MILTRA IMAGING INC., IMAGE VAULT

K974102 · Mitra Imaging, Inc. · LMD · Jan 20, 1998 · Radiology

Device Facts

• Record ID: K974102
• Device Name: MILTRA IMAGING INC., IMAGE VAULT
• Applicant: Mitra Imaging, Inc.
• Product Code: LMD · Radiology
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

Vault is intended to act as a long term storage device (archive) for medical images. Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP): - Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images. - Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices. - Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.

Device Story

Image Vault is a PC-based, DICOM-compliant PACS software solution for medical image archiving. It functions as a DICOM Storage Service Class Provider (SCP), receiving images from modalities via TCP/IP, storing them on magnetic tape or hard disk, and enabling retrieval to workstations. It supports JPEG-compressed and non-compressed DICOM images. The system includes a display utility for patient and study identification, though it is not intended for diagnostic use. Operated by hospital staff or administrators, it manages large-scale image data using hierarchical storage management. It provides no image processing or quality enhancement; its primary benefit is secure, rapid, long-term storage and retrieval of clinical imaging data.

Clinical Evidence

Bench testing only. The software was validated through internal procedures and testing by programmers and potential customers. No clinical data was required as the software is used for storage and control purposes and does not affect image quality.

Technological Characteristics

PC-based software; DICOM-compliant; TCP/IP communication; supports magnetic tape and hard disk storage; CD-R media support; 1024x768 display resolution. No image processing algorithms. Software is used for control and storage management only.

Indications for Use

Indicated for long-term storage and retrieval of medical images in a hospital department setting. Users include service personnel, system administrators, and clinical staff (e.g., chief technologist).

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

• Kodak Cardiology Digital Archive & Review System (Cardiac Archive Station, CAS 6000) (K960043)

Submission Summary (Full Text)

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K974102

P 1/4

JAN < U 1998

# 510(k) SUMMARY of Safety and Effectiveness

- 1.1 Company Identification
Mitra Imaging, Inc. 115 Randall Drive Waterloo, Ontario, Canada N2V IC5 Tel: [phone] Fax: [phone]

- 1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116

- 1.3 Date of Submission
October 31, 1997

- 1.4 Device Name
CCCCCCCCCGGGG

Classification Name: Common/Usual Name: PACS Image Archive System/ Teleradiology System Image Vault

Proprietary Name:

- Substantial Equivalence 1.5
The Image Vault software is substantially equivalent to the Kodak Cardiology Digital Archive & Review System (Cardiac Archive Station, CAS 6000), K960043.

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K974102 2/4

#### 1.6 Device Description and Intended Use

Image Vault is a software package which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Image Vault is a PC-based, DICOMcompliant PACS device that is able to send & receive, display, store, and archive DICOM non-compressed and JPEG-compressed images. Images can be archived using standard magnetic tapes. It also has the ability to read/write a collection of images to/from CD-R media in a method defined by DICOM.

Images can be viewed using a simple display utility, for the purposes of properly identifying patients and their corresponding studies, and is not intended to be used for diagnosis.

Image Vault uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Image Vault.

#### 1.7 Software Development

Mitra certifies that the Image Vault software is designed, developed, tested and validated according to written 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 cardiology and storage only and does not affect image quality.

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K974102

### Substantial Equivalence Comparison Chart 1.8

Substantial Equivalence Comparison Chart (Image Vault)

| Specification | Image Vault | Kodak Cardiac Archive Station CAS 6000 |
|---------------------------------|------------------------------------|----------------------------------------|
| Graphical User Interface | Yes | Yes |
| Patient Demographics | Yes | Yes |
| Display Resolution | 1024x768 | 1024x768 |
| Communications | TCP/IP | TCP/IP |
| Image Review | Flip/Rotate/Pan/Zoom/Sequential | Flip/Rotate/Pan/Zoom/Sequential |
| CD Writers Supported | Yamaha CDR400<br>Yamaha CDR100 | Kodak PCD Writer 600 |
| CD Labeling | Yes | Yes |
| Temporary Image Storage | Yes | Yes |
| Image Archiving (Hard Disk) | Yes | Yes |
| Image Archiving (Magnetic Tape) | Yes | No |
| Magnetic Tape Drives Supported: | ADIC Scalar 218<br>ADIC Scalar 448 | No |
| Platform | PC | PC |
| | Yes | Yes |

#### Safety and Effectiveness 1.9

In accordance with the provisions of the Safe Medical Device Act of
the same with the providing a summary of safety and In accordance with the provisions of the Summary of safety and 1990, Mitra Imaging, Inc. Is providing a Sammary
effectiveness information regarding the Image Vault software.

# General Safety and Effectiveness Concerns:

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

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

# Validation and Effectiveness:

Extensive testing of the software package has been performed by
entify of the software commerce and by potential customers. Extensive testing of the soltware passes and by potential customers.
programmers, by non-programmers, and by potential customers. programmers, by non-programmers, and by p on any posses and has no bearing on Software is only used for control purposso and has and master in this software.
image quality. There is no image processing used with this software.

Images that are compressed are properly identified in the images Images that are compressed are propenty tierhinet in the DCOM standard.
information as being compressed as specified by the entire information as being compressed as spoolibus by and the entire life of the image.

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K974102

## Substantial Equivalence:

The Image Vault software is a software package used for archiving cardiac images and for writing to CD-ROM media. The intended use and technological characteristics of the system are similar to the Kodak Cardiac Archive Station CAS 6000. Any differences between the Image Vault software and the equivalent device have no significant influence on safety or effectiveness.

Its is our conclusion that there is no software component that we know of in the Image Vault software whose failure or latent design flaw would be expected to result in death or injury to a patient.

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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/4/Picture/4 description: The image shows the text "JAN 20 1998" in a bold, sans-serif font. The text is arranged horizontally, with the month abbreviation "JAN" on the left, followed by the day "20", and then the year "1998". The text is black against a white background.

Mitra Imaging, Inc. c/o Gary J. Állesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116

Re:

K974102 Image Vault Dated: October 31, 1997 Received: October 31, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Allesbrook:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 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 vitry diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions 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.Liau 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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Page 1 of 1

K974102

510(k) Number (if known):

## Device Name: Image Vault

Indications for Use:

Vault is intended to act as a long term storage device (archive) for medical images.

Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP):

- Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images.
- [ Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices.
- O Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.

Users:

The Vault will be located in a hospital department. The expected users are as follows:

Service personnel for installation, configuration and support.

- [ System administrator within the department, who in many cases will be chief technologist or other designated clinical staff.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 901.109) | |

Over-the-Counter Use

(Optional Format 1-2-96)

Gerrit C. Seymon

OR

510(k) Number

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