Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, 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 five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).

Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.

Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Centricity PACS-IW device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not establish specific quantitative acceptance criteria or provide detailed numerical performance metrics for the Centricity PACS-IW. Instead, it relies on substantial equivalence to a predicate device and verification/validation testing.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Intended Use Equivalence	Device functionality fits within 21 CFR 892.2050 (Picture Archiving and Communication Systems, Product Code LLZ)	Functionally equivalent to predicate device (K082318) in intended use and functionality.
Technological Equivalence	Same fundamental scientific technology as predicate device (K082318) with specified modifications (Windows server/database upgrade, JPEG lossless/non-wavelet compression support).	Modifications did not introduce adverse effects; device is as safe and effective as predicate.
Software Quality & Safety	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern). Application of quality assurance measures.	All stated quality assurance measures applied. Verification and Validation testing demonstrated no adverse effects from differences.
Image Review Specifications	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 five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.	Device adheres to these conditions as part of its intended use limitations and display requirements.
Clinical Performance	(No specific clinical performance criteria provided for this submission)	Clinical studies were not required to support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW, did not require clinical studies to support substantial equivalence."

Therefore, there is no clinical test set, sample size, or data provenance information provided for an evaluation of the device's diagnostic performance on medical images. The testing focused on software verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical test set was used for performance evaluation, no experts were involved in establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states that clinical studies were not required. There is no mention of an MRMC study or an effect size for human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The device is a PACS system, designed for human use in interpreting images. Its "performance" is primarily related to its ability to store, communicate, process, and display images reliably, rather than providing automated diagnoses.

7. Type of Ground Truth Used

For the software verification and validation testing, the "ground truth" would have been the expected behavior and outcomes defined by the software requirements and design specifications. For example, for a functional test, the ground truth would be that a specific image should display correctly or that a data transfer should complete without error.

8. Sample Size for the Training Set

Not applicable. This device is a PACS system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for diagnostic inference. The "training" here refers to software development and testing cycles, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of AI/ML for diagnostic inference. The development process likely involved thorough software engineering practices where expected behaviors and outputs were defined by system architects and engineers.

Summary

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K121387

JUN - 5 2012

UN - 4 2019

GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

May 04, 2012 Date:

Submitter: GE Healthcare 540 West Northwest Highway Barrington, IL 60010

Primary Contact Person: John Manarik Regulatory Affairs Manager GE Healthcare Phone: 847-277-5504 Fax: 847-277-5240

Jeme Wallace Secondary Contact Requlatory Affairs Director Person: GE Healthcare Phone: 847-277-4468 Fax: 847-939-1446

Device Trade Name: Centricity* PACS-IW

Common/Usual Name: Picture Archiving and Communication System

Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological

Product Code: LLZ

Predicate Device: K082318 - GE Healthcare Centricity PACS-IW

" GE, the GE Monogram and Centricity are trademarks of General Electric Company

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Image /page/0/Picture/17 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and connected, and there are decorative swirls around the letters.

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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 within a circular frame. The letters and the frame are black, creating a strong contrast against the white background.

GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary

Device Description: Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).

Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.

Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.

Intended Use: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammoarams) and data from various imaging sources. Images and data can be stored, communicated, processed and displaved within the system or across computer networks at distributed locations.

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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 border. The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Technology: The Centricity PACS-IW device employs the same fundamental scientific technology as its predicate device, Centricity PACS-IW cleared under K082318, with the following modifications:

. Uparade of the Windows server and database management systems; and

. Support for JPEG lossless and JPEG non-wavelet compression techniques

Centricity PACS-IW receives medical images and other information from various data sources. The information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations, the same as its predicate devices. Centricity PACS-IW is a softwareonly device that runs on commercially available off-theshelf computer hardware platforms.

The Centricity PACS-IW 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.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is black and white, with the letters and border appearing in black against a white background.

GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary

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 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, did not require clinical studies to support substantial equivalence.

Conclusion: Comparison of the Intended Uses, the technological 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 medical device to be as safe, as effective and substantially equivalent to its predicate device.

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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 stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

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

JUN - 5 2012

Mr. John Manarik Regulatory Affairs MAnager GE Healthcare, HCIT 540 W. Northwest Highway BARRINGTON IL 60010

Re: K121387

Trade/Device Name: Centricity* PACS-IW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 4, 2012 Received: May 8, 2012

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 mediour active related as rebe quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quarny of evice as described in your Section 510(k) premarket whitication. 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 11 you destre poverily ad receive 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 I valual 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,

Janine M. Morris

Acting 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): K121387

Device Name:

Centricity" PACS-IW

Indications for Use:

Typical users of this system are trained professionals, including but not limited to physicians, 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

510k)

Page 1 of

GE, the GE Monogram and Centricity are trademarks of General Electric Company

Regulation Number and Section

§ 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).