(77 days)
Not Found
No
The document describes a system for digitizing, storing, displaying, and analyzing medical images, primarily focusing on replacing cine film. It mentions standard computer components and software for image management and analysis, but there is no mention of AI or ML technologies, algorithms, or capabilities. The analysis is provided via "3rd party industry standard software," which is not indicative of AI/ML.
No
The device is described as an independent computerized system for managing, displaying, and analyzing digitized x-ray images, and is intended to replace cine film for archival and review purposes. It does not exert a therapeutic action on the patient.
No
The device is designed for the storage, display, and analysis of digital images, and to replace existing image archival and review systems (35mm cine film and projectors). While it enables analysis via 3rd party software, its primary function is managing and displaying images for review, not generating new diagnostic information.
No
The device description explicitly lists hardware components such as an IBM compatible computer, SVGA monitor, laser jet printer, and CD-ROM/CD-R disk as major components of the WriteStar system. While software is a key part, it is integrated with and relies on specific hardware.
Based on the provided text, the WriteStar/ViewStar device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- WriteStar/ViewStar analyzes medical images: The WriteStar/ViewStar is explicitly described as a system for storing, displaying, and analyzing digital images of heart catheterization and other coronary procedures. It works with digitized x-ray, cine, and fluoro images.
- No mention of biological sample analysis: The description focuses entirely on image handling and analysis, with no indication of processing or analyzing any biological samples.
Therefore, the WriteStar/ViewStar falls under the category of medical imaging devices or image management systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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 WriteStan'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 verficication.
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.
Product codes
JAA
Device Description
The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing, displaying, and analyzing digitized xray 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images, cine-film, fluoro images
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiologist, or other qualified personnel, cardiac catheterization laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2010 Medical image storage device.
(a)
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.(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.
0
JAN 10 1997
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 |
Description:
The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing, displaying, and analyzing digitized xray images. It has the following major components(minimally):
Analytical Workstation manufactured by Camtronics (RE: K941979); and c) the
AccuLupe digital image archival and review station (RE: K955184).
-
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.
1
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 WriteStan'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 verficication.
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).
2
Comparison of Predicate Devices
Com View, 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
914-736-3804
914-736-3428
Signature:
Telephone:
Fax:
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