(326 days)
Not Found
No
The document describes a hardware-based rTMS system with standard components and a focus on the physical principles of magnetic stimulation. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies summary.
Yes.
The device is intended to be used as an "adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD)," and it produces "pulsed magnetic fields... for the treatment of Obsessive-Compulsive Disorder (OCD)," indicating its therapeutic purpose.
No
The device is described as an "adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD)" and produces pulsed magnetic fields "for the treatment of Obsessive-Compulsive Disorder (OCD)". There is no mention of the device being used to diagnose OCD or any other condition.
No
The device description explicitly lists multiple hardware components beyond just software, including a mobile console, cooling unit, power supply, coil, coil fixture, flexible arm, and trolley.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- CloudTMS for OCD Function: The CloudTMS for OCD is a device that applies repetitive transcranial magnetic stimulation (rTMS) directly to the brain (bilateral dorsomedial prefrontal cortex). It is a non-invasive treatment method that induces electrical currents in neurons.
- No Sample Analysis: The description clearly states that the device works by applying magnetic fields to the brain and does not involve the analysis of any biological samples taken from the patient.
Therefore, the CloudTMS for OCD falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).
Product codes (comma separated list FDA assigned to the subject device)
OCI
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 (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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bilateral dorsomedial prefrontal cortex (DMPFC)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Non-clinical testing focusing on electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, magnetic field characteristics (linearity of output levels, magnetic field strength gradients, output waveform, and magnetic field spatial distribution), and acoustic output measurements.
The magnetic field plots and acoustic output measurements were conducted to demonstrate safety, performance and substantial equivalence to predicate devices.
Comparative testing of the magnetic field distribution for the DCC-03-125-C coil and the primary predicate device's Cool D-B80 coil was performed, establishing substantial equivalence in magnetic spatial distribution.
Well-established simulation models and bench-top experimental measurements were used to support technological equivalence.
Comparative data on the electrical field distribution produced by both devices, superimposed on T1-weighted MRI coronal, sagittal, and axial slices, were provided to support substantial equivalence.
Clinical trials were not conducted on the subject device.
Clinical experience safety data on the CloudTMS K160309 (for MDD) was provided, which shares the same hardware platform, reporting no patient discomfort or adverse events even at maximum machine output.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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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3
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
4
(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.
5
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.
6
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 |
|---|---|---|---|
| CloudTMS | |||
| with DCC-03-125-C Coil | K160309 | ||
| CloudTMS | |||
| with AFEC-02-100-C Coil | K193006 | ||
| MagVenture TMS Therapy | |||
| system - for treatment of OCD | |||
| with Cool D-B80 Coil | |||
| Tonica Elektronik A/S,Denmark | |||
| Indications for use | 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). | The Neurosoft TMS is indicated | ||
| for the treatment of Major | |||
| Depressive Disorder in adult | |||
| patients who have failed to | |||
| receive satisfactory | |||
| improvement from prior | |||
| antidepressant medication in | |||
| the current episode. | The MagVenture TMS Therapy | ||
| System is intended to be used | |||
| as an adjunct for the treatment | |||
| of adult patients suffering from | |||
| Obsessive-Compulsive Disorder | |||
| (OCD). | |||
| Recommended Standard Treatment: | |||
| Magnetic Field | |||
| Intensity | 100% | ||
| of the Leg MT (Leg Motor | |||
| Threshold) | 120% of the MT | 100% | |
| of the Leg MT (Leg Motor | |||
| Threshold) | |||
| Frequency | 20 Hz | 10 Hz | 20 Hz |
| New Device | Predicate Device | Primary Predicate Device | |
| Area | CloudTMS | ||
| with DCC-03-125-C Coil | K160309 | ||
| CloudTMS | |||
| with AFEC-02-100-C Coil | K193006 | ||
| MagVenture TMS Therapy | |||
| system - for treatment of OCD | |||
| with Cool D-B80 Coil | |||
| Tonica 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 Pulses | |||
| per Session | 2000 | 3000 | 2000 |
| Treatment Session | |||
| Duration | 18 min | 18.75 - 37.0 min | 18 min |
| Sessions/wk | 5 | 5 | 5 |
| Treatment | |||
| Schedule | 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 be | |||
| stimulated | Dorsomedial Prefrontal | ||
| Cortex | Frontal Cortex | Dorsomedial Prefrontal Cortex | |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid |
| Amplitude in | |||
| Standard Motor | |||
| Threshold (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 MT | |||
| determination | Used for both MT | ||
| determination and | |||
| treatment. | Used for both MT | ||
| determination and treatment. | Used for both MT | ||
| determination and treatment. | |||
| NUMBER OF | |||
| TURNS/WING | 8 | 8 | 7 |
| Upper layer N = 4 turns/wing | |||
| Lower layer N = 3 turns/wing | |||
| NUMBER OF | |||
| WINGS | 2 | 2 | 2 |
| NUMBER OF | |||
| LAYERS | 2 | 2 | 2 |
| New Device | Predicate Device | Primary Predicate Device | |
| K160309 | K193006 | ||
| Area | CloudTMS | ||
| with DCC-03-125-C Coil | CloudTMS | ||
| with AFEC-02-100-C Coil | MagVenture TMS Therapy | ||
| system - for treatment of OCD | |||
| with Cool D-B80 Coil | |||
| Tonica Elektronik A/S,Denmark | |||
| INNER DIAMETER | |||
| OF WINDING, mm | 96 | 51 | 67 |
| OUTER DIAMETER | |||
| OF WINDING, mm | 130 | 106 | 95 |
| Design | |||
| The system consists of: |
- Mobile console
- System software with GUI
- Treatment chair*
- Head support system*
- Coil positioning system
- Same Coil for both MT
and treatment - Coil Fixture
- Data Management
System
*optional | The system consists of: - Mobile console
- System software with GUI
- Treatment chair*
- Head support system*
- Coil positioning system
- Same Coil for both MT and
treatment - Coil Fixture
- Data Management System
*optional | The system consists of: - Mobile console
- System software with GUI
- Treatment chair*
- Head support system*
- Coil positioning system
- Same Coil for both MT and
treatment - Coil Fixture
- Data Management System
*optional |
| | | Machine Output Parameters | |
| The system will
automatically be
disabled when the
coil temperature
exceeds: | 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 on
model |
| Pulse train duration
range (s) | 0.5 - 100 | 0.5 - 100 | Rep Rate: 0.1 ...100Hz
Pulses in Train: 1,2,3,4 ... 1000
Train duration = Pulses in Train
/ Rep Rate |
| Inter-train interval
range (s) | 0 - 300 | 0 - 300 | 1 – 120 |
| Maximum trains
per 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 [min
pause] ) | 500 |
| Maximum # of
pulses per session | 72000(Stand-alone)=2400s
[max session] *30Hz
240000(with PC)=2400s
[max session] *100Hz | 72000(Stand-alone)=2400s
[max session] *30Hz
240000(with PC)=2400s [max
session] *100Hz | 500,000 = 1,000 (pulses
max per train) x 500 (trains max
per session) |
| Area | New Device | Predicate Device | Primary Predicate Device |
| | CloudTMS
with DCC-03-125-C Coil | K160309
CloudTMS
with AFEC-02-100-C Coil | K193006
MagVenture TMS Therapy
system - for treatment of OCD
with Cool D-B80 Coil
Tonica Elektronik A/S,Denmark |
| (cumulative
exposure) | | | |
| Standards | | | |
| Electrical
safety | Complies with
AAMI/ANSI ES 60601-
1:2005/(R)2012
IEC 60601-1-2:2014 | Complies with
AAMI/ANSI ES 60601-
1:2005/(R)2012
IEC 60601-1-2 | Complies with
IEC60601-1 v. 3.1, and
IEC60601-1-2. |
| ISO Standards
met | Company complies with DIN
EN
ISO13485:2016
ISO 10993-1:2018
ISO 14971:2019 | Company complies with DIN EN
ISO13485:2012
ISO 10993-1:2009
ISO 14971:2007 | Company complies with EN
ISO 13485:2016. |
Table 8-1. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
7
8
9
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.