(63 days)
The KODAK Oncology Image Manager (OIM) is a picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment.
KODAK Oncology Image Manager is designed to archive patient information and images gathered as the patient progresses through cancer treatment. The consolidated information and images can be reviewed as treatment progresses by onocologist and nurses. The general hardware configuration of the KODAK Oncology Image Manager contains the following major components: Touch screen Monitor, Central Processing Unit (CPU), Film and Document scanners, CD-ROM writer and reader.
This submission is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS) from 1997. Due to the nature of PACS devices, particularly those from this era, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria, ground truth, and statistical analyses typically associated with AI/ML-powered diagnostic devices.
Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable or available in this document as it predates the rigorous performance evaluation standards now expected for AI/ML medical devices.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the way a modern AI/ML device submission would. The performance is implied through substantial equivalence to the predicate device, IMPAC, IMAGErt, Image Management System. The "performance" in this context refers to its ability to perform PACS functions, not diagnostic accuracy.
The comparison of features in Section VII (reproduced below) serves as the primary "performance" and "acceptance criteria" through showing functional equivalence.
| Characteristics | KODAK Digital ScienceOncology Image Manager | IMPAC, IMAGErt, ImageManagement System |
|---|---|---|
| Knumber | this submission | K942346 |
| GENERAL | ||
| Advertised use | An acquisition, management,distribution and archiving system,PACS device. | A computerized image managementsystem. |
| Hardware requirements | 90-132vac/47-63Hz180-264vac/47-63Hz | 90-132vac/47-63Hz180-264vac/47-63Hz |
| Environmental | 4-45 degrees C/15-90% RHnon-condensing | 4-45 degrees C/15-90% RHnon-condensing |
| Hardware Description | Server, Workcenter, Review Computer | Viewstations, Maintenance, Namer |
| Network Capability | Ethernet, Internet, Intranet | Ethernet, Internet, Intranet |
| Data Type | Image, Text, Patient Information | Image, Text, Patient Information |
| Input Sources | Diagnostic interface, Networkedinterfaces, DICOM images, Removablemedia, Digital cameras | Diagnostic interface, Networkedinterfaces, DICOM images,Removable media |
| Output Devices | CD, Printers, offline storage devices | CD, Printers, offline storage devices |
| Operating System | Windows NT | PC Compatible |
| Image Preview | yes | yes |
| Open Case Preview | yes | yes |
| Receive Images fromother systems | yes | yes |
| Retrieve Images fromother systems | yes | yes |
| Patient DemographicInformation | yes | yes |
| Acquire Radiographic Filmsfrom Film Digitizer | yes | yes |
| Portable patient records | yes | yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified or applicable in the context of this 510(k) for a PACS device. No "test set" in the sense of a dataset for evaluating diagnostic performance metrics was used or discussed. The evaluation focused on functional equivalence.
- Data Provenance: Not specified or applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not specified or applicable. Ground truth for diagnostic performance is not relevant to a PACS functional equivalence submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not performed. This type of study is for evaluating diagnostic performance, which is not the focus of a PACS functional equivalence claim.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- No, a standalone performance study as understood for AI/ML algorithms was not performed. This device is a PACS, an infrastructure tool, not a diagnostic algorithm.
7. The Type of Ground Truth Used
- Not applicable. Ground truth for diagnostic performance is not relevant to a PACS functional equivalence submission. The "ground truth" here is the established functionality of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device is a PACS, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML model, no ground truth needed to be established for it.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1980118
MAR 17 1998
DATE PREPARED: December 1, 1997 I.
-
SUBMITTER: II.
Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester, New York 14653 -
CONTACT PERSON: III.
Nancy Butcher Regulatory Affairs (214) 454-1417 -
DEVICE NAME: IV
KODAK Oncology Image Manager (OIM) Trade Name
DEVICE CLASSIFICATION V
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
- PREDICATE DEVICE: VI.
IMPAC, IMAGErt, IMAGE Management System
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COMPARISON OF FEATURES: VII.
| Characteristics | KODAK Digital ScienceOncology Image Manager | IMPAC, IMAGErt, ImageManagement System |
|---|---|---|
| Knumber | this submission | K942346 |
| GENERAL | ||
| Advertised use | An acquisition, management,distribution and archiving system,PACS device. | A computerized image managementsystem. |
| Hardware requirements | 90-132vac/47-63Hz180-264vac/47-63Hz | 90-132vac/47-63Hz180-264vac/47-63Hz |
| Environmental | 4-45 degrees C/15-90% RHnon-condensing | 4-45 degrees C/15-90% RHnon-condensing |
| Hardware Description | Server, Workcenter, Review Computer | Viewstations, Maintenance, Namer |
| Network Capability | Ethernet, Internet, Intranet | Ethernet, Internet, Intranet |
| Data Type | Image, Text, Patient Information | Image, Text, Patient Information |
| Input Sources | Diagnostic interface, Networkedinterfaces, DICOM images, Removablemedia, Digital cameras | Diagnostic interface, Networkedinterfaces, DICOM images,Removable media |
| Output Devices | CD, Printers, offline storage devices | CD, Printers, offline storage devices |
| Operating System | Windows NT | PC Compatible |
| Image Preview | yes | yes |
| Open Case Preview | yes | yes |
| Receive Images fromother systems | yes | yes |
| Retrieve Images fromother systems | yes | yes |
| Patient DemographicInformation | yes | yes |
| Acquire Radiographic Filmsfrom Film Digitizer | yes | yes |
| Portable patient records | yes | yes |
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DESCRIPTION OF DEVICE: VIII.
KODAK Oncology Image Manager is designed to archive patient information and images gathered as the patient progresses through cancer treatment. The consolidated information and images can be reviewed as treatment progresses by onocologist and nurses..
IX. THE DEVICE
The general hardware configuration of the KODAK Oncology Image Manager contains the following major components:
-Touch screen Monitor -Central Processing Unit (CPU) -Film and Document scanners -CD-ROM writer and reader
X. INDICATION FOR USE
The KODAK Oncology Image manager (OIM) is a picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1998
Nancv Butcher Regulatory Affairs Specialist Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas. Texas 75252
Re:
Kodak Digital Science Oncology Image Manager Dated: December 1, 1997 Received: January 13, 1998 Regulatory class: Unclassified Procode: 90 LLZ
Dear Ms. Butcher:
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 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 (OS) for Medical Devices: General regulation (2) 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 vito 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) 594-639. 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/cdrf/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K980118 510(k) Number (if known): Device Name: KODAK Oncology Image manager (OIM)
INDICATION FOR USE:
The KODAK Oncology Image Manager (OIM) a Picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR., Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
7
Jamil C. Wynn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K980118
§ 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).