(36 days)
The Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
The Centricity PACS Workstation software is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility.
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Centricity PACS allows integration with other open interfaces, such as DICOM. to web client products and archive devices.
The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.
It is the user's responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Centricity PACS is an enterprise grade Picture Archiving and Communications System (PACS) for managing digital medical images and associated data. Centricity PACS enables the storage, retrieval, distribution, printing, and presentation of images acquired from diagnostic imaging modalities.
Centricity PACS is a standards-based, customizable, and scalable solution supporting several of the Integrating the Healthcare Enterprise (IHE) profiles, Digital Imaging and Communications in Medicine (DICOM), and the Health Level Seven (HL7) protocol standards for managing digital medical images and patient data. Centricity PACS supports radiographic imaging-as in clinical radiography, cardiology, dentistry, and mammography and non-radiologic imaging, including video support.
Centricity PACS v3.2.1 employs the same fundamental scientific technology as its predicate devices, however v3.2.1 is a software only product.
This GE Healthcare Centricity PACS submission (K110875) describes a Picture Archiving and Communication System (PACS) software product. As such, the submission does not contain information about the performance of an AI/ML algorithm.
Here's a breakdown of the information available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, there are no specific performance-based acceptance criteria or reported device performance metrics in the provided text. The device's "performance" is primarily tied to its functionality as a PACS system.
The acceptance criteria referenced are related to quality assurance measures during development:
| Acceptance Criteria (Quality Assurance) | Reported Device Performance |
|---|---|
| Risk Analysis | Complies with voluntary standards; Applied to development |
| Requirements Reviews | Applied to development |
| Design Reviews | Applied to development |
| Testing on unit level (Module verification) | Applied to development |
| Integration testing (System verification) | Applied to development |
| Performance testing (Verification) | Applied to development |
| Safety testing (Verification) | Applied to development |
| Simulated use testing (Validation) | Applied to development |
2. Sample Size Used for the Test Set and Data Provenance:
No test set for evaluating specific device performance (e.g., diagnostic accuracy) is mentioned because clinical studies were not conducted. The "testing" mentioned refers to software development and validation activities.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as no clinical studies requiring ground truth establishment were conducted.
4. Adjudication Method:
Not applicable, as no clinical studies requiring adjudication were conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as the submission explicitly states that clinical studies were not required. The device is a PACS system, not an AI-assisted diagnostic tool in the context of this submission.
6. Standalone (Algorithm Only) Performance Study:
Not applicable, as this device is a PACS system and the submission does not detail any specific AI/ML algorithms or their standalone performance.
7. Type of Ground Truth Used:
Not applicable, as no clinical studies requiring ground truth were conducted.
8. Sample Size for the Training Set:
Not applicable, as the submission does not describe the development or training of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the submission does not describe the development or training of an AI/ML algorithm.
Summary of the Study:
The "study" described in this 510(k) submission is primarily a non-clinical study focusing on design and quality assurance processes to demonstrate substantial equivalence to a predicate device (K043415 Centricity™ PACS).
The key points of the study are:
- Objective: To demonstrate that Centricity PACS v3.2.1 is substantially equivalent to its predicate device (K043415 Centricity™ PACS).
- Methodology: The submission relies on a comparison of technological characteristics and adherence to quality assurance measures during device development.
- Demonstration of Substantial Equivalence: The applicant argues that the proposed device employs the "same fundamental scientific technology" as its predicate and complies with voluntary standards. They performed various risk analyses, reviews, and testing (unit, integration, performance, safety, and simulated use testing) as part of their quality assurance process.
- Conclusion: GE Healthcare concludes that Centricity PACS is as safe, as effective, and its performance is substantially equivalent to the predicate device, thus not requiring clinical studies.
In essence, this 510(k) is for a software update to an existing PACS system, and the "study" is a collection of engineering and quality management documentation rather than a clinical trial or AI performance study.
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110875
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | February 11, 2011 |
|---|---|
| Submitter: | GE Healthcare540 W. Northwest HighwayBarrington, IL 60010 |
| Primary Contact Person: | Cheryl BorkRegulatory Affairs LeaderGE HealthcarePhone: 847-277-6038Fax: 847-277-5240 |
| Secondary ContactPerson: | Jeme WallaceDirector, Regulatory AffairsGE HealthcarePhone: 847-277-4468Fax: 847-277-5240 |
| Device:TradeName: | Centricity PACS |
| Common/UsualName: | PACS, Picture Archiving and Communication System |
| Classification Names: | 21 CFR 892.2050 System, Image Processing, Radiological |
| Product Code: | LLZ |
| Secondary ProductCode: | GCJ876.1500 Endoscope and accessories |
| Predicate Device(s): | K043415 Centricity™ PACS |
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| Device Description: | Centricity PACS is an enterprise grade Picture Archiving andCommunications System (PACS) for managing digital medicalimages and associated data. Centricity PACS enables thestorage, retrieval, distribution, printing, and presentation ofimages acquired from diagnostic imaging modalities.Centricity PACS is a standards-based, customizable, andscalable solution supporting several of the Integrating theHealthcare Enterprise (IHE) profiles, Digital Imaging andCommunications in Medicine (DICOM), and the Health LevelSeven (HL7) protocol standards for managing digital medicalimages and patient data. Centricity PACS supportsradiographic imaging-as in clinical radiography, cardiology,dentistry, and mammography and non-radiologic imaging,including video support. |
|---|---|
| Intended Use: | Centricity PACS software product is intended for the storage,reading, diagnostic review, analysis, annotation, distribution,printing, editing, and processing of digital images and dataacquired from diagnostic imaging devices.The Centricity PACS Workstation software is intended for useas a primary diagnostic and analysis tool for diagnosticimages by trained healthcare professionals, includingradiologists, physicians, technologists, clinicians and nurses. Itis also intended for use as a clinical review workstationthroughout the healthcare facility. |
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. . . . . . .
| Technology: | Centricity PACS employs the same fundamental scientific |
|---|---|
| technology as its predicate devices. |
| Summary ofTechnologicalCharacteristics: | Predicate DeviceCentricity PACSK043415 (v2.1) | Proposed DeviceCentricity PACS 3.2.1 | |
|---|---|---|---|
| DESIGN | Centricity PACS is a softwareproduct with optional turnkeysolution for hardwarecomponents.Centricity PACS is a standards-based, customizable, andscalable solution supportingseveral of the Integrating theHealthcare Enterprise (IHE)profiles, Digital Imaging andCommunications in Medicine(DICOM), and the Health LevelSeven (HL7) protocol standardsfor managing digital medicalimages and patient data.Centricity PACS supportsradiographic imaging-as inclinical radiography,cardiology, dentistry, andmammography and non-radiologic imaging, includingvideo support. | Centricity PACS v3.2.1 employsthe same fundamentalscientific technology as itspredicate devices, howeverv3.2.1 is a software onlyproduct.Centricity PACS is a standards-based, customizable, andscalable solution supportingseveral of the Integrating theHealthcare Enterprise (IHE)profiles, Digital Imaging andCommunications in Medicine(DICOM), and the Health LevelSeven (HL7) protocol standardsfor managing digital medicalimages and patient data.Centricity PACS supportsradiographic imaging-as inclinical radiography,cardiology, dentistry, andmammography and non-radiologic imaging, includingvideo support. | |
| Material | Not Applicable - CentricityPACS is a software product,and therefore, has no specificmaterials of manufacture. | Not Applicable - Like thepredicate product, theCentricity PACS v3.2.1, is asoftware only product, andtherefore, has no specificmaterials of manufacture. | |
| ChemicalComposition | Not Applicable - CentricityPACS is a software product,and therefore, has no specificchemical composition. | Not Applicable - Like thepredicate product, theCentricity PACS v3.2.1, is asoftware only product, andtherefore, has no specificchemical composition. | |
| EnergySource | Not Applicable - CentricityPACS is a software product,and therefore, has no EnergySource. | Not Applicable - Like thepredicate product, theCentricity PACS v3.2.1, is asoftware only product, andtherefore, has no EnergySource. |
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Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
Centricity PACS comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Centricity PACS, did not require clinical studies to support substantial equivalence.
GE Healthcare considers Centricity PACS to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
GE Healthcare % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
MAY - 5 2011
Re: K110875
Trade/Device Name: Centricity PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and GCJ Dated: March 29, 2011 Received: March 30, 2011
Dear Mr. Devine:
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 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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(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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Indications for Use Form
FDA CDRH DMC K56
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Centricity PACS |
| MAR 3 0 2011 | |
|---|---|
| Received |
Indications for Use:
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Centricity PACS allows integration with other open interfaces, such as DICOM. to web client products and archive devices.
The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.
It is the user's responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
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Indications for Use Form
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patel
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110875
§ 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).