(451 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on electromechanical and magnetic stimulation technology.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which signifies a therapeutic purpose.
No
Explanation: The device is indicated for the "treatment of Major Depressive Disorder," and its description details how it delivers magnetic stimulation for therapy, not for diagnosing conditions.
No
The device description explicitly states that the ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories, including a mobile console and a standing arm.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder by applying magnetic stimulation to the cerebral cortex. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system that generates and delivers magnetic pulses to the head. This is consistent with a therapeutic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological samples (like blood, urine, tissue, etc.), which are fundamental to IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly interacts with the patient's brain for therapeutic effect.
N/A
Intended Use / Indications for Use
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.
Product codes
OBP
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex, Frontal Cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed physician; inpatient and outpatient settings, including physicians' offices, hospitals, and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biocompatibility Testing:
GLP biocompatibility testing of the proposed ALTMS Magnetic Stimulation Therapy System has been completed with the favorable results according to ISO 10993-1. Specific tests included Cytotoxicity, Repeated Patch Dermal Sensitization Test (GLP - Buehler Method Modified for Medical Devices), and ISO Primary Skin Irritation Test.
Electrical Safety and Performance Testing:
Performed according to 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 and Validation Testing:
Software verification and validation testing was performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health 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)
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.
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
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
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
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.
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
| DESCRIPTIVE
INFORMATION | Proposed device:
ALTMS Magnetic Stimulation
Therapy System (K202537) | Predicate device:
Rapid² Therapy System (K143531) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Shape | The output waveform produced by
the biphasic figure 8 coil was
measured using a calibrated search
coil connected to an oscilloscope. As
a result, the waveform could be
quantified in three directions as well
as in time. | The output waveform produced by the
biphasic figure 8 coil was measured
using a calibrated search coil connected
to an oscilloscope. As a result, the
waveform could be quantified in three
directions as well as in time. |
| Pulse Train
Duration Range
(sec) | Pulse train durations range
0.11 Hz: 11800sec
230 Hz: 120sec | Pulse train durations range
120sec |120sec | Inter-train interval range
| | Inter-train interval range
1
10~60sec |
| Pulse Width | 430 μs | 300μs |
| Pulse Amplitude | 2.76V Pk-Pk at peaking coil | N/A |
| Spatial
distribution of the
output level | Refer to the sponsor's test report for
the Spatial distribution of the output
level by the proposed device ALTMS
Magnetic Stimulation Therapy
System. | Refer to the subject test report for the
Spatial distribution of the output level by
the predicate device Rapid²Therapy
System. |
| Linearity of the
output level | Refer to the sponsor's test report for
the linearity of the output level by the
proposed device ALTMS Magnetic
Stimulation Therapy System. | Refer to the subject test report for the
linearity of the output level by the
predicate device Rapid2 Therapy System. |
| Magnetic field
intensity | 120% of the MT | 120% of the MT |
| Number of trains | 75 | 75 |
| Magnetic pulses
per session | 3000 | 3000 |
| Treatment
session duration | 37.5 min | 37.5 min |
| Sessions per
week | 5 | 5 |
| Area if the brain
to be stimulated | Frontal Cortex | Frontal Cortex |
| Applicator
configuration and
core 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 winding
WC = 1.0 x 3.5 mm wire
N = 3x19 turns/wing x 2 wings |
| Maximum trains
per session | 120 | 140 |
| Temperature on
Surface at
Maximum Output | 41°C | 41°C |
| Magnetic Field:
Peak Magnetic
Field Strength at
2cm (in dB/dt) | 8.1kT/s | N/A |
| Machine Output
Stimulation
Parameters, with
Amplitude in SMT
Units | 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).