(22 days)
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No
The document describes a standard PACS system for image management and display, with no mention of AI/ML capabilities or related performance metrics.
No
The device is a PACS system used for managing and displaying medical images and patient information for diagnostic and referral purposes, and does not directly treat or alleviate a medical condition.
Yes
The device explicitly states its indication for "diagnostic and referral purposes" in the "Intended Use / Indications for Use" section, and it facilitates the display and organization of patient images for medical professionals, which is crucial for diagnosis.
No
The device description explicitly lists hardware components such as "Series of Viewing and Reading Workstations," "Teleradiology devices," "Archive," "LINX Network system," and "Printers," indicating it is a system with both software and hardware elements.
Based on the provided information, the iiSYS PACS System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The iiSYS PACS System deals with medical images and patient demographic information, not biological samples like blood, urine, or tissue.
- The intended use and device description clearly focus on the management and display of medical images. The system facilitates the transmission, display, archive, and printing of images for diagnostic and referral purposes.
- There is no mention of analyzing biological specimens or providing information about a patient's health status based on such analysis.
The iiSYS PACS System falls under the category of medical imaging software and hardware used for managing and viewing medical images.
N/A
Intended Use / Indications for Use
The iiSYS PACS System is a complete PACS System for thhe Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes.
Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.
Product codes
90 LMD
Device Description
The iiSYS PACS System is a full featured PACS System capable of transmission, archive, display, and print of patient image and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information at remote facilities and at locations other than that at which it was acquired. Data may be received as digital information, video signals, or hard copy prints and may be reviewed via monitor or printed hardcopy. The iiSYS PACS system consists of the following major components:
- Series of Viewing and Reading Workstations ●
- Teleradiology devices for digitizing and transmission of images over wide area or . local area networks for remote or at home review
- Archive for short or long term storage .
- LINX Network system for secondary capture and transmission of images to other . devices (workstation, telerad, printers, etc.)
- . Printers
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K980220 Page 1 of 2
Summary of Safety and Effectiveness
| CLASSIFICATION NAME: | The proposed classification is 21CFR892.2050 (FR 63774, Dec 2, 1997) This device is regulated as Class II Tier I. |
|---|---|
| COMMON/USUAL NAME: | PACS System |
| TRADE/PROPRIETARY NAME: | iiSYS PACS System |
| ESTABLISHMENT No. | 1043882 |
PREDICATE DEVICE
FEB 1 3 1998
There are no significant differences between the System and its assembled component devices other than the guaranteed connectivity provided by the integration testing. The integration of the devices into the Sterling Diagnostic Imaging iiSYS PACS System is accomplished via comprehensive testing protocol.
There is no change in intended use from the component devices. There is no change in indications for use of the component devices. The intended use and indications for use of the system is the compiled uses of the integrated components.
REASON FOR 510(k):
The submission is being made to identify Sterling Diagnostic Imaging, Inc. as offering a complete PACS System which may become a separate device category under proposed regulations. All integral parts of the system have been previously reviewed and cleared by the Agency.
SYSTEM DESCRIPTION:
The iiSYS PACS System is a full featured PACS System capable of transmission, archive, display, and print of patient image and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information at remote facilities and at locations other than that at which it was acquired. Data may be received as digital information, video signals, or hard copy prints and may be reviewed via monitor or printed hardcopy. The iiSYS PACS system consists of the following major components:
- Series of Viewing and Reading Workstations ●
- Teleradiology devices for digitizing and transmission of images over wide area or . local area networks for remote or at home review
- Archive for short or long term storage .
- LINX Network system for secondary capture and transmission of images to other . devices (workstation, telerad, printers, etc.)
- . Printers
The major elements of the System are previously cleared devices as identified in the following submission. Sterling is not altering the specifications, claims, indications, or intended use of any component. The Sterling iiSYS PACS System is a compilation of components that has been professionally tested to insure their connectivity and efficiency when utilized together. This testing is optimized to give the user assurance that the devices will provide a maximum value-added to the clinical environment without impacting safety or efficacy of the individual components. Connectivity and compatibility are evaluated and ensured via the Integration Test Protocol.
1
INTENDED USE
The iiSYS PACS System is a complete PACS System for the Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes.
Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.
SAFETY INFORMATION:
The System has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction. The device does not impact the quality or status of the original acquired image data.
Selection of the specific components of the system has been made to allow the system to remain cost effective and consistent with current technology through the substitution of components as technology develops. By retaining criteria for the substitution of components, any concerns about safety or efficacy and substantial equivalence can be satisfactorily met by a determination that the component substitution is not a significant change in this is consistent with existing Agency guidance.
CONCLUSION [21 CFR: 807.92(b)(3)]
The subject device has no patient contact, nor does it control, monitor, or effect any devices directly connected to or effecting such a patient contacting device. The images generated by the subject device is observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.
Sterling believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective as the component devices.
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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Timothy W. Capehart Manager of Regulatory Affairs and Compliance Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailstop 102 P.O. Box 19048 Greenville, SC 29602-9048
Re:
K980220 iiSYS PACS System Dated: January 22, 1998 Received: January 22, 1998 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Capehart:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 requirement, 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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 marked 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.btml".
Sincerely yours.
William Yu, 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
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510(k) Number (if known) :
Device Name :
iiSYS PACS System
Indications for Use:
The iiSYS PACS System is a complete PACS System for thhe Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes.
Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Varial A. Seym
(Division Sign-Off)
(Division of Reproductive, Abdominal, E and Radiological Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
Over the Counter Use