(34 days)
No
The summary describes a standard TMS device and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for the treatment of Major Depressive Disorder in adult patients and delivers non-invasive magnetic stimulation to induce electrical currents directed at the cerebral cortex. This aligns with the definition of a therapeutic device which aims to treat or alleviate a medical condition.
No
This device is indicated for the treatment of Major Depressive Disorder, not for diagnosis. It delivers magnetic stimulation to induce electrical currents in the cerebral cortex.
No
The device description explicitly states it is a "computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation," indicating it includes hardware components beyond just software.
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: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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 (also Blossom TMS 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 (also Blossom TMS Therapy System) is substantially equivalent to the predicate device, our own ALTMS Magnetic Stimulation Therapy System (K202537) and Neurosoft TMS (K173441). 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, and determination of patient's motor threshold, coil position, and treatment administration at the predetermined treatment stimulation parameters.
The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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 (also Blossom TMS 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 (also Blossom TMS Therapy System) is an integrated system consisting of a combination of hardware, software, and accessories. The Standing Arm, an accessory device included in the ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) 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 area
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)
Electrical safety and performance testing have been successfully carried out in accordance with IEC 60601, IEC 61000, and IEC 62366. Additionally, biocompatibility test also has been successfully fulfilled following ISO 10993-1. All the results already demonstrated through the primary predicate device, ALTMS Magnetic Stimulation Therapy System (K202537), and there is no change of the proposed device from the primary predicate device. The minor change to indicate the treatment protocols on the IFU has been evaluated by the risk analysis procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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April 6, 2022
REMED Co., Ltd Soojung Moon CEO Allura Medical Solutions Inc. 5485 Rathdrum Way Antioch, California 94531
Re: K220625
Trade/Device Name: ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: March 2, 2022 Received: March 3, 2022
Dear Soojung Moon:
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
1
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 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 (QS) 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 medical devices and radiation-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 Neuromodulation Psychiatry Devices 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
510(k) Number (if known) K220625
Device Name
ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System)
Indications for Use (Describe)
ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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) |
Dver-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
l. Submitter Information
| Company: | REMED Co., Ltd. |
|---|---|
| Address: | #301-#303 Migun Techno World II, 187, Techno 2-Ro, |
| Yuseong-gu, Daejeon, 34025, Republic of Korea | |
| Tel / Fax: | +82-42-934-5560 / +82-42-934-5562 |
| Contact Person: | S.J. Moon, Official correspondent of REMED Co., Ltd. |
| +1 (407) 242 9793 / sjmoon@allurameds.com | |
| Date of submission: | Date of submission: March 2nd, 2022 |
II. Device Information
| Proprietary Name(s): | ALTMS Magnetic Stimulation Therapy System
(Blossom TMS Therapy System) |
|-----------------------|---------------------------------------------------------------------------|
| Common Name: | Repetitive Transcranial Magnetic Stimulator |
| Classification Name: | Transcranial Magnetic Stimulator |
| Product Code: | OBP |
| Device Class: | Class II |
| Regulation Number: | 882.5805 |
| Classification Panel: | Neurology |
III. Predicate Information
- · ALTMS Magnetic Stimulation Therapy System (REDMED Co., Ltd. K202537) - Primary predicate device
- · Neurosoft TMS (TeleEMG, LLC. K173441) - Reference device
IV. Device Description
The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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 (also Blossom TMS Therapy System) is substantially equivalent to the predicate device, our own ALTMS Magnetic Stimulation Therapy System (K202537) and Neurosoft TMS (K173441). 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
4
the device use including the TMS system set up, patient preparation process, and determination of patient's motor threshold, coil position, and treatment administration at the predetermined treatment stimulation parameters.
The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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 (also Blossom TMS 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 (also Blossom TMS Therapy System) is an integrated system consisting of a combination of hardware, software, and accessories. The Standing Arm, an accessory device included in the ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) provides the coil positioning function.
V. Indication for Use
ALTMS Magnetic Stimulation Therapy System (also Blossom TMS 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 Indications for Use Statements and Technological Characteristics
The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is substantially equivalent to the predicate devices (our own ALTMS Magnetic Stimulation Therapy System and Neurosoft TMS). The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) and the predicate devices have identical intended use / indication for use, and technological characteristics. The principles of operation, the output stimulation parameters and the materials are equivalent to the predicates. The modification to the device allows a range of inter-train intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which will allow a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes.
The proposed, ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) and predicate device, our own ALTMS Magnetic Stimulation Therapy System (K202537) and Neurosoft TMS (K173441) share the same intended
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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 (also Blossom TMS Therapy System) and predicate device are substantially equivalent.
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 (also Blossom TMS 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 (also Blossom TMS 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 application are the same as the predicate device, our own ALTMS Maqnetic Stimulation Therapy System (K202537) and Neurosoft TMS (K173441).
VII. Safety & Performance
Electrical safety and performance testing have been successfully carried out in accordance with IEC 60601, IEC 61000, and IEC 62366. Additionally, biocompatibility test also has been successfully fulfilled following ISO 10993-1. All the results already demonstrated through the primary predicate device, ALTMS Magnetic Stimulation Therapy System (K202537), and there is no change of the proposed device from the primary predicate device. The minor change to indicate the treatment protocols on the IFU has been evaluated by the risk analysis procedure. Therefore, the proposed device, ALTMS Magnetic Stimulation Therapy System(also Blossom TMS Therapy System), is as safe and effective as the reference device, which meet user's needs, and the Instruction For Use (IFU) support the safe and effective use of the proposed device.
Substantial Equivalence Comparison
| DESCRIPTIVE
INVORMATION | Proposed Device:
ALTMS Magnetic
Stimulation Therapy | Predicate Device:
ALTMS Magnetic
Stimulation Therapy
System (K202537) | Predicate Device:
Neurosoft TMS
(K173441) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | System (also Blossom
TMS Therapy System) | | |
| 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. | 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) | 0.11 Hz: 11800sec
230 Hz: 120sec | 0.11 Hz: 11800sec
230 Hz: 120sec | 0.5100 (sec) |120sec | 1
| Inter-train interval
range | 1120sec | 0300 (sec) |
| Pulse Width | 430 µs | 430 µs | 280µS |
| Pulse Amplitude | 2.76V Pk-Pk at peaking
coil | 2.76V Pk-Pk at peaking
coil | Unknown |
| 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 sponsor's
test report for the Spatial
distribution of the output
level by the proposed
device ALTMS Magnetic
Stimulation Therapy
System. | Unknown |
| 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 sponsor's
test report for the linearity
of the output level by the
proposed device ALTMS
Magnetic Stimulation
Therapy System. | Unknown |
| Magnetic field
intensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Number of trains | 75 | 75 | 75 |
| Magnetic pulses
per session | 3000 | 3000 | 3000 |
| Treatment
session duration | 18.8 - 37.5 min | 37.5 min | 18.8 min - 37.5 min |
| Sessions per
week | 5 | 5 | 5 |
| Area if the brain
to be stimulated | Frontal Cortex area | Frontal Cortex area | Frontal Cortex area |
| Applicator
configuration and
core material | Biphasic Figure 8 Coil | Biphasic Figure 8 Coil | Figure 8 Coil |
| Coil Parameters | Flat spiral winding,
AIW 2.0 x 4.0mm wire,
12 turns/wing x 2 | Flat spiral winding,
AIW 2.0 x 4.0mm wire,
12 turns/wing x 2 | FEC-02-100C
Inner diameter:
47x50mm1
Outer diameter:
97x100mm1
Area: 184725mm²
Average Inductance:
10μH
Flat spiral winding
N: 16 turns (2 layers x 2
wings)
AFEC-02-100C
Inner diameter:
36x51mm1
Outer diameter:
84x106mm1
Area: 184725mm²
Average Inductance:
10μH
Flat spiral winding
N: 16 turns (2 layers x 2
wings)
FEC-02-100
Inner diameter:
47x50mm1
Outer diameter:
97x100mm1
Area: 91560mm²
Average Inductance:
10μH
Flat spiral winding
N: 16 turns (2 layers x 2
wings)
AFEC-02-100
Inner diameter:
36x51mm1 |
| | | | Outer diameter:
84x106mm¹
Area: 87200mm²
Average Inductance:
10μH
Flat spiral winding
N: 16 turns (2 layers x 2 wings) |
| Maximum trains
per session | 120 | 120 | 4800 |
| Temperature on
Surface at
Maximum Output | 41°C | 41°C | 41°C |
| Magnetic Field:
Peak Magnetic
Field Strength at
2cm (in dB/dt) | 8.1kT/s | 8.1kT/s | Unknown |
| Machine Output
Stimulation
Parameters, with
Amplitude in SMT
Units | 0.3-1.9 SMT | 0.3-1.9 SMT | FEC-02-100-C: 0 - 1.89
AFEC-02-100-C: 0 - 2.38
FEC-02-100: 0 - 1.92
AFEC-02-100: 0 - 2.33 |
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VIII. Conclusion
In conclusion, the critical aspects of the ALTMS magnetic Stimulation Therapy System (also Blossom TMS Therapy System) are the same as the predicate devices, Neurosoft TMS (K173441) and to our own ALTMS Magnetic Stimulation Therapy System (K202537) including the intended use, indications for use, operation principle. The comprehensive evaluations of the ALTMS magnetic Stimulation Therapy System (also Blossom TMS Therapy System) along with the aforementioned design verification and validation testing assessments provide assurance that the ALTMS magnetic Stimulation Therapy System (also Blossom TMS Therapy System) has met the predetermined design requirements per the FDA's recognized consensus standards or manufacturer's standards applied to the predicate devices in the same manner. The comparative and comprehensive assessments all point to the conclusion that the ALTMS magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is substantially equivalent to the predicate, Neurosoft TMS and to our own ALTMS Magnetic Stimulation Therapy System.