(106 days)
No
The summary describes a navigation system based on magnetic tracking technology and pre-acquired CT images, with no mention of AI or ML algorithms for image processing, tracking, or any other function.
No.
The device is a surgical navigation system that assists ENT physicians in tracking instruments during procedures; it does not directly treat or cure a disease or condition.
No
The device is described as a surgical navigation system used to track instruments during procedures, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components (Navigation Console, Field Ring, Instrument Hub, Patient Tracker, Registration Probe, Field Ring and Holder, Workstation and accessories) and describes a magnetic tracking technology that relies on hardware. Performance studies also include hardware-specific tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ACCLARENT® ENT Navigation System is a surgical navigation system used during procedures to guide instruments based on pre-acquired images (CT scans). It does not analyze samples from the body to diagnose or monitor a condition.
- Intended Use: The intended use is for "intranasal and paranasal image-guided navigation procedures," which is a surgical application, not a diagnostic one.
The device is a surgical tool that aids in the execution of a procedure, not a test that provides diagnostic information from a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
PGW
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
intranasal and paranasal (sinuses: sphenoid, frontal, and maxillary)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ENT physicians
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)
The ACCLARENT® ENT Navigation System 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 ACCLARENT® ENT Navigation System electromagnetic locations were compared to the locations provided by a, very accurate robot system over the entire navigation volume, to verify the system precision claim.
- Software functional tests, covering the complete system functionality, and including error handling, usability and time
- Safety, EMC, and mechanical 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARTO® ENT Navigation System; K161701
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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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.
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 (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 SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See 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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ACCLARENT® ENT Navigation System
Special 510(k) Premarket Notification
510(k) Summary
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Applicant: | Biosense Webster, Inc. |
| 33 Technology Drive | |
| Irvine, CA 92618, USA | |
| Tel.: (800) 729-9010 | |
| Fax: (949) 450-6886 | |
| Contact Person: | James Patrick Garvey II |
| Associate Director, Regulatory Affairs | |
| Phone: 949-789-8505 | |
| Fax: 650-687-5889 | |
| Authored by: | Anna Gantman |
| Quality and Regulatory Program Manager | |
| Biosense 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 System |
| 510(k)#: K161701 | |
| [807.92(a)(4)] Device Description | |
| Device Description: | 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 |
| [807.92(a)(5)] Intended Use
Indications for Use: | 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. |
| Difference in Indications
from Predicate Device: | The intended use of the device is unchanged from the predicate. |
| [807.92(a)(6)] Technical Characteristics
Technological
Characteristics: | The substantial equivalence of the ACCLARENT® ENT Navigation
System to the predicates is shown by similarity in intended use,
indications for use, and performance.
Like the predicate CARTO® ENT System, the ACCLARENT® ENT
Navigation System is an image-guided navigation system intended for
use during paranasal surgical procedures. ENT physicians can track
and display the real-time location of the tip of navigated instruments
relative to pre-acquired CT images.
Like the predicate, the ACCLARENT® ENT Navigation 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
image sets as reference images for the image-based model. The
instructions for use and product labels have been updated to reflect the
revised device. |
| Non-clinical Performance
Data: | The ACCLARENT® ENT Navigation System 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 ACCLARENT® ENT
Navigation System electromagnetic locations were compared to the
locations provided by a, very accurate robot system over the entire
navigation volume, to verify the system precision claim. -
Software functional tests, covering the complete system
functionality, 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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performance (latency).