PICTOOLS MEDICAL TOOL KIT MODEL 1.0

K982146 · Pegasus Imaging Corp. · LLZ · Sep 14, 1998 · Radiology

Device Facts

• Record ID: K982146
• Device Name: PICTOOLS MEDICAL TOOL KIT MODEL 1.0
• Applicant: Pegasus Imaging Corp.
• Product Code: LLZ · Radiology
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.

Device Story

PICTools Medical Compression Toolkit is a software development kit (SDK) written in 'C'. It provides high-performance image compression libraries for developers to integrate into medical imaging applications. The device processes digital medical image data using wavelet and JPEG compression algorithms. It is intended for use by software developers creating applications for radiology, cardiology, digital dentistry, ultrasound, and telepathology. The output is compressed image data, which facilitates storage and transmission within medical imaging systems. By enabling efficient compression, the toolkit assists in managing large medical image files, potentially improving workflow speed and storage capacity for healthcare providers.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software development kit (SDK) written in 'C'. Implements wavelet and JPEG image compression algorithms. Designed for integration into medical imaging software platforms. Operates as a library for developers.

Indications for Use

Indicated for use by software developers to integrate image data compression algorithms into medical imaging applications for radiology, cardiology, digital dentistry, ultrasound, and telepathology.

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

• Access Radiology (Framewave) (K972925)
• WinRad Teleradiology System (K936179)

Submission Summary (Full Text)

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SEP 1 4 1998

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# 510 (k) Summary as required by 807.92 9 (c) for PICTools Medical Compression Toolkit Prepared June 8, 1998

| Submitted by: | Pegasus Imaging Corporation<br>4010 Boy Scout Boulevard<br>Suite 400<br>Tampa, Florida 33607-5799<br>telephone: [phone] |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Andrew Hudson<br>Director of Business Development |
| Device Trade Name: | PICTools Medical Compression Toolkit |
| Common Name: | Medical Image Compression Software Toolkit |
| Classification: | Picture Archiving and Communications Systems were reviewed by<br>the Radiology Panel and are classified in Class II per 21 CFR<br>892.2050. Image compression devices that label all lossily<br>compressed images as such are being considered by the agency for<br>exemption from premarket notification requirements [510(k)]. |
| Predicate Devices: | Access Radiology (Framewave) K972925 and WinRad<br>Teleradiology System (K936179). |

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#### Description of Devices:

PICTools Medical is a software development kit written in 'C' for software developers to write applications interfaces to integrate particular image data compression algorithms into their medical imaging applications. It provides an array of high performance image compression libraries intended for use by developers of medical devices in the fields of radiology, cardiology, digital dentistry, ultrasound, and telepathology.

### Intended Use of Device:

PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.

## Substantial Equivalence to Predicate Device:

The wavelet compression algorithm in PICTools Medical Compression Toolkit is substantially equivalent to that in Access Radiology (Framewave) (K972925). The JPEG compression algorithms in PICTools Medical Compression Toolkit are substantially wquivalent to those in WinRad Teleradiology System (K936179). The clinical functionalities of the three devices are compared below.

| | Wavelet image<br>compression | JPEG image<br>compression |
|-------------------------------------------|------------------------------|---------------------------|
| PICTools Medical<br>Compression Toolkit | X | X |
| Access Radiology<br>(Framewave) (K972925) | X | |

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The symbol is black, and the text is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Andrew Hudson Director of Corporate Development Pegasus Imaging Corporation 4010 Boy Scout Blvd., Suite 400 Tampa, FL 33607

Re:

K982146 PICTools Medical Compression Toolkit Dated: June 10, 1998 Received: June 17, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Hudson:

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 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 (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 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/dsmam.html".

Sincerely yours,
Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K982146

PICTools Medical Compression Toolkit Device Name:

Indications For Use:

PICTools Medical Compression Toolkit is intended to be used by software developers ITC I ouls Medical Compression Foother is and in digital medical images.

(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 I

510(k) Number K982146

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)