(73 days)
Not Found
No
The description focuses on electromagnetic navigation and displaying instrument position on pre-operative scans, with no mention of AI or ML for image analysis, decision support, or other functions.
No
This device is an aid for precisely locating anatomical structures during surgery, not a device that directly treats a medical condition.
No
The device is described as an aid for precisely locating anatomical structures during surgical procedures, not for diagnosing medical conditions. It uses pre-operative scans (CT, MRI) to guide surgical instruments, which is a therapeutic/surgical aid function, not a diagnostic one.
No
The device description explicitly states that the device "incorporates a sensor" and is a "10 time use instrument," indicating it is a physical hardware component, not solely software.
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 diagnostic or monitoring purposes.
- Device Function: The Fiagon Navigation - PointerTube Straight and PointerTube Keat are instruments used during surgical procedures to help precisely locate anatomical structures based on pre-operative imaging. They are part of a navigation system that tracks their position in real-time relative to the patient's anatomy.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. Its function is entirely focused on spatial navigation within the body during surgery.
Therefore, the intended use and function of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are with the Fiagon Navigation system using electromagnetic navigation.
The instruments are 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 - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.
Each device incorporates a sensor, which is tracked by the navigation system within the lowenergy 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 based model of the anatomy, fluoroscopy
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 confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified instrument does not alter the performance characteristics of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Fiagon Gmbh % Ms. Yarmela Pavlovic Regulatory Counsel Hogan Lovells US LLP 3 Embarcadero Center, Ste. 1500 San Francisco, CA 94111
Re: K163416
Trade/Device Name: Fiagon Navigation - Pointertube Straight And Pointertube Keat Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: January 18, 2017 Received: January 18, 2017
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.
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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 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
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Indications for Use
510(k) Number (if known)
Device Name
Fiagon Navigation - PointerTube Straight and PointerTube Keat
Indications for Use (Describe) Indications for Use (Describe)
The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are with the Fiagon Navigation system using electromagnetic navigation.
The instruments are 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
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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SECTION 5 - 510(K) SUMMARY
510(k) Summary
December 5, 2016
1. Submitter Information/ 510(k) Holder
| Submitter: | Fiagon GmbH |
|---|---|
| Address: | Neuendorfstrasse 23b |
| 16761 Hennigsdorf, Germany |
| Telephone: | +49 3302 201 21 10 |
|---|---|
| Telefax: | +49 3302 201 21 15 |
Mr. Dirk Mucha, CTO Contact:
2. Device Information
| Trade Name: | Fiagon Navigation – PointerTube Straight and PointerTube Kea |
|---|---|
| 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 modified versions of two previously cleared instruments, Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456). The modified version of the PointerTube Straight has modified olive leaf-shaped tip with a different inner and outer diameter. The tube length remains identical in this case. The Sinus Frontalis has been modified in instrument length as well as diameter to a new instrument - the PointerTube Keat.
4. Predicate Device Information
Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456)
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ક. Device Description
The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.
Each device incorporates a sensor, which is tracked by the navigation system within the lowenergy 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 Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.
The instruments are indicated for any medical condition in which the use of stereotactic surgerv 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
Comparison of Technological Characteristics 7.
The PointerTube Straight and the PointerTube Keat are modified versions of previously cleared PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456) respectively. The reason for this Special 510(k) is to describe changes in the diameter and shape of the tip for the PointerTube Straight and change of diameter, length and tip for the PointerTube Keat. These changes do not raise new issues of safety and effectiveness of the instruments.
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8. Performance Data
Testing was performed in order to confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified 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 PointerTube Straight and the PointerTube Keat have been shown to be substantially equivalent to the predicate PointerTube Straight and the PointerTube Sinus Frontalis, respectively, and do not present any new issues of safety or effectiveness.