EchoNavigator

K200713 · Philips Medical Systems Nederland B.V. · LLZ · Apr 9, 2020 · Radiology

Device Facts

• Record ID: K200713
• Device Name: EchoNavigator
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: Apr 9, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

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 Story

EchoNavigator R3.0.3 assists interventionalists and surgeons during cardiovascular procedures requiring concurrent live X-ray and live Echo guidance. The device integrates inputs from compatible Echo-probes, Echo units, and Philips interventional X-ray systems. It transforms these inputs by synchronizing image orientation, providing multiple viewing modes (including a new 'Model View'), and enabling C-arm tracking. The system is operated in the interventional suite via a touch screen module (TSM) or wireless mouse on a tray table. Outputs are displayed to the clinician to facilitate anatomical structure identification and manual annotation. By providing fused or synchronized visualization of X-ray and ultrasound data, the device aids in procedural guidance, potentially improving clinical decision-making and patient outcomes during complex cardiovascular interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance data, including software verification testing and in-house simulated use design validation. All verification and validation protocols passed, confirming the device meets intended use, claims, and user needs.

Technological Characteristics

Class II PACS (21 CFR 892.2050). Features include synchronized image orientation, multiple views (X-ray, Free, Echo, C-arm, Model), C-arm tracking, and manual annotation. Connectivity includes integration with Philips interventional X-ray systems and compatible Echo units. Software developed per IEC 62304; cybersecurity per UL 2900-1. Usability per IEC 62366-1. Risk management per ISO 14971.

Indications for Use

Indicated for patients with cardiovascular diseases requiring treatment using both live X-ray and live Echo guidance.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• EchoNavigator R1 (K121781)

Reference Devices

• QLAB Advanced Quantification Software (K181264)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".

Philips Medical Systems Nederland B.V. % Ioana Ulea Regulatory Affairs Specialist Veenpluis 6 5684 PC Best THE NETHERLANDS

Re: K200713

Trade/Device Name: EchoNavigator R.3.0.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 16, 2020 Received: March 18, 2020

Dear Ioana Ulea:

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 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

April 9, 2020

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K200713

Device Name EchoNavigator R3.0.3

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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# PHILIPS

## 510(k) Summary

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

| Date Prepared: | March 16th, 2020 | | | | | | | | | | | | | | | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------|---------------|----------------------------------------|----------------------|---------------------------------------------|----------------------------|---------------------------------------------|----------------------------|-----------------------|-----------------------|-----------|---------------|----------|---------------|-----|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 6,<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | | | | | | | | | | | | | | | | |
| Primary Contact Person: | Ioana Ulea<br>Regulatory Affairs Specialist, IGT Systems<br>Phone: [phone]<br>E-mail: [e-mail] | | | | | | | | | | | | | | | | |
| Secondary Contact Person: | Michael Konings<br>Director Regulatory Affairs IGT Systems<br>Phone: [phone]<br>E-mail: [e-mail] | | | | | | | | | | | | | | | | |
| Device: | | | | | | | | | | | | | | | | | |
| | <table><tr><td>Trade Name:</td><td>EchoNavigator</td></tr><tr><td>Release Name:</td><td>R3.0.3</td></tr><tr><td>Classification Name:</td><td>Picture archiving and communications system</td></tr><tr><td>Classification Regulation:</td><td>21 CFR, Part 892.2050</td></tr><tr><td>Classification Panel:</td><td>Radiology</td></tr><tr><td>Device Class:</td><td>Class II</td></tr><tr><td>Product Code:</td><td>LLZ</td></tr></table> | Trade Name: | EchoNavigator | Release Name: | R3.0.3 | Classification Name: | Picture archiving and communications system | Classification Regulation: | 21 CFR, Part 892.2050 | Classification Panel: | Radiology | Device Class: | Class II | Product Code: | LLZ | | |
| Trade Name: | EchoNavigator | | | | | | | | | | | | | | | | |
| Release Name: | R3.0.3 | | | | | | | | | | | | | | | | |
| Classification Name: | Picture archiving and communications system | | | | | | | | | | | | | | | | |
| Classification Regulation: | 21 CFR, Part 892.2050 | | | | | | | | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | | | | | | | | |
| Device Class: | Class II | | | | | | | | | | | | | | | | |
| Product Code: | LLZ | | | | | | | | | | | | | | | | |
| Predicate Device: | | | | | | | | | | | | | | | | | |
| | <table><tr><td>Trade Name:</td><td><i>EchoNavigator R1</i></td></tr><tr><td>Manufacturer:</td><td>Philips Medical Systems Nederland B.V.</td></tr><tr><td>510(k) Clearance:</td><td>K121781 (October 26, 2012)</td></tr><tr><td>Classification Name:</td><td>Picture archiving and communications system</td></tr><tr><td>Classification Regulation:</td><td>21 CFR, Part 892.2050</td></tr><tr><td>Classification Panel:</td><td>Radiology</td></tr><tr><td>Device Class:</td><td>Class II</td></tr><tr><td>Product Code:</td><td>LLZ</td></tr></table> | Trade Name: | <i>EchoNavigator R1</i> | Manufacturer: | Philips Medical Systems Nederland B.V. | 510(k) Clearance: | K121781 (October 26, 2012) | Classification Name: | Picture archiving and communications system | Classification Regulation: | 21 CFR, Part 892.2050 | Classification Panel: | Radiology | Device Class: | Class II | Product Code: | LLZ |
| Trade Name: | <i>EchoNavigator R1</i> | | | | | | | | | | | | | | | | |
| Manufacturer: | Philips Medical Systems Nederland B.V. | | | | | | | | | | | | | | | | |
| 510(k) Clearance: | K121781 (October 26, 2012) | | | | | | | | | | | | | | | | |
| Classification Name: | Picture archiving and communications system | | | | | | | | | | | | | | | | |
| Classification Regulation: | 21 CFR, Part 892.2050 | | | | | | | | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | | | | | | | | |
| Device Class: | Class II | | | | | | | | | | | | | | | | |
| Product Code: | LLZ | | | | | | | | | | | | | | | | |

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# PHILIPS

| Reference Device: | Trade Name: | QLAB Advanced Quantification Software |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | Manufacturer: | Philips Ultrasound, Inc. |
| | 510(k) Clearance: | K181264 |
| | Classification Name: | Picture archiving and communications system |
| | Classification<br>Regulation: | 21 CFR 892.2050 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | LLZ |
| Device description: | EchoNavigator 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. | |
| Indications for Use: | 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. | |
| Technological characteristics: | The proposed EchoNavigator R3.0.3 has similar technological characteristics compared to the predicate device.<br><br>The subject and predicate devices are based on the following same technological characteristics:<br>The ability of the proposed 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 proposed device: Synchronize Image Orientation, Multiple Views, Follow C-arm, Table Side Control, Mannual Annotations and Image Capture Export. The following modifications were implemented in EchoNavigator R3.0.3: The <i>Multiple Views</i> functionality provided by the predicate device is extended in the proposed device with the <i>Model View</i> , which is an additional view compared to the <i>Multiple Views</i> available in the predicate device (X-ray, Free, Echo and C-arm). Although the <i>Table Side Control</i> is available in both devices, the proposed device offers basic control from the Touch Screen Module (TSM) in addition to the wireless mouse control on the tray table, as offered by the predicate device. While both devices are allowing the user to identify anatomical structures in one modality and annotate them by <i>Mannual</i> | |

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## PHILIPS

| Summary of Non-<br>Clinical<br>Performance<br>Data: | No# | Standard<br>Number<br>and Date | Standard Name | Recognition<br>Number |
|-----------------------------------------------------|-----|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------|
| | 1. | IEC 62304 Edition<br>1.1 2015-06 | Medical device software –<br>Software life cycle processes | 13-79 |
| | 2. | IEC 62366-1<br>Edition 1.0 2015-<br>02 | Medical devices – Part 1:<br>Application of usability<br>engineering to medical devices | 5-114 |
| | 3. | IEC 82304-1<br>Edition 1.0 2016-<br>10 | Health software – Part 1:<br>General requirements for<br>product safety | 13-97 |
| | 4. | ISO 14971:2007/<br>(R)2010<br>(Corrected 4<br>October 2007) | Medical devices – Application<br>of risk management to medical<br>devices | 5-40 |
| | 5. | ISO 15223-1 Third<br>Edition 2016-11-<br>01 | Medical devices – Symbols to<br>be used with medical device<br>labels, labelling and information<br>to be supplied | 5-117 |
| | 6. | UL 2900-1<br>First Edition 2017 | Software Cybersecurity for<br>Network-Connectable Products,<br>Part 1: General Requirements | 13-96 |
| | 7. | IEC 80001-1<br>Edition 1.0 2010-<br>10 | Application of risk management<br>for IT-networks incorporating | 13-38 |

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Software verification testing has been performed to verify that all System Requirements Specification including all the Privacy and Security requirements have been implemented. Results demonstrated that all executed verification tests were passed. Software Verification data supports the proposed EchoNavigator R3.0.3 relative to the predicate EchoNavigator R1.

Non-clinical in-house simulated use design validation testing has been performed to validate that EchoNavigator R3.0.3 conforms to intended use, claims and user needs. Results demonstrated that all executed validation protocols were passed.

Summary of The EchoNavigator R3.0.3 introduces no new indications for use or Clinical technological characteristics relative to predicate device (K121781) that would Performance require clinical testing. Data: The EchoNavigator R3.0.3 is substantially equivalent to the predicate device Substantial Equivalence EchoNavigator R1 in terms of indications for use, technological characteristics, Conclusion: safety and effectiveness. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that EchoNavigator R3.0.3 complies with the user need requirements as well as the requirements specified in the FDA-recognized consensus standards and guidance documents.

> Therefore EchoNavigator R3.0.3 is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.