(66 days)
Not Found
No
The summary describes a navigation system that tracks a physical instrument using electromagnetic fields and displays its position on pre-operative scans. There is no mention of AI or ML being used for image analysis, navigation algorithms, or any other function. The technology described is standard electromagnetic navigation.
No.
This device is described as an aid for precisely locating anatomical structures and a pointing device for navigation during procedures. It does not exert a therapeutic effect on the body.
No
The device is described as an aid for precisely locating anatomical structures during surgical procedures, not for identifying a medical condition or disease. It is a navigation tool for surgery, not a diagnostic one.
No
The device description explicitly states it is a "disposable instrument" and an "electromagnetically navigated pointing device (malleable, sensor within the tip)," indicating it is a physical hardware component, not solely software.
No, 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, tissue) to provide information for diagnostic purposes.
- Device Function: The GuideWire 0.6 Single Use is a surgical instrument used within the body during procedures. It's a pointing device that aids in navigation and localization of anatomical structures.
- Intended Use: The intended use clearly states it's for "precisely locating anatomical structures in either open or percutaneous procedures" and is used with a navigation system. This is a surgical guidance tool, not a diagnostic test performed on a specimen.
- No Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
The device is a surgical navigation tool, not an IVD.
N/A
Intended Use / Indications for Use
The GuideWire 0.6 Single Use 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.
It 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing device (malleable, sensor within the tip).
Each device incorporates a sensor device, which is tracked by the navigation system within 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 or MR
Anatomical Site
rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy
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)
Testing was performed in order to determine device precision and accuracy of the modified device. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system. Also testing was performed to ensure sterilization of the modified disposable instrument does not alter the performance characteristics of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 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 is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an emblem that resembles a stylized bird or eagle, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Fiagon GmbH % Ms. Yarmela Pavlovic Regulatory Consultant Hogan Lovells 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111
Re: K161940
Trade/Device Name: Guidewire 0.6 Single Use Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: August 22, 2016 Received: August 22, 2016
Dear Ms. Pavlovic:
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.
1
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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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 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
2
Indications for Use
510(k) Number (if known)
Device Name GuideWire 0.6 Single Use
Indications for Use (Describe)
The GuideWire 0.6 Single Use 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.
It 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.
| 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
SECTION 5 - 510(K) SUMMARY
510(k) Summary
July 14, 2016
Submitter Information/ 510(k) Holder 1.
| 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, CTO
2. Device Information
| Trade Name: | Fiagon Navigation - GuideWire 0.6 Single Use |
|---|---|
| Common Name: | Image guided surgery system |
| Classification: | Class II per 21 CFR 882.4560 |
| Device: | Ear, Nose, and Throat Stereotaxic Instrument |
| Product Code: | PGW |
Purpose of Submission 3.
The purpose of this submission is to gain clearance for a modified version of the previously cleared instrument, Fiagon Navigation - Guidewire 0.6 (K160369).
Predicate Device Information 4.
Fiagon Navigation - Guidewire 0.6 (K160369)
5. Device Description
The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing device (malleable, sensor within the tip).
4
Each device incorporates a sensor device, which is tracked by the navigation system within 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).
6. Intended Use
The GuideWire 0.6 Single Use 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.
It 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. ENT related anterior skull base procedures.
7. Comparison of Technological Characteristics
The GuideWire 0.6 Single Use is a modified version of the previously cleared GuideWire 0.6 (K160369). The reason for this Special 510(k) is to describe a change in material as well as a change from a reprocessed device to one that is provided sterile and is Single Use and disposable. Sterilization validation tests reports are provided to demonstrate that these differences do not raise new issues of safety and effectiveness.
8. Performance Data
Testing was performed in order to determine device precision and accuracy of the modified device.
5
Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system. Also testing was performed to ensure sterilization of the modified disposable instrument does not alter the performance characteristics of the device.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device does not present any new issues of safety or effectiveness.