(37 days)
No
The document describes a standard image-guided navigation system using electromagnetic tracking and DICOM communication. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or the sections specifically checked for AI/ML mentions.
No.
The device is a navigation system used for image-guided minimally invasive interventions, which plans trajectories and displays simulated images and planning information to assist the physician; it does not directly treat or diagnose a disease or condition.
No
The device is described as an intraoperative image-guided navigation system that assists in planning and guiding interventions (e.g., placing biopsy needles). It uses existing imaging data (CT, C-Arm) and tracks devices for real-time guidance but does not independently diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states that the navigation system is a "software and hardware tool" and details various hardware components including an industrial PC, mobile rack, electromagnetic tracking system (field generator, coils), patient fixation device, and patient panel/reference panel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The NavStationIrad EMT is an image-guided navigation system used during surgical or interventional procedures. It helps physicians plan trajectories and guide instruments (like needles) within the patient's body based on medical images.
- Lack of Specimen Analysis: The device does not collect, prepare, or analyze any specimens from the patient's body. Its function is entirely focused on providing real-time guidance and visualization during an intervention.
Therefore, the NavStationIrad EMT falls under the category of a surgical or interventional guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NavStationIrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationIrad EMT can be used in combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-Arm systems.
It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.
The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
Product codes
JAK
Device Description
The navigation system NavStationIrad EMT is a software and hardware tool to plan different trajectories to selected targets and to place tools (e.g. biopsy needles) with navigation control inside the selected targets. The navigation system can be used within the scope of interventional radiology.
Navigation System:
The navigation station consists of an industrial PC with integrated touch screen as user interface and dedicated navigation software. The PC is mounted on a mobile rack. For image acquisition the navigation system is connected to a C-arm system with CT option. For the communication of the navigation system with the imaging system, a DICOM network application using the DICOM standard protocol is used.
In order to place the patient safe and comfortable on the intervention table we use a patient fixation device BodyFix Medical Intelligence (510(k) Number: K001052).
In order to track navigation devices the electromagnetic (EM) tracking system is used. The EM tracking system consists of a field generator producing an alternating electromagnetic field for operation. The EM field induces a voltage in small coils implemented in the tips of the tracked navigation devices. The voltage is measured by the EM tracking system and used to calculate the current position and orientation of the coil inside the EM field thus determining the sensor coordinates in five degrees of freedom (DoF).
The navigation hardware (PC, Monitor, Rack and tracking system) are combined to NaviBase. NaviBase is a CE labeled hardware and software platform for all navigation systems of CAS innovations and part of this technical file.
Navigation Devices:
As devices electro-magnetic-needles with small coils embedded in their tips are used.
For image-to-patient registration a patient panel/reference panel (PP) is used. With the panel it is possible to map the patient image space to the physical space. This procedure is called registration.
To control residual patient motion, an additional tracked device (skin marker/skin sensor) is used. The tracking system is able to detect the sensor and send its position relative to the PP to the navigation system. The patient motion is visualized at the monitor and the physician is able to recognize the motion and can react on it accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computer Tomography (CT) or C-Arm systems
Anatomical Site
anatomic relevant regions of the patient. The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053610, K002258, K974432, K990214
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
X080624
510(k) Summary of Safety and Effectiveness for NavStationIrad EMT
APR 1 1 2008
l, Manufacture
CAS innovations AG Heusteg 47 91056 Erlangen Germany
II. Contact Person:
Dr. Markus Nagel Head of R&D/Head of Q-/P-Management CAS Innovations Inc. Phone: (0049) 9131 6166030 Fax: (0049) 9131 6166031
III. Device Name and Classification:
| Trade Name: | NavStationlrad EMT |
|---|---|
| Common Name: | Computer assisted, image-guided surgery system |
| Classification Name: | Computer Tomography X-ray System |
| Classification Panel: | Interventional Radiology |
| CFR Section: | 21 CFR 892.1750 |
| Device Class: | Class II |
| Device Code: | JAK |
- Date Prepared IV.
March 19, 2008
1
V. Device Description
The navigation system NavStationIrad EMT is a software and hardware tool to plan different trajectories to selected targets and to place tools (e.g. biopsy needles) with navigation control inside the selected targets. The navigation system can be used within the scope of interventional radiology.
Navigation System:
The navigation station consists of an industrial PC with integrated touch screen as user interface and dedicated navigation software. The PC is mounted on a mobile rack. For image acquisition the navigation system is connected to a C-arm system with CT option. For the communication of the navigation system with the imaging system, a DICOM network application using the DICOM standard protocol is used.
In order to place the patient safe and comfortable on the intervention table we use a patient fixation device BodyFix Medical Intelligence (510(k) Number: K001052).
In order to track navigation devices the electromagnetic (EM) tracking system is used. The EM tracking system consists of a field generator producing an alternating electromagnetic field for operation. The EM field induces a voltage in small coils implemented in the tips of the tracked navigation devices. The voltage is measured by the EM tracking system and used to calculate the current position and orientation of the coil inside the EM field thus determining the sensor coordinates in five degrees of freedom (DoF).
The navigation hardware (PC, Monitor, Rack and tracking system) are combined to NaviBase. NaviBase is a CE labeled hardware and software platform for all navigation systems of CAS innovations and part of this technical file.
Navigation Devices:
As devices electro-magnetic-needles with small coils embedded in their tips are used.
For image-to-patient registration a patient panel/reference panel (PP) is used. With the panel it is possible to map the patient image space to the physical space. This procedure is called registration.
To control residual patient motion, an additional tracked device (skin marker/skin sensor) is used. The tracking system is able to detect the sensor and send its position relative to the PP to the navigation system. The patient motion is visualized at the monitor and the physician is able to recognize the motion and can react on it accordingly.
2
ج Intended Use
NavStationIrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationIrad EMT can be used in combination with imaging systems that create a 3D based model of the anatomy, like Computer Tomography (CT) or C-Arm systems.
It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.
The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
VI. Substantial Equivalence
NavStationIrad EMT is substantially equivalent to the following FDA cleared frameless stereotaxic systems:
| Manufacture | System Name | 510(k) number |
|---|---|---|
| Traxtal Technologies | ABARIS | K053610 |
| UltraGuide Ltd. | UltraGuide CT-Guide | K002258 |
| UltraGuide 1000 | K974432 | |
| Medtronic | StealthStation FluoroNav | K990214 |
The device labeling contains instructions for use, the indication for use, clinical workflow, cautions, contraindications, warnings, and planning guidance. All information assures safe and effective use of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
CAS Innovations AG, % Mr. Stefan Preiss TÜV America, Inc. Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K080624
Trade/Device Name: NavStation/RAD EMT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 22, 2008 Received: March 5, 2008
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for of to rove 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. 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.
APR 1 1
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket It your do the subject to such additional controls. Existing major regulations affecting your Apple rary, it ind of ot only of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/9 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. There are three stars at the bottom of the logo. The logo is surrounded by a circular border with small design elements.
Protesting and Promoting Public Health
4
Page 2
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdri/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: NavStationIRad EMT
Indications For Use:
NavStationIrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationIrad EMT can be used in combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-Arm systems.
It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.
The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arni Mertz
productive, Abdom
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