(326 days)
The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).
The CloudTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).
The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.
The CloudTMS for OCD consists of the following main components:
- . Mobile console
- Cooling unit .
- Extra power supply unit ●
- System software with GUI ●
- Treatment chair*
- Head support system*
- Coil DCC-03-125-C for both MT and treatment ●
- K8 Coil fixture
- K3 flexible arm coil positioning system ●
- Data Management System ●
- Trolley with casters .
- (* optional)
The acceptance criteria and study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Area | Acceptance Criteria (Primary Predicate Device K193006) | Reported Device Performance (CloudTMS for OCD) |
|---|---|---|
| Indications for use | Treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). | The CloudTMS for OCD system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). |
| Magnetic Field Intensity | 100% of the Leg MT (Leg Motor Threshold) | 100% of the Leg MT (Leg Motor Threshold) |
| Frequency | 20 Hz | 20 Hz |
| Train duration | 2 s | 2 s |
| Inter-train interval | 20 s | 20 s |
| Number of trains | 50 | 50 |
| Magnetic Pulses per Session | 2000 | 2000 |
| Treatment Session Duration | 18 min | 18 min |
| Sessions/wk | 5 | 5 |
| Treatment Schedule | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week | 5 daily sessions for 5 weeks, 4 daily sessions for 1 week |
| Area of brain to be stimulated | Dorsomedial Prefrontal Cortex | Dorsomedial Prefrontal Cortex |
| Waveform | Biphasic sinusoid | Biphasic sinusoid |
| Amplitude in Standard Motor Threshold (SMT) units | 0 - 1.9 SMT | 0 - 2.27 SMT (The new device indicates a slightly higher maximum amplitude, but the overall conclusion focuses on "substantially equivalent" magnetic field characteristics and recommended treatment parameters matching the predicate for OCD treatment). |
| Coil Configuration | Double-cone coil | Double-cone coil |
| Core material | Air core | Air core |
| Cooling | Liquid cooling | Liquid cooling |
| Coil for MT determination | Used for both MT determination and treatment. | Used for both MT determination and treatment. |
| Number of Turns/Wing | 7 (Upper layer N = 4 turns/wing; Lower layer N = 3 turns/wing) | 8 |
| Number of Wings | 2 | 2 |
| Number of Layers | 2 | 2 |
| Inner Diameter of Winding, mm | 67 | 96 |
| Outer Diameter of Winding, mm | 95 | 130 |
| Coil Temperature Disablement | 41 °C (106 °F) | 41 °C (106 °F) |
| Frequency range (Hz) | 0.1-30 or 0.1-100, depending on model | 0.1 - 30 (Stand-alone), 0.1 - 100 (with PC) |
| Pulse train duration range (s) | Rep Rate: 0.1 ...100Hz, Pulses in Train: 1,2,3,4 ... 1000, Train duration = Pulses in Train / Rep Rate | 0.5 - 100 |
| Inter-train interval range (s) | 1 – 120 | 0 - 300 |
| Maximum trains per session | 500 | 4800 (The document states 4800 is calculated based on max session time and min train/pause, allowing for more trains than the predicate's 500.) |
| Maximum # of pulses per session | 500,000 | 72000 (Stand-alone), 240000 (with PC) (The new device's number of pulses per session is lower than the predicate, but the overall treatment protocol for OCD matches). |
| Electrical Safety | Complies with IEC60601-1 v. 3.1, and IEC60601-1-2. | Complies with AAMI/ANSI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014 |
| ISO Standards met | Company complies with EN ISO 13485:2016. | Company complies with DIN EN ISO 13485:2016, ISO 10993-1:2018, ISO 14971:2019 |
Study Proving Device Meets Acceptance Criteria:
The provided document describes a non-clinical performance study to demonstrate substantial equivalence to a legally marketed predicate device (Tonica Electronik A/S, MagVenture TMS Therapy System for Treatment of OCD, K193006). The study primarily focused on comparing the technological characteristics of the new device (CloudTMS for OCD) with the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set of patient data was used. This was a non-clinical study focused on device characteristics and substantial equivalence, not a clinical trial with patient outcomes. Therefore, data provenance is not applicable in this context.
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):
Not applicable. No ground truth was established by experts for a test set of patient data, as this was a non-clinical substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no external test set requiring adjudication was used.
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:
Not applicable. This was not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a medical device, not an algorithm, and the focus was on hardware and operational parameter equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this substantial equivalence application, the "ground truth" was the established and legally marketed predicate device (K193006) and its characterized technological parameters as specified in its FDA clearance. The new device's performance was compared against these established specifications.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 10, 2023
TeleEMG, LLC % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079
Re: K221129
Trade/Device Name: CloudTMS for OCD Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions Regulatory Class: Class II Product Code: OCI Dated: March 28, 2022 Received: April 18, 2022
Dear Barry Ashar:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221129
Device Name CloudTMS for OCD
Indications for Use (Describe)
The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for the TeleEMG, LLC CloudTMS for OCD
(per 21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidant.htm)
1. SUBMITTER/510(K) HOLDER
TeleEMG, LLC 7304 Beverly Blvd, #357 Los Angeles, CA 90036 USA
Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: (603) 890-3311 Date Prepared: March 28, 2022
2. DEVICE NAME
| Proprietary Name: | CloudTMS for OCD |
|---|---|
| Regulation Name: | Transcranial Magnetic Stimulation System for Obsessive- Compulsive Disorder |
| Regulation Number: | 21 CFR 882.5802 |
| Classification Name: | Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions |
| Device Class: | Class II |
| Product Code: | QCI |
3. PREDICATE DEVICES
- Primary Predicate: Tonica Electronik A/S, MagVenture TMS Therapy System for ● Treatment of OCD, K193006
- Predicate: TeleEMG, LLC, CloudTMS, K160309 .
4. DEVICE DESCRIPTION
The CloudTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).
The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor
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(1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.
The CloudTMS for OCD consists of the following main components:
- . Mobile console
- Cooling unit .
- Extra power supply unit ●
- System software with GUI ●
- Treatment chair*
- Head support system*
- Coil DCC-03-125-C for both MT and treatment ●
- K8 Coil fixture
- K3 flexible arm coil positioning system ●
- Data Management System ●
- Trolley with casters .
- (* optional)
5. INTENDED USE
The CloudTMS for OCD system is indicated to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
6. STANDARDS
The CloudTMS for OCD system has been tested and complies with the following standards:
- . DIN EN ISO 13485:2016
- ISO 10993-1:2018 ●
- ISO 14971:2019 .
- . IEC 60601-1:2005/(R)2012
- . IEC 60601-1-2:2014
7. NON-CLINICAL PERFORMANCE DATA
Electrical safety and electromagnetic compatibility testing demonstrate that the CloudTMS for OCD is compliant with IEC 606101: 2005/(R)2012 and IEC 60601-1-2: 2014.
Only the patient caps in the delivery set of the CloudTMS for OCD have direct contact with the patients. The biocompatibility evaluation demonstrates that the caps meet ISO 10993-1:2018 standard.
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Software verification and validation is performed in accordance with the FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." It demonstrates that the software performs as intended and in accordance with specifications. The potential risks of the CloudTMS for OCD have been identified and evaluated in compliance with ISO14971:2019, and the risks were determined to be acceptable, or have been addressed with risk control measures.
Additionally, non-clinical testing with the CloudTMS for OCD included testing of the magnetic field characteristics of the system, as required by the FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems". The magnetic field plots and acoustic output measurements were conducted to demonstrate safety, performance and substantial equivalence to predicate devices.
8. SUBSTANTIAL EQUIVALENCE
The CloudTMS for OCD and the primary predicate device have identical intended use / indication for use and identical treatment parameters and treatment target (see table 8-1 below). Their technological characteristics and performance are very similar so that they can be considered substantially equivalent.
All components of CloudTMS for OCD. except the coil DCC-03-125-C. have been previously cleared by the FDA for MDD indication (Ref: K160309). The new coil is a double cone design whereas the predicate four coils of K160309 were figure-of-eight design. The coils share the same coil materials, cooling mechanism and media, isolation design and functionalities. The new coil is subjected to the same high-voltage tests and leakage current tests as the predicate coils to demonstrate safety.
The new coil DCC-03-125-C share the same Double Cone design of the primary predicate device coil Cool D-B80 (K193006), containing two coils that do not overlap, and allowing for a deeper and broader stimulation of the cortex. To establish substantial equivalence, we have performed comparison of the magnetic field characteristics of the two coils with their respective systems. in accordance with section 4 of the FDA's Class II Special Controls Guidance Document -Repetitive Transcranial Magnetic Stimulation (rTMS) Systems. These include linearity of output levels, magnetic field strength gradients, output waveform and magnetic field spatial distribution.
We have performed a comparative testing of the magnetic field distribution for the DCC-03-125-C coil and compared to that of the primary predicate device. This comparison establishes that the magnetic spatial distribution is substantially equivalent. Both coils are double cone coils with equivalent depth and spread of stimulation of the cortex.
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We have performed comparison with the predicate device using well-established simulation models as well as using bench-top experimental measurements. Both methods support technological equivalence between our and the predicate device.
We have provided comparative data on the electrical field distribution produced by both devices, superimposed on T1-weighted MRI coronal, sagittal, and axial slices. These images support the substantial equivalence comparisons determination.
We have not conducted any clinical trials on the subject device of this 510(k) submission. The substantial equivalence is established based on similar technological characteristics. However, we have provided clinical experience safety data on our predicate device (CloudTMS K 160309 for MDD) that shares the exact same hardware platform with the subject device. It establishes safe treatments even with the machine output set towards its maximum, with no patient discomfort or adverse events reported.
The basic operational procedures including system setup, patient preparations, motor threshold determination, coil positioning and treatment with predefined treatment stimulation parameters are essentially the same between the CloudTMS for OCD device and the primary predicate device. A detailed comparison of these two devices along with the CloudTMS (Neurosoft TMS for MDD -K160309) device is shown in a tabular form (see table 8-1) below:
| Area | New Device | Predicate Device | Primary Predicate Device |
|---|---|---|---|
| CloudTMSwith DCC-03-125-C Coil | K160309CloudTMSwith AFEC-02-100-C Coil | K193006MagVenture TMS Therapysystem - for treatment of OCDwith Cool D-B80 CoilTonica Elektronik A/S,Denmark | |
| Indications for use | The CloudTMS for OCDsystem is intended to beused as an adjunct for thetreatment of adult patientssuffering from Obsessive-Compulsive Disorder (OCD). | The Neurosoft TMS is indicatedfor the treatment of MajorDepressive Disorder in adultpatients who have failed toreceive satisfactoryimprovement from priorantidepressant medication inthe current episode. | The MagVenture TMS TherapySystem is intended to be usedas an adjunct for the treatmentof adult patients suffering fromObsessive-Compulsive Disorder(OCD). |
| Recommended Standard Treatment: | |||
| Magnetic FieldIntensity | 100%of the Leg MT (Leg MotorThreshold) | 120% of the MT | 100%of the Leg MT (Leg MotorThreshold) |
| Frequency | 20 Hz | 10 Hz | 20 Hz |
| New Device | Predicate Device | Primary Predicate Device | |
| Area | CloudTMSwith DCC-03-125-C Coil | K160309CloudTMSwith AFEC-02-100-C Coil | K193006MagVenture TMS Therapysystem - for treatment of OCDwith Cool D-B80 CoilTonica Elektronik A/S,Denmark |
| Train duration | 2 s | 4 s | 2 s |
| Inter-train interval | 20 s | 11-26 s | 20 s |
| Number of trains | 50 | 75 | 50 |
| Magnetic Pulsesper Session | 2000 | 3000 | 2000 |
| Treatment SessionDuration | 18 min | 18.75 - 37.0 min | 18 min |
| Sessions/wk | 5 | 5 | 5 |
| TreatmentSchedule | 5 daily sessions for 5 weeks,4 daily sessions for 1 week | 5 daily sessions for 6 weeks | 5 daily sessions for 5 weeks,4 daily sessions for 1 week |
| Area of brain to bestimulated | Dorsomedial PrefrontalCortex | Frontal Cortex | Dorsomedial Prefrontal Cortex |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid |
| Amplitude inStandard MotorThreshold (SMT)units | 0- 2.27 SMT | 0- 2.33 SMT | 0 - 1.9 SMT |
| Coils | |||
| Configuration | Double-cone coil | Figure-of-eight coil | Double-cone coil |
| Core material | Air core | Air core | Air core |
| Cooling | Liquid cooling | Liquid cooling | Liquid cooling |
| Coil for MTdetermination | Used for both MTdetermination andtreatment. | Used for both MTdetermination and treatment. | Used for both MTdetermination and treatment. |
| NUMBER OFTURNS/WING | 8 | 8 | 7Upper layer N = 4 turns/wingLower layer N = 3 turns/wing |
| NUMBER OFWINGS | 2 | 2 | 2 |
| NUMBER OFLAYERS | 2 | 2 | 2 |
| New Device | Predicate Device | Primary Predicate Device | |
| K160309 | K193006 | ||
| Area | CloudTMSwith DCC-03-125-C Coil | CloudTMSwith AFEC-02-100-C Coil | MagVenture TMS Therapysystem - for treatment of OCDwith Cool D-B80 CoilTonica Elektronik A/S,Denmark |
| INNER DIAMETEROF WINDING, mm | 96 | 51 | 67 |
| OUTER DIAMETEROF WINDING, mm | 130 | 106 | 95 |
| Design | |||
| The system consists of:1. Mobile console2. System software with GUI3. Treatment chair*4. Head support system*5. Coil positioning system6. Same Coil for both MTand treatment7. Coil Fixture8. Data ManagementSystem*optional | The system consists of:1. Mobile console2. System software with GUI3. Treatment chair*4. Head support system*5. Coil positioning system6. Same Coil for both MT andtreatment7. Coil Fixture8. Data Management System*optional | The system consists of:1. Mobile console2. System software with GUI3. Treatment chair*4. Head support system*5. Coil positioning system6. Same Coil for both MT andtreatment7. Coil Fixture8. Data Management System*optional | |
| Machine Output Parameters | |||
| The system willautomatically bedisabled when thecoil temperatureexceeds: | 41 °C (106 °F) | 41 °C (106 °F) | 41 °C (106 °F) |
| Frequency range(Hz) | 0.1 - 30 (Stand-alone)0.1 - 100 (with PC) | 0.1 - 30 (Stand-alone)0.1 - 100 (with PC) | 0.1-30 or 0.1-100, depending onmodel |
| Pulse train durationrange (s) | 0.5 - 100 | 0.5 - 100 | Rep Rate: 0.1 ...100HzPulses in Train: 1,2,3,4 ... 1000Train duration = Pulses in Train/ Rep Rate |
| Inter-train intervalrange (s) | 0 - 300 | 0 - 300 | 1 – 120 |
| Maximum trainsper session | 4800 = 2400s [max session]/ (0.5 s [min train] + 0 sec[min pause] ) | 4800 = 2400s [max session] /(0.5 s [min train] + 0 sec [minpause] ) | 500 |
| Maximum # ofpulses per session | 72000(Stand-alone)=2400s[max session] *30Hz240000(with PC)=2400s[max session] *100Hz | 72000(Stand-alone)=2400s[max session] *30Hz240000(with PC)=2400s [maxsession] *100Hz | 500,000 = 1,000 (pulsesmax per train) x 500 (trains maxper session) |
| Area | New Device | Predicate Device | Primary Predicate Device |
| CloudTMSwith DCC-03-125-C Coil | K160309CloudTMSwith AFEC-02-100-C Coil | K193006MagVenture TMS Therapysystem - for treatment of OCDwith Cool D-B80 CoilTonica Elektronik A/S,Denmark | |
| (cumulativeexposure) | |||
| Standards | |||
| Electricalsafety | Complies withAAMI/ANSI ES 60601-1:2005/(R)2012IEC 60601-1-2:2014 | Complies withAAMI/ANSI ES 60601-1:2005/(R)2012IEC 60601-1-2 | Complies withIEC60601-1 v. 3.1, andIEC60601-1-2. |
| ISO Standardsmet | Company complies with DINENISO13485:2016ISO 10993-1:2018ISO 14971:2019 | Company complies with DIN ENISO13485:2012ISO 10993-1:2009ISO 14971:2007 | Company complies with ENISO 13485:2016. |
Table 8-1. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
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1 see Fig. 1
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Image /page/10/Picture/0 description: The image shows a medical device with a light source and a flexible tube. The device has a gray handle with a green switch and a light source at the end. The flexible tube is connected to the handle and has a corrugated design. There is also a connector with multiple pins and a cable attached to it.
Fig. 1 Double Cone Coil for magnetic stimulator
9. CONCLUSION
The CloudTMS for OCD and the predicate devices have identical intended use /indication for use, target population, treatment procedure, treatment position and all recommended standard treatment protocol parameters (intensity, frequency, number of pulses in a train, number of trains in a session, number of treatment sessions).
Both the proposed device and primary predicate device share the same Double Cone coil design. The tested magnetic properties of the CloudTMS for OCD and the primary predicate devices are substantial equivalent for the coils.
The reliability of the positioning method used by the CloudTMS for OCD is based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate devices. The method for identifying the correct treatment position in the CloudTMS for OCD is at least as effective as the method employed by the predicate devices.
The CloudTMS for OCD does not introduce any new safety considerations in comparison to the predicate devices. All other identified differences between the two systems are minor and without any known impact on safety or efficacy.
Based on the information and supporting documentation provided in the premarket notification, the CloudTMS for OCD is substantially equivalent to the cited primary predicate device. Testing demonstrates that the CloudTMS for OCD fulfills prospectively defined design and performance specifications.
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.