ECHONAVIGATOR RELEASE 1

K121781 · Philips Medical Systems Nederland B.V. · LLZ · Oct 26, 2012 · Radiology

Device Facts

• Record ID: K121781
• Device Name: ECHONAVIGATOR RELEASE 1
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 Rel. 1 is a software medical device assisting interventionalists and surgeons during cardiovascular procedures. It integrates live X-ray and live Echo guidance inputs from compatible Philips Echo-probes, Echo units, and interventional X-ray systems. The software runs on a PC-based platform to provide image guidance, aiding the clinician in visualizing anatomy during treatment. By fusing or displaying these modalities simultaneously, it supports clinical decision-making and procedural navigation, potentially improving accuracy and outcomes for patients undergoing complex cardiovascular interventions.

Clinical Evidence

Bench testing only. Non-clinical verification and validation tests were performed regarding requirement specifications and risk management results, including software verification and validation activities. Results demonstrated that the device met all acceptance criteria.

Technological Characteristics

PC-based software medical device. Operates as an image guidance tool for cardiovascular procedures. Integrates with existing Philips Echo-probes, Echo units, and interventional X-ray systems. Complies with international recognized standards for software verification and validation.

Indications for Use

Indicated for patients with cardiovascular diseases requiring treatment involving 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

• HeartNavigator Release 1 (K111245)
• QLAB with FHN and VPQ plug-in (K121223)

Submission Summary (Full Text)

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EchoNavigator Rel. 1

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K121781

Page 21 of 380

OCT 2 6 2012

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## 510(k) Summary of Safety and Effectiveness .

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| Identification of manufacturer | |
|-----------------------------------------|----------------------------------------|
| Company: | Philips Medical Systems Nederland B.V. |
| Address: | Veenpluis 4-6, |
| | 5684-PC, Best, the Netherlands |
| Registration number: | 3003768277 |
| Identification of U.S. designated agent | |
| Company: | Philips Medical Systems |
| Address: | 22100 Bothell Everett Highway |
| | Bothell, WA 98021-8431, U.S.A. |
| Registration number: | 1217116 |

Identification of official correspondent

| Name: | Frans Jacobs |
|----------------|----------------------------|
| Position: | Regulatory Affairs Manager |
| Telephone: | [phone] |
| Date prepared: | June 6, 2012 |

Device identification

| Trade name: | EchoNavigator |
|-------------------------|---------------------------------------------|
| Device name: | EchoNavigator Release 1 |
| Regulation description: | Picture archiving and communications system |
| Regulation number: | 21CFR 892.2050 |
| Class: | II |
| Product code: | 90LLZ |

Legally marketed devices

| Trade names: | HeartNavigator Release 1 |
|-----------------|--------------------------|
| Manufacturer: | Philips |
| 510(k) numbers: | K111245 - Jul 29, 2011 |

Trade names: Manufacturer: 510(k) numbers:

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QLAB with FHN and VPQ plug-in Philips K121223 – May 15, 2012

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#### Device description

The EchoNavigator Rel. 1 software medical device is a tool that assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo guidance. The EchoNavigator Rel. 1 device can be used with the currently marketed Philips EchoNavigator compatible Echo-probes, Echo units and interventional X-ray systems. t ي وي

### 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 EchoNavigator Rel. 1 software medical device is executed on a PC based hardware platform.

#### Summary of testing

The EchoNavigator Rel. 1 software medical device complies with international recognized standards as detailed in the premarket submission. Non-clinical verification and validation tests were performed with regards to the requirement specifications and risk management results, specifically including software verification and validation activities. The results of these tests demonstrate that EchoNavigator Rel. 1 met the acceptance criteria.

#### Conclusion:

The EchoNavigator Rel. 1 software medical device is substantially equivalent to the currently marketed and predicate Philips' HeartNavigator and QLAB with FHN and VPQ plug-in software medical devices based on the similar indications for use, device functionality and technology (hardware and software).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT 2 6 2012

Mr. Frans Jacobs RegulatoryAffairs Manager Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS

Re: K121781

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Trade/Device Name: EcoNavigator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 16, 2012 Received: August 31, 2012

#### Dear Mr. Jacobs:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

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.

Over-The-Counter Use _ No____________________________________________________________________________________________________________________________________________________________________________ Prescription Use __yes AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Munkel O'Hern

(Division Sign Division of Radiological H Office of In Vitro Diagnostics and Ra

510(k) K121781