioning System:
- Similar functionality to predicate devices	- Met: Integrated into Head-and-Neck-Support System, Landmark-Aided Coil Placement
Safety and EMC:
- Compliance with IEC 60601-1:2005 MOD	- Met: Complies with IEC 60601-1:2005 MOD
- Compliance with IEC 60601-1-2:2007	- Met: Complies with IEC 60601-1-2:2007
Software Verification & Validation:
- Per FDA guidance for "moderate level of concern"	- Met: Conducted with documentation provided
Risk Management:
- Compliance with ISO 14971:2007	- Met: Identified and evaluated risks per ISO 14971:2007

2. Sample size used for the test set and the data provenance:

This document describes non-clinical testing for substantial equivalence, not a clinical study on patient outcomes with a "test set" in the context of, for example, diagnostic accuracy. Therefore, this information is not applicable and not provided. The "testing" primarily involved engineering and safety assessments (electromagnetic field characteristics, electrical safety, EMC, software, risk management).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

As no clinical test set for diagnostic or interpretative performance is described, this information is not applicable and not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As no clinical test set requiring expert adjudication is described, this information is not applicable and not provided.

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 device is a therapeutic system (Repetitive Transcranial Magnetic Stimulation) for Major Depressive Disorder, not an AI-assisted diagnostic or interpretive tool that would involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a therapeutic system, not an algorithm. Performance evaluation focuses on its physical and functional characteristics, and its equivalence to predicate devices, not on a standalone algorithm's performance. Therefore, this concept is not applicable.

7. The type of ground truth used:

For the non-clinical testing performed, the "ground truth" would be established by:

Engineering standards and specifications: For electromagnetic field characteristics, pulse width, frequency accuracy, amplitude, etc.
International safety standards: Such as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
FDA guidance documents: For software verification and validation, and special controls for rTMS systems.
Risk management standards: ISO 14971.

8. The sample size for the training set:

As this is a 510(k) submission for a physical medical device, not a machine learning model, the concept of a "training set" is not applicable and not provided.

9. How the ground truth for the training set was established:

As the concept of a training set is not applicable, this information is not provided.

Summary

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May 4, 2018 Mag & More GmbH Kerstin Haringer Regulatory Affairs and Quality Assurance Machtlfinger Strasse 13 Munich, 81379 De

Re: K180313

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 Dated: January 26, 2018 Received: February 5, 2018

Dear Kerstin Haringer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Kerstin Haringer

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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).

Sincerely,

William J. Heetderks -S 2018.05.04 17:04:25 -04'00'

Carlos L. Peña. PhD. MS for 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)

Device Name Apollo TMS Therapy System

Indications for Use (Describe)

Type of Use (Select one or hoth, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

I. SUBMITTER

MAG & More GmbH Machtlfinger Straße 13 81379 Munich, Germany

Phone: +49 (0)89 2018 5248 Fax: +49 (0)89 2018 5328

Contact Person: Dr. Kerstin Häringer Date prepared: January 26, 2018

II. DEVICE

Name of Device	Apollo TMS Therapy System
Common or Usual Name	Repetitive Transcranial Magnetic Stimulation (rTMS) System
Classification Name	Repetitive transcranial magnetic stimulation (rTMS) system(21 CFR 882.5805)
Regulatory Class	II
Product Code	OBP

lll. PREDICATE DEVICES

NeuroStar TMS Therapy System, Neuronetics, Inc. (K161519), decision date September 11, 2016 Rapid2 Therapy System, Magstim Ltd., (K162935), decision date March 10, 2017 No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

The Apollo TMS Therapy System is comprised of four principal components. These include:

. User Interface
Main Unit
Stimulation Coil
Coil Positioning System

The operator controls the Apollo TMS Therapy System via the User Interface. The Treatment and Data Management Software administrates the treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. The stimulation is applied via the Stimulation Coil which 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 (10Hz) rTMS has been shown to persist beyond the train of stimulation.

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Both devices, the Apollo TMS Therapy System and the predicate device have equivalent system components, consisting of a main unit containing the stimulation coil, a coil positioning system, and 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.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both systems, the Apollo TMS Therapy System and the predicate device use the technology named Transcranial Magnetic Stimulation (TMS). TMS makes use of electromagnetic induction to activate and modulate cortical neurons.

The similarities and minor differences between the Apollo TMS Therapy System and the Predicates are listed in the table below.

DESCRIPTIVEINFORMATION	Apollo TMS Therapy System	NeuroStar TMS TherapySystem	Rapid² Therapy System
Indications for Use	The Apollo TMS TherapySystem is indicated for thetreatment of MajorDepressive Disorder in adultpatients who have failed toachieve satisfactoryimprovement from priorantidepressant medication inthe current episode.	The NeuroStar TMS TherapySystem is indicated for thetreatment of MajorDepressive Disorder in adultpatients who have failed toachieve satisfactoryimprovement from priorantidepressant medication inthe current episode.	The Rapid² Therapy System isindicated for the treatmentof Major Depressive Disorderin adult patients who havefailed to achieve satisfactoryimprovement from priorantidepressant medication inthe current episode.
Treatment StimulationParameters
1. Area of brain to bestimulated	1. Left DLPFC	1. Left DLPFC	1. Left DLPFC
2. Stimulation intensity	2. 120% of MT	2. 120% of MT	2. 120% of MT
3. %MT range	3. 50% to 150% MT	3. 25% to 140% MT	3. 0% to 200% MT
4. Stimulation frequency	4. 10 Hz	4. 10 Hz	4. 10 Hz
5. Pulse train duration	5. 4 sec	5. 4 sec	5. 4 sec
6. Inter-train interval	6. 11 – 26 sec	6. 11 - 26 sec	6. 26 sec
7. Trains per session	7. 75	7. 75	7. 75
8. Max No. of Pulses	8. 3,000	8. 3,000	8. 3,000
Output StimulationParameters
1. Amplitude in SMT units	1. 0 – 2.0 SMT	1. 0.22 – 2.08 SMT	1. 0.28 – 1.9 SMT
2. Pulse width (± accuracy)	2. 167 μs (± 10%)	2. 185 μs (± 10%)	2. 300 μs (± 10%)
3. Frequency (± accuracy)	3. 0-100 Hz (± 2%)	3. 0.1-30 Hz (± 2%)	3. 0.1-30 Hz (± 2%)
Stimulation CoilParameters
1. Configuration	1. Figure 8 Coil	1. Figure 8 Coil	1. Figure 8 Coil
2. Core material	2. Air	2. Iron Core	2. Air

Characteristics of the device as compared to the predicate devices

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Coil Positioning System	Integrated into Head-and-Neck-Support System,Landmark-Aided CoilPlacement	Integrated into Head SupportSystem, Laser-Aided CoilPlacement	Cap positioned in relation tonasion
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PERFORMANCE DATA

Non-Clinical Testing

The non-clinical testing with the Apollo TMS Therapy System included testing of the electromagnetic field characteristics of the system, as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems".

The data presented demonstrates that the Apollo TMS Therapy system is in summary adequate to the Predicate Devices. Furthermore tests show that the major characteristics of the Apollo TMS Therapy system and the Predicate Devices are similar and that the minor differences do not impact safety or effectiveness. Both systems are very similar in function, safety and therapeutic benefit. In conclusion, the Apollo TMS Therapy system is as safe, as effective, and performs as well as the predicate device.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the Apollo TMS Therapy System. The system complies with the IEC 60601-1:2005 MOD (IEC 60601-1:2005 +AMD1:2012) standard for basic safety and essential performance and the IEC 60601-1-2:2007 standard for electromagnetic compatibility.

Software Verification and Validation Testing

Software verification and validation testing were conducted and 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 for this device is considered as a "moderate level of concern" (supported by Special Controls Guidance "rTMS Class II"), since a failure or latent design flaw could either directly result in minor injury to the patient or operator or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Risk management

The potential risks of the Apollo TMS Therapy System have been identified and evaluated in compliance with ISO 14971:2007 and were determined to be acceptable, or have been addressed with risk control measures.

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VII. CONCLUSION

Substantial Equivalence

The indication for use, the patient population, the treatment procedure, and all relevant protocol parameters (stimulation intensity, stimulation frequency, number of pulses in a train, numbers of trains, number of treatment sessions) are identical for the Apollo TMS Therapy System and the Predicate Devices. The identified minor differences between the systems are without any known impact on safety or efficacy.

The figure-of-eight coil design, the coil positioning method and the electromagnetic characteristics of the Apollo TMS Therapy System and the Predicate Devices are equivalent.

The Apollo TMS Therapy System does not introduce any new safety considerations in comparison to the Predicate Devices.

The above comparison, demonstrates and supports the substantial equivalency of the Apollo TMS Therapy System to the Predicate Devices.

Regulation Number and Section

§ 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.