(81 days)
The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.
Not Found
This document is a 510(k) clearance letter for the Oasis, Release 1.0 device, which is a Picture Archiving and Communication System (PACS). This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in the 510(k) submission summary or in the actual performance studies conducted by the manufacturer, which are not directly part of this FDA clearance letter.
Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable relative to those devices, but it does not specify performance metrics or the studies used to establish this equivalence in detail.
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Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be three stylized, curved lines, possibly representing a stylized image of an eagle or a similar bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Dr. Philippe Briandet, Ph.D. President Segami Corporation Segami Technology for Nuclear Medicine 8325 Guilford Road, Suite B COLUMBIA MD 21046
AUG 3 1 2007
Re: K071584
Trade/Device Name: Oasis, Release 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: August 10, 2007 Received: August 13, 2007
Dear Dr. Briandet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a circular logo with the letters "PA" in the center. Above the letters, the numbers "1886-1986" are displayed. Below the letters, the word "Centennial" is written. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Oasis Release 1.0
510(k) Number (if known): K071584 Device Name: Oasis, Release 1.0
Indications for Use:
The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.
(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)
Thhan
(Division Sign-Utt) Division of Reproductive, Abdominal and Radiological Devices Appendix 11-2 510(k) Number __
§ 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).