(441 days)
Not Found
No
The description focuses on signal acquisition, analysis, and 3D mapping based on electromagnetic signals and electrical activity, without mentioning AI or ML algorithms for these processes. The performance studies also do not describe AI/ML model training or validation.
No
The device is a diagnostic tool that provides information about the heart's electrical activity and catheter location; it does not explicitly state that it treats a disease or condition.
Yes
The device is a diagnostic device because it provides information about the electrical activity of the heart and catheter location, and displays 3D electro-anatomical maps of the heart, all of which are used to aid in diagnosis or understanding of a patient's condition.
No
The device description explicitly states it is a "catheter-based cardiac mapping system" that acquires information using "standard electrophysiological (EP) catheters and proprietary external sensors." It also mentions "electromagnetic signals from all sensors and electrodes attached to it." This indicates the system includes significant hardware components beyond just software.
Based on the provided information, the KODEX-EPD™ System 1.5.0 is not an In Vitro Diagnostic (IVD) device.
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 device used to examine specimens in vitro (outside the living body).
- Device Description: The description details how the system acquires electromagnetic signals from sensors and electrodes attached to the patient to create 3D images 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 specimens (like blood, urine, tissue samples, etc.) or performing tests on these specimens outside the body, which are hallmarks of IVD devices.
The KODEX-EPD™ System 1.5.0 is a medical device used for cardiac mapping and navigation during EP procedures, which is an in vivo application.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DOK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart, cardiac chambers, left atrium and adjacent pulmonary veins
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 1.5.0 meets its design specifications and is substantially equivalent to the predicate and reference devices. Specifically, the following bench and animal testing was conducted:
- KODEX EPD™ System 1.5.0 verification testing .
- Software verification and validation (IEC 62304)
- . Electromagnetic Compatibility (IEC 60601-1-2, IEC 60601-2-27)
- Electrical Safety Testing (ANSI/AAMI ES 60601-1. IEC 62366. IEC 62304)
- GLP animal study ●
- Usability testing
- . The Cryo Occlusion Viewer was verified through system software verification that demonstrated that the software requirements specifications were met, regression testing that demonstrated that the system functionality was not impacted by upgrade to version 1.5.0., verification of the Cryo Occlusion Viewer and verification of the compatibility and interoperability of the Medtronic Achieve Catheter when connected to the KODEX-EPD™ System. In addition, the Cryo Occlusion Viewer was validated through retrospective analysis of KODEX-EPD™ cases for which KODEX occlusion status was compared to venography, an acute animal study and as part of a summative usability study. Verification and validation testing demonstrated that the Cryo Occlusion viewer met its specifications and performed as intended.
- . The Tissue Engagement Viewer (TEV) was assessed on the bench to verify the capability to indicate if the catheter tip touches the tissue or not, indicate the touch level in latency up to 1 second and to indicate if the catheter tip touches the tissue with high force. The feature was validated in an acute GLP animal study in which the clinician first established contact quided by clinical standards (fluoroscopy. EGM, impedance, ICE) and then verified TEV utilizing KODEX-EPD™ SW 1.5.0. At each location the engagement was increased from no touch, to touch to high touch based on these standards and then compared TEV on KODEX-EPD™ SW v.1.5.0. Verification and validation testing demonstrated that the TEV feature met its specifications and performed as intended.
The testing demonstrated that the product meets its performance specifications and performs as intended. In addition, the KODEX – EPD™ System 1.5.0 was found to be substantially equivalent to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, 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
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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) | |
|---|---|
| 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 KODEX-EPD™ System 1.5.0
| Submitter: | Philips Medical Systems Nederland B.V. (d/b/a EPD Solutions
Veenpluis 6, 5684 PC Best, Netherlands |
|-----------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Betina Schepers
Head of Quality
EPD Solutions
+31 611 710 116
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.
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| Regulatory | Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K212493 | K180940 | N/A |
| Device class | Class II | Class II | Same |
| Classification | Programmable diagnostic computer;
21 CFR 870.1425 | Programmable diagnostic computer;
21 CFR 870.1425 | Same |
| Product code | DQK | DQK | Same |
| Indications/Intended 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. | 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. | 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 | | | |
| | Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments |
| System Components | The KODEX – EPD™ System 1.5.0 is
comprised of the following components: | The KODEX – EPD™ System is
comprised of the following components: | Identical components except
that the subject device
includes use of a Gemalto key
and catheter key. The
Gemalto key encrypts the
software. The catheter key is
a stand-alone connector
specific to the type of catheter
to be used by the customer.
The keys serve commercial
purposes and have no impact
on the clinical functionality or
performance of the system. |
| | 1) KODEX-EPD™ PU: Processing Unit
2) KODEX-EPD™-WS: Workstation
with Graphic User Interface
3) KODEX-EPD™ BS Pin Box:
a. Seven input pins for body patches.
b. One input pin for ground patch
(right leg).
4) Diagnostic catheters connection
boxes (formerly referred to as
D700 Diagnostic catheter
connection boxes): boxes with 16
optional input pin connectors.
5) KODEX-EPD™ RS connection
Boxes: boxes with 20 optional
output pin connectors.
6) Foot pedals
7) Keyboard and mouse
8) Cart (optional)
9) Gemalto key
10) Catheter key | 1) KODEX-EPD™ PU: Processing Unit
2) KODEX-EPD™-WS: Workstation
with Graphic User Interface
3) KODEX-EPD™ BS Pin Box:
a. Six inputs for body sensors.
b. One input pin for reference sensor
(right leg).
4) D700 Diagnostic catheters
connection boxes: boxes with 16
optional input pin connectors.
5) KODEX-EPD™ RS connection
Boxes: boxes with 20 optional
output pin connectors.
6) Foot pedals
7) Keyboard and mouse
8) Cart (optional) | |
| Patient Patches/
electrodes | Six (6) external sensors (formerly
referred to as patches) plus one (1)
right leg patch. | Six (6) external sensors plus one (1)
right leg sensor. | Same |
| Catheters | Compatible with off the shelf EP
catheters. | Compatible with off the shelf EP
catheters. | Same |
| Foot Pedals | Commercial foot pedals used for hands
free acquisition of points (Local
Activation Time and tagging points). | Commercial foot pedals used for hands
free acquisition of points (Local
Activation Time and tagging points). | Same |
| Technology | | | |
| Principles of operation | Mapping of electrical fields and
impedances (dielectric mapping):
Mapping of global induced electrical
fields and impedances (dielectric | Mapping of electrical fields and
impedances (dielectric mapping). | Same. The actual principles
of operation are identical,
however, the language for the
subject device has been |
| | Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments |
| | mapping) for intra-body localization.
Local interrogation of locally induced
electrical fields and impedances
(dielectric mapping) for electrode-tissue
interface characterization. | | revised in order to provide
additional explanation about
how the technology is used. |
| Location Technology | Impedance localization technology
(Dielectric); any catheter. | Impedance localization technology
(Dielectric); any catheter. | Same. The actual principles of
operation are identical,
however, the language for the
subject device has been
revised in order to provide
additional explanation about
how the technology is used. |
| 3D Geometry mapping by
aggregating catheter
location; Geometry
rotation and flexible
display | Yes, based on ablation and/or
diagnostic catheters, and Dielectric
technology. | Yes, based on ablation catheter and
Dielectric technology. | Same principle, the KODEX-
EPD 1.5.0 utilizes both
ablation and diagnostic
catheters that are pre-
qualified. |
| Flattened 3D view of the
whole cardiac chamber | Yes, PANO flattened chamber display. | Yes, PANO flattened chamber display. | Same |
| Simultaneous Navigation
of multiple catheters | Yes, one (1) off-the-shelf ablation
catheter and up to four (4) diagnostic
catheters. | Yes, one (1) off the shelf ablation
catheter and up to three (3) diagnostic
catheters. | The KODEX-EPD 1.5.0 has
been qualified for use with up
to four (4) diagnostic catheters
as opposed to three (3) for the
predicate device. The use of
up to four (4) catheters has
been verified and does not
raise any new questions of
safety or effectiveness. |
| Electrograms for
activation and voltage
mapping | Yes. Local Activation Time maps,
voltage maps and propagation maps. | Yes. Local Activation Time maps,
voltage maps and propagation maps. | Same |
| | Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments |
| Ablation parameter
visualization and tagging
tool | Yes. KODEX-EPD System 1.5.0
provides catheter stability, intracardiac
electrical activation information, and
during ablation, impedance drop and
temperature as read from the
radiofrequency (RF) generator.
Ablation point tagging is conducted
based on a user defined combination of
parameters and thresholds. In addition,
the KODEX-EPD System 1.5.0 provides
power, power integral over ablation time
and duration. | Yes. KODEX-EPD System provides
catheter stability, intracardiac electrical
activation information, and during
ablation, impedance drop and
temperature as read from the
radiofrequency (RF) generator.
Ablation point tagging is conducted
based on a user defined combination of
parameters and thresholds. In addition,
the KODEX-EPD System provides
power, power integral over ablation time
and duration. | Same |
| Compatibility with RF
generator | Yes, Stockert 70, Maestro 4000, and
SmartAblate. | Yes, Stockert 70 and Maestro 4000. | Both systems are compatible
with RF generators. |
| Tissue Engagement
Viewer | Tissue Engagement Viewer (TEV) is a
software feature which provides
information regarding the engagement
level of an ablation catheter with the
tissue by tracking catheter's proximity to
the tissue together with the real-time
change in local dielectrics. TEV is not
available for diagnostic catheters. The
tissue engagement viewer displays
visual feedback on the tissue
engagement of three (3) states: No
Touch (NT), Touch (T), High Touch
(HT).
TEV is active, following manual zeroing
in the blood pool when not in contact
with the myocardial wall, only when the
RF ablation is not in use. | | The TEV feature enables
verification that the catheter is
in close proximity and in the
desired engagement level with
the cardiac wall, facilitating
generation of improved and
more accurate anatomical
reconstruction as well as
electro-anatomical maps.
Refraining from acquiring
points in higher than desired
engagement level can prevent
tissue displacement or tenting
and negatively impacting
quality and correctness of
both reconstruction and
electro-anatomical maps.
The feature is based on the
same characteristics that exist
in the predicate device; local |
| Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments | |
| | | electrical fields and
impedances (dielectric
mapping) for electrode-tissue
interface characterization.
The feature is intended to
supplement common clinical
practice for real time
verification of catheter location
(e.g., inspection of IC signals
and annotations, fluoroscopy
or other imaging modality,
etc.). | |
| | | While the TEV feature utilizes
dielectric mapping to
additional visual feedback to
the user this additional
information does not raise any
new questions of safety or
effectiveness. | |
| | Subject Device
KODEX – EPD™ System 1.5.0 | Predicate Device
KODEX – EPD™ System | Comments |
| Cryo Occlusion Viewer | Pulmonary Vein (PV) occlusion state
derived from local change in dielectrics
read off the spiral mapping catheter's
electrodes, placed inside the PV, when
the cryoballoon is inflated at the PV
ostium and/or when dye is being
injected.
PV occlusion assessment is intended to
be used as additional method to confirm
occlusion, next to contrast injection and
other appropriate visualization
techniques as described in the
cryoballoon technical manual.
The feature facilitates cryoballoon
Pulmonary Vein Isolation procedures
without modifying or replacing the
recommended workflow and by
providing an additional method to
confirm pulmonary vein occlusion. | | The KODEX-EPD™ System
1.5.0 tracks and localizes the
Achieve Spiral Mapping
Catheter, and generates a
detailed 3D and panoramic
image and an electro-
anatomical map of the left
atrium and adjacent
pulmonary veins, using (1) the
same first induced intra-body
global electrical field
generated by the body surface
sensors, (2) the same raw
signals, and (3) the same
intra-body tracking,
navigation, imaging, and
electro-anatomical mapping
technology as the predicate
device.
The subject device uses the
same characteristic dielectric
change in field shape and
tissue signature and the same
technology (i.e., continuously
interrogating locally the
change in electrical fields) as
the predicate device to
provide additional insight
about PV occlusion state and
cryoballoon appositioning.
This feature does not raise
any new questions off safety
or effectiveness. |
Table 1: Comparison of Technological Characteristics for the KODEX – EPD™ System 1.5.0 and Predicate Device
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Substantial Equivalence Discussion:
The KODEX-EPD™ System 1.5.0 has the same intended use as the legally marketed predicate and reference devices. The indications for use for the KODEX - EPD™ System 1,5,0 is identical to the proposed indications for use for the predicate device and nearly identical to the indications for use for the reference device. 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 1.5.0 is substantially equivalent to the predicate and reference devices.
Performance Data
The company conducted extensive bench and animal testing which demonstrated that the KODEX -EPD™ System 1.5.0 meets its design specifications and is substantially equivalent to the predicate and reference devices. Specifically, the following bench and animal testing was conducted:
- KODEX EPD™ System 1.5.0 verification testing .
- Software verification and validation (IEC 62304)
- . Electromagnetic Compatibility (IEC 60601-1-2, IEC 60601-2-27)
- Electrical Safety Testing (ANSI/AAMI ES 60601-1. IEC 62366. IEC 62304)
- GLP animal study ●
- Usability testing
- . The Cryo Occlusion Viewer was verified through system software verification that demonstrated that the software requirements specifications were met, regression testing that demonstrated that the system functionality was not impacted by upgrade to version 1.5.0., verification of the Cryo Occlusion Viewer and verification of the compatibility and interoperability of the Medtronic Achieve Catheter when connected to the KODEX-EPD™ System. In addition, the Cryo Occlusion Viewer was validated through retrospective analysis of KODEX-EPD™ cases for which KODEX occlusion status was compared to venography, an acute animal study and as part of a summative usability study. Verification and validation testing demonstrated that the Cryo Occlusion viewer met its specifications and performed as intended.
- . The Tissue Engagement Viewer (TEV) was assessed on the bench to verify the capability to indicate if the catheter tip touches the tissue or not, indicate the touch level in latency up to 1 second and to indicate if the catheter tip touches the tissue with high force. The feature was validated in an acute GLP animal study in which the clinician first established contact quided by clinical standards (fluoroscopy. EGM, impedance, ICE) and then verified TEV utilizing KODEX-EPD™ SW 1.5.0. At each location the engagement was increased from no touch, to touch to high touch based on these standards and then compared TEV on KODEX-EPD™ SW v.1.5.0. Verification and validation testing demonstrated that the TEV feature met its specifications and performed as intended.
11
The testing demonstrated that the product meets its performance specifications and performs as intended. In addition, the KODEX – EPD™ System 1.5.0 was found to be substantially equivalent to the predicate and reference devices.
Conclusions
After analyzing the intended use/indications for use, technological characteristics (including fundamental operating principle, functional characteristics, design features and performance characteristics) and labeling, the Company has concluded that the subject device, the KODEX-EPD™ System 1.5.0, is substantially equivalent to the predicate device. The only technological differences between the KODEX - EPD™ System 1.5.0 and its predicate device are the Cryo Occlusion Viewer and Tissue Engagement Viewer. These technological differences do not present different questions of safety or effectiveness as compared to the legally marketed predicate device because the features are only intended to provide the physician with additional information which supplements common clinical practice. Thus, the KODEX - EPD™ System 1.5.0 is substantially equivalent to the KODEX -EPD™ System, cleared in October 2018 (K180940).