ALTMS Magnetic Stimulation 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 Description

The ALTMS Magnetic Stimulation Therapy System is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. It includes a Mobile console which houses the electronic components, provides mechanical support for the ferromagnetic Treatment Coil. The Standing Arm, an accessory device included in the ALTMS provides the coil positioning function.

AI/ML Overview

The provided text is a 510(k) summary for the ALTMS Magnetic Stimulation Therapy System, which is a medical device for the treatment of Major Depressive Disorder. This document primarily focuses on demonstrating substantial equivalence to a predicate device, the Rapid2 Therapy System (K143531), rather than presenting a detailed clinical study with specific acceptance criteria and results for the device's effectiveness in treating MDD.

However, based on the provided text, I can extract information related to the device's safety and performance against established standards, as this forms the basis of its substantial equivalence claim.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of clinical efficacy for Major Depressive Disorder as typically seen in a randomized controlled trial. Instead, it demonstrates compliance with safety and performance standards to establish substantial equivalence.

Here's a table based on the safety and performance data presented:

Acceptance Criteria (Based on FDA Recognized Standards & Predicate Device Characteristics)	Reported Device Performance (ALTMS Magnetic Stimulation Therapy System)
Biocompatibility: Meet ISO 10993-1 requirements for medical devices. Specific tests include: Cytotoxicity, Repeated Patch Dermal Sensitization, Primary Skin Irritation.	Biocompatibility Testing: Completed with favorable results for Cytotoxicity, Repeated Patch Dermal Sensitization Test (GLP - Buehler Method Modified for Medical Devices), and ISO Primary Skin Irritation Test. Biocompatibility risk assessments concluded no additional testing necessary.
Design Verification & Validation: Meet predefined safety and performance requirements; effectiveness of risk control measures (per ISO 14971:2012).	Design Verification and Validation (DV&V) Testing: Favorable results demonstrating the device meets predetermined safety and performance requirements and that risk control measures are effective. The design output matches design input and is appropriate for intended use.
Electrical Safety & Performance: Compliance with various IEC 60601 series and IEC 61000 series standards.	IEC Electrical Safety and Performance Testing: Comprehensive completion with favorable test results for IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11, and IEC 62366.
Software Verification & Validation: Ensure software functions correctly and safely.	Software Verification and Validation Testing: Completed (results implied to be favorable, though not detailed).
Shipping Validation: Meet pre-determined requirements for shipping.	Shipping Validation Test: Results demonstrate that the device (equivalent to Talent-Pro Electromagnetic Stimulator in size and weight) met all pre-determined shipping validation test requirements.
Technological Characteristics (similar to Predicate Device): Pulse Shape, Pulse Train Duration Range, Inter-train interval range, Pulse Width, Magnetic Field Intensity, Number of trains, Magnetic pulses per session, Treatment session duration, Sessions per week, Area of the brain to be stimulated, Applicator configuration and core material, Coil Parameters, Maximum trains per session, Temperature on Surface at Maximum Output, Magnetic Field: Peak Magnetic Field Strength at 2cm (in dB/dt), Machine Output Stimulation Parameters.	Technological Characteristics Comparison: The document states that the "critical aspects... are substantially equivalent to the predicate device." While some minor differences exist (e.g., Pulse Train Duration, Inter-train interval range, Pulse Width), these are "not considered to raise different questions of safety and effectiveness." The device’s performance on these parameters is documented in the comparison table on page 8, showing substantial similarity or acceptable variations. For example, Pulse Width is 430 μs for the proposed device vs. 300 μs for the predicate, and Temperature on Surface at Maximum Output is 41°C for both.

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 describes engineering and performance testing of the device itself and its components, not a clinical trial involving a "test set" of patients. Therefore, concepts like sample size for a clinical test set or data provenance in terms of patient data (e.g., country of origin, retrospective/prospective) are not applicable to the studies presented for this 510(k) submission.

The studies mentioned (biocompatibility, design verification, electrical safety, software, shipping validation) are laboratory-based or bench testing, focusing on the device's physical and functional characteristics.

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)

This is not applicable as there was no clinical "test set" requiring expert ground truth establishment. The studies are technical and engineering evaluations conducted by qualified personnel in testing facilities.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as point 3. There was no clinical test set requiring adjudication.

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

No MRMC comparative effectiveness study was done. This device is a therapeutic (magnetic stimulation) device, not an AI-assisted diagnostic or interpretive device that would involve "human readers." The 510(k) summary focuses on demonstrating the device's safety and performance equivalence to a predicate device, not its comparative clinical effectiveness in a human trial setting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the device performance standalone, not an algorithm's performance. The entire submission details "standalone" testing of the ALTMS Magnetic Stimulation Therapy System (excluding its clinical use in patients, which is assumed to be similar to the predicate based on equivalence).

The studies described (biocompatibility, design verification, electrical safety, software, shipping validation) are all evaluations of the device in a standalone capacity (i.e., the physical device and its associated software components are tested directly).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the safety and performance studies described:

Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and the expected biological responses in specific in vitro or in vivo tests.
Design Verification & Validation: Ground truth is the "predefined safety and performance requirements" and the "design input" as established by the manufacturer, often guided by regulatory standards.
Electrical Safety & Performance: Ground truth is defined by the specific parameters and limits outlined in the referenced IEC and other recognized consensus standards (e.g., maximum temperature, electrical leakage, electromagnetic compatibility).
Software Verification & Validation: Ground truth is the software's functional specifications and adherence to design requirements.
Shipping Validation: Ground truth is the "pre-determined shipping validation test requirements."

8. The sample size for the training set

This is not applicable. The document describes laboratory and bench testing of a physical medical device, not the development or training of an AI algorithm.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

{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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 26, 2021

REMED Co., Ltd Kyungyoon Kang CEO K-Biotech 201 South 4th Street, Suite 727 San Jose, California 95112

Re: K202537

Trade/Device Name: ALTMS Magnetic Stimulation Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: October 20, 2021 Received: October 28, 2021

Dear Kyungyoon Kang:

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. 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 located 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.

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

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

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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).

Sincerely,

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202537

Device Name

ALTMS Magnetic Stimulation Therapy System

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)

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 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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

510(k) Summary

Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, REMED Co., Ltd. submits the following information as premarket notification for the proposed device ALTMS Magnetic Stimulation Therapy System.

-SUBMITTER
. Company: REMED Co., Ltd.
. Address: #301-#303 Migun Techno World II, 187, Techno 2-Ro. Yuseong-qu. Daejeon. Republic of Korea, Postal code: 34025
Tel: 82-42-934-5560 ●
Fax: 82-42-934-5562 .
510(k) Number: K202537

510(k) Correspondent: Seong Hyeon Kim, Manager K-Bio Solutions sarah.kim@kbiotechsolutions.com Tel: 82-2-597-2700, USA: 408-750-7843

Date Prepared: November 22nd, 2021

II. PROPOSED DEVICE

Type of Submission: Traditional Premarket Notification ●
Trade Name of Device: ALTMS Magnetic Stimulation Therapy System ●
Classification Name of Device: Repetitive Transcranial Magnetic Stimulation System
Review Panel: Neurology .
Regulation Number: 21 CFR 882.5805 ●
Regulatory Class: Class II ●
Product Code: OBP

III. PREDICATE DEVICE

Rapid2 Therapy System (K143531, Manufacturer: Magstim Company Limited) The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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

fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.

The ALTMS Magnetic Stimulation Therapy System is substantially equivalent to the predicate device, Rapid2 Therapy System (K143531, Manufacturer: Magstim Company Limited). The intended use and indications for use of the proposed device are identical to the predicate device. Both devices are clinically operated based on the same course of the device use including the TMS system set up, patient preparation process, determination of patient's motor threshold, coil position, and treatment administration at the predetermined treatment stimulation parameters.

The ALTMS Magnetic Stimulation Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in audit patients, who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The ALTMS Magnetic Stimulation Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. The proposed device can be used in both inpatient and outpatient settings, including physicians' offices, hospitals, and clinics. The ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. It includes a Mobile console which houses the electronic components, provides mechanical support for the ferromagnetic Treatment Coil. The Standing Arm, an accessory device included in the ALTMS provides the coil positioning function.

V. INDICATIONS FOR USE

VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed, ALTMS Magnetic Stimulation Therapy System and predicate device, Rapid2 Therapy System (K143531) share the same intended use and indications for use. The actual substance and essential scopes of the intended use and indications for use between the ALTMS Magnetic Stimulation Therapy System and predicate device are substantially equivalent.

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

Few minor differences between the proposed and predicate devices are primarily identified through dimensional differences in modest levels, which are not considered to raise different questions of safety and effectiveness compared to the predicate device. The favorable results of the design verification and electrical safety testing of the ALTMS Magnetic Stimulation Therapy System have demonstrated that the proposed device has met the predetermined design requirements and the FDA's recognized standards, including the electrical safety and performance standards and EMC standards as the predicate device. The design and function of the ALTMS Magnetic Stimulation Therapy System do not involve a new or different technological principle that would be considered to raise different questions in safety and effectiveness compared to the predicate device. The principle of operation, critical function and clinical use and applicatio are the same as the predicate device, Rapid2 Therapy System (K143531).

VII. SAFETY & PERFORMANCE DATA

The following safety and performance data were provided in support of this substantial equivalence determination.

A Biocompatibility Testing

In order to meet the FDA's consensus standards for biocompatibility requirements identified in the FDA Guidance titled, "Use of ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process (Issued June 16, 2016)", GLP biocompatibility testing of the proposed. ALTMS Magnetic Stimulation Therapy System has been completed with the favorable results.

Our biocompatibility risk assessments of the ALTMS Magnetic Stimulation Therapy System have concluded that it is warranted no additional biocompatibility testing of the proposed device is necessary.

Biocompatibility Testing Evaluations of ALTMS Magnetic Stimulation Therapy System Per ISO 10993 and FDA Guidance (June 16, 2016):

Cytotoxicity
. Repeated Patch Dermal Sensitization Test (GLP - Buehler Method Modified for Medical Devices)
ISO Primary Skin Irritation Test

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

Design Verification and Validation Testing A

Design Verification and Validation (DV&V) testing was performed to verify that the proposed ALTMS Magnetic Stimulation Therapy System meets the predefined safety and performance requirements. Testing was also conducted to verify the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process (per ISO 14971:2012, Medical Devices - Application of Risk Management to Medical Devices). The following design verification, or performance testing of ALTMS Magnetic Stimulation Therapy System have been completed with the favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards related to evaluation of performance of ALTMS Magnetic Stimulation Therapy System.

The favorable results of the design verification and validation tests have demonstrated that the design output of the proposed ALTMS Magnetic Stimulation Therapy System matches its design input and is appropriate to be used for the intended use, which support its substantially equivalent profile to the predicate device. The following design verification, validation, electrical safety and performance testing of the ALTMS Magnetic Stimulation Therapy System have been comprehensively completed with the favorable test results:

Design Verification Performed (Safety and Performance Testing)

ALTMS Magnetic Stimulation Therapy System Test .

IEC Electrical Safety and Performance Testing

IEC 60601-1 ●
. IEC 60601-1-6
IEC 60601-1-2
IEC 61000-3-2
IEC 61000-3-3
. IEC 61000-4-2
. IEC 61000-4-3
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-8
IEC 61000-4-11
IEC 62366

{7}------------------------------------------------

Software Verification and Validation Testing

Shipping Validation Test

The results of the shipping validation test of Talent-Pro Electromagnetic Stimulator demonstrate that the proposed, ALTMS Magnetic Stimulation Therapy System which is equivalent to Talent-Pro Electromagnetic Stimulator in size and weight has met all the pre-determined shipping validation test requirements.

Substantial Equivalence Comparison

DESCRIPTIVEINFORMATION	Proposed device:ALTMS Magnetic StimulationTherapy System (K202537)	Predicate device:Rapid² Therapy System (K143531)
Pulse Shape	The output waveform produced bythe biphasic figure 8 coil wasmeasured using a calibrated searchcoil connected to an oscilloscope. Asa result, the waveform could bequantified in three directions as wellas in time.	The output waveform produced by thebiphasic figure 8 coil was measuredusing a calibrated search coil connectedto an oscilloscope. As a result, thewaveform could be quantified in threedirections as well as in time.
Pulse TrainDuration Range(sec)	Pulse train durations range0.1~~1 Hz: 1~~1800sec2~~30 Hz: 1~~20sec	Pulse train durations range1~20sec
	Inter-train interval range1~120sec	Inter-train interval range10~60sec
Pulse Width	430 μs	300μs
Pulse Amplitude	2.76V Pk-Pk at peaking coil	N/A
Spatialdistribution of theoutput level	Refer to the sponsor's test report forthe Spatial distribution of the outputlevel by the proposed device ALTMSMagnetic Stimulation TherapySystem.	Refer to the subject test report for theSpatial distribution of the output level bythe predicate device Rapid²TherapySystem.
Linearity of theoutput level	Refer to the sponsor's test report forthe linearity of the output level by theproposed device ALTMS MagneticStimulation Therapy System.	Refer to the subject test report for thelinearity of the output level by thepredicate device Rapid2 Therapy System.
Magnetic fieldintensity	120% of the MT	120% of the MT
Number of trains	75	75
Magnetic pulsesper session	3000	3000
Treatmentsession duration	37.5 min	37.5 min
Sessions perweek	5	5
Area if the brainto be stimulated	Frontal Cortex	Frontal Cortex
Applicatorconfiguration andcore material	Biphasic Figure 8 Coil	Biphasic Figure 8 Coil
Coil Parameters	Flat spiral winding,AIW 2.0 x 4.0mm wire,12 turns/wing x 2	Flat spiral windingWC = 1.0 x 3.5 mm wireN = 3x19 turns/wing x 2 wings
Maximum trainsper session	120	140
Temperature onSurface atMaximum Output	41°C	41°C
Magnetic Field:Peak MagneticField Strength at2cm (in dB/dt)	8.1kT/s	N/A
Machine OutputStimulationParameters, withAmplitude in SMTUnits	0.3-1.9 SMT	0.28-1.9 SMT

{8}------------------------------------------------

{9}------------------------------------------------

VIII. CONCLUSIONS

In conclusion, the critical aspects of the ALTMS Magnetic Stimulation Therapy System are substantially equivalent to the predicate device Rapid2 Therapy System (K143531). The proposed ALTMS Magnetic Stimulation Therapy System shares the same intended use, indications for use and operation principle as the predicate device, Rapid2 Therapy System (K143531). The technological characteristics of the ALTMS Magnetic Stimulation Therapy System are similar to the predicate and the minor differences are assessed not to raise different questions in terms of safety and effectiveness. The comprehensive evaluations of the ALTMS magnetic Stimulation Therapy System along with the aforementioned design verification and validation testing assessments provide assurance that the ALTMS Magnetic Stimulation Therapy System has met the predetermined design requirements per the FDA's recognized consensus standards or manufacturer's standards which have been applied to the predicate devices in the same manner. The comparative assessments all point to the conclusion that the ALTMS Maqnetic Stimulation Therapy System is substantially equivalent to the predicate, Rapid² Therapy System (K143531).

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.