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 MagVenture Coil T65 is a figure-of-eight, actively cooled coil designed for use in transcranial magnetic stimulation (TMS) therapy as part of the MagVenture TMS Therapy System. The system delivers magnetic pulses for generating evoked responses, assessing motor thresholds (MT), and administering therapeutic treatments.

The T65 is a redesign of the treatment coil Cool-B65, to include the motor threshold (MT) determination capability of the C-B60 coil. This reduces the need for coil exchange during patient sessions, supporting a more streamlined workflow for clinicians.

The T65 incorporates several ergonomic and functional enhancements compared to the existing coil:

Integrated intensity control wheel allowing direct manual adjustment of stimulation output.
Built-in trigger button with LED status indication to display coil readiness.
Reduced weight for improved maneuverability and ease of use.
Strain relief mechanisms at both the coil and connector ends to improve durability and reduce cable stress.

AI/ML Overview

The provided FDA 510(k) clearance letter for the T65 Repetitive Transcranial Magnetic Stimulation System does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

This document is a Special 510(k) submission, which signifies that the device (T65 coil) is a modification of an existing cleared device (Cool-B65 coil) and that the modifications do not raise new questions of safety or effectiveness. The core of such a submission is to demonstrate substantial equivalence to a predicate device.

Specifically, the document states:

"No clinical testing is required to support this submission." This explicitly indicates that no comparative effectiveness study (like an MRMC study) or standalone performance study was performed or needed.
The comparison focuses on technological characteristics (weight, integrated intensity control, trigger button, materials, electrical safety, etc.) and states that these differences "does not raise different questions of safety and effectiveness compared to the existing device."
The non-clinical testing focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, ISO 13485, ISO 14971) and ensuring magnetic field characteristics are within a ±5% tolerance of the predicate device. This is a performance verification of the physical device components, not an AI or algorithm performance evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert involvement, or AI performance metrics because this information is not present in the provided text. The device is a physical medical device (a TMS coil), not an AI-powered diagnostic or therapeutic algorithm.

Summary

FDA 510(k) Clearance Letter - T65 Repetitive Transcranial Magnetic Stimulation System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 30, 2025

Tonica Elektronik A/S
℅ Freja Lüthje
Regulatory Affairs Specialist
MagVenture A/S
Lucernemarken 15
Farum, DK-3520
Denmark

Re: K252032
Trade/Device Name: T65 (9016E0611)
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive Transcranial Magnetic Stimulation System
Regulatory Class: Class II
Product Code: OBP
Dated: June 30, 2025
Received: June 30, 2025

Dear Freja Lüthje:

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.

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K252032 - Freja Lüthje Page 2

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" (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-

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K252032 - Freja Lüthje Page 3

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).

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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FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252032

Device Name: T65 (9016E0611)

Indications for Use (Describe):
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.

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
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PRAStaff@fda.hhs.gov

"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."

Page 5

Special 510(k) Submission
Coil T65
TONICA ELEKTRONIK A/S

510(k) SUMMARY

Date Prepared: June 30, 2025

SUBMITTER

Tonica Elektronik A/S
Lucernemarken 15
DK-3520 Farum, Denmark
Tel: +45 4499 1544

Primary Contact: Freja Lea Lüthje, Ph.D.
Regulatory Affairs Specialist
Phone: +45 2168 9645
E-mail: fll@magventure.com

Secondary Contact: Jan Kjøller
Head of Regulatory Affairs
Phone: +45 2489 9976
E-mail: jk@magventure.com

DEVICE

Device Trade Name: T65
Classification Names: Repetitive transcranial magnetic stimulation system
Regulation: 21 CFR 882.5805
Regulatory Class: Class II
Device Panel: Neurology
Product Classification Code: OBP

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Special 510(k) Submission
Coil T65
TONICA ELEKTRONIK A/S

PREDICATE DEVICE

Predicate Trade Name: Cool-B65
Predicate 510(k): K150641

DEVICE DESCRIPTION

The T65 incorporates several ergonomic and functional enhancements compared to the existing coil:

Integrated intensity control wheel allowing direct manual adjustment of stimulation output.
Built-in trigger button with LED status indication to display coil readiness.
Reduced weight for improved maneuverability and ease of use.
Strain relief mechanisms at both the coil and connector ends to improve durability and reduce cable stress.

INDICATIONS FOR USE STATEMENT

Treatment of Major Depressive Disorder in adult patients who fail to receive satisfactory improvement from prior antidepressant medication in the current episode.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The following table compares the T65 to the existing Cool-B65. The change does not affect the device's intended use and does not raise different questions of safety and effectiveness compared to the existing device.