(69 days)
Not Found
No
The description focuses on geometric alignment and structured light techniques for motion tracking, with no mention of AI or ML algorithms for data processing or analysis.
No.
The device is an accessory to an MRI scanner that tracks patient movement and provides real-time position data to the scanner; it does not directly diagnose, treat, or prevent disease.
No.
Explanation: The TCL3 Motion Tracking System provides real-time patient position data to an MRI scanner to track movement. It does not provide any diagnostic information or diagnosis of a disease or condition. Its purpose is to support and augment the performance of MRI scanners by providing real-time motion data, not to diagnose.
No
The device description explicitly mentions hardware components like a camera and an infrared light modulator used in the structured light technique, which are integral to the system's function. It is not solely software.
Based on the provided information, the TCL3 Motion Tracking System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- TCL3 Function: The TCL3 Motion Tracking System directly interacts with the patient's head using a structured light technique to track movement during an MRI scan. It does not analyze biological specimens.
- Intended Use: The intended use is to support, supplement, and/or augment the performance of MRI scanners by providing real-time patient position data. This is a function related to the imaging process itself, not the analysis of biological samples.
Therefore, the TCL3 Motion Tracking System falls under the category of a medical device that assists in the imaging process, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 Motion Tracking System is intended to support, supplement, and/or augment the performance of MRI scanners that have been validated for compatibility.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The TCL3 Motion Tracking System monitors the patient's head for the duration of the scan. It can be turned off between patient scans. While running, the TCL3 Motion Tracking System continuously scans the surface of the patient's head, producing high-resolution 3D surfaces consisting of thousands of individual points. A structured light technique is utilized, using the combination of a camera and an infrared light modulator to reconstruct 3D surfaces of the patient's head. Each second, 30 surfaces are created. Each of these surfaces is used for geometric alignment relative to an initial reference position obtained at the beginning of the scan. From these alignments, motion data can be calculated in real-time. The system is intended for use with performance tested scanners. The modified device includes a revised indications for use and an update to the system components and system software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
patient's head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use Environment: Hospital, doctor's office, or any facility that uses an MRI device.
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)
- Bench testing for electrical and mechanical safety in compliance with the standards cited above
- Bench testing for EMC in compliance with the standard cited above
- Software testing, consisted of verification and validation testing in compliance with ISO 62304. including test cases related to off the shelf software, as well as cybersecurity features and wireless coexistence.
- Bench testing for tracking quality and accuracy, MR compatibility and Mechanical compatibility Clinical data was not required for this type of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Substantially Equivalent
Translational accuracy: 200 micrometer
Rotational accuracy: 0.2 degrees
Recording rate: 30 frames per second
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2022
TracInnovations A/S % Stefan Glimberg CTO Brydehusvej 13 Ballerup, 2750 DENMARK
Re: K221785
Trade/Device Name: TCL3 Motion Tracking System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 13, 2022 Received: June 21, 2022
Dear Stefan Glimberg:
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.
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
1
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 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).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221785
Device Name
TCL3 Motion Tracking System
Indications for Use (Describe)
The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 Motion Tracking System is intended to support, supplement, and/or augment the performance of MRI scanners that have been validated for compatibility.
| 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) |
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3
K221785 510(k) Summary Prepared August 26, 2022
| Sponsor: | TracInnovations
Brydehusvej 13 DK-2750
Ballerup Denmark |
|------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Stefan Glimberg
CTO
sg@tracinnovations.com |
| Telephone: | +45 93 88 11 65 |
| Submission Date: | August 26, 2022 |
| Device Name: | TCL3 Motion Tracking System |
| Common Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Trade Name: | TCL3 Motion Tracking System |
| Classification: | Regulatory Class: II
Review Category: 21CFR 892.1000 (LNH)
Classification Panel: Radiology |
A. Legally Marketed Predicate Devices
The predicate device is the TCL3 Motion Tracking System Motion Correction System (K203451) manufactured by TracInnovations.
B. Device Description:
The TCL3 Motion Tracking System monitors the patient's head for the duration of the scan. It can be turned off between patient scans. While running, the TCL3 Motion Tracking System continuously scans the surface of the patient's head, producing high-resolution 3D surfaces consisting of thousands of individual points. A structured light technique is utilized, using the combination of a camera and an infrared light modulator to reconstruct 3D surfaces of the patient's head. Each second, 30 surfaces are created. Each of these surfaces is used for geometric alignment relative to an initial reference position obtained at the beginning of the scan. From these alignments, motion data can be calculated in real-time. The system is intended for use with performance tested scanners. The modified device includes a revised indications for use and an update to the system components and system software.
4
C. Intended Use / Indications for Use
The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 Motion Tracking System is intended to support, supplement, and/or augment the performance of MRI scanners that have been validated for compatibility.
D. Substantial Equivalence
The TracInnovations Motion Tracking System is substantially equivalent to the TracInnovations Motion Tracking System (K203451).
| Device Name | Predicate Device
TracInnovations Motion
Tracking System (K203451) | Subject Device
TracInnovations Motion
Tracking System | SE |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for
Use | The TCL3 Motion Tracking
System is an accessory to a
Magnetic Resonance Imaging
(MRI) scanner. The system
uses a markerless sensor based
technology for tracking of
patient movement during an
MRI session. It provides the
current position of the patient
in real-time to the MRI
scanner.
The TCL3 System is intended
to support, supplement and/or
augment the performance of
the Siemens Magnetom Skyra,
Siemens Magnetom Prisma,
Philips Achieva and GE Signa
Premier scanners. | The TCL3 Motion Tracking
System is an accessory to a
Magnetic Resonance Imaging
(MRI) scanner. The system
uses a markerless sensor based
technology for tracking of
patient movement during an
MRI session. It provides the
current position of the patient in
real-time to the MRI scanner.
The TCL3 Motion Tracking
System is intended to
support, supplement, and/or
augment the performance of
MRI scanners that have been
validated for compatibility. | Yes |
| Intended Users | Professional Use
Environment: Hospital,
doctor's office, or any facility
that uses an MRI device. | Professional Use Environment:
Hospital, doctor's office, or any
facility that uses an MRI
device. | Identical |
| Review Panel | Radiology | Radiology | Identical |
| Product code | LNH | LNH | Identical |
| Regulation
number | 892.1000 | 892.1000 | Identical |
| Regulation | Magnetic resonance diagnostic
device | Magnetic resonance diagnostic
device | Identical |
| Classification | II | II | Identical |
| | Predicate Device
TracInnovations Motion
Tracking System
(K203451) | Subject Device
TracInnovations Motion
Tracking System | Substantially
Equivalent |
| Core Technology | TracInnovations defines its
TCL3 Motion Tracking
System as an accessory to a
medical device. It is intended
to support, supplement and/or
augment the performance of
the scanners indicated below. | TracInnovations defines its
TCL3 Motion Tracking System
as an accessory to a medical
device. It is intended to support,
supplement and/or augment the
performance of scanners. | Identical |
| Marker required | No. Attachment of a
marker is not required | No. Attachment of a marker
is not required | Identical |
| Data acquisition
sensor | Use one camera and one
infrared light modulator
(projection of structured
light patterns) to identify
and track a surface. | Use one camera and one
infrared light modulator
(projection of structured light
patterns) to identify and track
a surface. | Identical |
| Line of sight | Line of sight for the
camera and infrared light
modulator to the patient | Line of sight for the camera
and infrared light modulator
to the patient | Identical |
| MRI scanner
compatibility | Siemens MAGNETOM
Prisma 3T
Siemens MAGNETOM
Skyra 3T
Siemens Biograph mMR
3T
Philips Achieva 3T | Scanners that have been
validated for compatibility | Substantially
Equivalent |
| Scanner bore
compatibility | 60 cm and 70 cm bore
systems | 60 cm and 70 cm bore
systems | Identical |
| Scanner mounting | Attachment on the scanner
table, Detachable | Attachment on the scanner
table, Detachable | Identical |
| Communication
with scanners | Ethernet connection,
UDP/IP protocol | Ethernet connection, UDP/IP
protocol | Identical |
| Powering | Battery, >8 hours | Battery, >8 hours | Identical |
| Motion tracking | Tracks motion of the head
in 6 degrees of freedom
(x,y,z translations, and
rotations) | Tracks motion of the head in
6 degrees of freedom (x,y,z
translations, and rotations) | Identical |
| Translational
accuracy | 200 μm | 200 μm | Identical |
| Rotational accuracy | 0.2 degrees | 0.2 degrees | Identical |
| Recording rate | 30 frames per second | 30 frames per second | Identical |
| Cross calibration
procedure | Iteratively adapting | Iteratively adapting | Identical |
Table 1. Substantial Equivalence Comparison of Indications for Use
5
Table 2 Substantial Equivalence Comparison for Technological Characteristics
Based on the comparison of indications for use and technological characteristics, the subject device is substantially equivalent to the TracInnovations original predicate device. Based on the performance data provided in the submission the differences do not introduce new issues related to safety and efficacy.
6
E. Performance Data
Each specification of the TracInnovations Motion Tracking System has been verified and validated as required by the risk analysis. All design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. The verification and validation testing included testing to the following applicable standards:
| ISO 14971 | Application of risk management to medical devices |
|---|---|
| IEC 60601-1 | Medical electrical equipment- General requirements for |
| basic safety and essential performance | |
| IEC 60601-1-2 | Electromagnetic disturbances |
| IEC 62304 | Medical device software - Software life-cycle |
| processes | |
| EN IEC 62471; 2006 | Photobiological safety of lamps and lamp systems – |
| Part 2 Guidance on manufacturing requirements | |
| relating to Non-Laser Optical Radiation Safety |
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:
-
Bench testing for electrical and mechanical safety in compliance with the standards cited above
-
Bench testing for EMC in compliance with the standard cited above
-
Software testing, consisted of verification and validation testing in compliance with ISO 62304. including test cases related to off the shelf software, as well as cybersecurity features and wireless coexistence.
-
Bench testing for tracking quality and accuracy, MR compatibility and Mechanical compatibility Clinical data was not required for this type of device.
F. Conclusion
Potential risks were identified according to the ISO 14971 Standards. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, the performance data demonstrated that these did not result in any new issues of safety or efficacy.
Therefore, the TracInnovations Motion Tracking System is substantially equivalent to the original TracInnovations predicate device (K203451) with regards to intended use and technological characteristics. Results of performance testing demonstrated that the design requirements and as well as the user needs.