TMS-Cobot TS MV

K182768 · Axilum Robotics · QFF · Feb 17, 2019 · Neurology

Device Facts

• Record ID: K182768
• Device Name: TMS-Cobot TS MV
• Applicant: Axilum Robotics
• Product Code: QFF · Neurology
• Decision Date: Feb 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System

Device Story

TMS-Cobot TS MV is a computer-controlled electromechanical collaborative robotic arm used to position and orient TMS treatment coils. It integrates with the MagVita TMS Therapy System, replacing the manual 'Super Flexible Arm'. The system utilizes a 3D camera and optical tracking system to monitor patient head position; a contact sensor on the coil monitors head contact. The device provides robot-automated head motion compensation and collision detection at joint and coil levels. Physicians operate the device via a 'free-drive' mode for manual adjustment or a control panel for fine-tuning. By automating coil positioning and maintaining orientation despite patient movement, the device assists clinicians in delivering TMS therapy, potentially improving treatment accuracy and consistency compared to manual positioning.

Clinical Evidence

Bench testing only. Testing included technical hardware/firmware verification, functional integration testing (accuracy, repeatability, head motion compensation, free-drive mode), and usability testing per IEC 62366:2015. Compatibility testing confirmed safe operation with MagVita system components. Software/firmware validated per IEC 62304:2015.

Technological Characteristics

Electromechanical collaborative arm with 6 degrees of freedom; aluminum coil holder; optical tracking system with 3D camera; contact sensor; collision detection at joints. Connectivity: integrated with MagVita TMS system. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366.

Indications for Use

Indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System in adult patients with Major Depressive Disorder who have failed to receive satisfactory improvement from prior antidepressant medication.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MagVita TMS Therapy System (K150641)

Reference Devices

• Medtech SA ROSA Spine (K151511)

Submission Summary (Full Text)

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February 17, 2019

Axilum Robotics % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K182768

Trade/Device Name: TMS-Cobot TS MV Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: QFF Dated: January 18, 2019 Received: January 18, 2019

Dear Janice Hogan:

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 Actinclude 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Pamela D. Scott -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182768

Device Name TMS-Cobot TS MV

Indications for Use (Describe)

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System

| 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 K182768 Axilum Robotics' TMS-Cobot TS MV

### Submitte r

Axilum Robotics, SAS. 8, Rue Schertz, Building B1 67100 Strasbourg France Phone: [phone] Contact Person: Michel BERG, CEO E-mail: [e-mail] Date Prepared: September 28, 2018

### Submission Correspondent

Janice Hogan Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, PA 19103 Phone: [phone] Fax: [phone] E-mail: [e-mail]

Name of Device: TMS-Cobot TS MV

Common or Usual Name: Electromechanical arm for transcranial magnetic stimulation system

Classification Name: 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation System

Regulatory Class: Class II

Product Code: QFF

Predicate Devices MagVita TMS Therapy System (K150641)

Reference Devices Medtech SA ROSA Spine (K151511)

#### De vice De scription

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm based on collaborative robotics technology, providing guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil - connected to its stimulator - under the supervision of an optical tracking system.

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Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor.

The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.

## Intended Use / Indications for Use

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.

## Summary of Technological Characteristics

The TMS-Cobot TS MV is an accessory to the predicate MagVita TMS Therapy System (K150641). The MagVita TMS Therapy System contains a component intended to position the treatment coil called the Super Flexible Arm. The TMS-Cobot TS MV can be utilized in place of the Super Flexible Arm along with the other components of the MagVita TMS Therapy System.

The company believes that the TMS-Cobot TS MV does not present any new unique risks compared to the MagVita system, and that accurate coil positioning is key for both systems. The general risks of contacting the patient's head or mispositioning the coil are risks that are common to both manual and robotically controlled arms:

The use of robotic arms to position tools such as surgical instruments is not novel, see for example, the Medtech SA ROSA Spine device (K151511). Both the TMS-Cobot TS MV and the ROSA Spine are electromechanical arms intended to assist physicians in the spatial positioning and orientation of instrument holders. The TMS-Cobot TS MV and the ROSA Spine both contain a hardware structure that supports the electromechanical arm, along with a holder for the coil or instruments. Recording for both the TMS-Cobot TS MV and the ROSA Spine utilize fiducial markers and an optical registration device.

| Feature | MagVita TMS Therapy<br>System with Super Flexible<br>Arm (alone)<br>K150641 (Predicate) | MagVita TMS Therapy System using<br>Axilum Robotics TMS-Cobot TS MV<br>in lieu of Super Flexible Arm<br>K182768 (Subject) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The MagVita TMS Therapy<br>System is indicated for the<br>treatment of Major<br>Depressive Disorder in adult<br>patients who have failed to<br>receive satisfactory<br>improvement from prior<br>antidepressant medication in<br>the current episode | Axilum Robotics TMS-Cobot TS MV is<br>a computer controlled electromechanical<br>arm indicated for spatial positioning and<br>orientation of the treatment coil of the<br>MagVita TMS Therapy System * |
| Intended use of<br>Electromechanical<br>arm | N/A | Axilum Robotics TMS-Cobot TS MV<br>is a computer controlled<br>electromechanical arm indicated for<br>spatial positioning and orientation of<br>the treatment coil of the MagVita<br>TMS Therapy System. |
| Coil holder<br>Joints | Passive mechanical arm | Active electromechanical arm |
| Degrees of<br>freedom | 3 | 6 |
| Coil holder | Coil handle is directly<br>tightened in the tip of the<br>articulated arm | Coil is attached to the robotic arm via a<br>coil adapter fixed to the coil |
| Coil holder<br>material | Aluminum | Aluminum |
| Position of coil<br>holder | Mobile, attached to<br>stimulator wheel cart or<br>(optionally) either to the back<br>of the treatment chair or to a<br>table. | Mobile, mounted on a wheel cart |
| Piloting system | Human pilot manually acting<br>on the articulated arm | Human pilot through the free-drive<br>mode, and: 3D tracking system |
| Coil for<br>depression<br>treatment | Cool-B65 coil | Cool-B65-RO coil which is the robotic<br>adaptation of Cool-B65 coil. |
| Patient chair | Included, FDA-cleared | Can use the chair included in MagVita<br>system |
| Coil positioning<br>strategy | Guided by user via<br>anatomical landmarks on the<br>head (no MRI imaging prior<br>to treatment) | With 3D tracking system: guided by<br>user via anatomical landmarks on<br>the head (no MRI imaging prior to<br>treatment), and fine-tuning from the<br>control panel. |
| Coil to head<br>contact<br>management | None, user-managed contact<br>from visual observation of coil<br>and head | From measurements of a contact sensor<br>added to the treatment side of the coil |
| Head motion<br>compensation | User-managed from<br>visual observation of the<br>patient and acting on the<br>articulated stand | Robot-automated, from real-time<br>camera measurements.<br>In addition, user can activate the free-<br>drive mode and manually re-adjust<br>the position; Or, user can use the<br>device's control panel to fine tune the<br>position and orientation of the coil |
| Collision management | None (user-managed while acting on the knob of the articulated stand) | Collaborative robotics technology allows for collision detection at each joint level in addition to coil contact sensor level |

### Substantial Equivalence comparison

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*Although the IFU of the subject device is different than the IFU of the predicate device the subject device is an accessory to the system and its intended use is identical to the intended use of the passive mechanical arm of the predicate device.

# Performance Data

TMS-Cobot TS MV was tested to the following standards:

- AAMI ANSI ES 60601-1:2005/(R)2012 And A1:2012Electromedical devices Part 1: ● general requirements for basic safety and essential performances
- IEC 60601-1-2: 2014, Edition 4.0, Electromedical devices - Part 1.2: general requirements for basic safety and essential performances. Collateral Standard: Electromagnetic Disturbances - Requirements and Testing

The nonclinical testing completed for the TMS-Cobot TS MV included three major categories of testing:

1. Technical tests, which include: internal hardware, firmware component tests, tests of the software communication protocol used between the various firmware and software components, packaging tests. Software verification and validation for firmware and software components of the device have been tested against their specifications and according to IEC 62304:2015.

2. Functional tests, which include integrated product testing using the tracking system and TMS coil that have been designed to verify key aspects of performance of the system such as accuracy, repeatability, operation of the robotic arm's freedrive mode and ability to provide sufficient head motion compensation. Moreover, usability testing was conducted on the device according to IEC 62366:2015 and FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices.

3. Compatibility tests, which verify that the TMS-Cobot TS MV can operate safely with both the treatment coil and the patient seat of the MagVita TMS Therapy System. Particularly, accessbility of the patient's head inside the robotic arm's workspace has been checked to be compatible with the range of patient positions permitted by the patient seat included in MagVita TMS Therapy System.

Robot controller firmware features have been validated in accordance with EN 62304:2006 and FDA's Guidance for General Principles of Software Validation.

# Conclusions

The TMS-Cobot TS MV used in combination with the MagVita TMS Therapy System is as safe and effective as the MagVita TMS Therapy System (K150641) alone. The TMS-Cobot TS MV has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the TMS-Cobot TS MV and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the TMS-Cobot TS MV

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is as safe and effective as the MagVita TMS Therapy System. Thus, the TMS-Cobot TS MV is substantially equivalent.