EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment.

Device Description

EchoNavigator R4.0 is a tool that assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance. EchoNavigator can be used with compatible Echo-probes and Echo units in combination with compatible Philips interventional X-ray systems.

AI/ML Overview

The provided text does not contain specific acceptance criteria or an analytical study comparing the device's performance against such criteria. Instead, it describes a substantial equivalence determination for the EchoNavigator R4.0 device, comparing it to a predicate device (EchoNavigator R3.0.3, K200713).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. Also, many of the requested details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present.

However, based on the information provided, here's what can be extracted regarding the device's demonstration of substantial equivalence:

Summary of Device Evaluation for Substantial Equivalence:

The document states that the EchoNavigator R4.0 is substantially equivalent to its predicate device (EchoNavigator R3.0.3, K200713). This determination is based on:

Indications for Use: The subject device has the same indications for use as the predicate device.
Technological Characteristics: The subject device has the same fundamental scientific technology as the predicate device. Minor modifications (new user interface location, automated alignment functionality, minor 3D heart model updates, and updated rendering modes) were assessed and deemed not to affect safety or effectiveness.
Non-Clinical Performance Testing: This testing was performed to demonstrate compliance with recognized consensus standards and guidance documents, as well as to verify and validate software requirements and intended use.

Here's a breakdown of the available information, noting the absence of details for many of your specific questions:

Table of Acceptance Criteria and Reported Device Performance:
- Not explicitly provided as a set of quantified performance metrics (e.g., sensitivity, specificity) against defined acceptance criteria.
- The document states that "Non-clinical verification and validation test results demonstrate that the subject device, EchoNavigator R4.0: Complies with the aforementioned FDA recognized consensus standards and guidance documents [and] Meets the acceptance criteria and is adequate for its intended use." However, the specific acceptance criteria and their corresponding results are not detailed.
Sample Size Used for the Test Set and Data Provenance:
- Not specified. The document mentions "software verification testing" and "non-clinical in-house simulated use design validation testing" but does not give sample sizes for these tests or the nature of the "test set" (e.g., number of cases, type of data). There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data).
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not specified. The evaluation appears to be based on non-clinical testing and comparison to a predicate device, rather than a study requiring expert-established ground truth on patient cases.
Adjudication Method for the Test Set:
- Not applicable/specified. Since no clinical study with expert ground truth is described, there is no mention of an adjudication method like 2+1 or 3+1.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. The document explicitly states: "The subject device, EchoNavigator R4.0 did not require clinical study since substantial equivalence to the predicate device (EchoNavigator R3.0.3, K200713) was demonstrated in terms of the indication for use; technological characteristics; non-clinical performance testing; and safety and effectiveness." Therefore, an MRMC study and its effect size are not applicable here.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- Not explicitly detailed in terms of reported performance metrics. The software verification testing and design validation testing would implicitly evaluate the algorithm's functionality. The mention of "automatic annotations" and "AutoViews" suggests automated algorithmic functions, but their standalone performance against specific metrics is not reported in this summary.
The Type of Ground Truth Used:
- For the non-clinical verification and validation, the "ground truth" would be established by the specified system requirements, intended use, and consensus standards. There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as no clinical study was performed.
The Sample Size for the Training Set:
- Not applicable/specified. This document describes a substantial equivalence submission for an existing product (EchoNavigator R4.0, an update to R3.0.3). There is no mention of machine learning model training or associated training set sizes. The device's "core algorithm for probe (transducer) detection is fundamentally unchanged" and "automatic annotations functionality is fundamentally unchanged," suggesting an established technology rather than a newly trained AI system.
How the Ground Truth for the Training Set Was Established:
- Not applicable/specified, as there is no mention of a training set for machine learning models.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The text is in a sans-serif font.

Philips Medical Systems Nederland B.V. % Supriya Dalvi Regulatory Affairs Specialist Veenpluis 6 Best. 5684 PC NETHERLANDS

May 31, 2022

Re: K221270

Trade/Device Name: EchoNavigator R4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 26, 2022 Received: May 2, 2022

Dear Supriya Dalvi:

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 avare 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 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-reporting

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combination-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 mediation-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,

Jessica Lamb Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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) K221270

Device Name EchoNavigator R4.0

Indications for Use (Describe)

EchoNavigator supports the interventionalist and surgeon in treatments where both live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment

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

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	April 26th, 2022
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 6,5684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Dr. Supriya A. DalviRegulatory Affairs Specialist, IGT SystemsPhone: +31 628945536E-mail: supriya.dalvi@philips.com
Device:
Trade Name:	EchoNavigator
Release Name:	R4.0
Classification Name:	Picture archiving and communications system
ClassificationRegulation:	21 CFR, Part 892.2050
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	LLZ
Predicate Device:
Trade Name:	EchoNavigator R3.0.3
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) Clearance:	K200713 (April 9th, 2020)
Classification Name:	Picture archiving and communications system
ClassificationRegulation:	21 CFR, Part 892.2050
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	LLZ
Devicedescription:	EchoNavigator R4.0 is a tool that assists the interventionalist and surgeonwith image guidance during treatment of cardiovascular disease for which theprocedure uses both live X-ray and live Echo guidance. EchoNavigator can beused with compatible Echo-probes and Echo units in combination with

compatible Philips interventional X-ray systems.

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Indications for EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient Use: population consists of patients with cardiovascular diseases requiring such a treatment.
Technological The subject device, EchoNavigator R4.0, has the same fundamental scientific characteristics: technology as the predicate device (EchoNavigator R3.0.3, K200713).

The subject and predicate devices are based on the following same technological characteristics:

The ability of the subject device to display images from the live X-ray ● and Ultrasound modalities and the core algorithm for probe (transducer) detection is fundamentally unchanged compared to the predicate device.
. The following functionalities are available in both predicate and subject device: Synchronize Image Orientation, Multiple Views, Follow C-arm, Table Side Control, Mannual Annotations and Image Capture Export.

The following modifications were implemented in subject device, EchoNavigator R4.0:

In addition to the existing workspots, the subject device has introduced ● the Echonavigator functionality on the touch screen user interface of the Echo console. The user interface functions of subject device are same as those for the predicate device (EchoNavigator R3.0.3, K200713). This additional user interface has exactly the same functions as the existing workspots.
In the subject device, automatic annotations can be used to . automatically align the 3D echo volume and the MPR planes with the position of these automatic annotations (called 'AutoViews'). In the predicate device (EchoNavigator R3.0.3, K200713), the automatic annotations were already present, however, positioning of 3D echo volume and the MPR planes was done manually. The automatic annotations functionality is fundamentally unchanged in subject device compared to predicate device (EchoNavigator R3.0.3, K200713).
Minor updates to the existing 3D heart model (Adding mitral valve ● leaflets and transseptal zone area). These are solely intended to be used by the user as context information for the patient's anatomy. These changes are not fundamental changes to the technological characteristics of automatic annotations.
Rendering modes like the MPR visualisation, TrueVue and GlassVue ● are updated in the subject device to support the rendering modes introduced in recent releases of Echo console.

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The outcome of this technological characteristics comparison and risk assessment demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the subject device, EchoNavigator R4.0, when compared to the legally marketed predicate device (EchoNavigator R3.0.3, K200713). Thus demonstrating the substantial equivalence of the subject device with the predicate device.

Summary of Non-Non-clinical performance testing has been performed on the subject device, EchoNavigator R4.0, and it demonstrates compliance with the following Clinical Performance FDA-recognized consensus standards and guidance documents: Data:

· IEC 62304 Edition 1.1 2015-06. Medical device software Software life cycle processes. FDA recognition number 13-79
· IEC 62366-1 Edition 1.1 2020-06. Medical devices Part 1: Application of usability engineering to medical devices. FDA recognition number 5-129
· IEC 82304-1 Edition 1.0 2016-10. Health software Part 1: General requirements for product safety. FDA recognition number 13-97
· ISO 14971 Third Edition 2019-12. Medical devices Application of risk management to medical devices. FDA recognition number 5-125
· ISO 15223-1 Third Edition 2016-11-01. Medical devices Symbols to be used with medical device labels, labelling and information to be supplied -Part 1: General requirement. FDA recognition number 5-117
· ANSI UL 2900-1 First Edition 2017. Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements. FDA recognition number 13-96
· IEC 80001-1 Edition 1.0 2010-10. Application of risk management for ITnetworks incorporating medical devices -- Part 1: Roles, responsibilities and activities. FDA recognition number 13-38. (Compliance to the medical device requirements of IEC 80001-1:2010, Edition 1.0 are applicable and followed by EchoNavigator)
· "Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". May 11, 2005
· "Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016
"Guidance for Industry and FDA Staff Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014
"Guidance for Industry and FDA Staff The 510(k) Program: Evaluating ● Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014

Software verification testing has been performed on the subject device, EchoNavigator R4.0, to verify that all System Requirements Specification

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including all the Privacy and Security requirements have been implemented. Results demonstrated that all executed verification tests were passed.

Non-clinical in-house simulated use design validation testing has been performed to validate that the subject device, EchoNavigator R4.0, conforms to intended use, claims and user needs. Results demonstrated that all executed validation testing passed as per the test protocols.

Non-clinical verification and validation test results demonstrate that the subject device, EchoNavigator R4.0:

Complies with the aforementioned FDA recognized consensus standards and guidance documents.
. Meets the acceptance criteria and is adequate for its intended use.

The subject device, EchoNavigator R4.0 did not require clinical study since substantial equivalence to the predicate device (EchoNavigator R3.0.3, K200713) was demonstrated in terms of the indication for use; technological characteristics; non-clinical performance testing; and safety and effectiveness.

The subject device, EchoNavigator R4.0, is substantially equivalent to the Substantial Equivalence predicate device (EchoNavigator R3.0.3, K200713), in terms of indications for Conclusion: use, technological characteristics, safety and effectiveness.

Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that subject device. EchoNavigator R4.0. complies with the user need requirements as well as the requirements specified in the FDArecognized consensus standards and guidance documents.

Therefore, the subject device, EchoNavigator R4.0, is as safe and effective as the predicate device (EchoNavigator R3.0.3, K200713) and does not raise any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).