PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION

K990455 · Philips Medical Systems, Inc. · LLZ · May 12, 1999 · Radiology

Device Facts

• Record ID: K990455
• Device Name: PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
• Applicant: Philips Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Easy Vision Legs option enables visualization, (digital) registration, and measurement of the lower limb skeletal geometry. Diagnosis of leg length discrepancies (when both legs are acquired in the same image), as well as length and angle information on anatomical and mechanical axis are supported through the measurement tools provided.

Device Story

The Philips Easy Vision Legs Option is a software-based workstation feature designed for clinical use by healthcare professionals. It processes multiple digital fluoroscopic X-ray images of skeletal leg anatomy, performing digital registration to reconstruct them into a single composite image of the complete lower limb. The workstation provides measurement tools for clinicians to assess skeletal geometry, including leg length discrepancies and anatomical/mechanical axis angles. By enabling the visualization of the entire limb in one view, the device assists clinicians in diagnostic decision-making regarding orthopedic alignment and length. It functions as an extension of the existing Easy Vision Workstation platform.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Image processing workstation software. Operates on digital fluoroscopic X-ray input. Features digital registration and reconstruction algorithms to create composite skeletal images. Provides measurement tools for length and angle quantification. Standalone workstation architecture.

Indications for Use

Indicated for visualization, registration, and measurement of lower-limb skeletal geometry to assist in the diagnosis of leg length discrepancies and assessment of anatomical and mechanical axes.

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 Easyvision Workstation, Spine Option

Submission Summary (Full Text)

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MAY 1 2 1999

Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Below the word is a circle with two stars and three horizontal wavy lines inside. The logo is black and white.

# 510 (k) Summary

## Philips Medical Systems

K990455

| Company Name: | Philips Medical Systems North America Company |
|----------------------|----------------------------------------------------|
| Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | February 11, 1999 |
| Device Name: | Philips Easy Vision Family Workstation Legs Option |
| Classification Name: | Image Processing System (90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Philips Easyvision Workstation, Spine Option |

### System Description:

The Legs Option uses a series of images of the skeletal leg anatomy generated with a digital fluoroscopic X-ray system and reconstructs these images as a single composite image of the complete skeletal anatomy of the lower limbs.

#### Intended Use:

The Easy Vision Legs option enables visualization, (digital) registration, and measurement of the lower limb skeletal geometry. Diagnosis of leg length discrepancies (when both legs are acquired in the same image), as well as length and angle information on anatomical and mechanical axis are supported through the measurement tools provided.

### Safety Information:

No new hazards are introduced by the addition of the Legs Option to the Easy Vision Workstation.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: [phone] Fax: [phone]

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1999

Frank Gianelli Senior Regulatory Affairs Specialist Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917

Re:

K990455 Philips Easy Vision Family Workstation Option: Legs Option Dated: February 11, 1999 Received: February 12, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Gianelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT David C. Scholl, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract caduceus symbol with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

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K99045 510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

Philips EasyVision Legs Option

Indications for Use:

The Easy Vision Legs option is intended for visualization, registration, and measurement of the lower-limb skeletal geometry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)