CARTO ENT System

K161701 · Biosense Webster · PGW · Oct 24, 2016 · Neurology

Device Facts

• Record ID: K161701
• Device Name: CARTO ENT System
• Applicant: Biosense Webster
• Product Code: PGW · Neurology
• Decision Date: Oct 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The CARTO® ENT System is intended for use during intranasal image-guided navigation procedures for patients who are eligible for sinus procedures.

Device Story

CARTO ENT System provides real-time navigation for ENT physicians during intranasal/paranasal sinus procedures. System components include navigation console, field ring, instrument hub, patient tracker, and workstation. Magnetic field generated by field ring induces current in magnetic sensor at tip of flexible navigated tool; system calculates tool tip position relative to pre-acquired CT images. Patient tracker fixed to patient forehead compensates for head movement. Physician views tool tip icon overlaid on registered CT images on workstation display. Real-time visualization aids precise location of anatomical structures, potentially improving surgical accuracy and patient outcomes. System supports manual and force-sensing registration probe modes.

Clinical Evidence

No clinical data. Evidence consists of bench testing and pre-clinical cadaver studies. Bench tests included proof of design electrical tests, location accuracy (0.55 mm ± 0.7 mm), software functional tests, and simulated use accuracy (0.63 mm ± 0.2 mm). Pre-clinical cadaver tests assessed sinuplasty workflow and qualitative clinical accuracy.

Technological Characteristics

Electromagnetic tracking system; uses CT image sets for reference. Components: Navigation console, field ring, instrument hub, patient tracker, workstation. Flexible navigated tools with embedded magnetic sensors. Registration via manual or force-sensing probe (1-10g range). Software-controlled navigation. Connectivity: Workstation-based. Sterilization: Not specified.

Indications for Use

Indicated for patients eligible for sinus procedures requiring intranasal and paranasal image-guided navigation.

Regulatory Classification

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.

Predicate Devices

• Fiagon Navigation System (K133573)
• CARTO® 3 EP Navigation System (K133916)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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Image /page/3/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. Below the name, in smaller letters, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES", with the Johnson & Johnson part in red. Above the company name is a teal-colored abstract design that resembles a heart with intersecting lines.

## [807.92(a)(1)] Submitter Information

| Sponsor/Submitter: | Biosense Webster, Inc.<br>3333 S. Diamond Canyon Road<br>Diamond Bar, CA 91765 USA |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Melissa C. Schultz<br>Email: [e-mail]<br>Telephone: [phone]<br>Telefax: 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 locating<br>anatomical structures during intranasal and paranasal image-guided<br>navigation procedures. |
| Difference in<br>Indications from<br>Predicate Device: | The difference in indications for use between the subject and predicate<br>devices is supported is presented in Table 1 of this summary. |
| [807.92(a)(6)] Technical Characteristics | |
| Technological<br>Characteristics: | The substantial equivalence of the CARTO® ENT Navigation System to<br>the predicates is shown by similarity in intended use, indications for use,<br>and performance. |
| | Like the predicate Fiagon System, the CARTO® ENT Navigation<br>System is an image-guided navigation system intended for use during<br>paranasal surgical procedures. ENT physicians can track and display the<br>real-time location of the tip of navigated instruments relative to pre-<br>acquired CT images. |
| | Like the predicate, the CARTO® ENT System utilizes electromagnetic<br>tracking technology for navigation, uses anatomical reference points on<br>the patient's anatomy for intraoperative registration to the image-based<br>model of the anatomy, and uses CT image sets as reference images for<br>the 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 locating<br>anatomical structures in either open or<br>percutaneous neurosurgical procedures. | Intended for use during intranasal and paranasal<br>image-guided navigation procedures |
| Fundamental Scientific Technology | Electromagnetic tracking | Same |
| Control Mechanism | Software controlled | Same |
| Navigation method | Electromagnetic location in reference to<br>registered CT/MR background of patient head | Same, CT only |
| Registration method | Fiducial matching and surface matching | Same |
| Bench test location accuracy | 0.9 mm<br>(Standard deviation 0.34 mm) | 0.55 mm<br>(Standard deviation 0.7 mm) |
| Simulated Use Accuracy | 1.79 mm<br>(Standard deviation 0.4 mm) | 0.63 mm<br>(Standard deviation 0.2 mm) |
| Location update rate | 15 to 45 Hz | 10 Hz |
| Main components | 1. Navigation unit<br>2. Head rest with field generator<br>3. Patient reference localizer<br>4. Navigation instrument | 1. Same (Navigation console)<br>2. Same (Field Ring)<br>3. Same (Patient Tracker)<br>4. Same (Acclarent NavWire, not included with<br>CARTO® ENT System) |
| Supported navigation instruments | Flexible tip instruments with magnetic sensor<br>on instrument tip | Same |
| Registration tools | Registration pointer, manual acquisition of<br>anatomic points and surfaces | Registration probe, manual or force sensing<br>acquisition of anatomic points and surfaces |
| Registration Probe Sensing | No | Force measurement range 1 to 10 gr.<br>Automatic acquisition of registration points or<br>surfaces. |

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.