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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIGITIZER DIRECTOR device, structured as requested:

Device Name: DIGITIZER DIRECTOR

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics. The core of the submission revolves around demonstrating substantial equivalence to a predicate device (Star Technologies FISS) by matching functional characteristics.

Feature / Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Input	Digital Image from film digitizer in proprietary format	Digital Image from film digitizer in proprietary format
Function Performed	Conversion to DICOM 3.0 Format	Conversion to DICOM 3.0 Format
Output	Sent image to specified DICOM application	Sent image to specified DICOM application
Store and Forward Option	Yes	Yes
Image buffering during Network Downtime	Yes	Yes
Compression	No (as per predicate device and intended use limitation)	No
DICOM 3.0 Compliance	Compliant with DICOM 3.0 standards (for PACS, QRSCP)	DIGITIZER DIRECTOR is a DICOM 3.0 compliant secondary image capture application. It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR translates the images from digitizer format to DICOM format and sends them on to another DICOM application.
Software Development Quality	Designed, developed, tested, and verified according to ISO 9001 procedures	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.
No Effect on Image Quality	Software does not affect image quality	The software used in this product is used for teleradiology and / or image storage only and does not effect image quality. There is no image processing or compression used with this software.
Safety	No failure or latent system design flaw expected to result in death or injury to a patient	"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."

Key Observation: The "acceptance criteria" are primarily based on functional equivalence to the predicate device and adherence to industry standards (DICOM 3.0, ISO 9001) for software development. There are no performance metrics like accuracy, sensitivity, specificity, or processing speed reported as one might find in AI/CAD substantial equivalence. This is characteristic of older 510(k) submissions for devices primarily focused on data conversion and transmission rather than diagnostic interpretation or complex image processing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for a "test set" in the context of typical algorithm validation. The validation described is more focused on software functionality and its ability to convert and transmit images, rather than evaluating diagnostic performance on a dataset of patient images.

Sample Size: Not specified as a discrete number of cases or images.
Data Provenance: Not specified. The testing described appears to be internal software validation rather than clinical data testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable/not specified.
Qualifications of Experts: Not applicable/not specified.

This type of "ground truth" and expert review is typically associated with diagnostic algorithms that provide interpretative outputs. Since the DIGITIZER DIRECTOR's function is conversion and transmission, it does not generate diagnostic findings that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

Similar to point 3, adjudication is not relevant for this type of software.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study: No.
Effect Size: Not applicable.

The device is a teleradiology system for image capture, conversion, and transmission. It is not an AI/CAD device intended to assist human readers in making diagnoses. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study: Yes, to the extent that it describes "Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers." This testing would have evaluated the software's ability to correctly perform its intended functions (image capture, DICOM conversion, transmission) independently, without a human actively interpreting the output in a diagnostic capacity. However, this is functional testing, not a diagnostic performance study.

7. Type of Ground Truth Used

The concept of "ground truth" in the diagnostic sense (e.g., pathology, longitudinal outcomes) is not applicable to this device. The "truth" for this device's validation is whether it correctly converts proprietary digitizer formats to DICOM 3.0 and transmits them without affecting image quality. This is a functional correctness truth, not a diagnostic truth.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified.

This device is not an AI/machine learning model that undergoes a training phase with a specific dataset. It is a software application designed for specific functional tasks.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

As it's not an AI/ML model, there is no "training set" or ground truth established for training. The "truth" for software development would be based on functional specifications and DICOM 3.0 standards.

Summary

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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 Incorporated21 Park AvenueHudson, New Hampshire 03051
1.3 Official Correspondent:	M. Russell LeonardChief Operating Officer
1.3 Device Common / Usual Name:	Teleradiology System
1.4 Device Trade Name:	DIGITIZER DIRECTOR
1.5 Classification Name:	PACSClass IITeleradiology DevicePAC Peripheral Device
1.6 Predicate or LegallyMarketed Devices:	Star TechnologiesFISS (Film Image Scan System)#K952914Manufactured by Star Technologies, Inc.515 Shaw RdSterling, VA 20166

1.7 Description of Device:

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	HowtekDIGITIZER DIRECTOR	Star TechnologiesFISS
Input	Digital Image from filmdigitizer in proprietaryformat	Digital Image from filmdigitizer in proprietaryformat
Function Performed	Conversion to DICOM 3.0Format	Conversion to DICOM 3.0Format
Output	Sent image to specifiedDICOM application	Sent image to specifiedDICOM application
Store and Forward Option	Yes	Yes
Image buffering duringNetwork 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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

Over-The-Counter Use:_________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.