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 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.

AI/ML Overview

The provided document, a 510(k) Summary for the KODEX-EPD™ System 1.5.0, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed acceptance criteria table with specific quantitative performance metrics like sensitivity, specificity, or AUC, as might be found in a study for an AI-driven diagnostic device.

The KODEX-EPD™ System 1.5.0 is a cardiac mapping and navigation system that provides real-time 3D electro-anatomical maps of the heart and catheter location. This is a medical device that generates data for clinical interpretation, rather than an AI or CADe/CADx device that interprets medical images or data. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of meeting design specifications, demonstrating functionality, and showing substantial equivalence to a legally marketed predicate device.

However, I can extract the relevant information from the document that addresses the spirit of your request, adapting it to the nature of this particular device's submission. The document emphasizes functional performance and safety as the primary acceptance criteria for the new features (Cryo Occlusion Viewer and Tissue Engagement Viewer) and the updated system.

Here's an attempt to present the information structured according to your request, with the understanding that the "acceptance criteria" are more about functionality and safety in this context:

Acceptance Criteria and Study for KODEX-EPD™ System 1.5.0

The acceptance criteria for the KODEX-EPD™ System 1.5.0, particularly for its new features (Cryo Occlusion Viewer and Tissue Engagement Viewer), are primarily focused on functionality, accuracy in providing supplemental information, and ensuring that these new features do not raise new questions of safety or effectiveness compared to the predicate device. The studies conducted were verification and validation tests aligned with these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Functional/Safety)	Reported Device Performance / Study Finding
System Functionality	- Meets design specifications	"The testing demonstrated that the product meets its performance specifications and performs as intended."
	- Performs as intended	"The KODEX-EPD™ System 1.5.0 was found to be substantially equivalent to the predicate and reference devices."
Cryo Occlusion Viewer	- Software requirements met	"verified through system software verification that demonstrated that the software requirements specifications were met"
	- Regression testing passed (no impact on functionality)	"regression testing that demonstrated that the system functionality was not impacted by upgrade to version 1.5.0."
	- Compatibility & interoperability with Medtronic Achieve Catheter	"verification of the compatibility and interoperability of the Medtronic Achieve Catheter when connected to the KODEX-EPD™ System."
	- Validation of occlusion status	"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."
	- Meets specifications & performs as intended	"Verification and validation testing demonstrated that the Cryo Occlusion viewer met its specifications and performed as intended."
Tissue Engagement Viewer (TEV)	- Indicate catheter tip touch status (Touch/No Touch/High Touch)	"assessed on the bench to verify the capability to indicate if the catheter tip touches the tissue or not"
	- Indicate touch level with low latency (up to 1 second)	"indicate the touch level in latency up to 1 second"
	- Indicate high force touch	"to indicate if the catheter tip touches the tissue with high force."
	- Validated in animal study (compared to clinical standards)	"validated in an acute GLP animal study in which the clinician first established contact guided 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."
	- Meets specifications & performs as intended	"Verification and validation testing demonstrated that the TEV feature met its specifications and performed as intended."
Safety & Effectiveness	- No new questions of safety or effectiveness compared to predicate	"The only 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."

2. Sample Sizes Used for the Test Set and Data Provenance

Due to the nature of the device (a medical system for creating maps/location, not a diagnostic AI), specific "test set" sample sizes in the typical AI sense (e.g., number of images or cases for classification) are not explicitly detailed. Instead, the testing involved:

Cryo Occlusion Viewer:
- Retrospective analysis of KODEX-EPD™ cases: The exact number of cases is not specified in the document.
- Acute animal study: The number of animals is not specified.
- Summative usability study: The number of participants/cases is not specified.
- Data Provenance: Not explicitly stated, but clinical cases likely from a medical center where KODEX-EPD™ is used. Retrospective implies existing data.
Tissue Engagement Viewer (TEV):
- Acute GLP animal study: The number of animals is not specified.
- Data Provenance: Not explicitly stated beyond "animal study."
General System Testing:
- Bench testing, software verification/validation, EMC testing, Electrical Safety Testing, Usability testing. Specific sample sizes (e.g., number of test runs, number of usability participants) are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Cryo Occlusion Viewer: "KODEX occlusion status was compared to venography." This implies venography served as a ground truth or reference standard. The number or qualifications of experts interpreting the venography or other clinical data for the retrospective analysis is not specified.
Tissue Engagement Viewer (TEV): "clinician first established contact guided by clinical standards (fluoroscopy, EGM, impedance, ICE)." This indicates that experienced clinicians judging by established clinical methods served as the "ground truth" for the animal study. The number or specific qualifications of these clinicians are not specified.

4. Adjudication Method for the Test Set

Explicit adjudication methods (e.g., 2+1, 3+1 for discordant reads) are NOT mentioned.
For the Cryo Occlusion Viewer, the comparison was made against venography, suggesting a direct comparison rather than a human consensus process for ground truth.
For the TEV, the animal study relied on "clinician-established contact guided by clinical standards." This inherently involves expert judgment but without a specified formal adjudication process for multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was NOT done to compare human readers with vs. without AI assistance. This device is not an AI-driven image interpretation tool in that typical sense. It is a system that generates mapping data and provides additional information (TEV, Cryo Occlusion Viewer) to the clinician. The new features supplement existing clinical practice rather than replacing or directly assisting in complex diagnostic interpretation in an MRMC comparative method.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in spirit, elements of standalone performance were evaluated for the features of the device.
- Cryo Occlusion Viewer: Verified through software verification and compatibility/interoperability testing. Its "validation" involved comparing its output (occlusion status) to venography, which is akin to evaluating the algorithm's output against a reference.
- Tissue Engagement Viewer (TEV): 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." This is an algorithm-only performance evaluation of its core functionality before human-in-the-loop validation.

7. The Type of Ground Truth Used

Cryo Occlusion Viewer: Compared to venography (a gold standard imaging technique for confirming occlusion) and other unnamed appropriate visualization techniques. Implicitly, clinical outcomes from the retrospective cases also contribute to validation.
Tissue Engagement Viewer (TEV): Ground truth was established by clinicians guided by established clinical standards (fluoroscopy, EGM, impedance, ICE) in an animal model. This is a form of expert consensus based on established clinical practice.
For general system performance, internal design specifications and regulatory standards (IEC, ANSI/AAMI) serve as the "ground truth" for verification.

8. The Sample Size for the Training Set

This device is not an AI/ML model that explicitly undergoes "training" on a distinct dataset in the way a deep learning classification model would. It's a deterministic system whose new features are based on impedance/dielectric mapping principles.
Therefore, there is no "training set" in the context of AI/ML model development. The system's underlying algorithms are based on established biophysical principles, not learned from data in an iterative training process.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense, this question is not applicable. The "ground truth" for the development of the system's principles and algorithms would be fundamental physics, physiology, and engineering principles validated through design and verification testing.

Summary

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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

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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)

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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510(k) SUMMARY KODEX-EPD™ System 1.5.0

Submitter:	Philips Medical Systems Nederland B.V. (d/b/a EPD SolutionsVeenpluis 6, 5684 PC Best, Netherlands
Contact Person:	Betina SchepersHead of QualityEPD Solutions+31 611 710 116Betina.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

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 DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – 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 isindicated for catheter-based cardiacelectrophysiological (EP)procedures. The KODEX-EPD™System 1.5.0 provides informationabout the electrical activity of theheart and about catheter locationduring the procedure. The systemcan be used on patients who areeligible for a conventionalelectrophysiological procedure.	The KODEX-EPD™ System is indicatedfor catheter-based cardiacelectrophysiological (EP) procedures.The KODEX-EPD™ System providesinformation about the electrical activityof the heart and about catheter locationduring the procedure. The system canbe used on patients who are eligible fora conventional electrophysiologicalprocedure.	Same
Intended users	EP's and EP lab staff trained on the useof the system.	EP's and EP lab staff trained on the useof the system.	Same
Physical Characteristics
	Subject DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – EPD™ System	Comments
System Components	The KODEX – EPD™ System 1.5.0 iscomprised of the following components:	The KODEX – EPD™ System iscomprised of the following components:	Identical components exceptthat the subject deviceincludes use of a Gemalto keyand catheter key. TheGemalto key encrypts thesoftware. The catheter key isa stand-alone connectorspecific to the type of catheterto be used by the customer.The keys serve commercialpurposes and have no impacton the clinical functionality orperformance of the system.
	1) KODEX-EPD™ PU: Processing Unit2) KODEX-EPD™-WS: Workstationwith Graphic User Interface3) KODEX-EPD™ BS Pin Box:a. Seven input pins for body patches.b. One input pin for ground patch(right leg).4) Diagnostic catheters connectionboxes (formerly referred to asD700 Diagnostic catheterconnection boxes): boxes with 16optional input pin connectors.5) KODEX-EPD™ RS connectionBoxes: boxes with 20 optionaloutput pin connectors.6) Foot pedals7) Keyboard and mouse8) Cart (optional)9) Gemalto key10) Catheter key	1) KODEX-EPD™ PU: Processing Unit2) KODEX-EPD™-WS: Workstationwith Graphic User Interface3) KODEX-EPD™ BS Pin Box:a. Six inputs for body sensors.b. One input pin for reference sensor(right leg).4) D700 Diagnostic cathetersconnection boxes: boxes with 16optional input pin connectors.5) KODEX-EPD™ RS connectionBoxes: boxes with 20 optionaloutput pin connectors.6) Foot pedals7) Keyboard and mouse8) Cart (optional)
Patient Patches/electrodes	Six (6) external sensors (formerlyreferred 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 EPcatheters.	Compatible with off the shelf EPcatheters.	Same
Foot Pedals	Commercial foot pedals used for handsfree acquisition of points (LocalActivation Time and tagging points).	Commercial foot pedals used for handsfree acquisition of points (LocalActivation Time and tagging points).	Same
Technology
Principles of operation	Mapping of electrical fields andimpedances (dielectric mapping):Mapping of global induced electricalfields and impedances (dielectric	Mapping of electrical fields andimpedances (dielectric mapping).	Same. The actual principlesof operation are identical,however, the language for thesubject device has been
	Subject DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – EPD™ System	Comments
	mapping) for intra-body localization.Local interrogation of locally inducedelectrical fields and impedances(dielectric mapping) for electrode-tissueinterface characterization.		revised in order to provideadditional explanation abouthow the technology is used.
Location Technology	Impedance localization technology(Dielectric); any catheter.	Impedance localization technology(Dielectric); any catheter.	Same. The actual principles ofoperation are identical,however, the language for thesubject device has beenrevised in order to provideadditional explanation abouthow the technology is used.
3D Geometry mapping byaggregating catheterlocation; Geometryrotation and flexibledisplay	Yes, based on ablation and/ordiagnostic catheters, and Dielectrictechnology.	Yes, based on ablation catheter andDielectric technology.	Same principle, the KODEX-EPD 1.5.0 utilizes bothablation and diagnosticcatheters that are pre-qualified.
Flattened 3D view of thewhole cardiac chamber	Yes, PANO flattened chamber display.	Yes, PANO flattened chamber display.	Same
Simultaneous Navigationof multiple catheters	Yes, one (1) off-the-shelf ablationcatheter and up to four (4) diagnosticcatheters.	Yes, one (1) off the shelf ablationcatheter and up to three (3) diagnosticcatheters.	The KODEX-EPD 1.5.0 hasbeen qualified for use with upto four (4) diagnostic cathetersas opposed to three (3) for thepredicate device. The use ofup to four (4) catheters hasbeen verified and does notraise any new questions ofsafety or effectiveness.
Electrograms foractivation and voltagemapping	Yes. Local Activation Time maps,voltage maps and propagation maps.	Yes. Local Activation Time maps,voltage maps and propagation maps.	Same
	Subject DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – EPD™ System	Comments
Ablation parametervisualization and taggingtool	Yes. KODEX-EPD System 1.5.0provides catheter stability, intracardiacelectrical activation information, andduring ablation, impedance drop andtemperature as read from theradiofrequency (RF) generator.Ablation point tagging is conductedbased on a user defined combination ofparameters and thresholds. In addition,the KODEX-EPD System 1.5.0 providespower, power integral over ablation timeand duration.	Yes. KODEX-EPD System providescatheter stability, intracardiac electricalactivation information, and duringablation, impedance drop andtemperature as read from theradiofrequency (RF) generator.Ablation point tagging is conductedbased on a user defined combination ofparameters and thresholds. In addition,the KODEX-EPD System providespower, power integral over ablation timeand duration.	Same
Compatibility with RFgenerator	Yes, Stockert 70, Maestro 4000, andSmartAblate.	Yes, Stockert 70 and Maestro 4000.	Both systems are compatiblewith RF generators.
Tissue EngagementViewer	Tissue Engagement Viewer (TEV) is asoftware feature which providesinformation regarding the engagementlevel of an ablation catheter with thetissue by tracking catheter's proximity tothe tissue together with the real-timechange in local dielectrics. TEV is notavailable for diagnostic catheters. Thetissue engagement viewer displaysvisual feedback on the tissueengagement of three (3) states: NoTouch (NT), Touch (T), High Touch(HT).TEV is active, following manual zeroingin the blood pool when not in contactwith the myocardial wall, only when theRF ablation is not in use.		The TEV feature enablesverification that the catheter isin close proximity and in thedesired engagement level withthe cardiac wall, facilitatinggeneration of improved andmore accurate anatomicalreconstruction as well aselectro-anatomical maps.Refraining from acquiringpoints in higher than desiredengagement level can preventtissue displacement or tentingand negatively impactingquality and correctness ofboth reconstruction andelectro-anatomical maps.The feature is based on thesame characteristics that existin the predicate device; local
Subject DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – EPD™ System	Comments
		electrical fields andimpedances (dielectricmapping) for electrode-tissueinterface characterization.The feature is intended tosupplement common clinicalpractice for real timeverification of catheter location(e.g., inspection of IC signalsand annotations, fluoroscopyor other imaging modality,etc.).
		While the TEV feature utilizesdielectric mapping toadditional visual feedback tothe user this additionalinformation does not raise anynew questions of safety oreffectiveness.
	Subject DeviceKODEX – EPD™ System 1.5.0	Predicate DeviceKODEX – EPD™ System	Comments
Cryo Occlusion Viewer	Pulmonary Vein (PV) occlusion statederived from local change in dielectricsread off the spiral mapping catheter'selectrodes, placed inside the PV, whenthe cryoballoon is inflated at the PVostium and/or when dye is beinginjected.PV occlusion assessment is intended tobe used as additional method to confirmocclusion, next to contrast injection andother appropriate visualizationtechniques as described in thecryoballoon technical manual.The feature facilitates cryoballoonPulmonary Vein Isolation procedureswithout modifying or replacing therecommended workflow and byproviding an additional method toconfirm pulmonary vein occlusion.		The KODEX-EPD™ System1.5.0 tracks and localizes theAchieve Spiral MappingCatheter, and generates adetailed 3D and panoramicimage and an electro-anatomical map of the leftatrium and adjacentpulmonary veins, using (1) thesame first induced intra-bodyglobal electrical fieldgenerated by the body surfacesensors, (2) the same rawsignals, and (3) the sameintra-body tracking,navigation, imaging, andelectro-anatomical mappingtechnology as the predicatedevice.The subject device uses thesame characteristic dielectricchange in field shape andtissue signature and the sametechnology (i.e., continuouslyinterrogating locally thechange in electrical fields) asthe predicate device toprovide additional insightabout PV occlusion state andcryoballoon appositioning.This feature does not raiseany new questions off safetyor 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.

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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).

Regulation Number and Section

§ 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).