Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy.

EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.

Device Description

EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG))
superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system,
. register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures.
The 3D segmented data set can be displayed with a color map annotation received ● from an external source.
position visual markers on the 3D volume ●
visualize the inside of the 3D volume (EndoView) .
certain buttons on the user interface control EP Logix functions; ●
visual marker positions are transmitted to EP Logix; .
color map information is received from EP Logix. .

AI/ML Overview

The provided document is a 510(k) Summary for the Philips EP navigator device. It describes the device, its intended use, indications for use, and a summary of testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "EP navigator 3 complies with standards as detailed in annex 009 of this premarket submission" and "Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results". It also states that a "Clinical evaluation was performed to show safety and effectiveness to of EP-Navigator in the intended clinical environment."

However, the document does not provide a table specifying the acceptance criteria (e.g., accuracy metrics, specific performance thresholds) nor does it report detailed device performance against those criteria. It merely states that the device "complies" and that "clinical evaluation" showed "safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

The document makes a general statement: "Corresponding clinical evaluation report and test results are included in this submission."

However, it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document mentions a "Clinical evaluation" but does not specify the number of experts, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set:

No information on adjudication methods (e.g., 2+1, 3+1, none) is provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention any MRMC study or the effect size of human readers improving with AI assistance. It focuses on the device's standalone capabilities and its intended use for navigation support.

6. Standalone (Algorithm Only) Performance:

The document states that "EP navigator image software processing algorithms are executed on a PC based hardware platform," and its functions involve "segment previously acquired DICOM 3D CT or other image data," "superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image," and "register the segmented 3D CT or other data with live fluoroscopic X-ray images."

This strongly implies that the algorithm has standalone performance for these image processing and registration tasks. However, the document does not explicitly present a dedicated standalone performance study with specific metrics, but rather refers to "non-clinical verification and validation tests performed relative to the requirement specifications."

7. Type of Ground Truth Used:

While "clinical evaluation" and "non-clinical verification and validation tests" are mentioned, the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data) for validating the device's performance is not detailed.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. Given that it is an "image software processing algorithm," it likely involves some form of training or calibration, but this is not discussed in the summary.

9. How the Ground Truth for the Training Set Was Established:

As no training set information is provided, there is no description of how ground truth for a training set was established.

In summary:

The 510(k) Summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety risks. It indicates that clinical evaluation and non-clinical verification/validation were performed, but it lacks the specific quantitative details about acceptance criteria, detailed study designs (test set size, provenance, expert involvement, adjudication), and training set information that you've requested. This level of detail is typically found in the full submission referenced by the summary, not in the summary itself.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the handwritten text "KL01311". The text is smaller than the word "PHILIPS" and is written in black ink.

510(k) Summary

, ৮

The following information is submitted in accordance with the requirements of 21CFR 807.92.

ldentification of manufacturer

Company:	Philips Medical Systems Nederland B.V
Address:	Veenpluis 4-6,5684-PC, Best, The Netherlands
Registration number:	3003768277

ldentification of submitter

Name:	Lynn Harmer
Position:	Senior Manager, Regulatory Affairs
Telephone:	(425) 487-7312\
Fax:	(425) 487-8666
Date prepared:	May 7, 2010

Device identification

Trade name:	Philips
Device name:	EP navigator
Regulation description:	Picture archiving and communications system
Regulation number:	21CFR 892.2050
Class:	II
Product code:	90L--LZ

Legally marketed devices

Trade names:	Philips EP navigator, Philips Brilliance CT,Philips Allura 3D-CA, Philips Integris 3D-RA,Philips Xper CT, GE Innova Vision Applications
Manufacturer:	Philips and GE
510(k) numbers:	K062650, K042293, K042334, K040254, K060749 K092639

{1}------------------------------------------------

Device description

EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG))
superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system,
. register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures.
The 3D segmented data set can be displayed with a color map annotation received ● from an external source.
position visual markers on the 3D volume ●
visualize the inside of the 3D volume (EndoView) .
certain buttons on the user interface control EP Logix functions; ●
visual marker positions are transmitted to EP Logix; .
color map information is received from EP Logix. .

Intended use

Indications for Use

Patient population EP navigator is intended to be used with patients who suffer from heart rhythm disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.

Contact with body part / tissue type The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).

Operator profile The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist. Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.

Contra-indications Within the mentioned patient population, there are no contraindications.

510(k) Summary

{2}------------------------------------------------

Technological characteristics

EP navigator image software processing algorithms are executed on a PC based hardware platform

Summary of testing

EP navigator 3 complies with standards as detailed in annex 009 of this premarket submission. Clinical evaluation was performed to show safety and effectiveness to of EP-Navigator in the intended clinical environment. Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. Corresponding clinical evaluation report and test results are included in this submission.

Conclusion:...................................EP-Navigator is substantially equivalent to the currently legally marketed devices.

This opinion is based on the following:

EP navigator does not introduce new indications for . use,
. EP navigator has the same technological characteristics as the predicate devices,
EP navigator does not introduce new potential haz-. ards or safety risks.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Evert Highway BOTHELL WA 98041-3003

SEP 3 O 2010

Re: K101311

Trade/Device Name: EP Navigator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2010 Received: May 11, 2010

Dear Ms. Harmer:

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 of

{4}------------------------------------------------

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 vours.

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Kl01311

Image /page/5/Picture/1 description: The image shows the word "Philips" in a stylized, bold font. The letters are black and have a slightly distressed or textured appearance. The word is presented in a single line and is centered in the image.

Appendix 005

Indications for Use Statement

Device Name

EP navigator

Indications for Use

Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as calheters and guidewires, during the interventional treatment of heart rhythm dlsorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic Xray images of the same anatomy.

Patient population EP navigator is intended to be used with panents who suffer from heart rhything disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.

Contact with body part / tissue type The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).

Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.

Contra-Indications Within the mentioned patient population, there are no contra-indications.

Intended use

EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.

Prescription Use __yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ No (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)

Indications for Use Statement.docx

1/1

(Division Sign-Off) (Division of Radiological Devices Division of Radiological Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety

K101311
510K

SEP 30 2010

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).