(66 days)
No
The summary describes a system for digital image acquisition, review, and processing, but there is no mention of AI or ML capabilities. The focus is on standard image handling, multi-modality display, and DICOM conformance.
No
The device is described as providing digital acquisition, review, processing, and analysis capabilities for cardiac images to support diagnosis and therapy, but it does not directly perform any therapeutic actions.
Yes
Explanation: The device's "Intended Use / Indications for Use" states that it "provides image review... as well as processing and analysis capability" and includes "multi-modality imaging to support diagnosis and therapy of cardiovascular patients," directly indicating its role in diagnosis.
No
The device description explicitly mentions "real-time high resolution 1024 line analog secondary image capture" and "high speed direct digital connection," indicating hardware components for image acquisition. It also mentions a "dedicated cardiology remote control (optional)" for the CWS 3000, further suggesting hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The InfiMed Cardiovascular Workstation is described as a system for the digital acquisition, review, processing, and analysis of medical images (MR, CT, Nuclear, Ultrasound, CR, and angiography). It handles images obtained from various imaging modalities, not samples taken from the body.
- Intended Use: The intended use is to support the diagnosis and therapy of cardiovascular patients through the review and analysis of medical images. This is distinct from performing tests on biological samples.
The device is clearly focused on handling and analyzing medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.
Product codes
90 LLZ
Device Description
The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. The CWS 5000 will acquire ACC/NEMA DICOM images or real-time, high resolution 1024 line analog secondary image capture. The CWS 5000 output is ACC/NEMA DICOM. Patient images may be written to CD-R media according to the ACC/NEMA DICOM standards for permanent archive and/or patient interchange. In addition, the CWS 5000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 5000 is compatible with standard network technology and is conformant to DICOM standards.
The InfiMed Cardiovascular Workstation CWS 3000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. Patient studies may be reviewed in real-time or slow motion using a knob on a dedicated cardiology remote control (optional). MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 3000 is compatible with standard network technology and is conformant to DICOM standards. In addition, the CWS 3000 is available with a high speed direct digital connection to the InfiMed Gold One for filmless operation including DICOM review, CD-R generation and networking.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM transfer, real-time high resolution 1024 line analog secondary image capture, high speed direct digital connection, MR, CT, Nuclear, Ultrasound, CR, cath lab cardiac and peripheral vascular angiography.
Anatomical Site
Cardiac, peripheral vascular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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)
Performance Data: Not required for the determination of substantial equivalence of this device.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
99 2575
ОСТ 7 1999
510(K) Summary
Date Prepared: June 7, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550
Device trade name: Cardiovascular Work Station ( CWS) 5000 and CWS 3000 Common name: Digital Imaging System Classification Name: Picture Archival and Communications System ( as per 892.2050)
Predicate substantially equivalent devices:
Kodak Digital Science Cardiac Viewer ( K974086) Kodak Digital Science Cardiac Archive and Review System ( K960043)
Device Description:
The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. The CWS 5000 will acquire ACC/NEMA DICOM images or real-time, high resolution 1024 line analog secondary image capture. The CWS 5000 output is ACC/NEMA DICOM. Patient images may be written to CD-R media according to the ACC/NEMA DICOM standards for permanent archive and/or patient interchange. In addition, the CWS 5000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 5000 is compatible with standard network technology and is conformant to DICOM standards.
The InfiMed Cardiovascular Workstation CWS 3000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. Patient studies may be reviewed in real-time or slow motion using a knob on a dedicated cardiology remote control (optional). MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 3000 is compatible with standard network technology and is conformant to DICOM standards. In addition, the CWS 3000 is available with a high speed direct digital connection to the InfiMed Gold One for filmless operation including DICOM review, CD-R generation and networking.
1
Intended Use:
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multimodality display and printing on laser cameras.
| | Cardiovascular
workstation | Kodak Digital
Science Cardiac
Viewer
( K974086) | Kodak Digital
Science Cardiac
Archive and Review
System
( K960043) |
|-------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Archiving data
format | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Image viewing
speed (maximum) | 60 frames / second | 60 frames / second | 24 frames / second |
| Display image
resolution | 1280 x 1024 pixels (
standard) 256 bit
color or
monochromatic | 800 x 600 pixel (
minimum) 256 bit
color or
monochromatic | 1280 x 1024 pixels (
standard)
monochromatic |
| Compression
concept and
standards | JPEG Lossless
Compression | JPEG Lossless
Compression | JPEG Lossless and
Lossy Compression |
| "Window / level /
zoom / edge features | Yes | Yes | Yes |
| Forward / Reverse /
Still capability | Yes | Yes | Yes |
| Hardcopy Capability | Yes, DICOM print
printers | Yes - windows
based printers | Yes - windows
based printers |
| User Input | Keyboard and
Cardiology Specific
Remote Control,
DICOM worklists | Keyboard and
mouse | Keyboard and
Cardiology Specific
Remote Control |
| Image acquisition | Multi modality
DICOM receive | DICOM receive -
XA and Ultrasound | DICOM receive -
XA class only |
Predicate device specifications comparison:
2
| | of video stream,
direct digital
connection | | | |
|------------------------------|--------------------------------------------------|-----------------------------------------------------------------------|------|------|
| | Outputs | DICOM send , ACC
/ NEMA DICOM
CD-R writing | None | None |
| | Measurement
capability | Quantitative
Coronary Analysis
and Left Ventricular
Analysis | None | None |
| Multi run dynamic
viewing | Yes | No | No | |
Performance Data: Not required for the determination of substantial equivalence of this device.
Conclusions drawn from comparison:
The CWS performs the same functions in the same environment as the predicate devices. There are some new features offered with the CWS, but these are built on the same basic functionality offered by the CWS and the predicate devices and raise no new questions of efficacy or substantial risk.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is a symbol consisting of three stylized human figures or abstract shapes, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 OCT
Ralph J. Flatau Quality Assurance Manager Infimed, Inc. 121 Metropolitan Drive Liverpool, NY 13088
Re:
K992575 CWS 3000/5000 Cardiovascular Work Station Dated: July 30, 1999 Received: August 2, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Flatau:
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 legally marketed predicate 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). 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 requirements, 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 the Electronic Product 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(K) Number ( if known): __
Dèvice Name: CWS 3000 / 5000 Cardiovascular Work Station
Indication for Use:
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ( DOE)
Prescription Use
Or
Over the counter Use
Per 21 CFR 801.109
( Optional format 1-2-96)
Jamil A. Seyam
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
CWS 3000 / 5000 FDA 510(k) submission