(30 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on the physical principles of rTMS and standard system functionalities.
Yes.
The device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD), which qualifies it as a therapeutic device.
No.
The device is described as an "adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)" and provides "repetitive stimulation (therapy)". It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "repetitive transcranial magnetic stimulation (rTMS) system" and describes hardware components like a "high voltage capacitor (1.8 kV)" and "stimulation coil" that generate magnetic fields. It also mentions electrical/mechanical/thermal safety testing, indicating a hardware component.
Based on the provided information, the CloudTMS Edge for OCD is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obsessive-Compulsive Disorder (OCD) in adult patients. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The device description clearly states it's a repetitive transcranial magnetic stimulation (rTMS) system that produces magnetic fields to induce neural action potentials in the prefrontal cortex. This is a therapeutic intervention, not a diagnostic test performed on a biological sample.
- Principle of Operation: The principle of operation involves generating magnetic fields to stimulate neurons, which is a physical therapy method, not an in vitro analysis of a biological specimen.
Therefore, the CloudTMS Edge for OCD is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Product codes
OCI
Device Description
The CloudTMS Edge 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 prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.General functionalities provided by the system are: - Single pulse stimulation (motor threshold detecting)
- Repetitive stimulation (therapy)
- Patient's data entering
- Stimulation algorithm editing
- Review of stimulation history
- Treatment report generation and printing
- Operation with list of treatment (selection for review, removal, etc.).
The CloudTMS Edge for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coll; 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.
Area of the brain to be stimulated for OCD treatment is Dorsomedial Prefrontal Cortex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
prefrontal cortex, bilateral dorsomedial prefrontal cortex (DMPFC)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.
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 Test Summary and Conclusion
- Electrical/mechanical/thermal safety and electromagnetic compatibility of both the subject and peen verified through testing to the following standards:
• IEC 60601-1:2005/(R)2012
• IEC 60601-1-2:2014 - Since the subject device uses the exact same patient device, their biocompatibility characteristics are identical. 3. Since both devices use the exact same double cone coil and the exact same treatment parameters ics of the electric and magnetic fields generated by them are identical. Thearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution and magnetic field strength gradient.
The subject device, CloudTMS Edge for OCD, does not introduce any new safety or effectiveness considerations in comparison to the predicate device, CloudTMS for OCD. All identified modifications between the two systems are minor and have any known impact on safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2023
TeleEMG, LLC % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, NH 03079
Re: K233742
Trade/Device Name: CloudTMS Edge 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: November 10, 2023 Received: November 22, 2023
Dear Mr. 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Robert M. Stefani Digitally signed by Robert M. Stefani -S -ਟ Date: 2023.12.22 14:50:02 -05'00'
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
| CloudTMS Edge for OCD |
|---|
| ----------------------- |
Indications for Use (Describe)
The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
Prepared on: 2023-11-20
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | TeleEMG, LLC |
|---|---|
| Applicant Address | 167 Poinsettia Pl Los Angeles CA 90036 United States |
| Applicant Contact Telephone | 6178403253 |
| Applicant Contact | Dr. Joe Jabre |
| Applicant Contact Email | jjabre@teleemg.com |
| Correspondent Name | Makromed, Inc. |
| Correspondent Address | 88 Stiles Road Salem NH 03079 United States |
| Correspondent Contact Telephone | 6036749074 |
| Correspondent Contact | Mr. Barry Ashar |
| Correspondent Contact Email | bashar@makromed.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | CloudTMS Edge for OCD |
|---|---|
| Common Name | Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions |
| Classification Name | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Regulation Number | 882.5802 |
| Product Code | QCI |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221129 | CloudTMS for OCD | QCI |
Device Description Summary
21 CFR 807.92(a)(4)
The CloudTMS Edge 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 prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.General functionalities provided by the system are: - Single pulse stimulation (motor threshold detecting)
5
-
Repetitive stimulation (therapy)
-
Patient's data entering
-
Stimulation algorithm editing
-
Review of stimulation history
-
Treatment report generation and printing
-
Operation with list of treatment (selection for review, removal, etc.).
The CloudTMS Edge for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coll; 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.
Area of the brain to be stimulated for OCD treatment is Dorsomedial Prefrontal Cortex.
Intended Use/Indications for Use
The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).
Indications for Use Comparison
The subject device of this 510(k) submission has the exact same Indication for Use as that of the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
Introduction
The proposed device (CloudTMS Edge for OCD) and the predicate device (Cloud TMS for OCD) are a repetitive transcranial magnetic stimulation (rTMS) systems. These computerized medical devices produce 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). Both devices have identical intended use / indication for use and identical treatment parameters and treatment target.
Design
The design of the two systems are near identical as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency of 20 Hz. Both systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers briefy alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the bilateral dorsomedial prefrontal cortex (DMPFC). Both systems use the exact same coil DCC-03-125-C, with a double cone coil transducer design. Both systems use the exact same software.
Operational Characteristics
For both the subject and the predicate device, their basic operational procedures including system seturs, motor threshold determination, coil positioning and treatment stimulation parameters are identical.
Technological Characteristics
The subject device and the predicate device use the exact same components and accessories, with the predicate device's main unit has been modified/enhanced with the following features in the subject device:
-
- Automatic detection and adjustment to the supply main power input of 110V or 220V.
-
- Upgraded power supply that provides faster charging of the voltage capacitor.
-
- Obsolescence and replacement of previous hydraulic quick couplers used for cooled coil connections.
- Improved graphical user interface to enhance user experience.
Non-clinical Performance Characteristics
- Electrical/mechanical/thermal safety and electromagnetic compatibility of both the subject and perified through testing to the following standards:
- IEC 60601-1:2005/(R)2012
- IEC 60601-1-2:2014
- Since the subject device uses the patient caps as the predicate device, their biocompatibility characteristics are identical. 3. Since both devices use the exact same double cone treatment parameters, the characteristics of the electric and magnetic fields generated by them are identical. These include linearity of output, biphasic sinusoidal and intensity, magnetic field spatial distribution and magnetic field strength gradient.
Conclusion
6
The subject device, CloudTMS Edge for OCD, does not introduce any new safety or effectiveness considerations in comparison to the predicate device, CloudTMS for OCD. All identified modifications between the two systems are minor and have been verified to not have any known impact on safety or efficacy.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical Test Summary and Conclusion
- Electrical/mechanical/thermal safety and electromagnetic compatibility of both the subject and peen verified through testing to the following standards:
• IEC 60601-1:2005/(R)2012
• IEC 60601-1-2:2014
- Since the subject device uses the exact same patient device, their biocompatibility characteristics are identical. 3. Since both devices use the exact same double cone coil and the exact same treatment parameters ics of the electric and magnetic fields generated by them are identical. Thearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution and magnetic field strength gradient.
Conclusion
The subject device, CloudTMS Edge for OCD, does not introduce any new safety or effectiveness considerations in comparison to the predicate device, CloudTMS for OCD. All identified modifications between the two systems are minor and have any known impact on safety or efficacy.