(72 days)
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
The provided text describes the Olicon Gateway, a device for converting and transmitting digital images and data, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document primarily focuses on:
- Device Description: What the Olicon Gateway is and how it functions as a protocol converter.
- Indications for Use: The purpose and scope of the device.
- Technological Characteristics: Reinforcing its function as a general-purpose computer system with software for protocol conversion.
- Safety and Effectiveness (Performance Data): It only mentions that "The subject and predicate devices both use standard data communications controls to detect and correct errors" and that "The subject device complies with UL-1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment."
- Conclusion on Substantial Equivalence: It asserts equivalence to a predicate device (DEJARNETTE RESEARCH SYSTEMS IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE - K963592) based on shared safety features (UL-1950 compliance, reliance on human intervention for interpretation, password protection) and functional similarity as a communications protocol converter.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as these details are not present in the provided text. The document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with quantitative metrics.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '973793'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
DEC 17 1997
Image /page/0/Picture/2 description: The image shows a logo with the text "OKICON" in large, bold letters. Below "OKICON" is the text "IMAGING SYSTEMS, INC." in a smaller font. The logo is set against a black background, with the text appearing in white.
5 1 0(k) Summary of Safety and Effectiveness
[as required by 21 CFR 807.92©]
Date Prepared: [21 CFR 807.92(a)(1)]
20 September, 1997
Submitter's Information: [21 CFR 807.92(a)(1)]
Olicon Imaging Systems, Inc. 120 Columbia Avenue, Suite 600 Aliso Viejo, CA 92656 phone: (714) 360-1830 fax:
Trade Name, Common Name, Classification: [21 CFR 807.92(a)(2)]
| Trade Name: | Olicon Gateway |
|---|---|
| Common Name: | Gateway to Digital Imaging Network |
| Classification Name: | System, Digital Image Communication, accessory |
Predicate Device: [21 CFR 807.92(a)(3)
| Applicant: | DEJARNETTE RESEARCH SYSTEMS |
|---|---|
| 510(k) Number: | K963592 |
| Device: | IMAGESHARE PROTOCOL CONVERTINGGATEWAY AND/OR SOFTWARE |
Device Description: [21 CFR 807.92(a)(4)]
The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
Indications for Use: [21 CFR 807.92(a)(5)]
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-
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NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
Technological Characteristics: [21 CFR 807.92(a)(6)]
The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. It functions as a communications protocol converter and not as a permanent image store device. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
Performance Data: [21 CFR 807.92(b)(1)]
The subject and predicate devices both use standard data communications controls to detect and correct errors.
The subject device complies with UL-1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.
Conclusion: [21 CFR 807.92(b)(1)]
Similar to the predicate device, the Olicon Gateway does not contact the patient, nor does it control any life sustaining devices. Images and information being relayed and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention.
The subject device and the predicate share the same certification of conformance to UL-1950 and both function as a communications protocol converter to relay and transmit images and data from different modalities and sources to specified locations. Device failures which might result in partial or failed transmissions may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.
We conclude that the subject devices are safe, effective and substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Olicon Imaging Systems, Inc. c/o Herman Oosterwijck Otech, Inc. 6741 Grant Avenue Plano, Texas 75024
Re:
K973793 Protocol Converting Network Gateway Dated: September 20, 1997 Received: October 6, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Oosterwijck:
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, 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 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 notification submission does 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 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 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.html".
Sincerely yours,
W.Liau Yu
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:
Device Name: Olicon Imaging Systems, Inc. - Gateway
Indications For Use:
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
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
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT(Optional Format 1-2-96)
and Radiological Devices
510(k) Number K973793
Olicon Imaging Systems, Inc. Gateway 510(k)
§ 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.