DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)

K973081 · Howtek, Inc. · LLZ · Nov 5, 1997 · Radiology

Device Facts

• Record ID: K973081
• Device Name: DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
• Applicant: Howtek, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.

Device Story

DIGITIZER DIRECTOR: Image Compression Module is a software expansion for the Howtek Digitizer Director system; operates on Windows NT or Windows 95 PCs. Device functions as a DICOM 3.0 compliant image compressor; enables efficient transmission of digitized film images to DICOM-compatible viewing stations and databases. Input consists of digital images from film digitizers; output is compressed DICOM-formatted image data. Used in clinical environments by healthcare staff; facilitates teleradiology and image storage workflows. Software does not alter image quality; provides store-and-forward capabilities and image buffering during network downtime. Benefits include improved efficiency in medical image distribution and storage within hospital networks.

Clinical Evidence

No clinical data. Effectiveness validated through extensive software testing by programmers, non-programmers, and potential customers. Software is used for control purposes only and does not affect image quality.

Technological Characteristics

Software-based DICOM image compression module; operates on Windows NT/95 PCs. Uses DICOM 3.0 compliant JPEG compression algorithms. Connectivity via standard network interfaces for DICOM entity communication. Designed and developed under ISO 9001 procedures.

Indications for Use

Indicated for use in hospital or medical facility settings to enable the transmission of DICOM-compliant images from film digitizers to other DICOM entities, such as viewing stations and databases, via PC-based systems.

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

• Applicare, BVI RadWorks (K962699)

Submission Summary (Full Text)

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#### FOI 510(k) Summary

K973081

In conformance with Section 513(l)(3) of the Food, Drug, and Cosmetic Act, Howtek Incorporated hereby submits with this Premarket Notification an adequate summary of any information.

| 1.1 Submission Date: | August 6, 1997 | NOV - 5 1997 |
|-----------------------------------------------|----------------------------------------------------------------------|--------------|
| 1.2 Owner / Operator: | Howtek Incorporated<br>21 Park Avenue<br>Hudson, New Hampshire 03051 | |
| 1.3 Official Correspondent: | M. Russell Leonard<br>Chief Operating Officer | |
| 1.3 Device Common / Usual Name: | Teleradiology System | |
| 1.4 Device Trade Name: | DIGITIZER DIRECTOR: Image Compression Module | |
| 1.5 Classification Name: | PACS<br>Class II<br>Teleradiology Device<br>PAC Peripheral Device | |
| 1.6 Predicate or Legally<br>Marketed Devices: | Applicare, BVI<br>RadWorks<br>#K962699 | |

## 1.7 Describilion of Device:

DIGITIZER DIRECTOR: Image Compression Module is an expansion module to Digitizer Director. The module provides a compression solution which uses compression algorithms which are fully supported by DICOM. Digitizer Director is a DICOM 3.0 compliant secondary image capture application for the Howtek family of film digitizers, It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR and the Image Compression Module are Microsoft Windows NT or Windows 95 based applications.

. .

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## 1.8 Intended Use:

The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.

## 1.9 Software Development

Howtek certifies that the DIGITIZER DIRECTOR: Image Compression Module software is designed, developed, tested and verified according to ISO 9001 procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used for teleradiology and / or image storage only and does not effect image quality.

## 2.0 Statement of Substantial Equivalence

| Function of Variable | Howtek<br>DIGITIZER DIRECTOR | Applicare<br>RadWorks |
|--------------------------------------------|----------------------------------------------|----------------------------------------------|
| Input | Digital Image from raw data | Digital Image from raw data |
| Function Performed | Conversion to DICOM 3.0<br>Format | Conversion to DICOM 3.0<br>Format |
| Output | Sent image to specified<br>DICOM application | Sent image to specified<br>DICOM application |
| Store and Forward Option | Yes | Yes |
| Image buffering during<br>Network Downtime | Yes | Yes |
| JPEG Compression | Yes | Yes |

Substantial Equivalence Chart (DIGITIZER DIRECTOR)

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### Summary Statement of Safety and Effectiveness

In accordance with the provisions of the Safe Medical Device Act of 1990, Howtek, Inc. provides this summary of safety and effectiveness information regarding DIGITIZER DIRECTOR.

#### 1.1 General Safety and Effectiveness

The device labeling contains instructions for use and indications for use.

The hardware components specified ( but not supplied) are all off-the-shelf computer components.

## 1.2 Validation of Effectiveness

Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this software.

## 1.3 Substantial Equivalence

Howtek's DIGITIZER DIRECTOR: Image Compression Module is used to compress secondary capture images in DICOM JPEG format. RadWorks uses IJG JEPG as well and sends the image in DICOM format. Any differences between the device and the predicate device have no significant influence on the safety or effectiveness of the product.

It is our conclusion that there is no software component that we know of in the Howtek DIGITIZER DIRECTOR: Image Ocmoression Module Application whose failure or latent system design flaw would be expect on the within thath or injury to trip sich ti

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized representation of human figures, with three abstract profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV - 5 1997

M. Russell Leonard Chief Operating Officer Howtek, Inc. 21 Park Ave. Hudson, NH 03051

Re:

K973081 Digitizer Director: Image Compression Module -H04059 - Rev 2.0 Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Leonard:

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, 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 (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 requirement, 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 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 question 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/dsmamain.html".

Sincerely yours.

W. Liao Yu

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

Enclosure

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#### Attachment C Indications For Use Statement

510(k) Number(if Known): イクフ 3つ8/

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinnit A. Grayson

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number K973081

Prescription Use:__X__

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OR

Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________