The CARTO® ENT System is intended as an aid for precisely locating anatomical structures during intranasal and paranasal image-guided navigation procedures.

Device Description

The CARTO® ENT 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 CARTO® ENT device enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology. The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, 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 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.

AI/ML Overview

The CARTO ENT System is an image-guided surgery system. The information provided describes the acceptance criteria and study proving its performance.

1. Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Predicate Fiagon Navigation System)	Reported Device Performance (CARTO® ENT Navigation System)
Bench test location accuracy	0.9 mm (Standard deviation 0.34 mm)	0.55 mm (Standard deviation 0.7 mm)
Simulated Use Accuracy	1.79 mm (Standard deviation 0.4 mm)	0.63 mm (Standard deviation 0.2 mm)
Location update rate	15 to 45 Hz	10 Hz

2. Sample size used for the test set and data provenance

The document does not specify an exact "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective for the accuracy tests.

Bench Test Location Accuracy: The test involved comparing the CARTO® ENT System's electromagnetic locations to those provided by a "very accurate robot system over the entire navigation volume." No specific sample size (e.g., number of measurements) is given.
Simulated Use Accuracy: This involved performing "a complete CT image registration and instrument navigation workflow." Again, no specific sample size (e.g., number of simulated procedures or measurements) is provided.
Pre-clinical (cadaver) tests: These were conducted to mimic surgical procedures "in a simulated clinical environment." No sample size (number of cadavers or procedures) is specified.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not provided. The accuracy tests rely on a "very accurate robot system" for bench accuracy and the overall system workflow for simulated use, rather than expert-established ground truth in the traditional sense of medical image interpretation. For pre-clinical cadaver tests, qualitative estimation of clinical accuracy was performed, but no details on expert involvement or qualifications are given.

4. Adjudication method for the test set

This information is not explicitly provided. Given the nature of the bench and simulated use accuracy tests (comparison to a robot system or workflow performance), an "adjudication method" as typically applied in human reader studies would not be directly applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC comparative effectiveness study was not done. The document states, "Clinical data was not necessary for the CARTO® ENT System."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance tests described (Bench test location accuracy, Simulated Use Accuracy) primarily evaluate the device's intrinsic capabilities and accuracy as an algorithm/system standalone. While a human operates the system during simulated use, the focus is on the system's ability to track and display positions accurately. The "pre-clinical (cadaver) tests" involved a human performing a sinuplasty procedure workflow, but the evaluation of "system clinical accuracy" was qualitative, and the primary accuracy metrics come from controlled technical tests.

7. The type of ground truth used

Bench test location accuracy: Ground truth was established by a "very accurate robot system."
Simulated Use Accuracy: Ground truth seems to be derived from the "complete CT image registration and instrument navigation workflow" itself, implying a reference standard within the controlled simulation.
Pre-clinical (cadaver) tests: The "ground truth" for these tests was for "qualitatively estimate the system clinical accuracy" rather than a defined, measurable anatomical truth.

8. The sample size for the training set

This information is not provided. The document describes a medical navigation system, and while it involves software, there's no mention of an "algorithm training set" in the context of machine learning, which is typically where a training set sample size would be relevant. The system's functionality is based on electromagnetic tracking technology, not explicitly on a learned model from a training data set described here.

9. How the ground truth for the training set was established

This information is not provided as a "training set" is not mentioned in the context of this device's validation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2016

Biosense Webster Ms. Melissa C. Schultz Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K161701

Trade/Device Name: CARTO ENT System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 21, 2016 Received: September 22, 2016

Dear Ms. Schultz:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161701

Device Name CARTO® ENT System

Indications for Use (Describe)

The CARTO® ENT System is intended for use during intranasal 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740 EF

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[807.92(a)(1)] Submitter Information

Sponsor/Submitter:	Biosense Webster, Inc.3333 S. Diamond Canyon RoadDiamond Bar, CA 91765 USA
Contact Person:	Melissa C. SchultzEmail: MSchult1@its.jnj.comTelephone: 909-839-8787Telefax: 909-839-8804

Date Summary Prepared: September 16, 2016

[807.92(a)(2)] Name of Device

Device Trade	CARTO® ENT Navigation System
Common Name:	Image Guided Surgery System
Device	Class II
Regulation	21 CFR 882.4560
Classification	Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 882.4560)
Product Code:	PGW

[807.92(a)(3)] Legally Marketed Devices

Predicate Devices: Fiagon Navigation System (K133573)

CARTO® 3 EP Navigation System (K133916) Reference Devices:

[807.92(a)(4)] Device Description

The CARTO® ENT System is intended to be used during intranasal and Device Description: 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 CARTO® ENT device enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology. The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, 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 image, indicating the position of the tool in

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Image /page/4/Picture/1 description: The image shows the logo for Biosense Webster, which is in teal. Below the logo, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" with Johnson & Johnson in red. The word "CONFIDENTIAL" is in bold black letters at the bottom right.

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 CARTO® ENT System is intended as an aid for precisely locatinganatomical structures during intranasal and paranasal image-guidednavigation procedures.
Difference inIndications fromPredicate Device:	The difference in indications for use between the subject and predicatedevices is supported is presented in Table 1 of this summary.
[807.92(a)(6)] Technical Characteristics
TechnologicalCharacteristics:	The substantial equivalence of the CARTO® ENT Navigation System tothe predicates is shown by similarity in intended use, indications for use,and performance.
	Like the predicate Fiagon System, the CARTO® ENT NavigationSystem is an image-guided navigation system intended for use duringparanasal surgical procedures. ENT physicians can track and display thereal-time location of the tip of navigated instruments relative to pre-acquired CT images.
	Like the predicate, the CARTO® ENT System utilizes electromagnetictracking technology for navigation, uses anatomical reference points onthe patient's anatomy for intraoperative registration to the image-basedmodel of the anatomy, and uses CT image sets as reference images forthe image-based model.

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Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

Image /page/5/Picture/1 description: The image shows the logo for Biosense Webster, a company that is part of the Johnson & Johnson family of companies. The logo features the company name in a teal color, with the words "Biosense" and "Webster" on the same line. Above the company name is a teal-colored graphic that resembles a heart with lines going through it. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

Table 1: Comparison of Predicate and Subject Device

Attribute	Fiagon Navigation System	CARTO® ENT Navigation System
	Predicate	Subject Device
Intended Use	Intended as an aid for precisely locatinganatomical structures in either open orpercutaneous neurosurgical procedures.	Intended for use during intranasal and paranasalimage-guided navigation procedures
Fundamental Scientific Technology	Electromagnetic tracking	Same
Control Mechanism	Software controlled	Same
Navigation method	Electromagnetic location in reference toregistered CT/MR background of patient head	Same, CT only
Registration method	Fiducial matching and surface matching	Same
Bench test location accuracy	0.9 mm(Standard deviation 0.34 mm)	0.55 mm(Standard deviation 0.7 mm)
Simulated Use Accuracy	1.79 mm(Standard deviation 0.4 mm)	0.63 mm(Standard deviation 0.2 mm)
Location update rate	15 to 45 Hz	10 Hz
Main components	1. Navigation unit2. Head rest with field generator3. Patient reference localizer4. Navigation instrument	1. Same (Navigation console)2. Same (Field Ring)3. Same (Patient Tracker)4. Same (Acclarent NavWire, not included withCARTO® ENT System)
Supported navigation instruments	Flexible tip instruments with magnetic sensoron instrument tip	Same
Registration tools	Registration pointer, manual acquisition ofanatomic points and surfaces	Registration probe, manual or force sensingacquisition of anatomic points and surfaces
Registration Probe Sensing	No	Force measurement range 1 to 10 gr.Automatic acquisition of registration points orsurfaces.

The primary difference between the Fiagon Navigation System and CARTO® ENT Navigation System is that on top of manual registration supported by the Fiagon system, where the physician manually selects points and surfaces to be registered, the CARTO® ENT System also supports a force sensing registration mode, where points and surfaces are automatic acquired when adequate pressure is applied with the registration probe on the patient face. Since the physician is instructed to verify the quality of the registration, this addition does not raise new issues of safety and effectiveness.

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Image /page/6/Picture/1 description: The image shows the logo for Biosense Webster, a part of the Johnson & Johnson family of companies. The logo features the company name in a teal color, with the words "Biosense" and "Webster" stacked on top of each other. Above the company name is a teal-colored graphic design that resembles a heart with lines going through it. Below the company name, in smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

The CARTO® ENT System was tested to ensure that it functions Non-Clinical in accordance with the system design specifications related to Performance Data: 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. 2. Location Accuracy tests, where the CARTO® ENT 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. 3. 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 4. 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 CARTO® ENT 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 results of the above tests support the safety of the device and demonstrate that the CARTO® ENT System perform as intended in the specified use conditions. The tests also demonstrate that the device performs comparably to the predicate device for the same intended use. [807.92(b) (2)] Determination of Substantial Equivalence Clinical data was not necessary for the CARTO® ENT System. Clinical Performance Data: The performance data demonstrated that the device performs as intended.

[807.92(b) (1)] Determination of Substantial Equivalence

[807.92(b) (3)] Conclusion

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Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

Image /page/7/Picture/1 description: The image shows the Biosense Webster logo, which is a medical device company. The logo is in blue and features the company name and a graphic of a heart with lines around it. Below the logo, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" and the word "CONFIDENTIAL" is at the bottom right.

Conclusion from Non-Clinical and Clinical Tests

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the CARTO® ENT Navigation System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present new issues of safety or effectiveness.

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).