(70 days)
The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use:
- Ampa L and M Coils - MT determination and Depression treatment
- Ampa Pulse Generator - Provide Electrical power to the coils
- Ampa Control Pad - The software interface for operators to control TMS treatment
- Axon Cable - Provides connections between the Ampa Pulse Generator and Ampa Control Pad
- Ampa Magic Arm - Support system to securely hold the coils in place during treatment
- Neuronavigation Cap - Fabric cap worn by patient with integrated markings for determination of cerebral cortex treatment targets
The system comes preloaded with a mobile app on the Ampa Control Pad containing the software interface for operation of the system.
This FDA 510(k) clearance letter pertains to a modification of an existing device, the Ampa One System (AMPA-001), specifically replacing a bridging connector and external pulse generator with an integrated Ampa Pulse Generator. The clearance relies on demonstrating substantial equivalence to the previously cleared Ampa One System (K243319).
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that the acceptance criteria are based on demonstrating "substantially equivalent magnetic characteristics compared to the predicate devices" and "equivalent in terms of safety and effectiveness." The reported performance is articulated through comparative testing against the predicate device.
| Category | Acceptance Criteria (Inferred from Document) | Reported Device Performance |
|---|---|---|
| Magnetic Characteristics (Effectiveness) | Substantial equivalence in the amplitude of magnetic field strength as a function of power input; substantial equivalence in spatial characteristics of the magnetic field. | Testing demonstrated that the Ampa One System (new configuration) produced substantially equivalent magnetic characteristics compared to the predicate devices (Ampa One System with MagVenture MagPro R30). Specifically, tests confirmed equivalence in: - Amplitude of the magnetic field strength as a function of power input. - Spatial characteristics of the magnetic field. - Waveforms (210 μs biphasic sinusoid for both L and M coils with the new system vs. 290 μs with predicate, deemed substantially equivalent) |
| Safety | The device is able to function as intended, with risks assessed of TMS therapy mitigated through design. | Safety testing established that the Ampa One System (new configuration) is able to function in its configuration with the Ampa One pulse generator to perform its intended use. Development and testing performed in conformance with FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices and voluntary consensus standards (e.g., IEC 60601-1 and IEC 60601-1-2 for electrical safety). |
| Treatment Protocol Parameters | Identical or substantially equivalent to the predicate device's parameters. | Identical: Repetition rate, pulses per train, number of trains, inter train interval, treatment time, coil configuration, patient contacting materials, coil positioning system. Substantially Equivalent: L Coil SMT range (0-1.7 SMT vs 0-2.0 SMT for predicate), M Coil SMT range (0-1.4 SMT vs 0-1.7 SMT for predicate). These differences are considered substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Data was not applicable for this submission."
Therefore, there was no clinical test set in the traditional sense, and thus no sample size for clinical efficacy or safety, nor data provenance information for such a test set. The testing conducted was non-clinical (bench testing) to demonstrate substantial equivalence of the modified device's performance to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical data or human evaluation of the device's diagnostic or therapeutic outcome was conducted for this 510(k), there were no experts used to establish a "ground truth" in the context of a clinical test set. The validation was based on engineering and performance specifications compared against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As per point 3, no clinical test set requiring expert adjudication was utilized for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Repetitive Transcranial Magnetic Stimulation System, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "standalone" performance in this context would refer to the performance of the Ampa One System itself, measured through its magnetic characteristics and functional safety. This type of non-clinical, standalone performance testing was indeed done. The effectiveness testing specifically focused on the magnetic characteristics of the Ampa One System with the new pulse generator, comparing them to the predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this non-clinical submission, the "ground truth" for demonstrating substantial equivalence was effectively the established performance characteristics of the legally marketed predicate device (Ampa One System K243319), as defined by its prior FDA clearance and the relevant FDA Special Controls Guidance. The new device's performance was measured and compared against these established characteristics to prove it met the same reasonable expectation of safety and effectiveness.
8. The sample size for the training set
Not applicable. This 510(k) pertains to a hardware modification of an existing medical device, not a machine learning or AI-driven system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there was no training set for this submission.
FDA 510(k) Clearance Letter - Ampa One System
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 26, 2025
Neuromodulatory Devices & Applications
℅ Matthieu Kirkland
Head of Regulatory Affairs
Avio Medtech Consulting
2300 Myrtle Ave, Suite 200
St. Paul, Minnesota 55114
Re: K251210
Trade/Device Name: Ampa One System (AMPA-001)
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP
Dated: May 29, 2025
Received: May 29, 2025
Dear Matthieu Kirkland:
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"
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K251210 - Matthieu Kirkland Page 2
(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).
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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K251210 - Matthieu Kirkland Page 3
Sincerely,
PAMELA D. SCOTT -S
Digitally signed by PAMELA D. SCOTT -S
Date: 2025.06.26 23:32:03 -04'00'
Pamela D. Scott
Assistant Director
DHT5B: Division of Neuromodulation and Physical Medicine Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K251210
Device Name
Ampa One System (AMPA-001)
Indications for Use (Describe)
The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
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.
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.
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510(k) #: 510(k) Summary Prepared on: 2025-06-05
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Neuromodulatory Devices & Applications |
|---|---|
| Applicant Address | 501 W. Broadway Suite 1025 San Diego CA 92101 United States |
| Applicant Contact Telephone | 619-846-5566 |
| Applicant Contact | Dr. Don Vaughn |
| Applicant Contact Email | don@ampahealth.com |
| Correspondent Name | Avio Medtech Consulting |
| Correspondent Address | 2300 Myrtle Ave Suite 200 St. Paul MN 55114 United States |
| Correspondent Contact Telephone | 310-748-2539 |
| Correspondent Contact | Mr. Matthieu Kirkland |
| Correspondent Contact Email | Matthieu@aviomedtech.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Ampa One System (AMPA-001) |
|---|---|
| Common Name | Repetitive transcranial magnetic stimulation system |
| Classification Name | Transcranial Magnetic Stimulator |
| Regulation Number | 882.5805 |
| Product Code(s) | OBP |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K243319 | Ampa One System | OBP |
Device Description Summary
21 CFR 807.92(a)(4)
Please note the subject device is nearly identical to the device cleared in K243319. The only change to the System is that the Bridge Box for connection to the MagVenture MagPro R30 pulse generator and the MagVenture MagPro R30 pulse generator itself have been replaced with an Ampa Pulse Generator. The Ampa One System with the Ampa Pulse Generator is substantially equivalent to its previously cleared design.
The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
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Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.
The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use:
- Ampa L and M Coils - MT determination and Depression treatment
- Ampa Pulse Generator - Provide Electrical power to the coils
- Ampa Control Pad - The software interface for operators to control TMS treatment
- Axon Cable - Provides connections between the Ampa Pulse Generator and Ampa Control Pad
- Ampa Magic Arm - Support system to securely hold the coils in place during treatment
- Neuronavigation Cap - Fabric cap worn by patient with integrated markings for determination of cerebral cortex treatment targets
The system comes preloaded with a mobile app on the Ampa Control Pad containing the software interface for operation of the system.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The Ampa One System and the predicate device have the same indications for use.
Technological Comparison
21 CFR 807.92(a)(6)
The subject device has nearly identical technological characteristics to the predicate device.
Both devices have identical treatment protocol parameters (e.g., repetition rate, pulses per train, number of trains, number of pulses, inter train interval, treatment time) and consist of the same general TMS system components (e.g., coils, pulse generator or pulse generator connector, navigation cap, tablet with software, coil holder arm). The only difference is that rather than using a bridging connector (i.e., Bridge Box) to connect to an external pulse generator (i.e., MagVenture MagPro R30), the subject device includes an Ampa Pulse Generator and does not require a bridging connector.
The Ampa Pulse Generator produces pulsed electrical current, which generates a time-varying magnetic field through the coil. It was intentionally designed & developed to closely match the well-known MagVenture R30, utilizing a nearly identical electrical topology to achieve functionally equivalent output.
All coils are unmodified within the subject device and identical to those in the predicate device clearance. Additional performance testing has been conducted using the well-established methods in the rTMS Special Controls guidance to evaluate the change and ensure both devices provide the same reasonable expectation of safety and effectiveness (e.g., methods, protocols, and acceptance criteria used to support clearance of K243319).
Please note that there is an attached Substantial Equivalence Table after the conclusions section with a complete comparison and analysis of device parameters.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Nonclinical testing evaluated the Ampa One System's performance to be equivalent in terms of safety and effectiveness compared to the predicate device. The suite of testing to demonstrate substantial equivalence can be divided into two aspects: safety (function and compatibility) and effectiveness (magnetic characteristics).
Safety testing established that the Ampa One System is able to function in its configuration with the Ampa One pulse generator to
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perform its intended use. Safety is defined as functioning with risks assessed of TMS therapy mitigated through design.
Effectiveness testing established that the Ampa One System produced substantially equivalent magnetic characteristics compared to the predicate devices. Specifically, testing demonstrated that the amplitude of the magnetic field strength as a function of power input, and the spatial characteristics of the magnetic field produced were substantially equivalent between the subject and predicate device.
Development and testing of the Ampa One System was performed in conformance with the FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices.
Clinical Data was not applicable for this submission.
Testing in accordance with the FDA Special Controls Guidance and voluntary consensus standards demonstrate that the Ampa One System achieves substantially equivalent safety and effectiveness compared to the legally marketed predicate devices.
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| Modified Device: | Predicate Device: | Comments |
|---|---|---|
| Ampa One System | Ampa One System (K243319) | |
| Product Code, Device Risk Classification | OBP Class II | OBP Class II |
| Indications for Use | The Ampa One System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. | The Ampa One System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. |
| Target Population | Adult subjects with Major Depressive Disorder | Adult subjects with Major Depressive Disorder |
| Energy Used / Delivered | Electromagnetic Energy is delivered | Electromagnetic Energy is delivered |
| Area of Brain to Stimulated | Ampa L-Coil: Head – theta burst stimulation to the left dorsolateral prefrontal cortex (DLPFC)Ampa M-Coil: Head – stimulation to the dorsolateral prefrontal cortex (DLPFC) | Ampa L-Coil: Head – theta burst stimulation to the left dorsolateral prefrontal cortex (DLPFC)Ampa M-Coil: Head – stimulation to the dorsolateral prefrontal cortex (DLPFC) |
| Components | Ampa L and M Coils | Ampa L and M Coils |
| Ampa Pulse Generator | Bridge Box | |
| Neuronavigation Cap | Neuronavigation Cap | |
| Ampa Control Pad | Ampa Tablet | |
| Ampa Magic Arm | Ampa Magic Arm | |
| Applicator: Configuration Core Material | Ampa L-Coil: Figure-of-eight coil Air coreAmpa M-Coil: Figure-of-eight coil Air Core | Ampa L-Coil: Figure-of-eight coil Air coreAmpa M-Coil: Figure-of-eight coil Air Core |
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| Modified Device: | Predicate Device: | Comments |
|---|---|---|
| Ampa One System | Ampa One System (K243319) | |
| Performance of Treatment Protocol | ||
| Physical unit of amplitude setting (e.g., coil current, peak magnetic field) at coil and its relation to the SMT unit | L Coil 0 – 1.7 SMTM Coil 0 – 1.4 SMT | L Coil 0 – 2.0 SMTM Coil 0 – 1.7 SMT |
| Patient Contacting Materials | Treatment Cap | Treatment Cap |
| Coil Positioning System | Cap positioned in relation to nasion | Cap positioned in relation to nasion |
| Electrical safety | Complies with IEC 60601-1 and IEC 60601-1-2 | Complies with IEC 60601-1 and IEC 60601-1-2 |
| Treatment stimulation parameters | L CoilWaveforms: 210 μs biphasic sinusoidMagnetic field strength: 120% of patients' hand-twitch motor threshold (MT)Repetition rate: 50 HzTrain duration: 2 sec*Inter-train interval: 8 secsBurst pulses: 3Bursts: 200Inter-pulse interval: 20 msecNumber of trains: 20Numbers of pulses/session: 600Total duration: 3 min 9 secM CoilWaveform: 210 μs biphasic sinusoidMagnetic Field Strength: 120% of patients' hand-twitch motor threshold (MT)Repetition rate: 18 HzTrain duration: 2 sec*Inter-train interval: 20 secNumber of trains: 55Magnetic Pulses per Session: 1980Treatment Session Duration: ~ 20 min | L CoilWaveforms: 290 μs biphasic sinusoidMagnetic field strength: 120% of patients' hand-twitch motor threshold (MT)Repetition rate: 50 HzTrain duration: 2 sec*Inter-train interval: 8 secsBurst pulses: 3Bursts: 200Inter-pulse interval: 20 msecNumber of trains: 20Numbers of pulses/session: 600Total duration: 3 min 9 secM CoilWaveform: 290 μs biphasic sinusoidMagnetic Field Strength: 120% of patients' hand-twitch motor threshold (MT)Repetition rate: 18 HzTrain duration: 2 sec*Inter-train interval: 20 secNumber of trains: 55Magnetic Pulses per Session: 1980Treatment Session Duration: ~ 20 min |
§ 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.