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.

Device Description

The Ampa One System is a computerized, electromechanical 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.

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
. Bridge Box & cables - Allows connection to the pulse generator and control treatment protocols from the pulse generator and Ampa tablet with software
Ampa tablet with software - The software interface for operators to control TMS treatment
. 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 is intended to be used with the MagVenture MagPro R30 Pulse Generator (K230014) and cannot be used without a compatible pulse generator.

The system comes with a tablet preloaded with a mobile app containing the software interface for operation of the system.

AI/ML Overview

The provided document is a 510(k) Summary for the Ampa One System, a repetitive transcranial magnetic stimulation (rTMS) device. While it details the device description, intended use, and a comparison to predicate devices, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

This document focuses on demonstrating substantial equivalence to existing predicate devices, which is a different regulatory pathway than requiring novel clinical studies to prove effectiveness against a predefined set of acceptance criteria. For devices demonstrating substantial equivalence, the focus is on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the information required to populate the tables and answer the questions (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary. The document primarily discusses non-clinical testing for safety (function and compatibility) and effectiveness (magnetic characteristics) by comparing them to predicate devices, asserting equivalence rather than demonstrating performance against a specific set of acceptance thresholds.

Summary

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February 13, 2025

Neuromodulatory Devices & Applications % Tyler Ting Director of Regulatory Affairs Avio Medtech Consulting 2300 Myrtle Ave Suite 200 St. Paul, Minnesota 55114

Re: K243319

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: January 14, 2025 Received: January 14, 2025

Dear Tyler Ting:

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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(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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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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Sincerely,

ROBERT KANG -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

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Indications for Use

Submission Number (if known)

K243319

Device Name

Ampa One System (AMPA-001)

Indications for Use (Describe)

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)

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Traditional 510(k) 510(k) Summary

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510(k) Summary – K243319

In accordance with 21 CFR 807.92 the following summary information is provided:

Contact Details

21 CFR 807.92(a)(1)

Applicant Name:	Neuromodulatory Devices & Applications
Applicant Address:	501 W. BroadwaySuite 1025San Diego, CA 82101United States
Applicant Contact	Dr. Don Vaughn
Applicant Telephone	+1 619 846 5566
Applicant Contact Email:	don@ampahealth.com
Correspondent Name:	Mr. Tyler Ting, MS, RAC-DevicesDirector of Regulatory AffairsAvio Medtech Consulting
Correspondent Address:	2300 Myrtle AveSuite 200St. Paul, MN 55114United States
Correspondent Telephone:	+1 970 404 1555
Correspondent Email:	tyler@aviomedtech.com

Device Trade 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)

510(k)	Trade Name	Product Code
K173620	MagVita TMS Therapy System w/Theta Burst Stimulation	OBP
K220819	Brainsway Deep TMS System	OBP

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Traditional 510(k) 510(k) Summary

Device Description Summary

21 CFR 807.92(a)(4)

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
. Bridge Box & cables - Allows connection to the pulse generator and control treatment protocols from the pulse generator and Ampa tablet with software
Ampa tablet with software - The software interface for operators to control TMS treatment
. 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 is intended to be used with the MagVenture MagPro R30 Pulse Generator (K230014) and cannot be used without a compatible pulse generator.

The system comes with a tablet preloaded with a mobile app containing the software interface for operation of the system.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The Ampa One System and the predicate devices have the same indications for use.

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Traditional 510(k) 510(k) Summary

Technological Comparison 21 CFR 807.92(a)(6)

The AMPA One System has similar technological characteristics to the predicate devices and the minor ancillary differences between the two devices do not raise different questions regarding safety and effectiveness.

The new device and predicate devices share the same technological characteristics to achieve their intended use of treating MDD using repetitive magnetic fields to induce electrical firing in the cerebral cortex. The Ampa One System coils and the predicate devices' coils are both wound coils of the same design where pulses of electric current are passed to deliver non-invasive, magnetic fields which induce electrical currents in targeted regions of the cerebral cortex.

The design of the M and L coils were based on the selected predicate devices, the Mag Vita B70 (K173620) and the BrainsWay H7 (K220819). The process of designing the coil windings used state-ofthe-art simulations in collaboration with a renowned expert in TMS coil analysis.

Because of the design process, the magnetic fields produced by the Ampa One System coils and the predicates are nearly indistinguishable from each other. The correlation coefficient between the L coil and the B70 coil is 0.981 and the correlation coefficient between the M coil and the H7 is 0.986. The concomitant induced electrical field distributions are also equally identical, with correlation coefficients of 0.985 and 0.997 for the L and M coil, respectively.

The minor differences between the subject device and the predicate devices are: 1. the cooling systems of the coils; 2. the software used to control the treatment; and 3. the use of an integrated camera and premarked patient cap for patient positioning.

The Ampa One System uses a phase change material alongside a software controlled cutoff to maintain both operational temperatures and prevent thermal harm whereas the predicate devices use active cooling svstems. The Ampa One System has its own software within a preloaded tablet to control treatment parameters whereas the predicate devices' software comes on their own capital equipment. The Ampa One System uses an integrated camera in the coil and software to control coil positioning whereas the predicate devices' use operator determined markings on the patient cap (K173620) and head positioning straps (K220819) to achieve accurate and reliable coil positioning. These represent the differences in technological characteristics.

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Traditional 510(k)

Ampa One System

510(k) Summary

Substantial Equivalence Table

	Subject Device:Ampa One System	Predicate for Ampa One System, LCoilMagVita TMS Therapy Systemw/Theta Burst StimulationK173620	Predicate for Ampa One System,M CoilBrainsway Deep TMSTM SystemK220819
Product Code,Device Risk Classification	OBPClass II	OBPClass II	OBPClass II
Indications for Use	The Ampa One System is indicatedfor the treatment of MajorDepressive Disorder in adult patientswho have failed to achievesatisfactory improvement fromprevious anti-depressant medicationtreatment in the current episode.	The MagVita TMS Therapy Systemis indicated for the treatment ofMajor Depressive Disorder in adultpatients who failed to achievesatisfactory improvement fromprevious anti-depressant medicationtreatment in the current episode.	The BrainsWay Deep TMSTM isindicated for the treatment ofdepressive episodes and fordecreasing anxiety symptoms forthose who may exhibit comorbidanxiety symptoms in adult patientssuffering from Major DepressiveDisorder (MDD) who failed toachieve satisfactory improvementfrom previous anti-depressantmedication treatment in the currentepisode.
Target Population	Adult subjects with MajorDepressive Disorder	Adult subjects with MajorDepressive Disorder	Adult subjects with MajorDepressive Disorder withcomorbid anxiety symptoms
Energy Used / Delivered	Electromagnetic Energy is delivered	Electromagnetic Energy is delivered	Electromagnetic Energy isdelivered
Area of brain tostimulated	Ampa L-Coil: Head - theta burststimulation to the left dorsolateralprefrontal cortex (DLPFC)Ampa M-Coil: Head – stimulation tothe dorsomedial prefrontal cortex	Theta burst stimulation to the leftDLPFC	Stimulation to the DMPFC
	Subject Device:Ampa One System	Predicate for Ampa One System, LCoilMagVita TMS Therapy Systemw/Theta Burst StimulationK173620	Predicate for Ampa One System,M CoilBrainsway Deep TMS SystemK220819
	(DMPFC)
Applicator:ConfigurationCore Material	Ampa L-Coil:Figure-of-eight coilAir core	Figure-of-eight coilAir core	Figure-of-eight coilAir core
	Ampa M-Coil:Figure-of-eight coilAir Core
Performance of TreatmentProtocol		Intermittent Theta BurstStimulation (iTBS) Treatment	Brainsway H7 Coil for treatmentof MDD and Depression withComorbid Anxiety
Physical unit of amplitudesetting (e.g., coil current,peak magnetic field) atcoil and its relation to theSMT unit	L Coil0 - 2.03 SMT (Standard MotorThreshold)M Coil0 - 1.76 SMT	0 - 1.7 SMT	0-1.4 SMT
Patient ContactingMaterials	Treatment Cap	Treatment Cap	Treatment Cap
Coil Positioning System	Cap positioned in relation tonasion	Cap positioned in relation tonasion	Cap positioned in relation tonasion
Sterility	Not Applicable	Not Applicable	Not Applicable
Electrical safety	Complies with IEC 60601-1 and IEC60601-1-2	Complies with IEC 60601-1 and IEC60601-1-2	Complies with IEC 60601-1 andIEC 60601-1-2
Treatment stimulationparameters	L CoilWaveforms: 275 us biphasic	Waveforms: 290 us biphasic
Subject Device:Ampa One System	Predicate for Ampa One System, LCoilMagVita TMS Therapy Systemw/Theta Burst StimulationK173620	Predicate for Ampa One System,M CoilBrainsway Deep TMS SystemK220819
sinusoid	sinusoid
Magnetic field strength: 120%	Magnetic field strength: 120%
MT (motor threshold)	MT
Repetition rate: 50 Hz	Repetition rate: 50 Hz
Train duration: 2 sec*	Train duration: 2 sec
Inter-train interval: 8 secs	Inter-train interval: 8 secs
Burst pulses: 3	Burst pulses: 3
Bursts: 200	Bursts: 200
Inter-pulse interval: 20 msec	Inter-pulse interval: 20 msec
Number of trains: 20	Number of trains: 20
Numbers of pulses/session: 600	Numbers of pulses/session: 600
Total duration: 3 min 9 sec	Total duration: 3 min 9 sec
M Coil
Waveform: 370 µs biphasic sinusoid		Waveform: 370 µs biphasicsinusoid
Magnetic Field Strength: 120% MT		Magnetic Field Strength: 120%MT
Repetition rate: 18 Hz		Repetition rate: 18 Hz
Train duration: 2 sec*		Train duration: 2 sec
Inter-train interval: 20 sec		Inter-train interval: 20 sec
Number of trains: 55		Number of trains: 55
Magnetic Pulses per Session: 1980		Magnetic Pulses per Session: 1980
Treatment Session Duration: ~ 20min

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Traditional 510(k)

510(k) Summary

Ampa One System

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Treatment Session Duration: ~ 20

min

Traditional 510(k)

510(k) Summary

Ampa One System

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Traditional 510(k)

Ampa One System

510(k) Summary

Maximum Safe Train Duration (seconds) Limits for Avoiding Seizure limits from Table 2 of the FDA Special Controls Guidance' are equivalent to the predicate devices, and therefore safe as prior clinical testing has established a minimal risk of seizure for these durations.

1 https://www.fda.gov/medical-devices/guidance-documents-mediation-emitting-products/repetitive-transcranial-magnetic-stimulation-rtmssystems-class-ii-special-controls-guidance

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Traditional 510(k) 510(k) Summary

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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 devices. 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 MagVenture R-30 pulse generator to 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 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 identical between the Ampa One coils vs. their respective predicate device coils.

Development and testing of the Ampa One System was performance with the FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices. Bench testing was performed in alignment with this Guidance document in order to support substantial equivalence.

Standards Conformance

The Ampa One System Complied with the following voluntary consensus standards:

Risk

ISO 14971 Third Edition 2019-1 | Medical devices Application of risk management to medical ● devices
Electrical Safety
IEC 60601-1 Edition 3.2 2020-08 Consolidated Version | Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version | Medical electrical equipment Part ● 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Software Development
IEC 62304 Edition 1.1 2015-06 Consolidated Version | Medical device software - Software life cycle processes
Biocompatibility
ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices Part 1: Evaluation ● and testing within a risk management process
Shipping and Transportation
ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers and . Systems

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Traditional 510(k) 510(k) Summary

ASTM D4332-22 | Standard Practice for Conditioning Containers Packages or Packaging ● Components for Testing

Conclusion

The evaluation of the subject device's safety and effectiveness has been performed as per the information that is listed above. Based upon this information, the subject device is substantially equivalent 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.