PHILIPS FRESCO RELEASE 1

K031836 · Philips Medical Systems North America Co. · LLZ · Aug 14, 2003 · Radiology

Device Facts

• Record ID: K031836
• Device Name: PHILIPS FRESCO RELEASE 1
• Applicant: Philips Medical Systems North America Co.
• Product Code: LLZ · Radiology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Philips Fresco release 1, option to Philips Integris Allura systems, is intended for use in a cardiovascular and vascular x-ray interventional application, viz. stent placing.

Device Story

Philips Fresco release 1 is an image processing software add-on for Philips Integris X-ray systems. It enhances visualization of deployed coronary stents during interventional procedures. Input consists of X-ray image sequences (Fresco run). The device identifies stent location by detecting radiopaque markers on the stent delivery catheter. It processes these areas across multiple frames to produce an improved, sharpened image of the stent while blurring distracting peripheral anatomy. Used in interventional suites by physicians; output is displayed to the clinician to assist in verifying stent deployment. Benefits include improved stent visibility compared to standard X-ray imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Image processing software add-on for Philips Integris X-ray systems. Complies with ACR/NEMA DICOM standards. Safety compliance with UL 60950 and 21 CFR Subchapter J (Radiological Health).

Indications for Use

Indicated for patients undergoing cardiovascular and vascular x-ray interventional procedures involving stent placement.

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

• Integris H5000 (K984545)
• Integris Allura (K002016)
• Integris Allura Flat Detector (K031333)

Submission Summary (Full Text)

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

Ko3 1836

Image /page/0/Picture/1 description: The image shows the Philips logo, which is a shield-shaped emblem. The word "PHILIPS" is written in bold, sans-serif font at the top of the shield. Below the text, there is a circular design featuring wavy lines and star-like shapes. The logo is presented in black and white.

# AUG 1 4 2003

# Philips Medical Systems

### 510(k) SUMMARY

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

| Company Name:<br>Address: | Philips Medical Systems North America Company<br>22100 Bothell Everett Highway<br>P.O.Box 3003<br>Bothell, WA 98041-3003, USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1217116 |
| Contact Person:<br>Telephone No.: | Lynn Harmer<br>[phone] |
| Date Prepared: | June 12, 2003 |
| Device (Trade) Name: | Philips Fresco release 1 |
| Classification Name: | Image processing system, Class II, LLZI, 892.2050 |

#### Predicate Device:

The Philips diagnostic X-ray systems Integris H5000 (K984545), Integris Allura (K002016) and the Integris Allura Flat Detector (K031333) systems have the ability to visualize the stent. (basic stent visibility). Philips Fresco release 1, as an add-on to these systems, will improve the visualization of the stent (enhanced stent visibility)

#### Device description:

The Philips Fresco release 1 will produce an enhanced image of a deployed stent in a coronary artery. To do so, it finds the area of the stent in every image of the Fresco run by finding the radiopaque bullets on the stent delivery catheter. These areas are processed such that the final result over all run images, produces an improved image of the stent area, whereas the distracting peripheral image parts have been blurred.

#### Indications for Use:

The Philips Fresco release 1, add-on to Philips Integris systems, is intended for use in a cardiovascular and vascular x-ray interventional application, viz. stent placing.

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

510(k) Summarv Philips Fresco, release 1 Page 2 of 2

#### General Safety and Effectiveness

The device and the labeling will comply with the applicable requirements of 21CFR. Subchapter J - Radiological Health, parts 1020.10 and 1040.10 The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 60950 and be classified by Underwriters Laboratories. The Philips Fresco release 1 will also comply with the ACR/NEMA DICOM digital imaging communication standard.

#### Conclusion:

The Philips Fresco release 1 does not introduce new indications for use, nor does the use of the device result in any new potential hazard.

Philips Medical Systems considers the Philips Fresco release 1 to be substantially equivalent with the predicate devices.

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

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings. The seal appears to be a logo or emblem, possibly representing a government agency related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems North America Company 22100 Bothell Everett Highway P.O. Box 3003 BOTHELL WA 98041-3003

#### Re: K031836

Trade/Device Name: Philips Fresco release 1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: June 12, 2003 Received: June 13, 2003

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 either class II (Special Controls) or class III (PMA). it may be subject to 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.

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.

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

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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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 statement

510(k) Number (if known):

Philips Fresco release 1 Device Name:

Indications for Use:

The Philips Fresco release 1, option to Philips Integris Allura systems, is intended for use in a cardiovascular and vascular x-ray interventional application, viz. stent placing.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

川 【NCCDCD 】 Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use .. (Per 21 CFR 801.109)

OR

Over-The-Counter Use .......

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)