EP NAVIGATOR SOFTWARE

K062650 · Philips Medical Systems · LLZ · Sep 21, 2006 · Radiology

Device Facts

• Record ID: K062650
• Device Name: EP NAVIGATOR SOFTWARE
• Applicant: Philips Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro Xray images of the same anatomy in order to support catheter/device navigation during specified procedures.

Device Story

EP-Navigator processes previously acquired 3D CT image data; segments anatomy; registers and superimposes segmented 3D CT datasets onto live fluoroscopic X-ray images from Philips Allura Xper FD angiography systems. Used in clinical settings by medical professionals to assist in catheter/device navigation during interventional procedures. Provides visual guidance by aligning pre-operative 3D data with real-time imaging; enhances anatomical visualization; supports precise device placement; potentially improves procedural efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based hardware platform; DICOM 3D CT image processing; image registration and overlay algorithms; compatible with Philips Allura Xper FD angiography X-ray systems.

Indications for Use

Indicated for users requiring segmentation of 3D CT datasets and registration/overlay with live fluoroscopic X-ray images to support catheter or device navigation during specified clinical procedures.

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

• Brilliance CT (K042293)
• Private Practice CV configuration CT scanner (K041955)
• Gemini PET/CT imaging system (K042334)
• Allura 3D-CA (K040254)
• Integris 3D-RA (K031836)
• Stentboost (K060749)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Below the word "PHILIPS" is a horizontal line, and below the line is the number "1062650" written in a handwritten style. The number is also in black ink, contrasting with the white background.

# 510(k) summary

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

SEP 2 1 2006

# 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 U.S. designated agent

| Company: | Philips Medical Systems North America Company |
|----------------------|-----------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>Bothell, WA 98021-8431, U.S.A. |
| Registration number: | 1217116 |

### ldentification of official correspondent

| Name: | Lynn Harmer |
|----------------|------------------------------------|
| Position: | Senior Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Date prepared: | July 31, 2006 |

### 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: | Brilliance CT, Private Practice CV configuration"<br>CT scanner, Gemini PET/CT imaging system,<br>Allura 3D-CA, Integris 3D-RA, Stentboost, Xper CT |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips (for all predicate devices) |
| 510(k) numbers: | K042293, K041955, K042334, K040254, K031836,<br>K060749 |

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

# Device description

Device description:..................EP-Naviga

Device description:....................EP-Navigator image processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

- segment previously acquired DICOM 3D CT image . data.
- superimpose the segmented 3D CT 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 data with live . fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray sysem for specified procedures.

### Intended use

Intended use:.........................EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro Xray images of the same anatomy in order to support catheter/device navigation during specified procedures.

### Technological characteristics

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 . hazards or safety risks.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 1 2006

Phillips Medical Systems c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

Re: K062650

Trade/Device Name: EP-Navigator Regulation Number: 21CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 5, 2006 Received: September 7, 2006

Dear Mr. Job:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text and star symbols.

Promoting Public Ste

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

Page 2 -

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known): Ko 6 26 St EP-Navigator Device Name: Indications for Use:

EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro X-ray images of the same anatomy in order to support catheter/device navigation during specified procedures.

Prescription Use yes (Part 21 CFR 801 Subpart D)

ANDIOR

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)

David R. Segerson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

Page