TruDi Navigation System

K192397 · Biosense Webster · PGW · Jan 30, 2020 · Neurology

Device Facts

• Record ID: K192397
• Device Name: TruDi Navigation System
• Applicant: Biosense Webster
• Product Code: PGW · Neurology
• Decision Date: Jan 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The TruDi™ Navigation System is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to rigid anatomic structure can be identified relative to a CT or MR based model.

Device Story

TruDi Navigation System V2 is an image-guided surgery system for ENT and skull base procedures. It uses electromagnetic tracking to navigate instruments relative to pre-acquired CT or MR images. The system consists of a navigation console, emitter pad, instrument hub, patient tracker, registration probe, and workstation. A magnetic field generated by the emitter pad induces current in a sensor at the tip of a flexible navigated tool, allowing real-time calculation of the tool's position. A patient tracker fixed to the forehead compensates for head movement. The system displays a tool-tip icon over the registered patient anatomy on a screen. Used by ENT physicians in surgical settings, the device assists in instrument positioning, potentially improving surgical accuracy and patient outcomes. It operates via software-controlled electromagnetic triangulation and image registration.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing: proof of design electrical tests, location accuracy tests (compared to robot system), software functional tests, safety/EMC/mechanical testing, simulated use accuracy tests, and pre-clinical cadaver testing. System accuracy confirmed within 2mm; angular accuracy within 6°.

Technological Characteristics

Electromagnetic tracking system; components include navigation console, emitter pad, instrument hub, patient tracker, registration probe. Connectivity via LAN, USB, CD-ROM. Software-controlled. Electromagnetic field generation and sensor-induced voltage acquisition. Non-sterile, reusable components.

Indications for Use

Indicated for patients undergoing ENT and ENT skull base surgical procedures requiring navigation of instruments to targeted anatomy relative to CT or MR models.

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

• Acclarent® ENT Navigation System (K173628)
• Fiagon Navigation System (K162176)

Submission Summary (Full Text)

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January 30, 2020

Biosense Webster David Locke Manager, Regulatory Affairs Acclarent Inc. 33 Technology Drive Irvine, California 92618

Re: K192397

Trade/Device Name: TruDi Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: December 31, 2019 Received: January 2, 2020

Dear David Locke:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192397

Device Name TruDi™ Navigation System (Version 2.0)

Indications for Use (Describe)

The TruDi™ Navigation System is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to rigid anatomic structure can be identified relative to a CT or MR based model.

Type of Use (Select one or both, as applicable):

| | <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Image /page/3/Picture/0 description: The image features the Acclarent logo, with the word "Acclarent" in a stylized font, the latter part of the word in purple. Above the word is a curved line, also in purple. Below the logo is the text "TruDi™ Navigation System V2". The text is in a simple, sans-serif font.

## 510(k) Summary

| [807.92(a)(1)] Submitter Information | |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Biosense Webster, Inc.<br>31 Technology Drive, Suite 200<br>Irvine, CA 92618, USA<br>Tel.: [phone]<br>Fax: [phone] |
| Contact Person: | David Locke<br>Manager, Regulatory Affairs<br>Acclarent Inc.<br>Phone: [phone] |
| Authored by: | Anna Gantman<br>NPD Quality and Regulatory Department Manager<br>Biosense Webster (Israel), Ltd.<br>[phone] |
| Date Summary Prepared:<br>January 30, 2020 | |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | TruDi™ Navigation System |
| Device Common Name: | Image Guided Surgery System |
| Device Classification: | Class II, 21 CFR 882.4560 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument (21 CFR<br>882.4560) |
| Product Code | PGW |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Devices: | Primary: Acclarent® ENT Navigation System (K173628)<br>Secondary: Fiagon Navigation System (K162176) |
| [807.92(a)(4)] Device Description | |
| Device<br>Description/Technological<br>Characteristics: | The TruDi™ Navigation System V2 is intended to be used during<br>surgical procedures in ENT and ENT skull base surgery to support<br>navigation of instruments to the targeted anatomy, where reference to a<br>rigid anatomical structure can be identified relative to a CT or MR<br>based model. |
| | The TruDi™ Navigation System V2 enables ENT physicians to access<br>sphenoid, frontal, and maxillary sinuses, as well as the skull base, by<br>using the systems magnetic tracking technology, which is the same<br>technology used by both of the predicate devices. |
| | The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, and Holder, Workstation and accessories. A magnetic field generated by the Emitter Ring (Field Ring) induces a current in the magnetic sensor embedded in the tip of the flexible navigated tool, which helps to accurately calculate the tool tip position. A CT image is imported and registered to the patient coordinates and a tool tip icon is displayed on top of the registered image, indicating the position of the tool in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the navigation procedure. |
| [807.92(a)(5)] Intended Use | |
| Indications for Use: | The TruDi™ Navigation System is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to rigid anatomic structure can be identified relative to a CT or MR based model. |
| Predicate Comparison | |
| Predicate Comparison<br>Table and Overview: | The substantial equivalence of the TruDi™ Navigation System V2 to the predicate devices is shown by similarity in intended use, indications for use, and performance.<br><br>Like the predicate devices, the TruDi™ Navigation System V2 is an image-guided navigation system designed for use during ENT and ENT skull base surgical procedures. ENT physicians can track and display the real-time location of the tip of navigated instruments relative to pre-acquired CT/MR images. Additionally, like the predicate devices, the subject system utilizes electromagnetic tracking technology for navigation, uses anatomical reference points on the patient's anatomy for intraoperative registration to the image-based model of the anatomy, and uses CT/MR image sets as reference images for the image-based model. The predicate ENT Navigation systems support substantial equivalence and the differences between the subject device and the predicate devices do not raise any new questions with respect to safety and effectiveness. The table below provides a comparison of the technological characteristics between the subject device and the predicate devices. |

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Image /page/5/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the last part in purple. There is a purple curved line above the last part of the word, and a trademark symbol is visible.

| Subject and Predicate Device Comparison Table | | | | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Secondary Predicate<br>Device<br>Fiagon® Navigation<br>System | Primary<br>Predicate Device<br>Acclarent® ENT<br>Navigation<br>System | Subject Device<br>TruDi™<br>Navigation<br>System V2 | Substantial<br>Equivalence<br>Rationale |
| 510(k)<br>Number | K162176 | K173628 | K192397 | N/A |
| Physical<br>Manufacturer | Fiagon GmbH | Biosense<br>Webster (Israel)<br>Ltd. | Biosense<br>Webster (Israel)<br>Ltd. | N/A |
| Distributer | Fiagon GmbH | Acclarent Inc. | Acclarent Inc. | N/A |
| Trade Name | Fiagon Navigation System | Acclarent® ENT<br>Navigation<br>System | TruDi™<br>Navigation<br>System | N/A |
| Common<br>Name | Image guided surgery<br>system | Image Guided<br>Surgery System | Image Guided<br>Surgery System | Same |
| Class | Class II | Class II | Class II | Same |
| Product Code | PGW | PGW | PGW | Same |
| Classification<br>Section | CFR 882.4560 | CFR 882.4560 | CFR 882.4560 | Same |
| Indications for<br>Use (IFU) | The Fiagon Navigation<br>System is intended as an<br>aid for precisely locating<br>anatomical structures in<br>either open or<br>percutaneous procedures.<br>The Fiagon Navigation<br>System is indicated for any<br>medical condition in which<br>the use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure in the<br>field of ENT surgery, such<br>as the paranasal sinuses,<br>mastoid anatomy, can be<br>identified. relative to a CT<br>or MR based model of the<br>anatomy.<br>Example procedures<br>include, but are not limited | The<br>ACCLARENT®<br>ENT Navigation<br>System is<br>intended for use<br>during intranasal<br>and paranasal<br>image-guided<br>navigation<br>procedures for<br>patients who are<br>eligible for sinus<br>procedures. | The TruDi™<br>Navigation<br>System is<br>intended for use<br>during surgical<br>procedures in<br>ENT and ENT<br>skull base<br>surgery to<br>support<br>navigation of<br>instruments to<br>targeted<br>anatomy, where<br>reference to a<br>rigid anatomical<br>structure can be<br>identified<br>relative to a CT<br>or MR based<br>model. | The IFU of<br>the subject<br>TruDi™<br>Navigation<br>System V2<br>device is<br>aligned with<br>the IFU of the<br>secondary<br>Predicate and<br>is an<br>expansion of<br>the IFU of the<br>primary<br> |
| | to:<br>-ENT Procedures<br>-Transphenoidal access<br>procedures<br>-Intranasal procedures<br>-Sinus procedures, such as<br>Maxillary antrostomies,<br>Ethmoidectomies,<br>Sphenoidotomies/Sphenoid<br>explorations, Turbinate<br>resections, and Frontal<br>sinusotomies<br>-ENT related anterior skull<br>base procedures | | | predicate<br>(additional<br>anatomical<br>sites). The<br>expansions in<br>the IFU are<br>supported by<br>the bench<br>testing. |
| Fundamental<br>Scientific<br>Technology | Electromagnetic location | Electromagnetic<br>location | Electromagnetic<br>location | Same |
| Principles of<br>Operation | Electromagnetic<br>triangulation and Image<br>registration. | Electromagnetic<br>triangulation and<br>Image<br>registration. | Electromagnetic<br>triangulation<br>and Image<br>registration. | Same |
| Technological<br>Characteristics | Radiation of low intensity<br>electromagnetic field.<br>Acquisition of magnetic<br>sensor induced voltages.<br>Electromagnetic location<br>in reference to registered<br>CT/MR background of<br>patient head. | Radiation of low<br>intensity<br>electromagnetic<br>field. Acquisition<br>of magnetic<br>sensor induced<br>voltages.<br>Electromagnetic<br>location in<br>reference to<br>registered CT<br>background of<br>patient head. | Radiation of low<br>intensity<br>electromagnetic<br>field.<br>Acquisition of<br>magnetic sensor<br>induced<br>voltages.<br>Electromagnetic<br>location in<br>reference to<br>registered<br>CT/MR<br>background of<br>patient head. | The<br>technological<br>characteristics<br>have been<br>tested through<br>the non-<br>clinical<br>testing and<br>they do not<br>impact<br>substantial<br>equivalence.<br>The<br>differences do<br>not raise any<br>new concerns. |
| Control<br>Mechanism | Software controlled | Software<br>controlled | Software<br>controlled | Same |
| Single Patient<br>Use | No | No | No | Same |
| Reusable | Yes | Yes | Yes | Same |
| Bench<br>Location<br>Accuracy | 0.9 mm (Standard<br>deviation 0.34 mm) | 0.55mm<br>(standard<br>Deviation 0.7<br>mm) | 0.55mm<br>(standard<br>Deviation 0.7<br>mm) | The bench<br>location<br>accuracy has<br>been tested<br>through the |
| | | | | non-clinical<br>testing and<br>the<br>differences do<br>not impact<br>substantial<br>equivalence,<br>nor do they<br>raise any new<br>concerns. |
| Simulated Use<br>Location<br>Accuracy | 1.79 mm (Standard<br>deviation 0.4 mm) | 0.63 mm<br>(Standard<br>deviation 0.2<br>mm) | 1.1 mm<br>(Standard<br>deviation 0.2<br>mm) | The simulated<br>use location<br>accuracy has<br>been tested<br>through the<br>non-clinical<br>testing and<br>the<br>differences do<br>not impact<br>substantial<br>equivalence,<br>nor do they<br>raise any new<br>concerns. |
| Main Feature | Displays the instruments<br>position in relation to<br>preoperative scans utilizing<br>electromagnetic tracking<br>technology. | Displays the<br>instruments<br>position in<br>relation to<br>preoperative<br>scans utilizing<br>electromagnetic<br>tracking<br>technology. | Displays the<br>instruments<br>position in<br>relation to<br>preoperative<br>scans utilizing<br>electromagnetic<br>tracking<br>technology. | Same |
| Intended Use | Intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or<br>percutaneous procedures. | Intended as an<br>aid for precisely<br>locating<br>anatomical<br>structures in ENT<br>procedures. | Intended as an<br>aid for precisely<br>locating<br>anatomical<br>structures in<br>ENT and ENT<br>skull base<br>procedures. | Minor<br>differences* |
| Location<br>Update Rate | 15 to 45Hz | 10Hz | 10Hz | The location<br>update rate<br>has been<br>tested through<br>the non-<br>clinical |
| | | | | testing and<br>the<br>differences do<br>not impact<br>substantial<br>equivalence,<br>nor do they<br>raise any new<br>concerns. |
| Main<br>Components | 1. Navigation unit with<br>navigation software with<br>interface to screen mouse<br>and items 2-4.<br>2. Head rest with field<br>generator<br>3. Navigation instrument<br>4. Patient reference<br>localizer (with fixation<br>material) | 1. Navigation<br>unit with<br>navigation<br>software, with<br>interface to 2-7<br>2. Field Ring<br>3. Patient tracker<br>4. Registration<br>Probe<br>5. Instrument<br>Hub<br>6. Isolation<br>Transformer<br>7. Mouse and<br>Keyboard | 1. Navigation<br>unit with<br>navigation<br>software, with<br>interface to 2-7<br>2. Emitter Pad<br>3. Patient<br>tracker<br>4. Registration<br>Probe<br>5. Instrument<br>Hub<br>6. Isolation<br>Transformer<br>7. Mouse and<br>Keyboard | Minor<br>differences* |
| Supported<br>Navigation<br>Instruments | Flexible tip instruments<br>with magnetic sensor on<br>instrument tip | Flexible tip<br>instruments with<br>magnetic sensor<br>on instrument tip | Flexible tip<br>instruments with<br>magnetic sensor<br>on instrument<br>tip | Same |
| Registration<br>Tools | Registration pointer | Registration<br>probe, manual<br>acquisition of<br>anatomic points<br>and surfaces | Registration<br>pointer | Minor<br>differences* |
| Supported<br>Preoperative<br>Images | DICOM CT, CBCT, MR | DICOM CT | DICOM CT,<br>MR | Minor<br>differences* |
| Supported<br>Import Media | CD-ROM, USB flash<br>drive, LAN network…