The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.

Device 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.

AI/ML Overview

The provided text describes the KODEX-EPD™ System and its FDA 510(k) clearance, establishing substantial equivalence to a predicate device (CARTO 3 EP Navigation System). The document focuses on regulatory equivalence rather than a study demonstrating the device's adherence to specific AI performance acceptance criteria, as one might expect for an AI/ML-driven diagnostic device.

Based on the provided text, the KODEX-EPD™ System is described as 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." It also "supports representation of the electrical activity of cardiac chambers." The device's primary function as described is mapping and navigation, rather than an AI-driven diagnostic interpretation. Therefore, the "acceptance criteria" and "device performance" would relate to the accuracy and reliability of its physiological measurements and mapping capabilities, not AI-specific metrics like sensitivity, specificity, or AUC for classification.

Crucially, the document does not explicitly state that the KODEX-EPD™ System uses Artificial Intelligence (AI) or Machine Learning (ML) for its core functionality of acquiring, analyzing, or displaying data. The "Programmable Diagnostic Computer" classification and description of its operation suggest it processes electromagnetic signals and electrophysiological data, which can be complex but not necessarily "AI" in the modern interpretative sense (e.g., image classification, natural language processing).

Given this, I cannot directly provide information on acceptance criteria and study details for an AI-driven device based on the provided text. The "Performance Data" section discusses general device verification and validation, but not the specific metrics typically associated with AI performance validation (e.g., sensitivity, specificity, accuracy, F1-score).

However, I can extract information related to the device's performance validation in general, as presented in the text.

Here's an attempt to answer your questions based solely on the provided text, interpreting "acceptance criteria" and "device performance" in the context of a medical device claiming substantial equivalence to a predicate, rather than an AI device:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria (e.g., specific accuracy thresholds for mapping) or reported performance metrics (e.g., mean mapping error, precision of catheter localization) for the KODEX-EPD™ System. Instead, it states that "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."

General Statement on Performance:
"The testing demonstrated that the product meets its performance specifications and performs as intended."
"This collection of testing demonstrates the safety and effectiveness of the KODEX – EPD™ System its substantial equivalence to the predicate device."

Implicit "Acceptance Criteria" (Substantial Equivalence):
The core acceptance criterion for FDA 510(k) clearance in this context is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the KODEX-EPD™ System has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

The document lists "extensive bench and animal testing" and "GLP animal study" as conducted.

Test Set Sample Size: Not specified for any particular test.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted by the applicant, Philips Medical Systems Nederland B.V.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. The device's performance validation (meeting design specifications, safety, effectiveness) would likely involve engineering verification and validation, and animal studies, not expert-labeled ground truth in the way it's used for AI diagnostic systems (e.g., radiologists labeling images).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. This concept typically applies to human expert review for establishing ground truth in AI studies, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not mentioned. The KODEX-EPD™ System as described is a mapping and navigation system, not an AI-assisted diagnostic tool that aids human "readers" (e.g., interpreting images). Therefore, a MRMC study of this nature would not be relevant to the device's described function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is inherently "human-in-the-loop" as it's an interactive diagnostic computer used during medical procedures. The document does not describe any "algorithm-only" performance metrics in the way one would for an AI diagnostic algorithm like an image classifier. The performance studies mentioned (bench, animal) validate the integrated system's functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The documentation refers to "design specifications" and "performance specifications" as the benchmarks. For the animal study, it would be based on physiological measurements and direct observation. For bench testing, it would be engineering tolerances and established physical principles. There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for validation in the typical sense of AI diagnostics.

8. The sample size for the training set

Not applicable. The document does not indicate the use of AI/ML models that would require a "training set." The system's functionality as described appears to be based on established physics and algorithms rather than learned patterns from a training dataset.

9. How the ground truth for the training set was established

Not applicable, as a training set for an AI/ML model is not mentioned.

Summary based on the provided text:

The provided document (FDA 510(k) clearance letter and summary) focuses on demonstrating substantial equivalence for the KODEX-EPD™ System to a predicate device. It describes the device's intended use, technological characteristics, and general performance validation activities (bench testing, animal studies, software verification, safety, EMC, etc.).

There is no indication or description of the KODEX-EPD™ System employing Artificial Intelligence or Machine Learning for its core functions of data analysis or display in a way that would require specific AI-centric acceptance criteria (e.g., sensitivity, specificity for a diagnostic task), nor are there details of studies (e.g., MRMC studies, training/test set splits with expert ground truth) typically associated with validating AI/ML-driven medical devices. The "Programmable Diagnostic Computer" classification suggests it processes data in a programmatic, deterministic way, not necessarily through learned AI models.

Summary

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October 24, 2018

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

Re: K180940

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

Dear Gina Crossetta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (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

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Indications for Use

510(k) Number (if known) K180940

Device Name KODEX - EPD™ System

Indications for Use (Describe)

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

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510(k) Summary

Applicant:	Philips Medical Systems Nederland B.V.Veenpluis 4, - 6, 5684 PC Best, Netherlands
Contact Person:	Gina CrossettaVice President, Regulatory and Quality
	Phone: (845) 558-2772Email: 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 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:

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 EPNavigation System¹	Comments
Regulatory
510(k)	TBD	K133916	N/A
Device class	II	II	Same
Classification	Programmable diagnostic-computerClass II; 21 CFR, 870.1425	Programmable diagnostic-computerClass II; 21 CFR, 870.1425	Same
Product code	DQK	DQK	Same
Indications/Intended use	The KODEX-EPD™ System is indicatedfor catheter-based cardiacelectrophysiological (EP) procedures.The KODEX-EPD™ System providesinformation about the electricalactivity of the heart and aboutcatheter location during theprocedure. The system can be usedon patients who are eligible for aconventional electrophysiologicalprocedure.	The intended use of the CARTO 3 Systemis catheter-based cardiacelectrophysiological (EP) procedures. TheCARTO 3 System provides informationabout the electrical activity of the heartand about catheter location during theprocedure. The system can be used onpatients who are eligible for aconventional electrophysiologicalprocedure. The system has no specialcontraindications.	Same
Intended users	EP's and EP lab staff trained on the use ofthe system	EP's and EP lab staff trained on the use ofthe system	Same
Physical Characteristics
	KODEX – EPD™ Mapping System	Biosense Webster's CARTO 3 EPNavigation System¹	Comments
System Components	The KODEX – EPD™ system is comprised of the following components:1) KODEX-EPD PU: Processing Unit2) KODEX-EPD -WS: Workstation with 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) 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 pedals7) Keyboard and mouse8) Cart (optional)	The CARTO 3 system is comprised of the following components:1) Patient Interface Unit (PIU)2) Workstation with Graphic User Interface3) Patches Connection Box and Cables4) Intracardiac In Port5) Intracardiac Out Port6) Foot pedals7) Keyboard, and mouse8) Cart (optional)9) Power Supply10) Monitor11) 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 EPNavigation System1	Comments
			The KODEX System includesthe external patches while theCARTO 3 patches are clearedseparately (K061468). Thisdoesn't raise any newquestions of safety oreffectiveness. The CARTO 3patches are cleared separatelyso that they may be used formultiple devices.
Catheters	Compatible EP catheters	Specialized catheters with integratedmagnetic sensor; several compatiblediagnostic and therapeutic catheters	Same
Foot Pedals	Commercial foot pedals used for handsfree acquisition of points (LocalActivation Time and tagging points)	Foot pedals used for hands freeacquisition of points	Same
Technology
Principles of operation	Mapping of electrical fields andimpedances (dielectric mapping)	Triangulation of magnetic fields (magnetictechnology) and impedance	Both systems achieve thedesired features (navigation,accuracy, electroanatomicalmapping, etc) by mappingimpedance with eitherelectrical fields (KODEX) ormagnetic fields (CARTO 3).
Location Technology	Impedance localization technology(Dielectric); any catheter	Magnetic sensor technology for locationand orientation of a specialized catheterwith magnet sensor on tip and impedancelocalization	Both systems achieve thedesired features (navigation,accuracy, electroanatomicalmapping, etc) by mappingimpedance with eitherelectrical fields (KODEX) ormagnetic fields (CARTO 3).
3D Geometry mapping byaggregating catheterlocation: Geometry	Yes, based on ablation catheter andDielectric technology	Yes, based on diagnostic and ablationcatheters	Same
	KODEX – EPD™ Mapping System	Biosense Webster's CARTO 3 EPNavigation System1	Comments
rotation and flexibledisplay
Flattened 3D view of thewhole cardiac chamber	Yes, PANOv flattened chamber display	No	The flattened chamber displayis an added feature providedby KODEX but doesn't raisenew questions of safety oreffectiveness. It is simply anadditional, optional viewingoption that provides analternative depiction of thechamber, but the standardview provided by both systems(i.e., without flattening)remains the same, as shown inthe performance testing.
Simultaneous Navigation ofmultiple catheters	Yes, 1 compatible ablation catheter andup to 3 diagnostic catheters	Yes, 1 sensor enabled ablation catheterand several diagnostic catheters.	Same
Electrograms for activationand voltage mapping.	Yes. Local Activation Time maps, voltagemaps and propagation maps	Yes, Local Activation Time maps,impedance maps and propagation maps	Both systems provideelectroanatomical maps. Themaps provided by the KODEXSystem are a subset of thoseprovided by CARTO, and theyare the most widely used.
Ablation parametervisualization and taggingtool	Yes. KODEX provides catheter stability,intracardiac electrical activationinformation, and during ablation,impedance drop and temperature as readfrom the RF generator. Ablation pointtagging is conducted based on a userdefined combination of parameters andthresholds. In addition the KODEX systemprovides power, power integral overablation time and duration.	Yes, optional (Visitag Module). CARTO 3provides catheter stability, contact force,intracardiac electrical activationinformation, and during ablation,impedance drop and temperature as readfrom the RF generator. Ablation pointtagging is conducted based on a userdefined combination of parameters andthresholds.	Both systems display RFgenerator communicatedparameters. Both systemsprovide catheter stability,intracardiac electricalactivation information, andduring ablation, impedancedrop and temperature as readfrom the RF generator.Ablation point tagging isconducted based on a user
	KODEX – EPD™ Mapping System	Biosense Webster's CARTO 3 EPNavigation System1	Comments
			defined combination ofparameters and thresholds.While the KODEX Systemprovides some additionalparameters not provided byCARTO (power, power integralover ablation time, andduration), and CARTO 3provides one additionalparameter (contact force),these provide the physicianwith additional informationbut do not raise new questionsof safety or effectiveness.Based on performance testingconducted these additionalfeatures perform as intended.
Compatibility with RFgenerator	Yes, Stockert 70 and Maestro 4000	Yes	Both systems are compatiblewith 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.

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).