EP NAVIGATOR R3

K101311 · Philips Medical Systems North America Co. · LLZ · Sep 30, 2010 · Radiology

Device Facts

• Record ID: K101311
• Device Name: EP NAVIGATOR R3
• Applicant: Philips Medical Systems North America Co.
• Product Code: LLZ · Radiology
• Decision Date: Sep 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

EP navigator is PC-based software used in cathlabs by radiologists or cardiologists to assist in interventional heart rhythm procedures. It takes previously acquired 3D DICOM CT or other image data as input. The software segments this 3D data and registers/overlays it onto live fluoroscopic X-ray images from a Philips Allura Xper FD system. It allows for visual marker placement on 3D volumes and provides an 'EndoView' for internal 3D volume visualization. The system integrates with EP Logix, receiving color map annotations and transmitting visual marker positions. By providing a real-time anatomical overlay, the device aids clinicians in navigating catheters and guidewires, potentially improving procedural accuracy and patient outcomes during cardiac interventions.

Clinical Evidence

Clinical evaluation was performed to demonstrate safety and effectiveness in the intended clinical environment. Non-clinical verification and validation testing included software verification, validation, and DICOM conformance testing against requirement specifications and risk management results.

Technological Characteristics

PC-based software platform. Integrates with Philips Allura Xper FD angiography X-ray systems. Supports DICOM 3D CT and other image datasets. Connectivity includes data exchange with external sources (e.g., EP Logix).

Indications for Use

Indicated for patients with heart rhythm disorders undergoing X-ray fluoroscopy-guided interventional procedures. Provides navigation support for intra-cardiac instruments (catheters, guidewires) by overlaying segmented 3D anatomical data onto live fluoroscopic images. No contraindications.

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

• Philips EP navigator (K062650)
• Philips Brilliance CT (K042293)
• Philips Allura 3D-CA (K042334)
• Philips Integris 3D-RA (K040254)
• Philips Xper CT (K060749)
• GE Innova Vision Applications (K092639)

Submission Summary (Full Text)

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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

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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,<br>5684-PC, Best, The Netherlands |
| Registration number: | 3003768277 |

# ldentification of submitter

| Name: | Lynn Harmer |
|----------------|------------------------------------|
| Position: | Senior Manager, Regulatory Affairs |
| Telephone: | [phone]\ |
| Fax: | [phone] |
| 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,<br>Philips Allura 3D-CA, Philips Integris 3D-RA,<br>Philips Xper CT, GE Innova Vision Applications |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips and GE |
| 510(k) numbers: | K062650, K042293, K042334, K040254, K060749<br>K092639 |

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#### 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

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.

#### Indications for Use

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-rav images of the same anatomy.

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

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#### 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.

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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

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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 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

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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).

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 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

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(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