INTEGRATED REGISTRATION by GE MEDICAL SYSTEMS SCS

INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.

Device Description

The INTEGRATED REGISTRATION tool runs on Advantage Workstation 4.5 or higher versions. This product is an extension to the Volume Viewer application, dedicated to the registration of multi-modality images, and comparison of volumetric datasets from Computed Tomography (CT), Magnetic Resonance (MR), Positron Emission Tomography (PET) or Single Photon Emission Computed Tomography (SPECT), and 3D X-Ray Angiography (XA). Note that the INTEGRATED REGISTRATION licenses control which algorithms are available and which modalities can be saved.

AI/ML Overview

The provided FDA 510(k) Premarket Notification Submission for the GE Healthcare INTEGRATED REGISTRATION device does not include acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based diagnostic devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and a summary of non-clinical tests. Clinical studies were explicitly stated as not required to support substantial equivalence.

Here's an breakdown based on the information provided, explicitly noting where information is missing for the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Not specified in the document.	Not specified in the document.	The document states that "INTEGRATED REGISTRATION complies with DICOM Standard NEMA PS 3.1 - 3.18(2008)." This is a compliance statement rather than a performance acceptance criterion. Performance testing mentioned includes "Verification" and "Validation" but no specific metrics or thresholds are provided.

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

Test Set Sample Size: Not specified.
Data Provenance: Not specified. (No clinical data was used for substantial equivalence.)
Retrospective/Prospective: Not applicable, as no clinical studies were performed.

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

Number of Experts: Not applicable. No clinical test set requiring expert ground truth was used.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

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

Was an MRMC study done? No. The submission explicitly states: "The subject of this premarket submission, INTEGRATED REGISTRATION, did not require clinical studies to support substantial equivalence."
Effect Size of Human Readers Improve with AI vs. without AI: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? No, not in the sense of a clinical performance study with specific metrics. The document mentions "Performance testing (Verification)" as part of non-clinical tests, but no details of such a study or its results are provided. The device itself is an "optimized combination of its predicate devices" with "optimized registration algorithms," implying algorithm-only functionality but without a standalone performance study as typically understood for AI devices.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. No clinical ground truth was established for "substantial equivalence." The basis for equivalence relies on compliance with standards and non-clinical testing.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. This device predates the common discussion around AI/ML training sets for medical devices. The "optimized registration algorithms" would have been developed using some form of data, but the submission does not detail any "training set."

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

Ground Truth Establishment: Not applicable/Not specified. Given the nature of the device as an "optimized combination" of existing algorithms for image registration, ground truth for algorithm development (if implicitly used) would likely relate to image alignment accuracy, which typically relies on synthetic data or manually established spatial correspondences rather than clinical "ground truth" labels.

Summary

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093234

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

OC1 3 0 2009

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

Date:	October 8th, 2009
Submitter:	GE Healthcare, (GE Medical Systems SCS)283, rue de la Minière78530 Buc - FRANCE
Primary Contact Person:	Sophie Le LoarerRegulatory Affairs SpecialistGE Healthcare, (GE Medical Systems SCS)TEL: (33) 1 30 70 43 31 - FRANCEFAX: (33) 1 30 70 41 00 - FRANCE
Secondary Contact Person:	Stephen G. Slavens, RACGlobal Regulatory Affairs DirectorGE Healthcare, (GE Medical Systems LLC)TEL: (262) 548-4992FAX: (262) 548-3884
Device: Trade Name:	INTEGRATED REGISTRATION
Common/Usual Name:	INTEGRATED REGISTRATION
Classification Name:	21CFR 892.2050 Picture archiving and communications system
Product Code:	90LLZ
Predicate Devices:	K010336: Advantage Windows CT/PET FusionK983256: Advantage Windows (CT/MR) FusionK022310: Advantage Windows X-Ray/MR Fusion
Device Description:	The INTEGRATED REGISTRATION tool runs on AdvantageWorkstation 4.5 or higher versions. This product is an extensionto the Volume Viewer application, dedicated to the registration ofmulti-modality images, and comparison of volumetric datasetsfrom Computed Tomography (CT), Magnetic Resonance (MR),Positron Emission Tomography (PET) or Single Photon EmissionComputed Tomography (SPECT), and 3D X-Ray Angiography(XA). Note that the INTEGRATED REGISTRATION licensescontrol which algorithms are available and which modalities canbe saved.
Intended Use:	INTEGRATED REGISTRATION permits comparison of three-dimensional (3D) images from Computed Tomography (CT),Magnetic Resonance Imaging (MRI), Emission Tomography(PET or SPECT) and X-Ray Angiography (XA) to helpphysicians in diagnostic radiology or therapy planning.
Technology:	INTEGRATED REGISTRATION consists of optimizedregistration algorithms for pairs of modality images,configuration options as licensed by the end user, and protocolsfor use within each configuration option.INTEGRATED REGISTRATION is an optimized combinationof its predicate devices and employs the same fundamentalscientific technology as these predicate devices.Major improvements to the device include:2D, 3D and hybrid 2D/3D Fusion capabilities The ability to load multiple (more than two) series andmultiple modalities (CT, MR, PET, SPECT, XA) in the sameregistration session Registration results propagation to all the supportedmodalities Optimized algorithms for modality pairs and anatomies Default registration at load Optimized tools for manual and regional registration, Reset, center and undo/redo tools to improve the usability, Protocols and layouts dedicated to typical clinical use cases, Saving ability for the new DICOM Registration Object Easier access to GE Radiotherapy simulation software:Advantage Sim MD
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:INTEGRATED REGISTRATION complies with DICOMStandard NEMA PS 3.1 - 3.18(2008). The following qualityassurance measures were applied to the development of thesystem:Risk Analysis Requirements Reviews Design Reviews Performance testing (Verification) Safety testing (Verification) Final acceptance testing (Validation)Summary of Clinical Tests:The subject of this premarket submission, INTEGRATEDREGISTRATION, did not require clinical studies to supportsubstantial equivalence.
Conclusion:	GE Healthcare considers the INTEGRATED REGISTRATIONSoftware application to be as safe, as effective, and performanceis substantially equivalent to the predicate devices.

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510(k) Premarket Notification Submission

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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

General Electric Medical Systems SCS % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K093234

OCT 3 0 2009

Trade/Device Name: Integrated Registration Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2009 Received: October 15, 2009

Dear Mr. Lehtonen:

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

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Enclosure

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): K093234

Device Name: INTEGRATED REGISTRATION

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

Torya M. Whiz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K093234

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).