(128 days)
No
The description focuses on electromagnetic tracking and displaying instrument position on pre-operative scans, with no mention of AI or ML for image processing, navigation, or any other function.
No.
The device is described as an aid for precisely locating anatomical structures during surgery and does not directly treat a medical condition.
No.
The device is described as an aid for precisely locating anatomical structures during surgical procedures using pre-operative imaging, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a set of reusable instruments that incorporate a sensor device and are tracked by a navigation system. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Fiagon Navigation – Extended Instrument Set ENT is a surgical navigation system. It is used during a surgical procedure to help the surgeon precisely locate anatomical structures within the patient's body. It uses electromagnetic tracking and pre-operative imaging (CT/MR) to guide the instruments.
- Intended Use: The intended use clearly states it is an "aid for precisely locating anatomical structures in either open or percutaneous procedures" and is used "with the Fiagon Navigation system using electromagnetic navigation." This describes a surgical guidance tool, not a diagnostic test performed on a sample.
The device's function and intended use are entirely focused on assisting in surgical procedures, not on performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access
Product codes
PGW
Device Description
The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are
- Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
- b. Navigated pointing devices (flexible, sensor within the tip)
- c. Registration probe (designed for non.sterile patient registration)
- d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)
Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, fluoroscopy
Anatomical Site
ENT surgery, such as the paranasal sinuses, mastoid anatomy. Example procedures include: Transphenoidal access procedures, Intranasal procedures, Sinus procedures (Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, Frontal sinusotomies), Skull base procedures for ENT access.
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)
Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism.
A mean bench accuracy of 0.7 mm - 1.2 mm (Standard deviation 0.29 mm - 0.42 mm) was measured for the different instrunents. All 95% confidence levels were
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2014
Fiagon GmbH % Dr. Dirk Mucha Manager, Regulatory Affairs Neuendorfstrasse 23b 16761 Hennigsdorf, Germany
Re: K141456
Trade/Device Name: Fiagon Navigation - Extended Instrument Set ENT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 5, 2014 Received: September 10, 2014
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.
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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 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/Resourcesfor You/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,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K141456
Device Name: Fiagon Navigation – Extended Instrument Set ENT
Indications for Use:
The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access
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)
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510(k) Summary
May 28, 2014
1. Submitter Information
| Submitter: | Fiagon GmbH |
|---|---|
| Address: | Neuendorfstrasse 23b |
| 16761 Hennigsdorf, Germany |
| Telephone: | +49 3302 201 21 10 |
|---|---|
| Telefax: | +49 3302 201 21 15 |
Contact: Mr. Dirk Mucha, Manager Regulatory Affairs
Device Information 2.
| Trade Name: | Fiagon Navigation - Extended Instrument Set ENT |
|---|---|
| Common Name: | Image guided surgery system |
| Classification: | Class II per 21 CFR 882.4560 |
| Device: | Ear, Nose, and Throat Stereotaxic Instrument |
| Product Code: | PGW |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new set of instruments for the Image Guided Surgery System, Fiagon Navigation system (K133573).
4. Predicate Device Information
The Fiagon Navigation System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| 1 | Fiagon Navigation System | Fiagon GmbH | K133573 |
| 2 | Malleable Suction™ Instruments | Medtronic | |
| Navigation, Inc. | K133665 | ||
| 3 | Instatrak® | Visualization | |
| Technology, Inc. | K960330 |
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5. Device Description
The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are
- Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
- b. Navigated pointing devices (flexible, sensor within the tip)
- c. Registration probe (designed for non.sterile patient registration)
- d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)
Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
| Components | Grouping | Sterility State | Patient contact |
|---|---|---|---|
| FlexTube 3 mm | Suction and navigation | ||
| Instrument | user sterilized, reusable, delivered in non steril state | limited duration ( |