(336 days)
No
The description focuses on electromagnetic tracking and image-to-patient registration based on fiducial markers, anatomical landmarks, or surface matching. There is no mention of AI or ML algorithms being used for image analysis, navigation, or any other function.
No
This device is a navigation system intended to aid in precisely locating anatomical structures during neurosurgical procedures. It does not directly treat or prevent a disease or condition but rather assists in performing the procedure.
No
This device is a surgical navigation system that aids in precisely locating anatomical structures during neurosurgical procedures by displaying instrument positions on pre-operative scans. It is used for guidance during surgery, not for diagnosing a condition or disease.
No
The device description explicitly lists hardware components beyond just a navigation unit with software, including a navigation sensor (Headrest with field generator), a navigation instrument, and a patient reference localizer. It also describes the physical connections and interactions between these hardware components and the software.
Based on the provided information, the Fiagon Navigation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Fiagon Navigation System's Function: The Fiagon Navigation System is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures during surgical procedures by displaying the position of instruments relative to pre-operative imaging. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures." This is a surgical guidance function, not an in vitro diagnostic function.
- Device Description: The description focuses on electromagnetic tracking technology, image-to-patient registration, and displaying instrument position on pre-operative scans. This aligns with surgical navigation, not laboratory analysis of specimens.
Therefore, the Fiagon Navigation System falls under the category of surgical navigation systems, which are distinct from In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
Product codes
HAW
Device Description
The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.
The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching.
Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
The device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device.
Mentions image processing
Yes, "The display of navigation information requires an image-to-patient registration procedure...Thereafter, the spatial position of the instrument is displayed superimposed to the image data."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, fluoroscopy. Also listed as CT/MR/Cone Beam CT.
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical procedures / OR Equipment
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 was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism.
The tests performed to validate the accuracy of our navigation instruments ranged from validation of required accuracy (Positional accuracy and angular accuracy with registration) to measurement of technical accuracy with co-ordinate measurement system followed by measurement of positional and angular accuracy without registration to measure the angular accuracy of the instrument itself.
The non-clinical data support the safety of the device demonstrate that the Fiagon Navigation System perform as intended in the specified use conditions. The non-clinical data demonstrate that the device performs comparably to the predicate device for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Position Mean:
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2016
Fiagon GmbH Dr. Dirk Mucha Manager Regulatory Affairs Neuendorfstrasse 23b Hennigsdorf, Germany 16761
Re: K151156
Trade/Device Name: Fiagon Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 25, 2016 Received: March 02, 2016
Dear Dr. Mucha:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -5)/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151156
Device Name Fiagon Navigation System
Indications for Use (Describe)
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
| 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 Fiagon Navigation System
1. Submitter Information
| Submitter:
Address: | Fiagon GmbH
Neuendorfstrasse 23b
16761 Hennigsdorf, Germany |
|------------------------|-------------------------------------------------------------------|
| Telephone: | +49 3302 201 21 10 |
| Telefax: | +49 3302 201 21 15 |
| Contact: | Dr. Dirk Mucha, Manager Regulatory Affairs |
| Date Prepared | 2016-02-24 |
2. Device Information
| Trade Name: | Fiagon Navigation System |
|---|---|
| Common Name: | Image guided surgery system |
| Classification: | Class II per 21 CFR 882.4560 |
| Device: | Stereotaxic Instrument |
| Product Code: | HAW |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new Image Guided Surgery System.
Predicate Device Information 4.
The Fiagon Navigation System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| 1. | |||
| Primary | |||
| predicate | Stealth station system with | ||
| synergy cranial Software | Medtronic | ||
| navigation, Inc | K150216 | ||
| 2. | BrightMatter Navigation | ||
| System V1.0 | Synaptive Medical | ||
| Inc. | K142024 |
4
Device Description
The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.
The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching.
Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
The device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device.
| Reference Device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| R1. | Fiagon Navigation System | ||
| Similar device, cleared for | |||
| different intended use | Fiagon GmbH | K133573 |
Device Design
The components of the navigation system are
-
- Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
-
- Navigation sensor (Headrest with field generator)
-
- Navigation instrument
- Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad)
The navigation unit is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM. USB storage media or LAN network and displayed in appropriate way (defined by the software).
The navigation unit compromises the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient reference localizer and the navigation instrument.
5
Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.
The patient reference localizer is fixed to the skull clamp and references the patient's anatomy, while the instrument is tracked in relation to the patient reference localizer and thus to the patient's anatomy.
| Components | Grouping | Material used
(if body contact) | Property |
|----------------------------------|-----------------------------------|-------------------------------------------|-----------------------------------------------------|
| Navigation Unit | Unit | n.a. | OR Equipment
Rating: 100 -240Vac 50-60 Hz, 200VA |
| Navigation Headrest
Flat | Navigation
Sensor | n.a. | OR Equipment |
| Navigation Headrest
Maquet | Navigation
Sensor | n.a. | OR Equipment |
| Navigation Headrest
Universal | Navigation
Sensor | n.a. | OR Equipment |
| FlexPointer | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| FlexPointer 1.5 | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| FinePointer | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| BiopsyPointer 190 | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| BiopsyPointer 250 | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| ShuntPointer | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| RegistrationPointer | Instrument | Stainless steel
medical grade adhesive | reusable, 10 times |
| Localizer Adhesive
Pad | Patient
reference
localizer | n.a. | reusable |
| Adhesive Pad | Fixation
material | medical grade adhesive
tape | single use |
List of components/accessories
6
5. Intended Use
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection) -
- Skull Base Procedures -
- Cranial Biopsies -
- -General Catheter Shunt Placement
6. Comparison of Technological Characteristics
The substantial equivalence of the Fiagon Navigation System to the predicates is shown by similarity in intended use, indications for use, materials, and performance. The Fiagon Navigation System and its predicates and the reference device utilize:
- Electromagnetic tracking technology for navigation in 2 cases and optical tracking in . 1 case. (For further details refer to the table below).
- . Anatomical or fiducial reference points on the patient's anatomy for intraoperative registration to the image-based model of the anatomy in 2 cases (Fiagon Navigation System and Stealth station system with synergy cranial Software) and Fiducial matching in the case of BrightMatter Navigation System V1.0).
- CT or MR image sets as reference images for the image-based model .
The primary difference between the Fiagon Navigation System and its two predicates is that the Fiagon System includes the option of navigating flexible-tip instruments by having the instrument localizer in the tip of the instrument. Since tracking a localizer in the tip of the instrument provides similar navigation accuracy as tracking the tip of a rigid instrument via a localizer mounted to the instrument handle, this difference does not raise new issues of safety and effectiveness.
| Property | Fiagon Navigation
System | Predicate 1
Stealth station
system with
synergy cranial
Software | Predicate 2
BrightMatter
Navigation System
V1.0 | Reference device
Fiagon Navigation
System |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Subject of
investigation | K150216 | K142024 | K133573 |
| Reference
images | CT/MR/ Cone Beam
CT | CT/X-Ray based,
MR based Nuclear
Medicine based | MRI Images and
DTI images of the
brain | CT/MR/ Cone Beam
CT |
| Property | Fiagon Navigation System | Predicate 1 Stealth station system with synergy cranial Software | Predicate 2 BrightMatter Navigation System V1.0 | Reference device Fiagon Navigation System |
| Tracking method | Electromagnetic | Optical (infra-red)
Electromagnetic
Either of the technologies can be selected | Optical tracking | Electromagnetic |
| Field generator | Integrated into headrest or bedside mounted, Head clamp mounted | Electromagnetic tracking system can be used from its discreet location on a StealthStation System or attached to the OR bedrail | Optical Tracking Technology.
The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart. | Integrated into headrest |
| Method of registration | Surface matching
Fiducial matching | Surface matching
Fiducial matching | Fiducial matching
The system works with 3D cameras that know the exact location and orientation of the tools being used. It overlays the location of the tools over the 3D visualizations of the brain and uses the BrightMatter Plan system to develop a path for the instruments to take. | Surface matching
Fiducial matching |
| Instrument verification | Instrument verified after registering of patient. User needs to confirm on anatomical landmark.
Same needs to be done after an interval of time. | Instrument is verified after registering to the system. User needs to confirm on anatomical landmark. | Instrument is verified after registering to the system. User needs to confirm on anatomical landmark. | Instrument verified after registering of patient. User needs to confirm on anatomical landmark.
Same needs to be done after an interval of time. |
| Tracker Location | Rigid instruments: handle
Flexible instruments: tip | Rigid instruments: handle
Flexible instruments: tip | Tip Tracking possible after calibrating the device to the navigation system. | Rigid instruments: handle
Flexible instruments: tip |
| Mean bench accuracy as Target Registration Error (TRE) and Angular registration | Position Mean: