(28 days)
No
The description focuses on magnetic tracking technology and image registration, with no mention of AI or ML algorithms for image analysis, navigation, or other functions.
No
The device is a surgical navigation system that assists physicians in guiding instruments to anatomical targets during surgery. It does not directly provide therapy or treatment to the patient.
No
Explanation: The device is described as a surgical navigation system that supports the accurate positioning of instruments during ENT and ENT skull base surgery. It helps guide instruments to targeted anatomy based on prerecorded CT or MR images. It does not diagnose medical conditions; rather, it assists in the surgical treatment of known conditions.
No
The device description explicitly lists multiple hardware components (Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation, peripherals) and describes a magnetic tracking technology involving hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy." This describes a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system that uses magnetic tracking to determine the position of surgical instruments relative to patient anatomy based on pre-operative imaging (CT or MR). This is consistent with a surgical navigation system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
Therefore, the TruDi® Navigation system falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
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 a rigid anatomical structure can be identified relative to a CT or MR based model.
Product codes
PGW
Device Description
The TruDi® Navigation System V3 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 V3 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 the predicate device.
The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
ENT and ENT skull base
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ENT physicians / surgical procedures
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:
- Location Accuracy tests, where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system over its entire navigation volume
- Software functional tests, covering the complete system functionality, and including error handling, usability and time performance (latency).
- Safety, and EMC tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices.
- 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.
The proposed TruDi® Navigation System V3 passed all tests in accordance with specified test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Clinical performance data: Clinical data was not necessary to determine that the subject TruDi® Navigation System V3 performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench Location Accuracy: 0.55 (STD 0.2)
Simulated Use Location Accuracy: 1.2 mm (Standard deviation 0.2mm)
Predicate Device(s)
TruDi® Navigation System V2 (K192397)
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).
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July 21, 2023
Acclarent, Inc. % Dikla Dayan Regulatory Affairs Manager Biosense Webster (Israel) Ltd. 4 Hatnufa St Yokneam, 2066717 Israel
Re: K231862
Trade/Device Name: TruDi® Navigation System V3 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: June 23, 2023 Received: June 23, 2023
Dear Dikla Dayan:
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.
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
1
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 (OS) 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 mediation-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,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT 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) K231862
Device Name TruDi® Navigation System V3
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 a rigid anatomical structure can be identified relative to a CT or MR based model.
| Type of Use (Select one or both, as applicable) | Registration Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) | Registration Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Registration Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
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 shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a combination of black and purple font, with a purple arc above the "ent" portion of the name. Below the name, in smaller font, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES".
Acclarent, Inc 31 Technology Drive
Main 650.687.5888 Fax 650.687.5889 www.acclarent.com
510(k) Summary - K231862
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Applicant: | Biosense Webster, Inc. |
| 31 Technology Drive, Suite200 | |
| Irvine, CA 92618, USA | |
| Tel.: 419-233-2611 | |
| Fax: 949-450-6886 | |
| Contact person: | Kamrie Sarnosky |
| Senior Regulatory Specialist | |
| Acclarent, Inc. | |
| Authored by: | Dikla Dayan |
| RA Manager | |
| Biosense Webster (Israel) Ltd | |
| Date summary prepared: | June 23, 2023 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name | TruDi® Navigation System V3 |
| Device Common Name | Image Guided Surgery System |
| Device Classification | Class II, 21 CFR 882.4560 |
| Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 882.4560) | |
| Product Code | PGW |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | TruDi® Navigation System V2 (K192397) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The TruDi® Navigation System V3 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 V3 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 the predicate device. | |
| The system incorporates a Navigation Console, Emitter Pad, Instrument | |
| Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A | |
| magnetic field generated by the Emitter Pad induces a current in the | |
| magnetic sensor embedded in the tip of the navigated tool, which helps to | |
| accurately calculate the tool tip position. A CT or MR image is imported | |
| and registered to the patient coordinates and the navigated tool tip icon is | |
| displayed on top of the registered image, indicating the position of the tool | |
| tip in reference to the patient anatomy. A Patient Tracker is fixed to the | |
| patient forehead to compensate for the head movement during the surgical | |
| procedure. | |
| [807.92(a)(5)] Intended Use | |
| Intended use | The TruDi® Navigation System V3 is intended for use during surgical |
| procedures in ENT and skull based 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. | |
| Difference in Indications | |
| from Predicate Device: | There is no difference in intended use between the subject device and |
| predicate device. | |
| [807.92(a)(6)] Technical Characteristics | |
| Predicate overview and | |
| comparison table: | The substantial equivalence of the TruDi® Navigation System V3 to the |
| predicate is shown by similarity in intended use, indications for use, | |
| technology, and performance. | |
| The TruDi® Navigation System V3 is an image-guided navigation system | |
| designed for use during ENT and skull based 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. Like the | |
| predicate device, the subject system utilizes electromagnetic tracking | |
| technology for navigation, uses anatomical reference points on the patient | |
| 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 table below provides a comparison of the technological | |
| characteristics between the subject device and the predicate device. |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the first part of the word in black and the "ent" in purple. Above the purple part of the word is a purple arc. Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
| Attributes | PREDICATE DEVICE:
TRUDI NAVIGATION SYSTEM V 2.0 | SUBJECT DEVICE:
TRUDI NAVIGATION SYSTEM V 3.0 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific
Technology | Electromagnetic location | 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 | Same |
| Technology | Software embedded device | Same |
| Platform | PC Based | Same |
| Operating System | Windows 10 (64 bits) | Same |
| Programming Languages | Visual C++, C# and C, MATLAB, HTML | Same |
| Accuracy specification | 2mm RMS | Same |
| Bench Location Accuracy | 0.55mm (standard Deviation 0.7 mm) | 0.55 (STD 0.2) |
| Simulated Use Location
Accuracy | 1.1 mm (Standard deviation 0.2 mm) | 1.2 mm (Standard deviation 0.2mm) |
| Attributes | PREDICATE DEVICE:
TRUDI NAVIGATION SYSTEM V 2.0 | SUBJECT DEVICE:
TRUDI NAVIGATION SYSTEM V 3.0 |
| Main Feature | Displays the instruments position in relation to
preoperative scans utilizing electromagnetic
tracking technology. | Same |
| Location Update Rate | 10Hz | Same |
| Supported Navigation
Instruments | Flexible and Rigid instruments with magnetic
sensor on instrument tip | Same |
| Supported Preoperative
Images | DICOM CT, MR | Same |
| Supported CT/MR Import
Media | CD-ROM, USB flash drive, LAN network
(PACs) | Same |
| Patient Data Archiving | Not supported | Supported in local disk, flash memory
and hospital network PACS (new
Software Function) |
| Packaging | Provided non-sterile | Same |
| HW Main components | | |
| Instrument Hub | Enables the user to connect components and
navigated tool to the system | Added connection flexibility.
Verification testing has demonstrated
that this change does not raise new
questions on the safety and
effectiveness of the device. |
| Workstation | Dell 5810 or Dell5820
Enables data processing | Same |
| Mouse and Keyboard | Standard mouse and keyboarded | Add touchpad mouse |
| Console | Drives the magnetic signals from Emitter Pad to
Workstation | Same |
| Emitter Pad | Generates magnetic field | Same |
| Patient tracker | Compensates on patient movement (reusable or
disposable) | Same |
| Registration Probe | Enables correlation between patient's face and
CT image | Same |
| Isolation Transformer | Adjusting power input to the system | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the first part of the word in black and the last part in purple. Above the purple part of the word is a purple arc. Below the word "Acclarent" is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
Acclarent, Inc 31 Technology in the line
www.acclarent.com
6
Image /page/6/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a combination of black and purple font, with a purple arc above the "ent" portion of the word. Below the logo, the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is written in red and gray.
Acclarent, Inc 31 Technology Drive Irvine, CA 92618 Main 650.687.5888 Fax 650.687.5889 www.acclarent.com
Summary of Technological Patient Data Archive Characteristics ● Note: The Patient Data Archive is a new Software Function, although, being a Medical Device Data System (MDDS), it is not regulated by the FDA. ● Instrument Hub improvement ● Support of additional navigated tools Software enhancements . Segmentation manual editing o Path to Target 3D visualization O ● Cables robustness improvement Optional touchpad mouse ● The TruDi® Navigation System V3 was tested to ensure that it functions in Non-clinical Performance accordance with the system design specifications related to substantial Data: equivalence in terms of device safety and effectiveness. The following non-clinical tests were performed: 1. Location Accuracy tests, where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system over its entire navigation volume 2. Software functional tests, covering the complete system functionality, and including error handling, usability and time performance (latency). 3. Safety, and EMC tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices. 4. 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. The proposed TruDi® Navigation System V3 passed all tests in accordance with specified 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 TruDi® Clinical performance data: Navigation System V3 performs as intended. Conclusion: The modified TruDi® Navigation System V3 is substantially equivalent to the currently cleared TruDi® Navigation System V2 based on the completion of non-clinical bench testing as well as similar principles of design, operation and indications for use.
The subject device has the same technological characteristics as the predicate device, with addition of: