KODEX EPD System

K180940 · Philips Medical Systems Nederland B.V. · DQK · Oct 24, 2018 · Cardiovascular

Device Facts

• Record ID: K180940
• Device Name: KODEX EPD System
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ 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.

Device Story

KODEX-EPD™ is a cardiac mapping and navigation system for EP procedures. It acquires electromagnetic signals via external body patches and standard EP catheters to generate real-time 3D electro-anatomical maps of the heart. The system tracks catheter position and displays electrical activity (local activation time, voltage, propagation maps). It includes a processing unit, workstation, pin boxes, and foot pedals. Used in clinical EP labs by trained electrophysiologists and staff. The system supports simultaneous navigation of multiple catheters and provides ablation parameter visualization (impedance drop, temperature, power, power integral). Output is displayed on a workstation GUI, assisting physicians in navigating catheters and identifying cardiac electrical activity to guide therapeutic interventions. Benefits include real-time visualization of cardiac anatomy and electrical activity to facilitate catheter-based procedures.

Clinical Evidence

No human clinical data provided. Evidence consists of extensive bench testing (verification, compatibility, electrical safety per IEC 60601-1/2-27, EMC, biocompatibility per ISO 10993), software V&V (ISO 62304), usability testing, and a GLP animal study. Testing demonstrated the system meets design specifications and performs equivalently to the predicate.

Technological Characteristics

Dielectric/impedance-based mapping system. Components: Processing unit, workstation, pin boxes, external patches, foot pedals. Connectivity: Standard EP catheter compatibility. Software: Rule-based/algorithmic processing of electrical signals. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, ISO 62304, ISO 10993, IEC 62366.

Indications for Use

Indicated for patients eligible for conventional catheter-based cardiac electrophysiological (EP) procedures.

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 (K133916)

Submission Summary (Full Text)

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October 24, 2018

Philips Medical Systems Nederland B.V. Gina Crossetta VP, Regulatory and Quality Veenpluis 4, -6 PC Best, 5684 Nl

Re: K180940

Trade/Device Name: KODEX EPD™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 26, 2018 Received: September 26, 2018

Dear Gina Crossetta:

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely

Mude Yellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180940

Device Name KODEX - EPD™ System

#### Indications for Use (Describe)

The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

| Applicant: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4, - 6, 5684 PC Best, Netherlands |
|----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Gina Crossetta<br>Vice President, Regulatory and Quality |
| | Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | October 18, 2018 |
| Device Trade Name: | KODEX – EPD™ System |
| Device Common Name: | Cardiac Mapping and Navigation Device |
| Classification Name: | Programmable Diagnostic Computer |
| Regulation Number: | Class II, 21 CFR 870.1425 |
| Product Code: | DQK |
| Predicate Device: | CARTO 3 EP Navigation System (K133916) |

#### Device Description:

The KODEX-EPD™ system is a catheter-based cardiac mapping system designed to acquire and analyze individual data points, and use this information to display 3D electro-anatomical maps of the human heart in real-time. The information needed to create the cardiac maps is acquired using standard EP catheters and proprietary external patches.

KODEX-EPD™ continuously collects electromagnetic signals from all patches and electrodes attached to it. The system then uses these to create a 3D image of the chamber, and superimposes the real time catheter position on the chamber image. In addition, the KODEX-EPD™ system supports representation of the electrical activity of cardiac chambers, based on the intra cardiac signals received from the all catheters and body surface signals.

The KODEX-EPD™ system includes the KODEX Processing Unit, BS Pin Box, Diagnostic Catheter Connection Box, Recording System Connection Box, Workstation, Foot Pedal and KODEX-EPD™ External Patches.

#### Intended Use/Indications for Use:

The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ 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.

#### Summary of Technology Characteristics:

Table 1 provides a comparison of the technological characteristics for the KODEX – EPD™ System and the predicate device.

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| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP<br>Navigation System¹ | Comments |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| 510(k) | TBD | K133916 | N/A |
| Device class | II | II | Same |
| Classification | Programmable diagnostic-computer<br>Class II; 21 CFR, 870.1425 | Programmable diagnostic-computer<br>Class II; 21 CFR, 870.1425 | Same |
| Product code | DQK | DQK | Same |
| Indications/Intended use | The KODEX-EPD™ System is indicated<br>for catheter-based cardiac<br>electrophysiological (EP) procedures.<br>The KODEX-EPD™ System provides<br>information about the electrical<br>activity of the heart and about<br>catheter location during the<br>procedure. The system can be used<br>on patients who are eligible for a<br>conventional electrophysiological<br>procedure. | The intended use of the CARTO 3 System<br>is catheter-based cardiac<br>electrophysiological (EP) procedures. The<br>CARTO 3 System provides information<br>about the electrical activity of the heart<br>and about catheter location during the<br>procedure. The system can be used on<br>patients who are eligible for a<br>conventional electrophysiological<br>procedure. The system has no special<br>contraindications. | Same |
| Intended users | EP's and EP lab staff trained on the use of<br>the system | EP's and EP lab staff trained on the use of<br>the system | Same |
| Physical Characteristics | | | |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP<br>Navigation System¹ | Comments |
| System Components | The KODEX – EPD™ system is comprised of the following components:<br><br>1) KODEX-EPD PU: Processing Unit<br>2) KODEX-EPD -WS: Workstation with Graphic User Interface<br>3) KODEX-EPD BS Pin Box:<br>a. Seven input pins for body patches.<br>b. One input pin for ground patch (right leg).<br>4) D700 Diagnostic catheters connection boxes: boxes with 16 optional input pin connectors.<br>5) KODEX-EPD RS connection Boxes: boxes with 20 optional output pin connectors.<br>6) Foot pedals<br>7) Keyboard and mouse<br>8) Cart (optional) | The CARTO 3 system is comprised of the following components:<br><br>1) Patient Interface Unit (PIU)<br>2) Workstation with Graphic User Interface<br>3) Patches Connection Box and Cables<br>4) Intracardiac In Port<br>5) Intracardiac Out Port<br>6) Foot pedals<br>7) Keyboard, and mouse<br>8) Cart (optional)<br>9) Power Supply<br>10) Monitor<br>11) Location Pad | Similar components |
| Patient Patches/ electrodes | 6 external patches plus one right leg patch | 6 external reference patches | KODEX relies on dielectric measurements from the external patches for mapping and navigation. Since each patch can have a different potential offset the measurements are referenced against an additional patch; the right leg patch.<br>For the reasons stated below, the reliance on dielectric mapping does not raise any new questions of safety or effectiveness. |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP<br>Navigation System1 | Comments |
| | | | The KODEX System includes<br>the external patches while the<br>CARTO 3 patches are cleared<br>separately (K061468). This<br>doesn't raise any new<br>questions of safety or<br>effectiveness. The CARTO 3<br>patches are cleared separately<br>so that they may be used for<br>multiple devices. |
| Catheters | Compatible EP catheters | Specialized catheters with integrated<br>magnetic sensor; several compatible<br>diagnostic and therapeutic catheters | Same |
| Foot Pedals | Commercial foot pedals used for hands<br>free acquisition of points (Local<br>Activation Time and tagging points) | Foot pedals used for hands free<br>acquisition of points | Same |
| Technology | | | |
| Principles of operation | Mapping of electrical fields and<br>impedances (dielectric mapping) | Triangulation of magnetic fields (magnetic<br>technology) and impedance | Both systems achieve the<br>desired features (navigation,<br>accuracy, electroanatomical<br>mapping, etc) by mapping<br>impedance with either<br>electrical fields (KODEX) or<br>magnetic fields (CARTO 3). |
| Location Technology | Impedance localization technology<br>(Dielectric); any catheter | Magnetic sensor technology for location<br>and orientation of a specialized catheter<br>with magnet sensor on tip and impedance<br>localization | Both systems achieve the<br>desired features (navigation,<br>accuracy, electroanatomical<br>mapping, etc) by mapping<br>impedance with either<br>electrical fields (KODEX) or<br>magnetic fields (CARTO 3). |
| 3D Geometry mapping by<br>aggregating catheter<br>location: Geometry | Yes, based on ablation catheter and<br>Dielectric technology | Yes, based on diagnostic and ablation<br>catheters | Same |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP<br>Navigation System1 | Comments |
| rotation and flexible<br>display | | | |
| Flattened 3D view of the<br>whole cardiac chamber | Yes, PANOv flattened chamber display | No | The flattened chamber display<br>is an added feature provided<br>by KODEX but doesn't raise<br>new questions of safety or<br>effectiveness. It is simply an<br>additional, optional viewing<br>option that provides an<br>alternative depiction of the<br>chamber, but the standard<br>view provided by both systems<br>(i.e., without flattening)<br>remains the same, as shown in<br>the performance testing. |
| Simultaneous Navigation of<br>multiple catheters | Yes, 1 compatible ablation catheter and<br>up to 3 diagnostic catheters | Yes, 1 sensor enabled ablation catheter<br>and several diagnostic catheters. | Same |
| Electrograms for activation<br>and voltage mapping. | Yes. Local Activation Time maps, voltage<br>maps and propagation maps | Yes, Local Activation Time maps,<br>impedance maps and propagation maps | Both systems provide<br>electroanatomical maps. The<br>maps provided by the KODEX<br>System are a subset of those<br>provided by CARTO, and they<br>are the most widely used. |
| Ablation parameter<br>visualization and tagging<br>tool | Yes. KODEX provides catheter stability,<br>intracardiac electrical activation<br>information, and during ablation,<br>impedance drop and temperature as read<br>from the RF generator. Ablation point<br>tagging is conducted based on a user<br>defined combination of parameters and<br>thresholds. In addition the KODEX system<br>provides power, power integral over<br>ablation time and duration. | Yes, optional (Visitag Module). CARTO 3<br>provides catheter stability, contact force,<br>intracardiac electrical activation<br>information, and during ablation,<br>impedance drop and temperature as read<br>from the RF generator. Ablation point<br>tagging is conducted based on a user<br>defined combination of parameters and<br>thresholds. | Both systems display RF<br>generator communicated<br>parameters. Both systems<br>provide catheter stability,<br>intracardiac electrical<br>activation information, and<br>during ablation, impedance<br>drop and temperature as read<br>from the RF generator.<br>Ablation point tagging is<br>conducted based on a user |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP<br>Navigation System1 | Comments |
| | | | defined combination of<br>parameters and thresholds.<br>While the KODEX System<br>provides some additional<br>parameters not provided by<br>CARTO (power, power integral<br>over ablation time, and<br>duration), and CARTO 3<br>provides one additional<br>parameter (contact force),<br>these provide the physician<br>with additional information<br>but do not raise new questions<br>of safety or effectiveness.<br>Based on performance testing<br>conducted these additional<br>features perform as intended. |
| Compatibility with RF<br>generator | Yes, Stockert 70 and Maestro 4000 | Yes | Both systems are compatible<br>with RF generators |

## Table 1: Comparison of Technological Characteristics for the KODEX – EPD™ System and Predicate

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### Substantial Equivalence Discussion:

The indications for use for the predicate device is identical to the proposed indications for use for the KODEX – EPD™ System. As demonstrated in Table 1 above, any differences in the technological characteristics do not raise any questions of safety or effectiveness. Thus the KODEX – EPD™ System is substantially equivalent to the predicate device.

### Performance Data

The company conducted extensive bench and animal testing which demonstrated that the KODEX – EPD™ System meets its design specifications and is substantially equivalent to the predicate device. Specifically, the following bench and animal testing was conducted:

- KODEX EPD™ System verification testing ●
- Compatibility testing ●
- Software verification and validation (ISO 62304:2006 + A1:2015 )
- Transportation testing
- Electromagnetic Compatibility (IEC 60601-1-2, IEC 60601-2-27) ●
- Electrical Safety Testing (IEC 60601-1, IEC 62366:2007 + A1:2014, IEC 62304:2006 + A1:2014)
- GLP animal study
- Usability testing ●
- Biocompatibility testing (ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010) ●

The testing demonstrated that the product meets is performance specifications and performs as intended. In addition, the KODEX – EPD™ System was found to be substantially equivalent to the predicate device.

### Conclusions

Extensive bench testing was conducted which demonstrated that the KODEX – EPD™ System meets its performance specifications. The company also conducted validation testing in the form of animal and usability to evaluate the overall performance of the KODEX – EPD™ System. This collection of testing demonstrates the safety and effectiveness of the KODEX – EPD™ System its substantial equivalence to the predicate device.