(26 days)
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
The FCRView is an image viewer workstation that offers a fully integrated solution for managing the CR modality, as well as built-in viewing, archiving and distribution capabilities. It can import and display ultrasonic images and generalpurpose images from digital cameras, and other general purpose images (such as jpeg images) on screen and/or print via a typical paper printer. Images captured on the FCR reader unit are displayed on the FCRView along with typical tools to aid in reading the images. The FCRView also incorporates a builtin archiving and CDR/DVDR image output system.
A summary description of the key features of the system follows:
- FCRView (CR VW 674) is a modality and Image Viewing workstation . intended to associate FCR images (except mammography images) with patient and exam information, and apply image processing to facilitate diagnosis.
- . Currently interfaces with Fuji CR and also accepts images from other modalities such as Ultrasound as well as general purpose (jpg) images.
- . FCRView incorporates a built-in archiving and CDR/DVDR image output svstem
The provided document is a 510(k) summary for a medical device called FUJIFILM FCRView. It states that the device is a modification to an already cleared product (FUJIFILM CR Console K041990) and the FCR AXON (Class I Exempt). The submission focuses on demonstrating substantial equivalence to these predicate devices rather than proving performance against specific acceptance criteria through a new clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not present:
- A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence, meaning it claims the modified device performs similarly to the predicate devices, rather than outlining new performance metrics and results.
- Sample size used for the test set and the data provenance: No new test set or provenance information is provided for a new study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: No such study is mentioned or referenced.
- Standalone performance study information: No standalone study performance is detailed.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as this is not a de novo submission describing algorithm training.
- How the ground truth for the training set was established: Not applicable.
The "SUMMARY OF STUDIES" section states: "The FCRView has been evaluated for electrical, mechanical and radiation safety and conforms with applicable medical device safety standards." This refers to safety testing, not a clinical performance study against specific acceptance criteria for image interpretation or diagnostic accuracy.
The document relies solely on establishing substantial equivalence to previously cleared devices based on similar technology, materials, safety, effectiveness features, and design.
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Image /page/0/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the logo, the words "Fujifilm Medical Systems, USA" are written in a smaller font.
:
K08/308
JUN - 4 2008
SECTION 5
SPECIAL 510(K) SUMMARY
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.
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FUJIFILM FCRView Special 510(k)
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Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the logo, the words "Fujifilm Medical Systems, USA" are written in a smaller, sans-serif font.
Special 510(k) Summary
Date: May 5, 2008
Contact Person:
| Name: | Debbie Peacock |
|---|---|
| Title: | Regulatory Coordinator |
| Telephone: | (203) 602-3774 |
| Facsimile: | (203) 363-3813 |
ldentification of Device:
| Proprietary/Trade Name: | FCR View |
|---|---|
| Classification: | Class II |
| Classification Name: | PACS |
| Product Code: | LLZ |
| Common Name: | PACS |
INDICATIONS FOR USE l.
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
-DEVICE DESCRIPTION
The FCRView is an image viewer workstation that offers a fully integrated solution for managing the CR modality, as well as built-in viewing, archiving and distribution capabilities. It can import and display ultrasonic images and generalpurpose images from digital cameras, and other general purpose images (such as jpeg images) on screen and/or print via a typical paper printer. Images captured on the FCR reader unit are displayed on the FCRView along with typical tools to aid in reading the images. The FCRView also incorporates a builtin archiving and CDR/DVDR image output system.
A summary description of the key features of the system follows:
- FCRView (CR VW 674) is a modality and Image Viewing workstation . intended to associate FCR images (except mammography images) with patient and exam information, and apply image processing to facilitate diagnosis.
- . Currently interfaces with Fuji CR and also accepts images from other modalities such as Ultrasound as well as general purpose (jpg) images.
- . FCRView incorporates a built-in archiving and CDR/DVDR image output svstem
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Image /page/2/Picture/0 description: The image shows the Fujifilm logo. The logo is in black and consists of the word "FUJIFILM" in large, bold letters. Below the main logo, in a smaller font, is the text "Fujifilm Medical Systems, USA".
III. SUMMARY OF STUDIES
The FCRView has been evaluated for electrical, mechanical and radiation safety and conforms with applicable medical device safety standards.
IV. SUBSTANTIAL EQUIVALENCE
The Fujifilm FCR View covered by this submission is a modification to and is substantially equivalent the Fujifilm CR Console (K041990) cleared by CDRH on 08/06/04 and the FCR AXON (Class I Exempt) image management and communication device. The combination of both Fujifilm devices utilizes similar technology and materials, comparable safety and effectiveness features, and are similar in design and construction to our proposed modified device. .
The Indications for Use for the proposed device is the same as the combined Indications for Use of the Fuji CR Console and the FCR AXON (Exempt). In addition, the labeling for all three devices are the same.
V. CONCLUSION
The FCRView is a modification to and substantially equivalent to our currently cleared CR Console (IIP) along with the image archive and retrieval functionality found in our Class I AXON product, and conforms to applicable medical device safety standards. The modifications do not change the indications for use, introduce new technology or significantly affect the safety or effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
Ms. Debbie Peacock Regulatory Coordinator FUJIFILM Medical Systems USA 419 West Avenue STAMPFORD CT 06902
Re: K081308
Trade/Device Name: FCRView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 5, 2008 Received: May 9, 2008
Dear Ms. Peacock:
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 (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Bragdon
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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Image /page/5/Picture/0 description: The image shows the Fujifilm logo in bold, black letters. Below the logo, in a smaller font, is the text "Fujifilm Medical Systems, USA". The logo is a stylized version of the company name, with a distinctive design.
Indications for Use
510(k) Number (if known):
Device Name: FCRView
Indications for Use:
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
FUJIFILM FCRView Special 510(k)
§ 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).