(197 days)
No
The summary describes a system that acquires and analyzes data to create 3D maps and display real-time catheter position and electrical activity. While this involves complex data processing and analysis, the description does not mention any terms or concepts typically associated with AI or ML, such as algorithms, learning, training data, or specific AI/ML techniques. The focus is on signal acquisition, processing, and display based on electromagnetic signals and standard EP catheters.
No
The device is a cardiac mapping system that provides information about the heart's electrical activity and catheter location for electrophysiological procedures, but it does not directly treat or alleviate a medical condition.
Yes
The device is indicated for catheter-based cardiac electrophysiological (EP) procedures to provide information about the electrical activity of the heart and catheter location, and to display 3D electro-anatomical maps of the heart, all of which are diagnostic functions.
No
The device description explicitly lists multiple hardware components including a Processing Unit, Pin Box, Connection Boxes, Workstation, Foot Pedal, and External Patches.
Based on the provided information, the KODEX-EPD™ System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is for "catheter-based cardiac electrophysiological (EP) procedures" and provides information about "electrical activity of the heart and about catheter location during the procedure." This describes a system used in vivo (within the living body) during a medical procedure, not a test performed in vitro (outside the living body) on biological samples.
- Device Description: The description details a system that acquires electromagnetic signals from catheters and external patches attached to the patient to create 3D maps and display real-time catheter position and electrical activity. This is consistent with an in vivo mapping and navigation system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.
Therefore, the KODEX-EPD™ System is a medical device used for in vivo cardiac mapping and navigation during EP procedures, not an IVD.
N/A
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.
Product codes
DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EP's and EP lab staff trained on the use of the system
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARTO 3 EP Navigation System (K133916)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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, 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
| Applicant: | Philips Medical Systems Nederland B.V.
Veenpluis 4, - 6, 5684 PC Best, Netherlands |
|----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Gina Crossetta
Vice President, Regulatory and Quality |
| | Phone: (845) 558-2772
Email: ginac@epd-medical.com |
| 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
Navigation System¹ | Comments |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| 510(k) | TBD | K133916 | N/A |
| Device class | II | II | Same |
| Classification | Programmable diagnostic-computer
Class II; 21 CFR, 870.1425 | Programmable diagnostic-computer
Class II; 21 CFR, 870.1425 | Same |
| Product code | DQK | DQK | Same |
| Indications/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. | 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. | Same |
| Intended users | EP's and EP lab staff trained on the use of
the system | EP's and EP lab staff trained on the use of
the system | Same |
| Physical Characteristics | | | |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP
Navigation System¹ | Comments |
| System Components | The KODEX – EPD™ system is comprised of the following components:
-
KODEX-EPD PU: Processing Unit
-
KODEX-EPD -WS: Workstation with Graphic User Interface
-
KODEX-EPD BS Pin Box:
a. Seven input pins for body patches.
b. One input pin for ground patch (right leg). -
D700 Diagnostic catheters connection boxes: boxes with 16 optional input pin connectors.
-
KODEX-EPD RS connection Boxes: boxes with 20 optional output pin connectors.
-
Foot pedals
-
Keyboard and mouse
-
Cart (optional) | The CARTO 3 system is comprised of the following components:
-
Patient Interface Unit (PIU)
-
Workstation with Graphic User Interface
-
Patches Connection Box and Cables
-
Intracardiac In Port
-
Intracardiac Out Port
-
Foot pedals
-
Keyboard, and mouse
-
Cart (optional)
-
Power Supply
-
Monitor
-
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.
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
Navigation System1 | Comments |
| | | | The KODEX System includes
the external patches while the
CARTO 3 patches are cleared
separately (K061468). This
doesn't raise any new
questions of safety or
effectiveness. The CARTO 3
patches are cleared separately
so that they may be used for
multiple devices. |
| Catheters | Compatible EP catheters | Specialized catheters with integrated
magnetic sensor; several compatible
diagnostic and therapeutic catheters | Same |
| Foot Pedals | Commercial foot pedals used for hands
free acquisition of points (Local
Activation Time and tagging points) | Foot pedals used for hands free
acquisition of points | Same |
| Technology | | | |
| Principles of operation | Mapping of electrical fields and
impedances (dielectric mapping) | Triangulation of magnetic fields (magnetic
technology) and impedance | Both systems achieve the
desired features (navigation,
accuracy, electroanatomical
mapping, etc) by mapping
impedance with either
electrical fields (KODEX) or
magnetic fields (CARTO 3). |
| Location Technology | Impedance localization technology
(Dielectric); any catheter | Magnetic sensor technology for location
and orientation of a specialized catheter
with magnet sensor on tip and impedance
localization | Both systems achieve the
desired features (navigation,
accuracy, electroanatomical
mapping, etc) by mapping
impedance with either
electrical fields (KODEX) or
magnetic fields (CARTO 3). |
| 3D Geometry mapping by
aggregating catheter
location: Geometry | Yes, based on ablation catheter and
Dielectric technology | Yes, based on diagnostic and ablation
catheters | Same |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP
Navigation System1 | Comments |
| rotation and flexible
display | | | |
| Flattened 3D view of the
whole cardiac chamber | Yes, PANOv flattened chamber display | No | The flattened chamber display
is an added feature provided
by KODEX but doesn't raise
new questions of safety or
effectiveness. It is simply an
additional, optional viewing
option that provides an
alternative depiction of the
chamber, but the standard
view provided by both systems
(i.e., without flattening)
remains the same, as shown in
the performance testing. |
| Simultaneous Navigation of
multiple catheters | Yes, 1 compatible ablation catheter and
up to 3 diagnostic catheters | Yes, 1 sensor enabled ablation catheter
and several diagnostic catheters. | Same |
| Electrograms for activation
and voltage mapping. | Yes. Local Activation Time maps, voltage
maps and propagation maps | Yes, Local Activation Time maps,
impedance maps and propagation maps | Both systems provide
electroanatomical maps. The
maps provided by the KODEX
System are a subset of those
provided by CARTO, and they
are the most widely used. |
| Ablation parameter
visualization and tagging
tool | Yes. KODEX provides catheter stability,
intracardiac electrical activation
information, and during ablation,
impedance drop and temperature as read
from the RF generator. Ablation point
tagging is conducted based on a user
defined combination of parameters and
thresholds. In addition the KODEX system
provides power, power integral over
ablation time and duration. | Yes, optional (Visitag Module). CARTO 3
provides catheter stability, contact force,
intracardiac electrical activation
information, and during ablation,
impedance drop and temperature as read
from the RF generator. Ablation point
tagging is conducted based on a user
defined combination of parameters and
thresholds. | Both systems display RF
generator communicated
parameters. Both systems
provide catheter stability,
intracardiac electrical
activation information, and
during ablation, impedance
drop and temperature as read
from the RF generator.
Ablation point tagging is
conducted based on a user |
| | KODEX – EPD™ Mapping System | Biosense Webster's CARTO 3 EP
Navigation System1 | Comments |
| | | | defined combination of
parameters and thresholds.
While the KODEX System
provides some additional
parameters not provided by
CARTO (power, power integral
over ablation time, and
duration), and CARTO 3
provides one additional
parameter (contact force),
these provide the physician
with additional information
but do not raise new questions
of safety or effectiveness.
Based on performance testing
conducted these additional
features perform as intended. |
| Compatibility with RF
generator | Yes, Stockert 70 and Maestro 4000 | Yes | Both systems are compatible
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.