Apollo TMS Therapy System

K180313 · Mag & More GmbH · OBP · May 4, 2018 · Neurology

Device Facts

• Record ID: K180313
• Device Name: Apollo TMS Therapy System
• Applicant: Mag & More GmbH
• Product Code: OBP · Neurology
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Apollo TMS Therapy System is an electromagnetic device delivering rapidly pulsed magnetic fields to the cerebral cortex to modulate neuronal activity without inducing seizures. System components include a user interface, main unit, stimulation coil, and coil positioning system. The operator uses the interface to manage treatment protocols and patient-specific stimulation doses based on individual motor thresholds. The stimulation coil is positioned over the left dorsolateral prefrontal cortex (DLPFC) using the integrated positioning system. By applying high-frequency (10Hz) rTMS, the device increases cortical excitability. The system is used in a clinical setting by trained operators to treat depression; it provides a non-invasive therapeutic alternative for patients resistant to medication, potentially improving clinical outcomes through targeted neuromodulation.

Clinical Evidence

Bench testing only. Evidence includes electromagnetic field characterization, electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2) testing. Software verification and validation were performed per FDA guidance for moderate level of concern devices. Risk management was conducted in compliance with ISO 14971:2007. No clinical trial data was required or presented for this 510(k) submission.

Technological Characteristics

Electromagnetic induction-based rTMS system. Components: main unit, figure-8 stimulation coil (air core), coil positioning system, and user interface. Compliance: IEC 60601-1:2005 (safety), IEC 60601-1-2:2007 (EMC). Stimulation parameters: 10Hz frequency, 120% motor threshold intensity, 4s pulse train duration. Software: moderate level of concern. Sterilization: not applicable (non-invasive).

Indications for Use

Indicated for adult patients with Major Depressive Disorder who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NeuroStar TMS Therapy System (K161519)
• Rapid2 Therapy System (K162935)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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);

{1}------------------------------------------------

# 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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known)

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.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

# 510(k) SUMMARY

#### I. SUBMITTER

MAG & More GmbH Machtlfinger Straße 13 81379 Munich, Germany

Phone: [phone] Fax: [phone]

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<br>(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 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. 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.

{4}------------------------------------------------

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

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.

## 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.

| DESCRIPTIVE<br>INFORMATION | Apollo TMS Therapy System | NeuroStar TMS Therapy<br>System | Rapid² Therapy System |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Apollo TMS Therapy<br>System is indicated for the<br>treatment of Major<br>Depressive Disorder in adult<br>patients who have failed to<br>achieve satisfactory<br>improvement from prior<br>antidepressant medication in<br>the current episode. | The NeuroStar TMS Therapy<br>System is indicated for the<br>treatment of Major<br>Depressive Disorder in adult<br>patients who have failed to<br>achieve satisfactory<br>improvement from prior<br>antidepressant medication in<br>the current episode. | The Rapid² Therapy System is<br>indicated for the treatment<br>of Major Depressive Disorder<br>in adult patients who have<br>failed to achieve satisfactory<br>improvement from prior<br>antidepressant medication in<br>the current episode. |
| Treatment Stimulation<br>Parameters | | | |
| 1. Area of brain to be<br>stimulated | 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 Stimulation<br>Parameters | | | |
| 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 Coil<br>Parameters | | | |
| 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

{5}------------------------------------------------

| Coil Positioning System | Integrated into Head-and-<br>Neck-Support System,<br>Landmark-Aided Coil<br>Placement | Integrated into Head Support<br>System, Laser-Aided Coil<br>Placement | Cap positioned in relation to<br>nasion |
|-------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------|
|-------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------|

## 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.

{6}------------------------------------------------

#### 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.