(87 days)
The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS system for the distribution, viewing, and printing of medical images at distributed locations.
The Kodak Digital Science™ (KDS) ImageVIEW family of products is designed to facilitate the distribution of images from standard DICOM storage devices within the radiology department and provide controlled Internet access to images stored on DICOM storage devices. Browser extensions will allow dynamic viewing and manipulation of these medical images. This family of products will initially provide image viewing and referral printing functionality to referring and clinical physicians, but will be extended to provide diagnostic viewing and printing functionality for radiology use. They will also provide intelligent management of images and information to facilitate productivity enhancements for its users. ImageVIEWs are not represented to be of use in supporting or sustaining human life, nor do they represent a potential of unreasonable risk of illness or injury.
The provided text describes the Kodak Digital Science™ (KDS) ImageVIEW, a Picture Archiving and Communications Systems (PACS) component. However, the document is a 510(k) summary for premarket notification, indicating substantial equivalence to a predicate device, rather than a study report detailing specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information required to populate the tables and answer the questions regarding acceptance criteria, device performance, or study details.
The text states: "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)." This indicates that the device was cleared based on its equivalence to a predicate device, not necessarily on a new clinical study assessing specific performance metrics against pre-defined acceptance criteria.
Information not found in the document:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information.
- Standalone performance details.
- Type of ground truth used.
- How ground truth for the training set was established.
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The 1 8 1398
SUMMARY OF SAFETY AND EFFECTIVENESS
DATE PREPARED: March 17, 1998 I.
SUBMITTER II.
Eastman Kodak Company 18325 Waterview Parkway Dallas, Texas 75252-8026
III. CONTACT PERSON
Robert M. Wolfarth Regulatory Affairs Specialist (972) 454-1466
IV DEVICE NAME
Kodak Digital Science™ (KDS) ImageVIEW Trade Name:
Picture Archiving and Communications Systems (PACS) Components Common Name:
V DEVICE CLASSIFICATION
The FDA has classified the predicate device as Unclassified (Product Code 90 LMD) under 21 CFR 892.1750.
VI. PREDICATE DEVICE
Trade Name:
MediSurf, currently marketed in the United States by Algotec Systems, Ltd. (K971347)
DESCRIPTION OF DEVICE VII.
The Kodak Digital Science™ (KDS) ImageVIEW family of products is designed to facilitate the distribution of images from standard DICOM storage devices within the radiology department and provide controlled Internet access to images stored on DICOM storage devices. Browser extensions will allow dynamic viewing and manipulation of these medical images. This family of products will initially provide image viewing and referral printing functionality to referring and clinical physicians, but will be extended to provide diagnostic viewing and printing functionality for radiology use. They will also provide intelligent management of images and information to facilitate productivity enhancements for its users. ImageVIEWs are not represented to be of use in supporting or sustaining human life, nor do they represent a potential of unreasonable risk of illness or injury.
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VIII. INDICATIONS FOR USE
The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS
system for the distribution, viewing, and printing of medical images at distributed l
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 1998
Robert Wolfarth Regulatory Affairs Specialist Eastman Kodak Company 18325 Waterview Parkway Dallas. Texas 75252
Re:
Kodak Digital Science (KDS) ImageView Dated: March 17, 1998 Received: March 23, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LMD
Dear Mr. Wolfarth:
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 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 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 (OS) 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 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-fire number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
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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Page 1 of 1
510(k) Number (if known): K987105 3
Device Name: Kodak Digital Science™ (KDS) ImageVIEW
INDICATION FOR USE:
The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS system for the distribution, viewing, and printing of medical images at distributed locations.
(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 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David Lee Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De
510(k) Number
§ 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.