FlexPointer 1.5 mm

K150473 · Fiagon GmbH · PGW · Apr 16, 2015 · Neurology

Device Facts

• Record ID: K150473
• Device Name: FlexPointer 1.5 mm
• Applicant: Fiagon GmbH
• Product Code: PGW · Neurology
• Decision Date: Apr 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

The FlexPointer 1.5 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.

Device Story

FlexPointer 1.5 is a reusable, malleable, electromagnetically navigated pointing instrument; used with Fiagon Navigation system. Device contains integrated sensor at tip; tracked within low-energy magnetic field generated by system. Navigation software maps instrument position onto preoperative CT/MRI/fluoroscopy scans. Used in ENT/skull base surgery; operated by surgeons to precisely locate anatomical structures. Provides real-time visual feedback on navigation display; assists in surgical guidance; improves accuracy during complex sinus/intranasal procedures.

Clinical Evidence

Bench testing only. Mean accuracy of 1.1 mm (SD 0.27 mm) with 95% confidence levels < 2 mm, demonstrating equivalence to predicate performance metrics.

Technological Characteristics

Malleable surgical instrument with integrated electromagnetic tracking sensor at tip. Pre-calibrated. Compatible with Fiagon Navigation system electromagnetic field generator. Reusable.

Indications for Use

Indicated for patients requiring stereotactic surgery in ENT procedures (e.g., paranasal sinus, mastoid, anterior skull base) where anatomical structures can be referenced to CT or MR models. Used for open or percutaneous procedures.

Regulatory Classification

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.

Predicate Devices

• Fiagon Navigation System Component FlexPointer and FinePointer (K133573)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 16, 2015

Fiagon GmbH Dr. Dirk Mucha Manager, Regulatory Affairs Neuendorfstrasse 23b Hennigsdorf, Germany 16761

Re: K150473

Trade/Device Name: Fiagon FlexPointer 1.5mm Regulation Number: 21 CFR 882.4560 Regulation Name: Ear. Nose, and Throat Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 11, 2015 Received: March 17, 2015

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 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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 - FlexPointer 1.5

Indications for Use:

The FlexPointer 1.5 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.

Prescription Use X Over-The-Counter-Use And / Or (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

# January 30, 2015

#### Submitter Information/ 510(k) Holder 1.

| <b>Submitter:</b><br><b>Address:</b> | Fiagon GmbH<br>Neuendorfstrasse 23b<br>16761 Hennigsdorf, Germany |
|--------------------------------------|-------------------------------------------------------------------|
| <b>Telephone:</b> | [phone] |
| <b>Telefax:</b> | [phone] |
| <b>Contact:</b> | Mr. Dirk Mucha, Manager Regulatory Affairs |

#### 2. Device Information

| Trade Name: | Fiagon Navigation – FlexPointer 1.5 |
|-----------------|----------------------------------------------|
| 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 geometrically modified instrument for the Image Guided Surgery System, Fiagon Navigation system (K133573).

#### Predicate Device Information 4.

The device described in this submission is substantially equivalent to the following comparable unmodified devices:

| | Predicate Device / legally marketed device | Manufacturer | 510(k) No. |
|---|-------------------------------------------------------------------|--------------|------------|
| 1 | Fiagon Navigation System Component<br>FlexPointer and FinePointer | Fiagon GmbH | K133573 |

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#### 5. Device Description

The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is

- a. Navigated pointing devices (maleable, sensor within the tip)
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)

#### 6. Intended Use

The FlexPointer 1.5 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 substantial equivalence of the FlexPointer 1.5 to the unmodified devices FlexPointer and finePointer is shown by similarity in intended use, indications for use, materials, and performance. All devices utilize:

- · Electromagnetic tracking technology for navigation included in surgical instruments
- · Malleable s instruments enabled for image guidance (FlexPointer and FlexPpointer 1.5)
- · Instruments with tracking sensor at the instrument tip, precalibrated

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The primary difference between the unmodified devices and the new device is geometrical change of the outer construction of the device (diameter and length). This different does not raise new issues of safety and effectiveness.

#### 8. Performance Data

Testing was performed in order to determine device precision and accuracy. The following nonclinical tests were performed to determine substantial equivalence:

A mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm) was measured for the new device. All 95% confidence levels were < 2mm which compares to the values 0.9 mm and 1.2 mm (mean) resp. < 2 mm (95% confidence) reported for the unmodified devices.

The results supports the claim of substantial equivalence to the unmodified devices.

Testing was completed to ensure functionality and compatibility with the Fiagon Navigation system.

#### 9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the FlexPointer 1.5 has been shown to be substantially equivalent to the comparable devices FlexPointer and FinePointer, and does not present any new issues of safety or effectiveness.