DIGITIZER DIRECTOR (HSC025-01)

K972191 · Howtek, Inc. · LMD · Sep 8, 1997 · Radiology

Device Facts

• Record ID: K972191
• Device Name: DIGITIZER DIRECTOR (HSC025-01)
• Applicant: Howtek, Inc.
• Product Code: LMD · Radiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.

Device Story

Digitizer Director is a DICOM 3.0-compliant secondary image capture software application; operates on Windows NT or Windows 95 PCs. Input: proprietary digital image data from Howtek film digitizers. Operation: queries DICOM databases to associate images with existing patient records or creates new records; translates proprietary digitizer image formats into DICOM 3.0 format. Output: transmits DICOM-formatted images to designated network entities (databases or viewing stations). Used in clinical settings by healthcare staff; supports store-and-forward and image buffering during network downtime. Does not perform image processing or compression; does not affect image quality. Facilitates teleradiology and image storage workflows.

Clinical Evidence

No clinical data. Bench testing only; software validated by programmers, non-programmers, and potential customers to ensure control functionality. Software does not perform image processing or compression and has no impact on image quality.

Technological Characteristics

Software-based teleradiology system; runs on off-the-shelf Windows NT/95 PCs. DICOM 3.0 compliant. No image compression or processing capabilities. Connectivity via standard network protocols to DICOM entities.

Indications for Use

Indicated for medical facilities using Howtek film digitizers to perform secondary image capture of films for transmission to DICOM-compliant applications. No specific patient population or contraindications defined.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Star Technologies FISS (Film Image Scan System) (K952914)

Submission Summary (Full Text)

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Section VII

510(k) Summary

#### FOI 510(k) Summary

K972191

In conformance with Section 513(I)(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: | May 19, 1997 | SEP - 8 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 | |
| 1.5 Classification Name: | PACS<br>Class II<br>Teleradiology Device<br>PAC Peripheral Device | |
| 1.6 Predicate or Legally<br>Marketed Devices: | Star Technologies<br>FISS (Film Image Scan System)<br>#K952914<br><br>Manufactured by Star Technologies, Inc.<br>515 Shaw Rd<br>Sterling, VA 20166 | |

#### 1.7 Description of Device:

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 queries the designated DICOM 3.0 database as each patient record is created. Association is made with the patients already existing in the database. New patient information is required when no association is made. When patient information is complete, the entire patient record is sent to a designated DICOM entity, such as a database or viewing station. DIGITIZER DIRECTOR is a Microsoft Windows NT or Windows 95 based application.

510(k) Submission DIGITIZER DIRECTOR

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### 1.8 Intended Use:

DIGITIZER DIRECTOR is a DICOM software package which enables any medical facility PC with adequate memory and film digitizer to perform a secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR is an integrated DICOM network product which does not have any compression capability. The operator uses the film digitizer to capture films. DIGITIZER DIRECTOR translates the images from digitizer format to DICOM format and sends them on to another DICOM application.

# 1.9 Software Development

Howtek certifies that the DIGITIZER DIRECTOR 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 | Star Technologies<br>FISS |
|--------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Input | Digital Image from film<br>digitizer in proprietary<br>format | Digital Image from film<br>digitizer in proprietary<br>format |
| 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 |
| Compression | No | No |

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 is used for secondary image capture of digitized films and for transmission of these images to DICOM applications. The intended use and technological characteristics of the system are similar to the Star Technologies FISS. 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 Application whose failure or latent system design flaw would be expected to result in death or injury to a patient.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by four curved lines, positioned to the right. To the left of the figure, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically in a circular fashion. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K972191 Digitizer Director (Secondary Image Capture Software) Dated: June 4, 1997 Received: June 10, 1997 Unclassified Procode: 90 LMD

SEP - 8 1997

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, 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 (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 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/dsmamain.html".

Sincerely yours,

h. Lillian Yin, Ph.D.

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 ): K972191

Device Name:

#### Indications for Use:

DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Heguson
(Division Sign-Off)

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

Prescription Use:__X

OR

Over-The-Counter Use:_________________________________________________________________________________________________________________________________________________________