(46 days)
The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.
Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.
The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
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This document is a 510(k) clearance letter for the Cerner ProVision™ Workstation, dating back to 2007. It's important to note that 510(k) clearances typically do not require specific clinical study data to demonstrate safety and effectiveness beyond substantial equivalence to a predicate device. The focus is on showing the new device is as safe and effective as a legally marketed device, not necessarily on proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval) application.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is generally not included in a 510(k) clearance letter unless it was part of the substantial equivalence argument, which is rare for devices like a PACS workstation whose primary function is displaying images. The letter confirms substantial equivalence but doesn't detail the performance testing that might have been part of the manufacturer's internal verification and validation.
Based on the provided text, I can extract the following information relevant to the device and its intended use:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the 510(k) clearance letter. The letter focuses on regulatory clearance for substantial equivalence, not detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the 510(k) clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the 510(k) clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the 510(k) clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the 510(k) clearance letter. Given the device is a PACS workstation, not an AI diagnostic tool, a MRMC study focused on AI impact would not be expected.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The letter states: "The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution." This indicates the workstation itself can operate in a standalone manner, meaning it's a complete system for image handling. It does not refer to a standalone algorithm without a human-in-the-loop for image interpretation. The device is a display and manipulation tool for clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the 510(k) clearance letter.
8. The sample size for the training set:
This information is not present in the 510(k) clearance letter.
9. How the ground truth for the training set was established:
This information is not present in the 510(k) clearance letter.
Summary of what can be gleaned from the document:
- Device Name: Cerner ProVision™ Workstation
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Picture archiving and communications system (PACS)
- Regulatory Class: II
- Product Code: LLZ
- Indications for Use: The software application is intended for rendering, visualization, and manipulating medical images to support the image display needs of clinicians, diagnosticians, and technologists. Application capabilities enable primary diagnostic review, interpretation, and distribution viewing for physician review.
- Important Caveat for Mammography: "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." This is a crucial safety control related to the display of mammographic images.
- Intended Use Environment: Can be used standalone or as part of a unified RIS/PACS solution.
The letter's purpose is to confirm that the device is substantially equivalent to legally marketed predicate devices, not to detail the performance studies typically associated with novel diagnostic algorithms or AI.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 2 7 2007
Ms. Shelley S. Looby, MT (ASCP) BB Director, Regulatory Affairs/Quality Assurance Cerner Corporation 2800 Rockcreek Parkway KANSAS CITY MO 64117-2551
Re: K070394
Trade/Device Name: Cerner ProVision™ Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2007 Received: February 9, 2007
Dear Ms. Looby:
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 max. 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/9 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in the center of the logo in a stylized font. Three stars are below the letters FDA.
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 see 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/cdrlvindustry/support/index.html.
Sincerely vours.
Nancy Cbrogdon
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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Indications for Use
510(k) Number (if known): K070394
Device Name: Cerner ProVisionTM Workstation
Indications for Use:
The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.
Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.
The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Prescription Use
Prescription Use (Part 21 CFR 801 Subpar
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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David A. Ingram
(Division Sign-Off Division of Repr. J Radiological I 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).