(149 days)
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.
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.
The provided text describes the TruDi™ Navigation System V2 and its testing to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides "Location Accuracy" and "Simulated Use Location Accuracy" as key performance metrics. It compares these against predicate devices.
| Metric | Acceptance Criteria (Implicit from Predicate/Testing) | Reported Device Performance (TruDi™ Navigation System V2) |
|---|---|---|
| Bench Location Accuracy | Similar to or better than predicate devices (e.g., 0.9 mm, 0.55 mm) | 0.55 mm (standard Deviation 0.7 mm) |
| Simulated Use Location Accuracy | Similar to or better than predicate devices (e.g., 1.79 mm, 0.63 mm) | 1.1 mm (Standard deviation 0.2 mm) |
| System Accuracy | Within 2 mm | Within 2 mm |
| Instrument Angular Accuracy | Within 6° | Within 6° |
| Location Update Rate | Similar to predicate (e.g., 15-45Hz, 10Hz) | 10Hz |
| Hardware Modules Performance | Within specifications | Verified |
| Software Functionality | Complete functionality, error handling, usability, time performance | Verified |
| Safety, EMC, and Mechanical Compliance | Compliance with relevant standards | Verified |
2. Sample Size Used for the Test Set and the Data Provenance
The document primarily describes non-clinical testing.
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the traditional sense, as the tests were non-clinical bench and cadaver studies. For location accuracy tests, it refers to measurements over the "entire navigation volume." For the simulated use accuracy test, it involved a "complete CT image registration and instrument navigation workflow."
- Data Provenance: Non-clinical (bench testing, software functional tests, cadaver tests). No country of origin is specified for these non-clinical tests, and they are inherently retrospective in that they are performed on the device itself and not on human subjects for clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable, as the ground truth for non-clinical accuracy was established using a "highly accurate robot system" and "pre-clinical (cadaver) tests" mimicking surgical procedures. These methods rely on controlled measurements and simulated environments rather than expert consensus on clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable, as the described tests are non-clinical, controlled laboratory measurements, and cadaver studies, not human subject studies requiring adjudication of clinical outcomes or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was not done. The document states: "Clinical data was not necessary to determine that the subject TruDi™ Clinical Performance Navigation System V2 performs as intended." The device is an image-guided navigation system, not an AI-assisted diagnostic device requiring human reader improvement comparison.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device is a "Navigation System" intended to aid surgeons. Its "standalone" performance (algorithm only) would be its accuracy in localizing instruments relative to image data, which is captured by the "Location Accuracy" and "Simulated Use Accuracy" tests. These tests assess the system's ability to accurately track and display instrument position within a simulated environment without direct human "performance" in the sense of a diagnostic interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests were:
- Location Accuracy: The locations provided by a "highly accurate robot system."
- Simulated Use Accuracy: The actual positions within the simulated CT image registration and instrument navigation workflow.
- System/Angular Accuracy: Controlled measurements against expected values for system and instrument angles.
8. The Sample Size for the Training Set
The document does not describe the use of machine learning or AI models with a "training set" in the context of this 510(k) submission. The TruDi™ Navigation System uses electromagnetic tracking technology and image registration, not a machine learning algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
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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 (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
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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):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Applicant: | Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618, USATel.: 419-233-2611Fax: 949-450-6886 |
| Contact Person: | David LockeManager, Regulatory AffairsAcclarent Inc.Phone: 419-233-2611 |
| Authored by: | Anna GantmanNPD Quality and Regulatory Department ManagerBiosense 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 CFR882.4560) |
| 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 | |
| DeviceDescription/TechnologicalCharacteristics: | The TruDi™ Navigation System V2 is intended to be used duringsurgical procedures in ENT and ENT skull base surgery to supportnavigation of instruments to the targeted anatomy, where reference to arigid anatomical structure can be identified relative to a CT or MRbased model. |
| The TruDi™ Navigation System V2 enables ENT physicians to accesssphenoid, frontal, and maxillary sinuses, as well as the skull base, byusing the systems magnetic tracking technology, which is the sametechnology 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 ComparisonTable 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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| Subject and Predicate Device Comparison Table | ||||
|---|---|---|---|---|
| Attribute | Secondary PredicateDeviceFiagon® NavigationSystem | PrimaryPredicate DeviceAcclarent® ENTNavigationSystem | Subject DeviceTruDi™NavigationSystem V2 | SubstantialEquivalenceRationale |
| 510(k)Number | K162176 | K173628 | K192397 | N/A |
| PhysicalManufacturer | Fiagon GmbH | BiosenseWebster (Israel)Ltd. | BiosenseWebster (Israel)Ltd. | N/A |
| Distributer | Fiagon GmbH | Acclarent Inc. | Acclarent Inc. | N/A |
| Trade Name | Fiagon Navigation System | Acclarent® ENTNavigationSystem | TruDi™NavigationSystem | N/A |
| CommonName | Image guided surgerysystem | Image GuidedSurgery System | Image GuidedSurgery System | Same |
| Class | Class II | Class II | Class II | Same |
| Product Code | PGW | PGW | PGW | Same |
| ClassificationSection | CFR 882.4560 | CFR 882.4560 | CFR 882.4560 | Same |
| Indications forUse (IFU) | The Fiagon NavigationSystem is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneous procedures.The Fiagon NavigationSystem is indicated for anymedical condition in whichthe use of stereotacticsurgery may beappropriate, and wherereference to a rigidanatomical structure in thefield of ENT surgery, suchas the paranasal sinuses,mastoid anatomy, can beidentified. relative to a CTor MR based model of theanatomy.Example proceduresinclude, but are not limited | TheACCLARENT®ENT NavigationSystem isintended for useduring intranasaland paranasalimage-guidednavigationprocedures forpatients who areeligible for sinusprocedures. | The TruDi™NavigationSystem isintended for useduring surgicalprocedures inENT and ENTskull basesurgery tosupportnavigation ofinstruments totargetedanatomy, wherereference to arigid anatomicalstructure can beidentifiedrelative to a CTor MR basedmodel. | The IFU ofthe subjectTruDi™NavigationSystem V2device isaligned withthe IFU of thesecondaryPredicate andis anexpansion ofthe IFU of theprimary |
| to:-ENT Procedures-Transphenoidal accessprocedures-Intranasal procedures-Sinus procedures, such asMaxillary antrostomies,Ethmoidectomies,Sphenoidotomies/Sphenoidexplorations, Turbinateresections, and Frontalsinusotomies-ENT related anterior skullbase procedures | predicate(additionalanatomicalsites). Theexpansions inthe IFU aresupported bythe benchtesting. | |||
| FundamentalScientificTechnology | Electromagnetic location | Electromagneticlocation | Electromagneticlocation | Same |
| Principles ofOperation | Electromagnetictriangulation and Imageregistration. | Electromagnetictriangulation andImageregistration. | Electromagnetictriangulationand Imageregistration. | Same |
| TechnologicalCharacteristics | Radiation of low intensityelectromagnetic field.Acquisition of magneticsensor induced voltages.Electromagnetic locationin reference to registeredCT/MR background ofpatient head. | Radiation of lowintensityelectromagneticfield. Acquisitionof magneticsensor inducedvoltages.Electromagneticlocation inreference toregistered CTbackground ofpatient head. | Radiation of lowintensityelectromagneticfield.Acquisition ofmagnetic sensorinducedvoltages.Electromagneticlocation inreference toregisteredCT/MRbackground ofpatient head. | Thetechnologicalcharacteristicshave beentested throughthe non-clinicaltesting andthey do notimpactsubstantialequivalence.Thedifferences donot raise anynew concerns. |
| ControlMechanism | Software controlled | Softwarecontrolled | Softwarecontrolled | Same |
| Single PatientUse | No | No | No | Same |
| Reusable | Yes | Yes | Yes | Same |
| BenchLocationAccuracy | 0.9 mm (Standarddeviation 0.34 mm) | 0.55mm(standardDeviation 0.7mm) | 0.55mm(standardDeviation 0.7mm) | The benchlocationaccuracy hasbeen testedthrough the |
| non-clinicaltesting andthedifferences donot impactsubstantialequivalence,nor do theyraise any newconcerns. | ||||
| Simulated UseLocationAccuracy | 1.79 mm (Standarddeviation 0.4 mm) | 0.63 mm(Standarddeviation 0.2mm) | 1.1 mm(Standarddeviation 0.2mm) | The simulateduse locationaccuracy hasbeen testedthrough thenon-clinicaltesting andthedifferences donot impactsubstantialequivalence,nor do theyraise any newconcerns. |
| Main Feature | Displays the instrumentsposition in relation topreoperative scans utilizingelectromagnetic trackingtechnology. | Displays theinstrumentsposition inrelation topreoperativescans utilizingelectromagnetictrackingtechnology. | Displays theinstrumentsposition inrelation topreoperativescans utilizingelectromagnetictrackingtechnology. | Same |
| Intended Use | Intended as an aid forprecisely locatinganatomical structures ineither open orpercutaneous procedures. | Intended as anaid for preciselylocatinganatomicalstructures in ENTprocedures. | Intended as anaid for preciselylocatinganatomicalstructures inENT and ENTskull baseprocedures. | Minordifferences* |
| LocationUpdate Rate | 15 to 45Hz | 10Hz | 10Hz | The locationupdate ratehas beentested throughthe non-clinical |
| testing andthedifferences donot impactsubstantialequivalence,nor do theyraise any newconcerns. | ||||
| MainComponents | 1. Navigation unit withnavigation software withinterface to screen mouseand items 2-4.2. Head rest with fieldgenerator3. Navigation instrument4. Patient referencelocalizer (with fixationmaterial) | 1. Navigationunit withnavigationsoftware, withinterface to 2-72. Field Ring3. Patient tracker4. RegistrationProbe5. InstrumentHub6. IsolationTransformer7. Mouse andKeyboard | 1. Navigationunit withnavigationsoftware, withinterface to 2-72. Emitter Pad3. Patienttracker4. RegistrationProbe5. InstrumentHub6. IsolationTransformer7. Mouse andKeyboard | Minordifferences* |
| SupportedNavigationInstruments | Flexible tip instrumentswith magnetic sensor oninstrument tip | Flexible tipinstruments withmagnetic sensoron instrument tip | Flexible tipinstruments withmagnetic sensoron instrumenttip | Same |
| RegistrationTools | Registration pointer | Registrationprobe, manualacquisition ofanatomic pointsand surfaces | Registrationpointer | Minordifferences* |
| SupportedPreoperativeImages | DICOM CT, CBCT, MR | DICOM CT | DICOM CT,MR | Minordifferences* |
| SupportedImport Media | CD-ROM, USB flashdrive, LAN network | USB flash driveand CD/DVDMedia | CD-ROM, USBflash drive,LAN network | Theadditionalsupportedimport media(LANnetwork) doesnot raise newconcern(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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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:
-
- Proof of Design electrical tests, to verify all hardware modules perform within specifications.
-
- 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.
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- Software functional tests, covering the complete system functionality, and including error handling, usability and time performance (latency).
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- Safety, EMC, and mechanical tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices.
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- 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.
§ 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).