FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION

K991257 · Fujifilm Medical System U.S.A., Inc. · LLZ · Jun 25, 1999 · Radiology

Device Facts

• Record ID: K991257
• Device Name: FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Fuji wavelet compression is intended to be used in applications to compress digital medical image data.

Device Story

Software-based tool for irreversible wavelet compression of digital medical images; integrates with PACS or workstations (e.g., Synapse). Operates via three user-configurable modes (Base Line, High Speed, Fast Decomp Mode-2). Physician determines appropriateness of compression; system labels images with compression type and ratio. Facilitates data storage/transmission efficiency. Clinical decision-making remains with the physician, who reviews compressed images for diagnostic purposes.

Clinical Evidence

No clinical data provided. Bench testing only; device is a candidate for JPEG-2000 proposal.

Technological Characteristics

Software-only device; performs irreversible wavelet compression. Features three user-configurable modes. Includes labeling and on-screen display of compression type/ratio. Employs standard communications error detection and correction methods. No patient contact; no energy source or physical materials.

Indications for Use

Indicated for the compression of digital medical image data. No specific patient population, age, or disease state contraindications are defined.

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

• FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 (K972256)

Reference Devices

• PICTools Medical Compression Toolkit (K982146)
• Kodak Digital Science™ Medical Image and Information Library (K972380)

Submission Summary (Full Text)

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

991257

04/12/99

FDA 510(k) Premarket Notification Fuji wavelet compression

JUN 25 1999

510(k) Summary [as required by 21 CFR 807.92]

Date Prepared [21 CFR 807.92(a)(1)] April 9, 1999

### Submitter's Information [21 CFR 807.92(a)(1)]

Fuji Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT. 06902 Telephone: [phone] Facsimile: [phone] Contact: Joseph Azary

# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade name is Fuji wavelet compression or FFCOMP irreversible compression. The device common name is medical image communication device or wavelet compression software.

#### Predicate Device [21 CFR 807.92(a)(3)]

FDA classified the predicate FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality display system for networks with FDA product code LLZ as unclassified (before medical device communication devices were put into class I) under 510(k) number K972256. Fuii received notification that FDA cleared the marketing of the predicate device in a letter dated September 12, 1997.

Fuji is aware of other medical devices on the market that utilize irreversible compression such as:

- PICTools Medical Compression Toolkit K982146 .
- Kodak Digital Science™ Medical Image and Information Library K972380 ●

### Description of the Device [21 CFR 807.92(a)(4)]

The subject device is a software product that consists of algorithms that perform irreversible wavelet compression on data found in digital medical images. This software may be used with current Fuji products (such as the Synapse™ Image & Information Management System, Fuji workstations) or future medical image communication or PACS devices.

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

The subject device has three user-configurable modes of operation; 1) Base Line Mode, The subject do roo nas high speed), and 3) Fast Decomp Mode-2 (high speed).

For further details on the Fuji Wavelet compression Algorithm, see the product description in Annex 1, as well as the quantitative test results in Annex 2.

# Intended Use [21 CFR 807.92(a)(5)]

Fuji wavelet compression is intended to be used in applications to compress digital medical image data.

# Technological Characteristics [21 CFR 807.92(a)(6)]

The device does not contact the patient, nor does it control any life sustaining devices. This device is used for the compression of data in digital medical images. The physician makes the choice whether to subject the digital medical images to irreversible compression. The labeling informs of the user of possible effects on image quality. Additionally, the image will include a displayed message to inform the observer whether it has been subjected to irreversible compression and what type and ratio. The images are interpreted by a physician, providing ample opportunity for competent human intervention.

# Performance Data [21 CFR 807.92(b)(1)]

There are no performance standards applicable to the subject device have been issued under authority of section 514 of the Food. Drug, and Cosmetic Act.

However, representatives from Fuji are active participants on the committee that is developing JPEG-2000. The Fuji wavelet compression is one of the candidates to the JPEG-2000 proposal.

### Conclusion [21 CFR 807.92(b)(3)]

As is the case with the predicate devices, the subject device has no patient contact. Nor does the subject device control, monitor, or effect any devices directly connected to or effecting a patient.

The physician makes the choice whether it is appropriate to subject the digital medical images to irreversible compression. Irreversibly compressed images are so labeled along with an indication of the compression type and ratio. Standard communications error detection and correction methods are employed. Images subjected to irreversible compression, by the subject device, are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

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

We conclude that the subject device is as safe and effective as the predicate device and poses no new questions for safety and effectiveness.

H:\510(k)\wavelet.com

510(k) Fuji Wavelet Compression 1999 April 12 d

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 1999

Joseph Azary Regulatoory Affairs Coordinator Fuji Medical Systems, Inc. 419 West Avenue Stamford, CT 06902

RE: K991257

> Fuji Wavelet Compression or FFCOMP Irreversible Compression Dated: April 12, 1999 Received: April 13, 1999 Regulatory Class: II 21 CFR 892.2050/ Procode: 90 LLZ

Dear Mr. Azary:

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 marked 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). 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 (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 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 regulatory 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,
Dan Letizia

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

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

FDA 510(k) Premarket Notification Fuji wavelet compression

Kagizo T 510(k) Number (if known): __

Device Name: Fuji_wavelet_compression

Indications For Use:

Fuji wavelet compression is intended to be used in applications to compress digital medical image data.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991257

Prescription Use ✗

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

H:\510(k)\wavelet.com

510(k) Fuji Wavelet Compression 1999 April 12 б