(88 days)
No reference devices were used in this submission.
No
The summary describes a hardware-based electromagnetic stimulation device and its software for administering treatment protocols and determining stimulation dose based on motor threshold. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which clearly defines it as a therapeutic device.
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosing it.
No
The device description explicitly lists hardware components: Main Unit, Stimulation Coil, and Coil Positioning System, in addition to the User Interface and software.
Based on the provided information, the Apollo TMS Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder by directly stimulating the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states it's an electromagnetic device that non-invasively delivers magnetic pulses to the cerebral cortex to activate neurons. This is a physical treatment method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Apollo TMS Therapy System does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OBP
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex, left dorsolateral prefrontal cortex (DLPFC)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical 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".
Key results: 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):
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NeuroStar TMS Therapy System, Neuronetics, Inc. (K161519), Rapid2 Therapy System, Magstim Ltd., (K162935)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
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 (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
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)
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3
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 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
INFORMATION | Apollo TMS Therapy System | NeuroStar TMS Therapy
System | Rapid² Therapy System |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The NeuroStar TMS Therapy
System is indicated for the
treatment of Major
Depressive Disorder in adult
patients who have failed to
achieve satisfactory
improvement from prior
antidepressant medication in
the current episode. | The Rapid² 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. |
| Treatment Stimulation
Parameters | | | |
| 1. Area of brain to be
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
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
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-
Neck-Support System,
Landmark-Aided Coil
Placement | Integrated into Head Support
System, Laser-Aided Coil
Placement | Cap positioned in relation to
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.