CARTO 3 EP Navigation System, Version 7.1 and Accessories

K191660 · Biosense Webster, Inc. · DQK · Jul 20, 2019 · Cardiovascular

Device Facts

• Record ID: K191660
• Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Indications for Use

The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Device Story

CARTO 3 EP Navigation System V7.1 is a catheter-based diagnostic system for atrial and ventricular mapping. It acquires intracardiac electrical signals and catheter location data using magnetic sensor and Advanced Catheter Location (ACL) technologies. The system processes these inputs to generate 3D anatomical and electroanatomical maps of the heart. Used in clinical settings by electrophysiologists during EP procedures; the system displays real-time electrograms and cardiac maps on a workstation. These outputs assist clinicians in visualizing cardiac electrical activity and catheter positioning, facilitating diagnostic decision-making during procedures. The system integrates previously cleared modules (CARTOFINDER, Coherent Mapping) and includes features like LAT histograms, parallel mapping, and advanced reference annotation to improve mapping accuracy and user experience.

Clinical Evidence

No clinical data. Evidence consists of extensive bench and pre-clinical testing under simulated clinical conditions to verify new/modified features and regression testing to ensure no negative impact on existing predicate features. All testing passed according to established criteria.

Technological Characteristics

Cardiac mapping system using magnetic sensor and Advanced Catheter Location (ACL) technology. Hardware includes Patient Interface Unit, 3D graphics workstation, monitors, and location pads. Identical hardware platform to predicate. Software-based processing for 3D anatomical and electroanatomical mapping. Connectivity via standard workstation peripherals.

Indications for Use

Indicated for patients eligible for conventional catheter-based cardiac electrophysiological (EP) procedures. No special contraindications.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• CARTO® 3 EP Navigation System Version 6.0 and Accessories with VISITAG SURPOINT (K180238)

Reference Devices

• CARTOFINDER (K173978)
• Coherent Mapping module (K173977)

Submission Summary (Full Text)

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July 20, 2019

Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618

Re: K191660

Trade/Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 19, 2019 Received: June 21, 2019

### Dear Phuong Chau:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular 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) K191660

Device Name

CARTO® 3 EP Navigation System Version 7.1 and Accessories

Indications for Use (Describe)

The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K191660 510(k) Summary

| Applicant: | Biosense Webster, Inc.<br>33 Technology Drive<br>Irvine, CA 92618, USA<br>Tel.: [phone]<br>Fax: [phone] |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phuong Chau<br>Senior Regulatory Affairs Program Lead<br>Phone: [phone]<br>Fax: [phone] |
| Authored by: | Elena Goldin<br>Quality and Regulatory Senior Specialist<br>Biosense Webster (Israel), Ltd.<br>And<br>Phuong Chau<br>Senior Regulatory Affairs Program Lead<br>Biosense Webster, Inc. |
| Date: | June 19, 2019 |
| Device Trade Name: | CARTO® 3 EP Navigation System Version 7.1 and<br>Accessories |
| Device Common<br>Name: | Cardiac Mapping System |
| Manufacturing<br>Number: | FG-5400-00/FG-5400-00U |
| Device<br>Classification: | Programmable diagnostic computer<br>Class II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 6.0 and<br>Accessories with VISITAG SURPOINT<br>510(k)#: K180238 |
| Manufacturing<br>Facilities: | Biosense Webster (Israel), Ltd.<br>a Johnson & Johnson Company<br>4 Hatnufa Street<br>Yokneam ISRAEL 2066717 |

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Biosense Webster, Inc. 15715 Arrow Hwy Irwindale, CA 91706

Device Description: The CARTO® 3 EP Navigation System, Version 7.1 is a catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The system allows electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V7.1 uses the same two distinct types of location technology as the predicate device - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

> The CARTO® 3 System V7.1 consists of the following hardware components:

- Patient Interface Unit (PIU) and Cables ●
- 3D Graphics Workstation
- Wide-Screen monitors, keyboard, and mouse ●
- Intracardiac In Port ●
- Intracardiac Out Port ●
- Power Supply
- Patches Connection Box and Cables 0
- Pedals ●
- Location Pad o

All hardware components of the CARTO® 3 System V7.1 are identical to those described for the predicate device.

The intended use of the CARTO® 3 System is catheter-based Indications for Use: cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

- The modified CARTO® 3 EP Navigation System, Version 7.1 Technological has the same technological characteristics (i. e., design, Characteristics: material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System device. A

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summary of the technological characteristics of the new device compared to the predicate device is as follows:

- Have identical intended use
- Use the same fundamental scientific technology ●
- Have the same hardware platform 0
- o Have identical magnetic location mapping technology

The main difference between the predicate device and the modified device are the merging of previously cleared functions (CARTOFINDER K173978 and Coherent Mapping module K173977 reference devices) in a CARTO3 software version, new modifications, and the addition of Letter to File changes as described below:

#### Summary of Modifications

#### Mapping and Annotations:

- LAT Histogram a graphical representation of the ● Local Activation Time (LAT) values of all points that contribute to the Active Map's LAT coloring, over a time interval (range) from the lowest to highest LAT value.
## Letter To File Changes:

- LAT Hybrid Maps
- Improvements for displays (Map Consistency Display) ●
- o Map filtering (Parallel Mapping)
- Signals displays (previous beat overlay)
- Signals annotations (Advanced Reference Annotation (ARA))
- Signals filtering (Power line noise rejection) ●
- GUI improvement to improve user experience ● (usability) such as high definition (HD) propagation style
- Updated Visualization Setup window display
- Increased limit of points in map
- Backup time reduction
- The CARTO® 3 EP Navigation System, Version 7.1 underwent Performance Data: extensive bench and pre-clinical testing under simulated

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# K191660

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clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features in the predicate and reference devices. All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. The CARTO® 3 EP Navigation System, Version 7.1 and Conclusions: Accessories is substantially equivalent to the cleared CARTO® 3 EP Navigation System V6 based on the completion of nonclinical bench testing and pre-clinical testing as well as similar

principles of design, operation and indications for use.