(34 days)
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.
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 provided text is a 510(k) Summary for the ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System). It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, rather than presenting a performance study against acceptance criteria for a new clinical claim.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- It does not provide a table of acceptance criteria and reported device performance.
- It does not detail a specific study with a test set, sample size, data provenance, ground truth establishment, or expert involvement to prove clinical performance.
- It does not mention an MRMC comparative effectiveness study or a standalone algorithm performance.
- It does not provide details on training set size or how its ground truth was established.
The document indicates that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, indications for use, and technological characteristics without raising new questions of safety or effectiveness. The modifications made (change in inter-train intervals) are primarily assessed through engineering and electrical safety testing (IEC 60601, IEC 61000, IEC 62366) and biocompatibility testing (ISO 10993-1), not through a clinical performance study with defined acceptance criteria for efficacy.
The document states:
- "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."
- "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."
This indicates that acceptance criteria would be related to these technical and safety standards, rather than clinical efficacy metrics.
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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
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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
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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
| DESCRIPTIVEINVORMATION | Proposed Device:ALTMS MagneticStimulation Therapy | Predicate Device:ALTMS MagneticStimulation TherapySystem (K202537) | Predicate Device:Neurosoft TMS(K173441) |
|---|---|---|---|
| System (also BlossomTMS Therapy System) | |||
| Pulse Shape | The output waveformproduced by the biphasicfigure 8 coil wasmeasured using acalibrated search coilconnected to anoscilloscope. As a result,the waveform could bequantified in threedirections as well as intime. | The output waveformproduced by the biphasicfigure 8 coil wasmeasured using acalibrated search coilconnected to anoscilloscope. As a result,the waveform could bequantified in threedirections as well as intime. | The output waveformproduced by the biphasicfigure 8 coil wasmeasured using acalibrated search coilconnected to anoscilloscope. As a result,the waveform could bequantified in threedirections as well as intime. |
| Pulse TrainDuration Range(sec) | 0.1 | 0.1 | 0.5~100 (sec) |
| Inter-train intervalrange | 1~120sec | 1~120sec | 0~300 (sec) |
| Pulse Width | 430 µs | 430 µs | 280µS |
| Pulse Amplitude | 2.76V Pk-Pk at peakingcoil | 2.76V Pk-Pk at peakingcoil | Unknown |
| Spatialdistribution of theoutput level | Refer to the sponsor'stest report for the Spatialdistribution of the outputlevel by the proposeddevice ALTMS MagneticStimulation TherapySystem. | Refer to the sponsor'stest report for the Spatialdistribution of the outputlevel by the proposeddevice ALTMS MagneticStimulation TherapySystem. | Unknown |
| Linearity of theoutput level | Refer to the sponsor'stest report for the linearityof the output level by theproposed device ALTMSMagnetic StimulationTherapy System. | Refer to the sponsor'stest report for the linearityof the output level by theproposed device ALTMSMagnetic StimulationTherapy System. | Unknown |
| Magnetic fieldintensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Number of trains | 75 | 75 | 75 |
| Magnetic pulsesper session | 3000 | 3000 | 3000 |
| Treatmentsession duration | 18.8 - 37.5 min | 37.5 min | 18.8 min - 37.5 min |
| Sessions perweek | 5 | 5 | 5 |
| Area if the brainto be stimulated | Frontal Cortex area | Frontal Cortex area | Frontal Cortex area |
| Applicatorconfiguration andcore 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-02-100CInner diameter:47x50mm1Outer diameter:97x100mm1Area: 184725mm²Average Inductance:10μHFlat spiral windingN: 16 turns (2 layers x 2wings)AFEC-02-100CInner diameter:36x51mm1Outer diameter:84x106mm1Area: 184725mm²Average Inductance:10μHFlat spiral windingN: 16 turns (2 layers x 2wings)FEC-02-100Inner diameter:47x50mm1Outer diameter:97x100mm1Area: 91560mm²Average Inductance:10μHFlat spiral windingN: 16 turns (2 layers x 2wings)AFEC-02-100Inner diameter:36x51mm1 |
| Outer diameter:84x106mm¹Area: 87200mm²Average Inductance:10μHFlat spiral windingN: 16 turns (2 layers x 2 wings) | |||
| Maximum trainsper session | 120 | 120 | 4800 |
| Temperature onSurface atMaximum Output | 41°C | 41°C | 41°C |
| Magnetic Field:Peak MagneticField Strength at2cm (in dB/dt) | 8.1kT/s | 8.1kT/s | Unknown |
| Machine OutputStimulationParameters, withAmplitude in SMTUnits | 0.3-1.9 SMT | 0.3-1.9 SMT | FEC-02-100-C: 0 - 1.89AFEC-02-100-C: 0 - 2.38FEC-02-100: 0 - 1.92AFEC-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.
§ 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.