(67 days)
The Olicon 02-Workstation and/or PACSView™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.
The provided text is a 510(k) Summary for the Olicon 02-Workstation and/or PACSView™ software, dated September 23, 1997. It describes a digital imaging workstation and software designed to store, communicate, process, and display radiological images and data.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific numerical device performance metrics in the way modern AI/CAD device submissions would.
Instead, the performance data section focuses on general compliance and functionality:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Data Communication Error Handling | "The subject and predicate devices both use standard data communications controls to detect and correct errors." |
| Electrical Safety Standard Compliance | "The subject device complies with UL-1950 Standard for Safety of Business Equipment. Including Electrical Information Technology Equipment." |
| Operating System Compatibility | "The Olicon 02-Workstation and/or PACSView™ software uses the Microsoft Windows NT or 95 operating systems, (as a minimum & depending upon system configuration)..." |
| DICOM Standard Compliance | "...and is DICOM 3.0 compliant." |
| Functionality as a Digital Imaging Workstation (Substantial Equivalence) | "Similar to the predicate device, the Olicon 02-Workstation and/or PACSView™ software does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, 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 Digital Imaging Workstations." |
| Data Recovery/System Reliability (Implied) | "Device failures which might result in partial or failed transmissions, images, and or data may be recovered by re-transmission after correcting the problems." |
| Security (Implied) | "Passwords are required for operation and to protect against unauthorized use of the system." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission pre-dates the era where detailed clinical performance studies, especially for AI/CAD devices, were commonly required for imaging workstations. This device is primarily for viewing, storage, and communication, not for diagnostic interpretation automation or assistance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As the device is not an AI/CAD system performing diagnostic tasks, there was no requirement for establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided. Not applicable as there was no diagnostic accuracy test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The document does not describe any study measuring the impact of the workstation on human reader performance. This is consistent with the device's function as a general-purpose imaging workstation rather than a diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study was not done or reported. The device is a workstation and software for image handling, not an algorithm that performs standalone diagnostic tasks separate from human review.
7. Type of Ground Truth Used
This information is not provided and is not applicable in the context of this device. The device's performance evaluation was based on its operational characteristics, standard compliance, and functionality in image management, not on diagnostic accuracy against a "ground truth" of disease presence or absence.
8. Sample Size for the Training Set
This information is not provided. The device is not an AI/ML product developed using training datasets in the modern sense. It's software developed using traditional programming paradigms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Not applicable for this type of device.
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5 1 0(k) Summary of Safety and Effectiveness
[as required by 21 CFR 807.92©]
DEC 22 1997
Date Prepared: [21 CFR 807.92(a)(1)]
23 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 (714) 362-1522 fax:
Trade Name, Common Name, Classification: [21 CFR 807.92(a)(2)]
| Trade Name: | Olicon 02 Workstation and/or PACSViewsoftware |
|---|---|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication,accessory |
Predicate Device: [21 CFR 807.92(a)(3)
| Applicant: | OLICON IMAGING SYSTEMS INC. |
|---|---|
| 510(k) Number: | K922164 |
| Device: | RAYTEL DIGITAL IMAGING SYSTEMS |
Device Description: [21 CFR 807.92(a)(4)]
The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.
Indications for Use: [21 CFR 807.92(a)(5)]
The Olicon 02-Workstation and/or PACSView™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
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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 02-Workstation and/or PACSView™ software uses the Microsoft Windows NT or 95 operating systems, (as a minimum & depending upon system configuration), and is basically an update of the current Olicon RAYTEL Digital Imaging System Workstation (K922164), and is DICOM 3.0 compliant.
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 Business Equipment. Including Electrical Information Technology Equipment.
Conclusion: [21 CFR 807.92(b)(1)]
Similar to the predicate device, the Olicon 02-Workstation and/or PACSView™ software does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, 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 Digital Imaging Workstations. Device failures which might result in partial or failed transmissions, images, and or data may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.
Based on the information supplied in this 5109(k), we conclude that the subject devices are safe, effective and substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1997
Olicon Imaging Systems, Inc. c/o Herman Oosterwijck Otech, Inc. 6741 Grant Avenue Plano, TX 75024
Re:
K973959 02 - Workstation and PACSView Software Dated: September 23, 1997 Received: October 16, 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 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 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 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
h. 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
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1973959 510(k) Number:
Device Name: Olicon Imaging Systems, Inc. - 02-Workstation and/or PACSView™ Software
Indications For Use:
The Olicon 02-Workstation and/or PACSView™™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
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)
§ 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.