(85 days)
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices.
Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols.
Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.
The provided 510(k) summary for GE Healthcare's Centricity Cardio Imaging does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Centricity PACS-IW and TomTec Imaging System's Image Arena) based on fundamental scientific technology, intended use, and general performance (receiving, storing, communicating, processing, and displaying images).
Here's why the requested information is absent:
- No Clinical Studies Required: The "Summary of Clinical Tests" explicitly states: "The subject of this premarket notification submission, Centricity* Cardio Imaging, did not require clinical studies to support substantial equivalence." This means no clinical performance data was generated or submitted for this device to prove it meets specific performance metrics.
- Focus on Substantial Equivalence: The primary objective of this 510(k) submission is to show that the new device is as safe and effective as a legally marketed predicate device. This is often achieved by demonstrating similar technology, intended use, and performance characteristics, without necessarily conducting new effectiveness studies against predefined acceptance criteria.
- Quality Assurance Measures: The document lists "non-clinical tests" such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, performance, safety, simulated use). These are general quality assurance and verification/validation activities for software development, ensuring the software functions as designed, but they are not presented as a "study" with specific performance acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance data from the provided text.
Based on the document, I can only state the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated as performance criteria for equivalence) | Reported Device Performance (as implied by nature of 510k submission) |
|---|---|
| No explicit performance-based acceptance criteria are provided in the document. | - Operates as a web-enabled cardiology Picture Archiving and Communication System (PACS).- Offers highly integrated imaging, workflow, and information management.- Leverages ECHO/NIPV clinical toolset and data management capability.- Receives, stores, communicates, processes, and displays medical images and other information from various data sources.- Intended to assist trained professionals in viewing, analysis, and diagnostic interpretation.- Complies with voluntary standards (not specified).- Underwent risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, safety testing, and simulated use testing. |
2. Sample size used for the test set and the data provenance: Not provided, as no clinical study was conducted. Non-clinical testing data provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was conducted.
4. Adjudication method for the test set: Not applicable, as no clinical study was conducted.
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: Not applicable. This device is a PACS system, not an AI-assisted diagnostic tool, and no clinical study (including MRMC) was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a PACS system, not a standalone diagnostic algorithm, and no clinical performance testing was explicitly described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was conducted. For non-clinical validation (simulated use testing), the "ground truth" would have been defined by the expected system behavior and output specifications.
8. The sample size for the training set: Not applicable, as no machine learning/AI training data is mentioned. The device is a PACS.
9. How the ground truth for the training set was established: Not applicable, as no machine learning/AI training data is mentioned.
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NOV 3 0 2011
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has decorative flourishes around the circle.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: August 31, 2011
Submitter: GE Healthcare 540 West Northwest Highway Barrington, IL 60010
John Manarik Primary Contact Person: Requlatory Affairs Manager GE Healthcare Phone: 847-227-5504 Fax: 847-277-5240
- Secondary Contact Jeme Wallace Person: Requlatory Affairs Director GE Healthcare Phone: 847-277-4468 Fax: 847-939-1446
- Centricity* Cardio Imaging Device: Trade Name:
Common/Usual Name: Picture Archiving and Communication System
Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological
Product Code: LLZ
Predicate Device(s): GE Healthcare's Centricity* PACS-IW and TomTec Imaging System's Image Arena
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in white, set against a black background, creating a high-contrast and recognizable emblem.
Device Description: Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices.
Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols.
Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.
- Intended Use: Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imagina is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular frame. The frame has four stylized protrusions, one at the top, bottom, left, and right, giving it a slightly decorative appearance.
Centricity* Cardio Imaging is not intended for use in the patient vicinity.
Technology: Centricity* Cardio Imaging employs the same fundamental scientific technology as its predicate devices, Centricity* PACS IW and Tomtec Imaging Systems Image Arena.
Centricity* Cardio Imaging receives medical images and other information from various data sources, and provides the capability to analyze echocardiography and NIPV images the same as its predicate devices.
Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations the same as its predicate devices.
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, set against a white background.
Summary of Non-Clinical Tests Determination of
Substantial Equivalence:
Centricity* Cardio Imaging and its applications comply 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 .
- Testing on unit level (Verification) ●
- Integration testing (Verification) �
- � Performance testing (Verification)
- Safety testing (Verification) .
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket notification submission, Centricity* Cardio Imaging, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Centricity* Cardio Imaging Conclusion: product to be as safe, as effective and substantially equivalent in performance to its predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. John Manarik Regulatory Affairs Manager GE Healthcare HCIT 540 West Northwest Highway BARRINGTON IL 60010
NOV 3 0 2011
Re: K112570
Trade/Device Name: Centricity Cardio Imaging Regulation Number: 21 CFR 872.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 31, 2011 Received: September 6, 2011
Dear Mr. Manarik:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,
Mary Pastel
Mary S. Pastel, Sc.D. 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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510(k) Number (if known):
Centricity Cardio Imaging Device Name:
Indications for Use:
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imaging is intended to assist trained professionals in the viewing. analysis, and diagnostic interpretation of images and other information. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 112576
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).