Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on magnetic tracking technology and image registration, with no mention of AI or ML. The performance studies are based on accuracy and functional testing, not AI/ML model performance metrics.

Therapeutic

No
The device is a surgical navigation system designed to support the accurate positioning of instruments during ENT and ENT skull base surgeries. It does not directly provide therapy or treatment to the patient.

Diagnostic

No

The device is a navigation system used during surgery to guide instruments, not to diagnose a medical condition. It supports instrument navigation by referencing CT or MR based models.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Holder, Workstation, accessories) and describes a magnetic tracking technology involving hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the TruDi™ Navigation System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
TruDi™ Function: The TruDi™ Navigation System is used during surgical procedures to guide instruments within the patient's body based on pre-operative imaging (CT or MR). It does not analyze biological specimens.
Intended Use: The intended use clearly states "during surgical procedures" and "to support navigation of instruments to targeted anatomy." This is an in-vivo application, not in-vitro.
Device Description: The description details how the system tracks the position of instruments within the patient's body using magnetic technology and registered imaging. This is consistent with surgical navigation, not diagnostic testing of specimens.

Therefore, the TruDi™ Navigation System falls under the category of a surgical navigation system, which is a type of medical device used in vivo (within the living body) during surgery, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

PGW

Device Description

The TruDi™ Navigation System V2 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
The TruDi™ Navigation System V2 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT or MR based model, DICOM CT, MR

Anatomical Site

ENT and ENT skull base, ENT anatomy including skull base, ENT 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)

Non-clinical Performance Data:
The TruDi™ Navigation System V2 was tested to ensure that it functions in accordance with the system design specifications related to substantial equivalence in terms of device safety and effectiveness.
The following nonclinical tests were performed:

1. Proof of Design electrical tests, to verify all hardware modules perform within specifications.
1. Location Accuracy tests, where the TruDi™ Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system over the entire navigation volume to verify the system precision claim.
1. Software functional tests, covering the complete system functionality, and including error handling, usability and time performance (latency).
1. Safety, EMC, and mechanical tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices.
1. Simulated use accuracy test, in which a complete CT image registration and instrument navigation workflow was performed to verify the overall accuracy of the system.

Pre-clinical (cadaver) tests were designed to mimic surgical procedures using the TruDi™ Navigation System V2 in a simulated clinical environment to assess the execution of a complete sinuplasty procedure, workflow and to qualitatively estimate the systems clinical accuracy.
System accuracy was tested confirming that it is within 2mm and instrument angular accuracy was tested confirming that it is within 6°.
The Robot system (angular accuracy of 1°) used to validate system accuracy, verifies its real location based on electromagnetic field location. The proposed TruDi™ Navigation System V2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. Clinical data was not necessary to determine that the subject TruDiTM Clinical Performance Navigation System V2 performs as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bench Location Accuracy: 0.55mm (standard Deviation 0.7 mm)
Simulated Use Location Accuracy: 1.1 mm (Standard deviation 0.2 mm)
System accuracy: within 2mm
Instrument angular accuracy: within 6°

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.

K173628, K162176

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

Regulation Number and Section

§ 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).

Summary

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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.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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):

	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
31 Technology Drive, Suite 200
Irvine, CA 92618, USA
Tel.: 419-233-2611
Fax: 949-450-6886
Contact Person:	David Locke
Manager, Regulatory Affairs
Acclarent Inc.
Phone: 419-233-2611
Authored by:	Anna Gantman
NPD Quality and Regulatory Department Manager
Biosense Webster (Israel), Ltd.
+972-52-808-9735
Date Summary Prepared:
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
882.4560)
Product Code	PGW
[807.92(a)(3)] Legally Marketed Devices
Predicate Devices:	Primary: Acclarent® ENT Navigation System (K173628)
Secondary: Fiagon Navigation System (K162176)
[807.92(a)(4)] Device Description
Device
Description/Technological
Characteristics:	The TruDi™ Navigation System V2 is intended to be used during
surgical procedures in ENT and ENT skull base surgery to support
navigation of instruments to the targeted anatomy, where reference to a
rigid anatomical structure can be identified relative to a CT or MR
based model.
	The TruDi™ Navigation System V2 enables ENT physicians to access
sphenoid, frontal, and maxillary sinuses, as well as the skull base, by
using the systems magnetic tracking technology, which is the same
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
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.

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
Device
Fiagon® Navigation
System	Primary
Predicate Device
Acclarent® ENT
Navigation
System	Subject Device
TruDi™
Navigation
System V2	Substantial
Equivalence
Rationale
510(k)
Number	K162176	K173628	K192397	N/A
Physical
Manufacturer	Fiagon GmbH	Biosense
Webster (Israel)
Ltd.	Biosense
Webster (Israel)
Ltd.	N/A
Distributer	Fiagon GmbH	Acclarent Inc.	Acclarent Inc.	N/A
Trade Name	Fiagon Navigation System	Acclarent® ENT
Navigation
System	TruDi™
Navigation
System	N/A
Common
Name	Image guided surgery
system	Image Guided
Surgery System	Image Guided
Surgery System	Same
Class	Class II	Class II	Class II	Same
Product Code	PGW	PGW	PGW	Same
Classification
Section	CFR 882.4560	CFR 882.4560	CFR 882.4560	Same
Indications for
Use (IFU)	The Fiagon Navigation
System is intended as an
aid for precisely locating
anatomical structures in
either open or
percutaneous procedures.
The Fiagon Navigation
System 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	The
ACCLARENT®
ENT Navigation
System is
intended for use
during intranasal
and paranasal
image-guided
navigation
procedures for
patients who are
eligible for sinus
procedures.	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 a
rigid anatomical
structure can be
identified
relative to a CT
or MR based
model.	The IFU of
the subject
TruDi™
Navigation
System V2
device is
aligned with
the IFU of the
secondary
Predicate and
is an
expansion of
the IFU of the
primary

| | 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 | | | predicate
(additional
anatomical
sites). The
expansions in
the IFU are
supported by
the bench
testing. |
| Fundamental
Scientific
Technology | Electromagnetic location | Electromagnetic
location | Electromagnetic
location | Same |
| Principles of
Operation | Electromagnetic
triangulation and Image
registration. | Electromagnetic
triangulation and
Image
registration. | Electromagnetic
triangulation
and Image
registration. | Same |
| Technological
Characteristics | Radiation of low intensity
electromagnetic field.
Acquisition of magnetic
sensor induced voltages.
Electromagnetic location
in reference to registered
CT/MR background of
patient head. | Radiation of low
intensity
electromagnetic
field. Acquisition
of magnetic
sensor induced
voltages.
Electromagnetic
location in
reference to
registered CT
background of
patient head. | Radiation of low
intensity
electromagnetic
field.
Acquisition of
magnetic sensor
induced
voltages.
Electromagnetic
location in
reference to
registered
CT/MR
background of
patient head. | The
technological
characteristics
have been
tested through
the non-
clinical
testing and
they do not
impact
substantial
equivalence.
The
differences do
not raise any
new concerns. |
| Control
Mechanism | Software controlled | Software
controlled | Software
controlled | Same |
| Single Patient
Use | No | No | No | Same |
| Reusable | Yes | Yes | Yes | Same |
| Bench
Location
Accuracy | 0.9 mm (Standard
deviation 0.34 mm) | 0.55mm
(standard
Deviation 0.7
mm) | 0.55mm
(standard
Deviation 0.7
mm) | The bench
location
accuracy has
been tested
through the |
| | | | | non-clinical
testing and
the
differences do
not impact
substantial
equivalence,
nor do they
raise any new
concerns. |
| Simulated Use
Location
Accuracy | 1.79 mm (Standard
deviation 0.4 mm) | 0.63 mm
(Standard
deviation 0.2
mm) | 1.1 mm
(Standard
deviation 0.2
mm) | The simulated
use location
accuracy has
been tested
through the
non-clinical
testing and
the
differences do
not impact
substantial
equivalence,
nor do they
raise any new
concerns. |
| Main Feature | Displays the instruments
position in relation to
preoperative scans utilizing
electromagnetic tracking
technology. | Displays the
instruments
position in
relation to
preoperative
scans utilizing
electromagnetic
tracking
technology. | Displays the
instruments
position in
relation to
preoperative
scans utilizing
electromagnetic
tracking
technology. | Same |
| Intended Use | Intended as an aid for
precisely locating
anatomical structures in
either open or
percutaneous procedures. | Intended as an
aid for precisely
locating
anatomical
structures in ENT
procedures. | Intended as an
aid for precisely
locating
anatomical
structures in
ENT and ENT
skull base
procedures. | Minor
differences* |
| Location
Update Rate | 15 to 45Hz | 10Hz | 10Hz | The location
update rate
has been
tested through
the non-
clinical |
| | | | | testing and
the
differences do
not impact
substantial
equivalence,
nor do they
raise any new
concerns. |
| Main
Components | 1. Navigation unit with
navigation software with
interface to screen mouse
and items 2-4.
2. Head rest with field
generator
3. Navigation instrument
4. Patient reference
localizer (with fixation
material) | 1. Navigation
unit with
navigation
software, with
interface to 2-7
2. Field Ring
3. Patient tracker
4. Registration
Probe
5. Instrument
Hub
6. Isolation
Transformer
7. Mouse and
Keyboard | 1. Navigation
unit with
navigation
software, with
interface to 2-7
2. Emitter Pad
3. Patient
tracker
4. Registration
Probe
5. Instrument
Hub
6. Isolation
Transformer
7. Mouse and
Keyboard | Minor
differences* |
| Supported
Navigation
Instruments | Flexible tip instruments
with magnetic sensor on
instrument tip | Flexible tip
instruments with
magnetic sensor
on instrument tip | Flexible tip
instruments with
magnetic sensor
on instrument
tip | Same |
| Registration
Tools | Registration pointer | Registration
probe, manual
acquisition of
anatomic points
and surfaces | Registration
pointer | Minor
differences* |
| Supported
Preoperative
Images | DICOM CT, CBCT, MR | DICOM CT | DICOM CT,
MR | Minor
differences* |
| Supported
Import Media | CD-ROM, USB flash
drive, LAN network | USB flash drive
and CD/DVD
Media | CD-ROM, USB
flash drive,
LAN network | The
additional
supported
import media
(LAN
network) does
not raise new
concern
(shown |
| Packaging | Provided, non-sterile | Provided, non-sterile | Provided, non-sterile | through non-clinical testing). Same |
| Accessory Devices Packed with Device | Yes | Yes | Yes | Same |
| Anatomical Site | ENT anatomy including skull base | ENT anatomy | ENT anatomy including ENT skull base | The differences in anatomical sites were shown to be substantially equivalent (through the non-clinical testing) and they do not raise any new concerns. |
| *Minor differences do not impact substantial equivalence and do not raise new concerns with respect to safety and effectiveness. | | | | |

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Image /page/9/Picture/0 description: The image shows the word "Acclarent" in a sans-serif font. The first part of the word, "Accla" is in black, while the "rent" portion is in a purple color. Above the purple "rent" is a curved line, also in purple, that extends from the top of the "r" to the top of the "t".

Non-clinical Performance Data:

The TruDi™ Navigation System V2 was tested to ensure that it functions in accordance with the system design specifications related to substantial equivalence in terms of device safety and effectiveness.

The following nonclinical tests were performed:

1. Proof of Design electrical tests, to verify all hardware modules perform within specifications.
1. Location Accuracy tests, where the TruDi™ Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system over the entire navigation volume to verify the system precision claim.
1. Software functional tests, covering the complete system functionality, and including error handling, usability and time performance (latency).
1. Safety, EMC, and mechanical tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices.
1. Simulated use accuracy test, in which a complete CT image registration and instrument navigation workflow was performed to verify the overall accuracy of the system.

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Image /page/10/Picture/0 description: The image shows the Acclarent logo, which is a company that specializes in ear, nose, and throat (ENT) products. The logo is a combination of the company name and a purple swoosh. Below the logo is the text "TruDi™ Navigation System V2".

Pre-clinical (cadaver) tests were designed to mimic surgical procedures using the TruDi™ Navigation System V2 in a simulated clinical environment to assess the execution of a complete sinuplasty procedure, workflow and to qualitatively estimate the systems clinical accuracy. 7. System accuracy was tested confirming that it is within 2mm and instrument angular accuracy was tested confirming that it is within 6°. 8. The Robot system (angular accuracy of 1°) used to validate system accuracy, verifies its real location based on electromagnetic field location. The proposed TruDi™ Navigation System V2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. Clinical data was not necessary to determine that the subject TruDiTM Clinical Performance Navigation System V2 performs as intended. Data: The modified TruDi™ Navigation System V2 is substantially Conclusion: equivalent to the currently cleared predicate devices based on the completion of non-clinical bench testing as well as similar principles of design, operation and indications for use.