WRITESTAR, AND VIEWSTAR
K964274 · Comview Corp. · LMB · Jan 10, 1997 · Radiology
Device Facts
| Record ID | K964274 |
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| Device Name | WRITESTAR, AND VIEWSTAR |
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| Applicant | Comview Corp. |
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| Product Code | LMB · Radiology |
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| Decision Date | Jan 10, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 892.2010 |
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| Device Class | Class 1 |
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Intended Use
The WriteStar is designed to create convenient and efficient storage, display, and analysis of digital images of heart catheterization and other coronary procedures involving cine-film applications. The WriteStar is designed to support the cine-less cath lab environment and is meant to replace 35mm cine film, and cine projectors currently being used by the majority of cardiac catheterization laboratories. Cine film is currently being used as the permanent archival media for images acquired during heart catheterization. The WriteStar is able to function as an independent unit that accepts images from any imaging system an RS-170 video source. The ViewStar is a review station. The ViewStar does not have the WriteStar’s capability to record to a CD-R disk. The ViewStar can only read (view) a case study from a DICOM compliant CD-R disk. The ViewStar/Write Star is able to review patient images from a CD-R disk that was previously recorded from an imaging device that uses the DICOM standard. The patient images are transferred from the CD-R disk to the internal hard disk of the WriteStar. Once the images are on the hard disk, the Cardiologist, or other qualified personnel, has the same means to review and analyze images. Analysis is provided via 3rd party industry standard software. The WriteStar interfaces with commercially available devices that digitize and/or process cine images and or fluoro images and records these images on a 2GB or 4GB SCSI hard drives. These images are simultaneously displayed on the system console for image quality verification. Images are acquired from the source device via RS-170 interface. The images are then displayed for review and analysis similar to a cine film projector. As in the cine film projector, the WriteStar will display cine images of a particular patient without the use of film.
Device Story
WriteStar/ViewStar are digital image archival and review stations for cardiac catheterization labs; replace 35mm cine film. Input: x-ray images via RS-170 interface from imaging systems. WriteStar digitizes, archives to CD-R/hard drive, and displays images; ViewStar retrieves/reviews images from DICOM-compliant CD-R. Operated by cardiologists/qualified personnel in clinical settings. Output: visual display of cine images for review/analysis. Analysis performed via 3rd party industry-standard software. Benefits: efficient storage, cine-less workflow, and digital image exchange.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
IBM-compatible 486/586/Pentium PC; SVGA monitor; HP-compatible laser printer; CD-ROM/CD-R storage; 2GB/4GB SCSI hard drives. Connectivity: RS-170 video input; DICOM-compliant exchange media. Software platform: IBM OS/2 V3.0 or higher.
Indications for Use
Indicated for cardiac catheterization laboratories to store, display, and analyze digital x-ray images of coronary procedures, replacing 35mm cine film and projectors.
Regulatory Classification
Identification
A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.
Predicate Devices
- Digital Disk Recorder (DDR) or the Digital ViewStation with Dual Path Archiver (K942264)
- Video Plus System with Analytical Workstation (K941979)
- AccuLupe digital image archival and review station (K955184)
Related Devices
- K983088 — INSTACINE D-2000 · Fidelity Medical, Inc. · Sep 22, 1998
- K031638 — CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION · Electromed Imaging, Inc. · Jul 21, 2003
- K971181 — THE MIDVIEW-MEDCON'S DICOM VIEWER · Medcon , Ltd. · Jul 29, 1997
- K081308 — FUJIFILM FCR VIEW, MODEL CR-VW674 · Fujifilm Medical Systems U.S.A, Inc. · Jun 4, 2008
- K955519 — ANALYTICAL REVIEW STATION · Camtronics, Ltd. · May 9, 1996
Submission Summary (Full Text)
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JAN 10 1997 K964274
# 510(k) Summary of Safety and Effectiveness
The following summary is submitted pursuant to 21 CFR 807.92:
Submitter: ComView
Date Prepared: October 21, 1996
Trade/Proprietary Name: WriteStar and ViewStar
Common/Usual Name: Digital image archival and review station.
Classification: Class II, 90JAA
Classification Name: None assigned; RE: HHS Publication FDA 91-4246
Panel: Radiology
Performance Standard: Voluntary; DICOM for digital exchange media.
Reason for 510(k): New product equivalency.
## Predicate Devices:
Legally marketed predicate devices with the same intended use include the a) Digital Disk Recorder (DDR) or the Digital ViewStation with Dual Path Archiver manufactured by Eigen (RE: K942264); b) the Video Plus System with Analytical Workstation manufactured by Camtronics (RE: K941979); and c) the AccuLupe digital image archival and review station (RE: K955184).
## Description:
The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing, displaying, and analyzing digitized x-ray images. It has the following major components(minimally):
- IBM compatible 486/586/ or Pentium computer.
- A SVGA monitor
- HP compatible laser jet printer.
- CD-ROM/CD-R disk
- Software program developed by ComView to run on the IBM OS/2 V3.0 or higher platform.
The archival/review is designed as an accessory to legally marketed medical devices that can digitize x-ray images in the cardiac cath lab. The WriteStar provides image digitization, archival, display, and exchange media compliant to the DICOM standard. The ViewStar provides image review and analysis capabilities and retrieval of data from CD-R disc.
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The following questions have been addressed:
| Is the device life supporting or life sustaining? | No |
| --- | --- |
| Is the device implanted? | No |
| Does the device design use software? | Yes |
| Level of concern for software (if applicable)? | Minor |
| Is the device sterile? | No |
| Is the device for single use? | No |
| Is the device for home use or prescription use? | No |
| Does the device contain drugs or biological products as a component? | No |
| Is the device a diagnostic Kit? | No |
## Intended Use
The WriteStar is designed to create convenient and efficient storage, display, and analysis of digital images of heart catheterization and other coronary procedures involving cine-film applications. The WriteStar is designed to support the cine-less cath lab environment and is meant to replace 35mm cine film, and cine projectors currently being used by the majority of cardiac catheterization laboratories. Cine film is currently being used as the permanent archival media for images acquired during heart catheterization. The WriteStar is able to function as an independent unit that accepts images from any imaging system an RS-170 video source.
The ViewStar is a review station. The ViewStar does not have the WriteStar’s capability to record to a CD-R disk. The ViewStar can only read (view) a case study from a DICOM compliant CD-R disk.
The ViewStar/Write Star is able to review patient images from a CD-R disk that was previously recorded from an imaging device that uses the DICOM standard. The patient images are transferred from the CD-R disk to the internal hard disk of the WriteStar. Once the images are on the hard disk, the Cardiologist, or other qualified personnel, has the same means to review and analyze images. Analysis is provided via 3rd party industry standard software.
The WriteStar interfaces with commercially available devices that digitize and/or process cine images and or fluoro images and records these images on a 2GB or 4GB SCSI hard drives. These images are simultaneously displayed on the system console for image quality verification.
Images are acquired from the source device via RS-170 interface. The images are then displayed for review and analysis similar to a cine film projector. As in the cine film projector, the WriteStar will display cine images of a particular patient without the use of film.
Legally marketed predicate devices with the same intended use include the Digital Disk Recorder (DDR) or the Digital ViewStation with Dual Path Archiver manufactured by Eigen (RE: K942264); the Video Plus System with Analytical Workstation manufactured by Camtronics (RE: K941979); and the AccuLupe digital image archival and review station (RE: K955184).
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# Comparison of Predicate Devices
ComView, Inc.'s WriteStar performs the same functions, in the same environment, as the Camtronics' Archium, Eigen's Digital Disk Recorder Plus with DualPath Archiver, and E for M's AccuLupe. A comparison of device specifications and principles of operation indicates no new questions of efficacy, or substantial risk are raised.
Official Correspondent: Shailander Mangla
Signature: 
Telephone: 914-736-3804
Fax: 914-736-3428
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