(37 days)
Centricity PACS-IW with Universal viewer is a software only product that is part of a Picture Archiving and Communication System (PACS) medical device. Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. 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 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Centricity PACS-IW with Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS-IW with Universal Viewer includes features to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear medicine (NM). Computerized radiography (CR). Diaital mammography (MG),Digital x-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic x-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN) and other DICOM imaging modalities. Centricity PACS-IW with Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in in most healthcare organizations and utilizes commercially available computer platforms and operating systems. The system does not produce any origing| medical images. All images located on the Centricity PACS, PACS-IW, and Enterprise Archive systems have been received from DICOM compliant modalities and/or image acquisition systems. The Universal Viewer Zero Foot Print (ZFP) clinical viewer is an optional viewer which allows trained professionals to display and manipulate images stored in Centricity Enterprise Archive or other DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants. The Universal Viewer Zero Foot Print option is not intended for primary diagnosis.
Here's a breakdown of the acceptance criteria and study information for the Centricity PACS-IW with Universal Viewer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table of acceptance criteria or quantified device performance metrics. Instead, it states that the device did not require clinical studies. The "acceptance" in this context refers to demonstrating substantial equivalence to a predicate device through non-clinical means.
The "performance" is implicitly deemed acceptable because the device leverages the same fundamental scientific technology as its predicate and the modifications are primarily related to user interface, integration, and minor enhancements, which were validated through non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Functional Equivalence | Demonstrated through comparison of intended uses, technological characteristics, and performance specifications with the predicate device. |
| Safety and Effectiveness | Demonstrated to be as safe and effective as the predicate device through verification and validation testing, ensuring no adverse effects from modifications. |
| Key Modifications | Verified to function as intended (e.g., unified workspace, PACS backend integration, Bookmark feature, enhanced hanging protocols, annotations, Mammo product interface, AW Server interface). |
| Non-Clinical Testing | Passed Risk Analysis, Requirements Reviews, Design Reviews, Usability Analysis, Unit Testing, Integration Testing, Performance Testing, Regression Testing, System Testing, and Simulated Use Testing. |
| Standards Compliance | Complies with voluntary standards as detailed in the premarket notification submission. |
| Hardware Compatibility | Runs on commercially available off-the-shelf computer hardware platforms; hardware minimum specifications updated due to technology advancements. |
| ZFP Clinician Viewer | Confirmed as a non-diagnostic DICOM image and results viewer, enabling EMR integration, displaying data from Centricity Enterprise Archive, and accessible without client-side installation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW with Universal Viewer, did not require clinical studies to support substantial equivalence."
- Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing data provenance is not specified (e.g., country of origin).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical studies were performed and no separate "test set" with expert-established ground truth for performance evaluation is mentioned beyond internal verification and validation.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies or a separate "test set" requiring adjudication for ground truth were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that clinical studies were not required.
6. Standalone Performance Study
No, a standalone (algorithm only without human-in-the-loop performance) study was not done or at least not described as a separate study for the purpose of demonstrating device performance in this submission. The device is a Picture Archiving and Communication System (PACS) component, intended to be used by human professionals (physicians, radiologists, etc.). Its performance is primarily assessed through its functionality, integration, and display capabilities as part of a human workflow, rather than as a standalone diagnostic algorithm.
7. Type of Ground Truth Used
Not applicable in the context of clinical performance evaluation. For non-clinical verification and validation testing, the "ground truth" would have been defined by the device's functional requirements and design specifications.
8. Sample Size for the Training Set
Not applicable. The Centricity PACS-IW with Universal Viewer is a software product for image DISPLAY and MANAGEMENT, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of software device.
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![GE logo]
GE Healthcare 510(k) Premarket Notification Submission Centricity PACS-IW with Universal Viewer Section 5: 510(k) Summary
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: October 8, 2012
Submitter: GE Healthcare 540 West Northwest Highway Barrington, IL 60010
Primary Contact Person:
Cheryl Bork Regulatory Affairs Manager GE Healthcare Phone: 847-277-6038 Fax: 847-277-4506
Secondary Contact Person:
Jeme Wallace Regulatory Affairs Director GE Healthcare Phone: 847-277-4468 Fax: 847-939-1446
Device Trade Name: Centricity PACS-IW with Universal Viewer
Common/Usual Name: Picture Archiving and Communication System
Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological
Product Code: LLZ
Predicate Device: K121387 - GE Healthcare Centricity PACS-IW
Device Description:
Centricity PACS-IW with Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
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510(k) Premarket Notification Submission Centricity PACS-IW with Universal Viewer Section 5: 510(k) Summary .
Device Description: (cont.) Centricity PACS-IW with Universal Viewer includes features to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear medicine (NM). Computerized radiography (CR). Diaital mammography (MG),Digital x-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic x-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN) and other DICOM imaging modalities.
Centricity PACS-IW with Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any origing| medical images. All images located on the Centricity PACS, PACS-IW, and Enterprise Archive systems have been received from DICOM compliant modalities and/or image acquisition systems.
The Universal Viewer Zero Foot Print (ZFP) clinical viewer is an optional viewer which allows trained professionals to display and manipulate images stored in Centricity Enterprise Archive or other DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The Universal Viewer Zero Foot Print option is not intended for primary diagnosis.
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510(k) Premarket Notification Submission Centricity PACS-IW with Universal Viewer Section 5: 510(k) Summary
Intended Use: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations.
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 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Technology: The Centricity PACS-IW with Universal Viewer device employs the same fundamental scientific technology as its predicate device, Centricity PACS-IW cleared under K121387, with the following modifications:
- . Modified viewer to present a common unified workspace for radiologists and clinicians to perform the review, manipulation and diagnostic interpretation of images and other information generated by acquisition.
- . Provides integration to Centricity PACS backend. The PACS-IW with Universal Viewer can read image data and other patient information from Centricity PACS backend.
- Implementation of a "Bookmark" feature for . image display, that enables the user to capture the Display State of an exam context as it exists at any particular time, and then restores this same state at a later time.
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- Enhanced hanging protocols ("smart" hanging . protocols) for image display, which will assess information provided in the DICOM tags to evaluate the type of study that is being displayed to determine the most appropriate method for the study to be hung.
- Enhanced image annotations and . measurements to include the ability to calculate Cardio Thoracic Ratio (CTR) (web client only) and Ellipse (ZFP only).
- Supports interface with GE Healthcare's IDI . Mammo product, in place of Cedara Mammo.
- . Supports interface with GE Healthcare's Advantage Workstation (AW) Server advanced visualization tools.
Technology (cont.)
- Hardware minimum specifications were . modified as a result of technology advancements and obsolescence issues.
- The optional ZFP (Zero Footprint) Clinician Viewer . is a non-diagnostic DICOM image and results viewer. Zero footprint:
- image enables an EMR or other similar o applications.
- displays image data from GE O Healthcare's Centricity Enterprise Archive.
- can be accessed on a client device o without requiring the user to override security settings or initiate an installation.
Centricity PACS-IW with Universal Viewer receives medical images and other information from various data sources. The information can be stored, communicated, processed and displayed within the
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510(k) Premarket Notification Submission Centricity PACS-IW with Universal Viewer Section 5: 510(k) Summary
system or across computer networks at distributed locations, the same as its predicate devices. Centricity PACS-IW with Universal Viewer is a software-only device that runs on commercially available off-the-shelf computer hardware platforms.
The Centricity PACS-IW with Universal Viewer device will continue to have an intended use and functionality fitting within the definition of 21 CFR 892.2050. Picture Archiving and Communication Systems, Product Code LLZ.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Centricity PACS-IW with Universal Viewer complies with voluntary standards as detailed in this premarket notification submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Usability Analysis .
- . Testing on unit level (Verification)
- Integration testing (Verification) .
- . Performance testing (Verification)
- . Regression testing (Verification)
- System testing (Verification) ♥
- Simulated use testing (Validation) .
Summary of Clinical Tests:
The subject of this premarket notification submission, Centricity PACS-IW with Universal Viewer, did not require clinical studies to support substantial equivalence.
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510(k) Premarket Notification Submission Centricity PACS-IW with Universal Viewer Section 5: 510(k) Summary
Comparison of the Intended Uses, the technological Conclusion: characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device. Verification and Validation testing results demonstrate that no adverse effects have been introduced by these differences.
Information provided in this premarket notification submission supports the Centricity PACS-IW with Universal Viewer medical device to be as safe, as effective and substantially equivalent to its predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
November 16, 2012
Ms. Cheryl Bork Regulatory Affairs Manager GE Healthcare-HCIT 540 W. Northwest Highway BARRINGTON IL 60010
Re: K123174
Trade/Device Name: Centricity PACS-IW with Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2012 Received: October 25, 2012
Dear Ms. Bork:
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 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Bork
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty of would provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Michael D. O'Hara
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123174
Device Name: Centricity PACS-IW with Universal Viewer
Indications for Use:
Lentricity PACS-IW with Universal viewer is a software only product that is part of a Picture Archiving and Communication System (PACS) medical device.
Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations.
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 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123174
Page 1 of
§ 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).