(106 days)
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 ACCLARENT® ENT Navigation System is intended to be used during intranasal and paranasal surgical procedures to help ENT physicians to track and display the real-time location of the tip of navigated instruments relative to pre-acquired reference images, such as CT.
The ACCLARENT® ENT Navigation System enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology, identical to the predicate device.
The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, Registration Probe, Field Ring and Holder, Workstation and accessories. A magnetic field generated by the 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
The provided document is a 510(k) premarket notification for the Acclarent® ENT Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device (CARTO® ENT Navigation System, K161701) rather than presenting a standalone study with a novel AI model's performance.
Therefore, many of the requested details regarding acceptance criteria, sample sizes for AI model training/testing, expert ground truth establishment, and MRMC studies are not applicable or not explicitly detailed in this type of regulatory submission. This document describes a medical device, not an AI/ML diagnostic or prognostic algorithm.
However, I can extract the relevant information regarding the performance testing that was conducted:
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for an AI model's performance in terms of metrics like sensitivity, specificity, or AUC, as it's a navigation system. Instead, it describes non-clinical tests performed to ensure the system functions according to design specifications and demonstrates safety and effectiveness.
| Acceptance Criterion (Type of Test) | Reported Device Performance / Outcome |
|---|---|
| Proof of Design electrical tests | Verified all hardware modules perform within specifications. |
| Location Accuracy tests | Electromagnetic locations compared to a very accurate robot system over the entire navigation volume. Verified the system precision claim. |
| Software functional tests | Covered complete system functionality, including error handling, usability, and time performance (latency). |
| Safety, EMC, and mechanical tests | Performed by a nationally recognized testing laboratory. Verified compliance with safety and EMC standards for medical devices. |
| Simulated use accuracy test | A complete CT image registration and instrument navigation workflow was performed. Verified the overall accuracy of the system. |
| Pre-clinical (cadaver) tests | Designed to mimic surgical procedures using the device in a simulated clinical environment. Assessed execution of a complete sinuplasty procedure workflow and qualitatively estimated system clinical accuracy. |
| Overall Conclusion | The proposed ACCLARENT® ENT Navigation System passed all tests in accordance with appropriate test criteria and standards. The modified device did not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of cases or patients. For the "Location Accuracy tests," it refers to "the entire navigation volume," suggesting a comprehensive evaluation within the system's operational space. For "Simulated use accuracy test" and "Pre-clinical (cadaver) tests," the number of cadavers or simulated procedures is not specified.
- Data Provenance: The tests are "nonclinical" and "pre-clinical (cadaver) tests." This suggests controlled laboratory and cadaveric environments, which do not typically involve patient data from specific countries in the way an AI model would. There's no indication of retrospective or prospective patient data collection for these specific performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as the "ground truth" for a navigation system's performance is established through physical measurements (e.g., comparison to a robot system for location accuracy) and functional assessments, not subjective expert annotations of medical images for diagnostic purposes.
- Qualifications of Experts: Not specified or applicable in the context of hardware/software functional and accuracy testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance is measured against engineering specifications and physical accuracy metrics, not through expert consensus on AI outputs.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging AI algorithms to assess their impact on human reader performance. The Acclarent ENT Navigation System is a surgical navigation device.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is not an AI diagnostic assistance tool.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The non-clinical tests (electrical, location accuracy, software functional, safety, EMC, mechanical) represent standalone performance of the device's components and system accuracy against established engineering parameters. The "Pre-clinical (cadaver) tests" involved human interaction but were qualitative assessments of workflow and clinical accuracy, not a comparative "human-in-the-loop" study in the AI sense.
7. The Type of Ground Truth Used
- Ground Truth:
- Engineering Specifications: For electrical, software functional, safety, EMC, and mechanical tests, the ground truth is defined by the device's design specifications and relevant industry/regulatory standards.
- Precise Robotic Measurements: For "Location Accuracy tests," the ground truth was provided by a "very accurate robot system."
- Simulated Clinical Workflows: For "Simulated use accuracy test" and "Pre-clinical (cadaver) tests," the ground truth involves assessing the system's ability to accurately guide instruments relative to pre-acquired CT images within a controlled, mimicked surgical environment. This is less about a single "ground truth" label and more about functional validation.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a medical device, not an AI model that undergoes a training phase with a specific dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI model.
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March 10, 2018
Acclarent, Inc. James Patrick Garvey II Associate Director, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K173628
Trade/Device Name: Acclarent® ENT Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: February 8, 2018 Received: February 9, 2018
Dear James Patrick Garvey II:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ACCLARENT® ENT Navigation System Special 510(k) Premarket Notification
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. | |
|---|---|---|
| ------------------------------------------------------------------------- | -- | --------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K173628 |
|---|---|
| Device Name | ACCLARENT® ENT Navigation System |
| Indications for Use (Describe) | 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. |
| 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 shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the first half in black and the second half in purple. Above the word "Acclarent" is a purple arc. Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES", with "Johnson & Johnson" in red.
ACCLARENT® ENT Navigation System
Special 510(k) Premarket Notification
510(k) Summary
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Applicant: | Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USATel.: (800) 729-9010Fax: (949) 450-6886 |
| Contact Person: | James Patrick Garvey IIAssociate Director, Regulatory AffairsPhone: 949-789-8505Fax: 650-687-5889 |
| Authored by: | Anna GantmanQuality and Regulatory Program ManagerBiosense Webster (Israel), Ltd.+972-52-808-9735 |
| Date Summary Prepared: | January 19, 2018 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | ACCLARENT® ENT 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 Device: | CARTO® ENT Navigation System510(k)#: K161701 |
| [807.92(a)(4)] Device Description | |
| Device Description: | The ACCLARENT® ENT Navigation System is intended to be usedduring intranasal and paranasal surgical procedures to help ENTphysicians to track and display the real-time location of the tip ofnavigated instruments relative to pre-acquired reference images, suchas CT.The ACCLARENT® ENT Navigation System enables ENT physiciansto access sphenoid, frontal, and maxillary sinuses by using the systemmagnetic tracking technology, identical to the predicate device.The system incorporates a Navigation Console, Field Ring, InstrumentHub, Patient Tracker, Registration Probe, Field Ring and Holder,Workstation and accessories. A magnetic field generated by the FieldRing induces a current in the magnetic sensor embedded in the tip ofthe flexible navigated tool, which helps to accurately calculate the tooltip position. A CT image is imported and registered to the patientcoordinates and a tool tip icon is displayed on top of the registered |
| [807.92(a)(5)] Intended UseIndications for Use: | The ACCLARENT® ENT Navigation System is intended for useduring intranasal and paranasal image-guided navigation proceduresfor patients who are eligible for sinus procedures. |
| Difference in Indicationsfrom Predicate Device: | The intended use of the device is unchanged from the predicate. |
| [807.92(a)(6)] Technical CharacteristicsTechnologicalCharacteristics: | The substantial equivalence of the ACCLARENT® ENT NavigationSystem to the predicates is shown by similarity in intended use,indications for use, and performance.Like the predicate CARTO® ENT System, the ACCLARENT® ENTNavigation System is an image-guided navigation system intended foruse during paranasal surgical procedures. ENT physicians can trackand display the real-time location of the tip of navigated instrumentsrelative to pre-acquired CT images.Like the predicate, the ACCLARENT® ENT Navigation Systemutilizes electromagnetic tracking technology for navigation, usesanatomical reference points on the patient's anatomy for intraoperativeregistration to the image-based model of the anatomy, and uses CTimage sets as reference images for the image-based model. Theinstructions for use and product labels have been updated to reflect therevised device. |
| Non-clinical PerformanceData: | The ACCLARENT® ENT Navigation System was tested to ensure thatit functions in accordance with the system design specifications relatedto 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 modulesperform within specifications.2. Location Accuracy tests, where the ACCLARENT® ENTNavigation System electromagnetic locations were compared to thelocations provided by a, very accurate robot system over the entirenavigation volume, to verify the system precision claim.3. Software functional tests, covering the complete systemfunctionality, and including error handling, usability and time |
| 4. | Safety, EMC, and mechanical tests were performed by a nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices. |
| 5. | 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. |
| 6. | Pre-clinical (cadaver) tests were designed to mimic surgical procedures using the ACCLARENT® ENT Navigation System in a simulated clinical environment, to assess the execution of a complete sinuplasty procedure workflow and to qualitatively estimate the system clinical accuracy. |
| The proposed ACCLARENT® ENT Navigation System 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 Performance Data: | Clinical data was not necessary to determine that the ACCLARENT® ENT Navigation System was substantially equivalent to the predicate device. The performance data demonstrated that the device performs as intended. |
| Conclusion: | The modified ACCLARENT® ENT Navigation System is substantially equivalent to the currently cleared CARTO® ENT Navigation System based on the completion of non-clinical bench testing as well as similar principles of design, operation and indications for use. |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the first half in black and the second half in purple. A purple arc is above the second half of the word. Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
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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 in black and the "ent" in purple. Above the purple part of the name is a purple arc. Below the name is the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES", with "Johnson-Johnson" in red script.
performance (latency).
§ 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).