(142 days)
No
The description focuses on computer-controlled electromechanical components, optical tracking, and standard software validation (IEC 62304, EN 62304). There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No.
This device is described as an electromechanical arm that
positions and guides a TMS coil. The "Intended Use" states it is
"indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System." It does not provide therapy itself; it is an accessory to a therapeutic system.
No
The device description clearly states its purpose is for spatial positioning and orientation of a treatment coil for Transcranial Magnetic Stimulation (TMS) therapy. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it comprises an electromechanical collaborative arm, optical tracking system with hardware (3D camera), coil adaptation kits with mechanical adaptors, and a contact sensor, all of which are hardware components. The performance studies also mention hardware and firmware component tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System." This describes a device that physically interacts with a treatment system and a patient, not a device used to examine specimens derived from the human body.
- Device Description: The description details an "electromechanical arm" that provides "guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil." This is a robotic system for physical manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is clearly a therapeutic positioning system.
N/A
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.
Product codes
QFF
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
The nonclinical testing completed for the TMS-Cobot TS MV included three major categories of testing:
-
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.
-
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.
-
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.
Performance data demonstrate that the TMS-Cobot TS MV is as safe and effective as the MagVita TMS Therapy System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MagVita TMS Therapy System (K150641)
Reference Device(s)
Medtech SA ROSA Spine (K151511)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +33 3 88 55 62 07 Contact Person: Michel BERG, CEO E-mail: michel.berg@axilumrobotics.com Date Prepared: September 28, 2018
Submission Correspondent
Janice Hogan Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, PA 19103 Phone: (267) 675-4600 Fax: (267) 675-4601 E-mail: janice.hogan@hoganlovells.com
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
System with Super Flexible
Arm (alone)
K150641 (Predicate) | MagVita TMS Therapy System using
Axilum Robotics TMS-Cobot TS MV
in lieu of Super Flexible Arm
K182768 (Subject) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The MagVita TMS Therapy
System 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 | 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 * |
| Intended use of
Electromechanical
arm | N/A | 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. |
| Coil holder
Joints | Passive mechanical arm | Active electromechanical arm |
| Degrees of
freedom | 3 | 6 |
| Coil holder | Coil handle is directly
tightened in the tip of the
articulated arm | Coil is attached to the robotic arm via a
coil adapter fixed to the coil |
| Coil holder
material | Aluminum | Aluminum |
| Position of coil
holder | Mobile, attached to
stimulator wheel cart or
(optionally) either to the back
of the treatment chair or to a
table. | Mobile, mounted on a wheel cart |
| Piloting system | Human pilot manually acting
on the articulated arm | Human pilot through the free-drive
mode, and: 3D tracking system |
| Coil for
depression
treatment | Cool-B65 coil | Cool-B65-RO coil which is the robotic
adaptation of Cool-B65 coil. |
| Patient chair | Included, FDA-cleared | Can use the chair included in MagVita
system |
| Coil positioning
strategy | Guided by user via
anatomical landmarks on the
head (no MRI imaging prior
to treatment) | With 3D tracking system: guided by
user via anatomical landmarks on
the head (no MRI imaging prior to
treatment), and fine-tuning from the
control panel. |
| Coil to head
contact
management | None, user-managed contact
from visual observation of coil
and head | From measurements of a contact sensor
added to the treatment side of the coil |
| Head motion
compensation | User-managed from
visual observation of the
patient and acting on the
articulated stand | Robot-automated, from real-time
camera measurements.
In addition, user can activate the free-
drive mode and manually re-adjust
the position; Or, user can use the
device's control panel to fine tune the
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
5
6
*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:
-
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.
-
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.
-
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
7
is as safe and effective as the MagVita TMS Therapy System. Thus, the TMS-Cobot TS MV is substantially equivalent.