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

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.

AI/ML Overview

The provided text describes the EchoNavigator Rel. 1, a software medical device, but it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a specific study proving device performance.

The text states that "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." However, it does not explicitly list the acceptance criteria or provide details about these studies.

Therefore, I cannot populate the table or provide specific details for sections 2 through 9.

Here's a breakdown of what can and cannot be inferred from the provided text:

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

Cannot provide. The document states that "EchoNavigator Rel. 1 met the acceptance criteria" but does not define what those criteria are or present specific performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot provide. No information about a specific test set, its size, or data provenance is present. The general statement about "non-clinical verification and validation tests" does not elaborate on these details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot provide. There is no mention of a ground truth established by experts for a test set.

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

Cannot provide. No information on adjudication methods is present.

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

Cannot provide. The document describes EchoNavigator as a "tool that assists the interventionalist and surgeon," implying human-in-the-loop, but does not mention any MRMC study or comparative effectiveness data quantifying improvement.

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

Cannot provide. The device is described as an assistive tool, but no standalone performance data is presented or even implied.

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

Cannot provide. No information on the type of ground truth used for any testing is present.

8. The sample size for the training set

Cannot provide. There is no mention of a training set or its size.

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

Cannot provide. As no training set is mentioned, its ground truth establishment is also not discussed.

In summary, the provided 510(k) summary focuses on the device description, indications for use, technological characteristics, and concluding that it met acceptance criteria and is substantially equivalent to predicate devices. It does not delve into the specifics of the performance studies as requested.

Summary

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EchoNavigator Rel. 1

K121781

Page 21 of 380

OCT 2 6 2012

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510(k) Summary of Safety and Effectiveness .

. :

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:	+31-40-27-99709
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:

. . .

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

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Device description

Indications for Use:

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

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

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).