KODEX – EPD™ System 1.5.0
Device Facts
| Record ID | K212493 |
|---|---|
| Device Name | KODEX – EPD™ System 1.5.0 |
| Applicant | Philips Medical Systems Nederland, B.V. (Pmsn) |
| Product Code | DQK · Cardiovascular |
| Decision Date | Oct 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K212493 · Oct 24, 2022 | KODEX – EPD™ System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | Retrospective analysis of clinical cases | Retrospective analysis of clinical cases was used to validate the Cryo Occlusion Viewer feature by comparing the system's occlusion status against venography. | Retrospective analysis; Cryo Occlusion Viewer; Validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective analysis of KODEX-EPD™ cases; Retrospective analysis | Patients undergoing cryoballoon pulmonary vein isolation procedures | Venography | Pulmonary vein (PV) occlusion status |
Indications for Use
The KODEX-EPD™ System 1.5.0 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System 1.5.0 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™ System 1.5.0 is a cardiac mapping and navigation system used in EP labs by physicians and staff. It acquires electromagnetic signals from body surface patches and standard EP catheters; processes these inputs to generate real-time 3D electro-anatomical maps of the heart; and displays catheter position. The system includes specialized software features: Tissue Engagement Viewer (TEV) to assess catheter-tissue contact (No Touch, Touch, High Touch) via local dielectric changes; and Cryo Occlusion Viewer to assess pulmonary vein occlusion during cryoballoon procedures. Output is visualized on a workstation for the clinician to guide catheter placement and ablation therapy. The system supports clinical decision-making by providing real-time anatomical and electrical information, potentially improving procedural accuracy and efficiency.
Clinical Evidence
Bench and animal testing only. Verification included software (IEC 62304), electromagnetic compatibility (IEC 60601-1-2), and electrical safety (ANSI/AAMI ES 60601-1). Cryo Occlusion Viewer validated via retrospective analysis of clinical cases compared to venography, acute animal study, and summative usability study. Tissue Engagement Viewer validated in acute GLP animal study comparing feature output against clinical standards (fluoroscopy, EGM, impedance, ICE).
Technological Characteristics
Dielectric mapping system using global induced electrical fields and impedances for intra-body localization. Components: Processing Unit, Workstation, BS Pin Box (7 body patch inputs), diagnostic/RS connection boxes, foot pedals. Compatible with off-the-shelf EP catheters. Software-based features for 3D geometry, PANO flattened chamber display, and ablation parameter visualization. Connectivity includes RF generator integration (Stockert 70, Maestro 4000, SmartAblate).
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
- KODEX – EPD™ System (K180940)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2022
Philips Medical Systems Nederland, B.V. (PMSN) Betina Schepers Head of Ouality, EPD Solutions Veenpluis 6, 5684 PC Best. Netherlands
Re: K212493
Trade/Device Name: KODEX-EPD™ System 1.5.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: September 21, 2022 Received: September 21, 2022
Dear Betina Schepers:
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
{1}------------------------------------------------
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) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K212493
Device Name KODEX-EPD™ System 1.5.0
#### Indications for Use (Describe)
The KODEX-EPD™ System 1.5.0 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD ™ System 1.5.0 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"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."
{3}------------------------------------------------
#### 510(k) SUMMARY KODEX-EPD™ System 1.5.0
| Submitter: | Philips Medical Systems Nederland B.V. (d/b/a EPD Solutions<br>Veenpluis 6, 5684 PC Best, Netherlands |
|-----------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Betina Schepers<br>Head of Quality<br>EPD Solutions<br>+31 611 710 116<br>Betina.schepers@philips.com |
| Date Prepared: | October 21, 2022 |
| Name of Device: | KODEX – EPD™ System 1.5.0 |
| Common or Usual Name: | Cardiac Mapping and Navigation Device |
| Classification Name: | Programmable Diagnostic Computer |
| Regulatory Class: | Class II, 21 CFR 870.1425 |
| Product Code: | DQK |
| Predicate Device: | KODEX – EPD™ System (K180940) |
## Device Description
The KODEX-EPD™ System 1.5.0 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 electrophysiological (EP) catheters and proprietary external sensors.
KODEX - EPD™ continuously collects electromagnetic signals from all sensors 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 1.5.0 supports representation of the electrical activity of cardiac chambers, based on the intra cardiac signals received from the all catheters and body surface signals.
## Intended Use / Indications for Use
The KODEX-EPD™ System 1.5.0 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System 1.5.0 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 Technological Characteristics
Table 1 provides a comparison of the technological characteristics for the KODEX – EPD™ System 1.5.0 and the predicate device.
{4}------------------------------------------------
| Regulatory | Subject Device<br>KODEX – EPD™ System 1.5.0 | Predicate Device<br>KODEX – EPD™ System | Comments |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K212493 | K180940 | N/A |
| Device class | Class II | Class II | Same |
| Classification | Programmable diagnostic computer;<br>21 CFR 870.1425 | Programmable diagnostic computer;<br>21 CFR 870.1425 | Same |
| Product code | DQK | DQK | Same |
| Indications/Intended use | The KODEX-EPD™ System 1.5.0 is<br>indicated for catheter-based cardiac<br>electrophysiological (EP)<br>procedures. The KODEX-EPD™<br>System 1.5.0 provides information<br>about the electrical activity of the<br>heart and about catheter location<br>during the procedure. The system<br>can be used on patients who are<br>eligible for a conventional<br>electrophysiological procedure. | 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 activity<br>of the heart and about catheter location<br>during the procedure. The system can<br>be used on patients who are eligible for<br>a conventional electrophysiological<br>procedure. | Same |
| Intended users | EP's and EP lab staff trained on the use<br>of the system. | EP's and EP lab staff trained on the use<br>of the system. | Same |
| Physical Characteristics | | | |
| | Subject Device<br>KODEX – EPD™ System 1.5.0 | Predicate Device<br>KODEX – EPD™ System | Comments |
| System Components | The KODEX – EPD™ System 1.5.0 is<br>comprised of the following components: | The KODEX – EPD™ System is<br>comprised of the following components: | Identical components except<br>that the subject device<br>includes use of a Gemalto key<br>and catheter key. The<br>Gemalto key encrypts the<br>software. The catheter key is<br>a stand-alone connector<br>specific to the type of catheter<br>to be used by the customer.<br>The keys serve commercial<br>purposes and have no impact<br>on the clinical functionality or<br>performance of the system. |
| | 1) KODEX-EPD™ PU: Processing Unit<br>2) KODEX-EPD™-WS: Workstation<br>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<br>(right leg).<br>4) Diagnostic catheters connection<br>boxes (formerly referred to as<br>D700 Diagnostic catheter<br>connection boxes): boxes with 16<br>optional input pin connectors.<br>5) KODEX-EPD™ RS connection<br>Boxes: boxes with 20 optional<br>output pin connectors.<br>6) Foot pedals<br>7) Keyboard and mouse<br>8) Cart (optional)<br>9) Gemalto key<br>10) Catheter key | 1) KODEX-EPD™ PU: Processing Unit<br>2) KODEX-EPD™-WS: Workstation<br>with Graphic User Interface<br>3) KODEX-EPD™ BS Pin Box:<br>a. Six inputs for body sensors.<br>b. One input pin for reference sensor<br>(right leg).<br>4) D700 Diagnostic catheters<br>connection boxes: boxes with 16<br>optional input pin connectors.<br>5) KODEX-EPD™ RS connection<br>Boxes: boxes with 20 optional<br>output pin connectors.<br>6) Foot pedals<br>7) Keyboard and mouse<br>8) Cart (optional) | |
| Patient Patches/<br>electrodes | Six (6) external sensors (formerly<br>referred to as patches) plus one (1)<br>right leg patch. | Six (6) external sensors plus one (1)<br>right leg sensor. | Same |
| Catheters | Compatible with off the shelf EP<br>catheters. | Compatible with off the shelf EP<br>catheters. | Same |
| Foot Pedals | Commercial foot pedals used for hands<br>free acquisition of points (Local<br>Activation Time and tagging points). | Commercial foot pedals used for hands<br>free acquisition of points (Local<br>Activation Time and tagging points). | Same |
| Technology | | | |
| Principles of operation | Mapping of electrical fields and<br>impedances (dielectric mapping):<br>Mapping of global induced electrical<br>fields and impedances (dielectric | Mapping of electrical fields and<br>impedances (dielectric mapping). | Same. The actual principles<br>of operation are identical,<br>however, the language for the<br>subject device has been |
| | Subject Device<br>KODEX – EPD™ System 1.5.0 | Predicate Device<br>KODEX – EPD™ System | Comments |
| | mapping) for intra-body localization.<br>Local interrogation of locally induced<br>electrical fields and impedances<br>(dielectric mapping) for electrode-tissue<br>interface characterization. | | revised in order to provide<br>additional explanation about<br>how the technology is used. |
| Location Technology | Impedance localization technology<br>(Dielectric); any catheter. | Impedance localization technology<br>(Dielectric); any catheter. | Same. The actual principles of<br>operation are identical,<br>however, the language for the<br>subject device has been<br>revised in order to provide<br>additional explanation about<br>how the technology is used. |
| 3D Geometry mapping by<br>aggregating catheter<br>location; Geometry<br>rotation and flexible<br>display | Yes, based on ablation and/or<br>diagnostic catheters, and Dielectric<br>technology. | Yes, based on ablation catheter and<br>Dielectric technology. | Same principle, the KODEX-<br>EPD 1.5.0 utilizes both<br>ablation and diagnostic<br>catheters that are pre-<br>qualified. |
| Flattened 3D view of the<br>whole cardiac chamber | Yes, PANO flattened chamber display. | Yes, PANO flattened chamber display. | Same |
| Simultaneous Navigation<br>of multiple catheters | Yes, one (1) off-the-shelf ablation<br>catheter and up to four (4) diagnostic<br>catheters. | Yes, one (1) off the shelf ablation<br>catheter and up to three (3) diagnostic<br>catheters. | The KODEX-EPD 1.5.0 has<br>been qualified for use with up<br>to four (4) diagnostic catheters<br>as opposed to three (3) for the<br>predicate device. The use of<br>up to four (4) catheters has<br>been verified and does not<br>raise any new questions of<br>safety or effectiveness. |
| Electrograms for<br>activation and voltage<br>mapping | Yes. Local Activation Time maps,<br>voltage maps and propagation maps. | Yes. Local Activation Time maps,<br>voltage maps and propagation maps. | Same |
| | Subject Device<br>KODEX – EPD™ System 1.5.0 | Predicate Device<br>KODEX – EPD™ System | Comments |
| Ablation parameter<br>visualization and tagging<br>tool | Yes. KODEX-EPD System 1.5.0<br>provides catheter stability, intracardiac<br>electrical activation information, and<br>during ablation, impedance drop and<br>temperature as read from the<br>radiofrequency (RF) generator.<br>Ablation point tagging is conducted<br>based on a user defined combination of<br>parameters and thresholds. In addition,<br>the KODEX-EPD System 1.5.0 provides<br>power, power integral over ablation time<br>and duration. | Yes. KODEX-EPD System provides<br>catheter stability, intracardiac electrical<br>activation information, and during<br>ablation, impedance drop and<br>temperature as read from the<br>radiofrequency (RF) generator.<br>Ablation point tagging is conducted<br>based on a user defined combination of<br>parameters and thresholds. In addition,<br>the KODEX-EPD System provides<br>power, power integral over ablation time<br>and duration. | Same |
| Compatibility with RF<br>generator | Yes, Stockert 70, Maestro 4000, and<br>SmartAblate. | Yes, Stockert 70 and Maestro 4000. | Both systems are compatible<br>with RF generators. |
| Tissue Engagement<br>Viewer | Tissue Engagement Viewer (TEV) is a<br>software feature which provides<br>information regarding the engagement<br>level of an ablation catheter with the<br>tissue by tracking catheter's proximity to<br>the tissue together with the real-time<br>change in local dielectrics. TEV is not<br>available for diagnostic catheters. The<br>tissue engagement viewer displays<br>visual feedback on the tissue<br>engagement of three (3) states: No<br>Touch (NT), Touch (T), High Touch<br>(HT).<br><br>TEV is active, following manual zeroing<br>in the blood pool when not in contact<br>with the myocardial wall, only when the<br>RF ablation is not in use. | | The TEV feature enables<br>verification that the catheter is<br>in close proximity and in the<br>desired engagement level with<br>the cardiac wall, facilitating<br>generation of improved and<br>more accurate anatomical<br>reconstruction as well as<br>electro-anatomical maps.<br>Refraining from acquiring<br>points in higher than desired<br>engagement level can prevent<br>tissue displacement or tenting<br>and negatively impacting<br>quality and correctness of<br>both reconstruction and<br>electro-anatomical maps.<br><br>The feature is based on the<br>same characteristics that exist<br>in the predicate device; local |
| Subject Device<br>KODEX – EPD™ System 1.5.0 | Predicate Device<br>KODEX – EPD™ System | Comments | |
| | | electrical fields and<br>impedances (dielectric<br>mapping) for electrode-tissue<br>interface characterization.<br>The feature is intended to<br>supplement common clinical<br>practice for real time<br>verification of catheter location<br>(e.g., inspection of IC signals<br>and annotations, fluoroscopy<br>or other imaging modality,<br>etc.). | |
| | | While the TEV feature utilizes<br>dielectric mapping to<br>additional visual feedback to<br>the user this additional<br>information does not raise any<br>new questions of safety or<br>effectiveness. | |
|…
