Innova EPVision 2.0 software application is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

Innova EPVision 2.0 software application is intended to enable users to load, overlay and register in real time 3D datasets with radioscopic or radiographic images of the same anatomy. Electrophysiological signal information is imported and used to color-code these 3D datasets in order to support catheter/device during cardiac electrophysiology guidance interventional procedures.

Device Description

Innova EPVision 2.0 is the new version of Innova EPVision software, which is part of the Innova Vision Applications [K092639] software. Innova EPVision 2.0, as all Innova Vision Applications image processing algorithms, is executed on a hardware called Advantage platform Workstation (AW) [K110834].
It can perform the following functions:

Superimpose the segmented DICOM 3D XA, CT, MR dataset on radioscopic or radiographic image of the same anatomy, obtained on an Innova Fluoroscopic X-ray system [K113034].
. Register the segmented DICOM 3D XA. CT. MR dataset with radioscopic or radiographic images obtained on an Innova Fluoroscopic X-ray system for interventional procedures.
. Image stabilization features such as ECG gated display or motion tracking in the image.
. Capability to load planning data, deposited on the 3D model in Volume Viewer [K041521], such as 3D landmarks, ablations lines, and to display them on the 3D-2D fused image to support the physician during procedures.
. Marking points of interest of different size and color during the procedures.
. The frequently used functions are also available from tableside on the Innova Central Touch Screen to provide efficient workflow during the interventional procedures.

Innova EPVision 2.0 can perform additionally the following functions:

Import electrophysiology (EP) data digitized and processed . on the CardioLab system [K111200] and use them to colorcode EP recording points on 3D model of the visualized anatomy in order to support catheter/device guidance during cardiac electrophysiology interventional procedures.
. Catheter tip detection to help locate the catheter tip on the 2D X-ray image. The user can modify or correct the automatically proposed tip location anytime.
. 3D side viewer allowing the user to freely rotate the 3D model independently from the Fluoro image and the gantry angulation.

Innova EPVision 2.0, as Innova EPVision targets clinical indication for interventional cardiology procedures and in particular cardiac electrophysiology procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Innova EPVision 2.0 device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Innova EPVision 2.0. Instead, it relies on demonstrating substantial equivalence to a predicate device (K092639, Innova Vision Applications) and adherence to various standards (NEMA PS 3.1 - 3.20 (2011) DICOM Set, IEC 60601-1-4 (2000), IEC 62304 (2006), IEC 62366 (2007)).

The "reported device performance" is described in terms of verification and validation activities designed to ensure the device works as required and meets user needs and intended use.

Summary of Device Performance (as described):

Acceptance Criteria (Implied by Regulatory Compliance)	Reported Device Performance
Compliance with NEMA PS 3.1 - 3.20 (DICOM Set)	Verified as compliant
Compliance with IEC 60601-1-4 (Medical Electrical Equipment)	Verified as compliant
Compliance with IEC 62304 (Software Life Cycle Processes)	Verified as compliant
Compliance with IEC 62366 (Usability Engineering)	Verified as compliant
Risk Management effectiveness	Implemented and tested
Requirements Reviews completion	Performed
Design Reviews completion	Performed
Performance and Safety testing (Verification)	Performed at Unit, Integration, and System levels to check functionality and risk mitigation.
Final Acceptance Testing (Validation)	Performed to ensure user needs, intended use, risk mitigation, and labeling are effective.
Substantial Equivalence to Predicate Device (K092639)	Concluded to be safe, effective, and substantially equivalent.
No new significant indications for use	Application works within predicate's intended use/indications.
No new issues of safety and effectiveness	Verified through testing
No new fundamental scientific technology	Application uses same fundamental technology as predicate.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for performance evaluation. Instead, it discusses verification and validation tests as part of the software development lifecycle. These tests would involve a variety of inputs and scenarios, but the exact sample sizes (e.g., number of test cases, number of images) for these engineering tests are not provided.

There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no clinical studies were deemed necessary or performed to support substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or provided as no clinical studies were performed that would require expert-established ground truth on a test set. The ground truth for the engineering verification and validation tests would be the expected behavior of the software as defined by its requirements and design specifications, not clinical expert consensus.

4. Adjudication method for the test set

This information is not applicable or provided since no clinical validation study involving adjudication of a test set was performed.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "The subject of this premarket submission, Innova EPVision 2.0, did not require clinical studies to support substantial equivalence." Therefore, there is no reported effect size of human readers improving with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as a software application that "enables users to load, overlay and register... in order to support catheter/device guidance." It also mentions "Catheter tip detection to help locate the catheter tip on the 2D X-ray image. The user can modify or correct the automatically proposed tip location anytime." This clearly indicates a human-in-the-loop design.

While the "Catheter tip detection" component could have an internal standalone performance evaluation during development, the submission does not report a standalone (algorithm only) performance study in the context of a regulatory submission outcome. The overall device is intended to be used with a human interventionalist.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the engineering verification and validation tests, the ground truth would be the expected software behavior and functionality based on design input (system requirements and specifications). For example, a test for "Superimpose the segmented DICOM 3D XA, CT, MR dataset on radioscopic or radiographic image" would have a ground truth defined by the correctness of the overlay as per the design specifications. There is no mention of clinical ground truth (expert consensus, pathology, or outcomes data) being used for the regulatory submission's performance evaluation because no clinical studies were conducted.

8. The sample size for the training set

This information is not provided. The document makes no mention of machine learning model training or a training set. The device is described as inheriting functions and employing the "same fundamental scientific technology" as its predicate, implying a rule-based or traditional image processing approach rather than a machine learning approach requiring distinct training data that would be relevant to this 510(k) submission.

9. How the ground truth for the training set was established

This information is not provided as no training set is mentioned in the context of this 510(k) submission.

Summary

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K130069

APR 5 2013

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

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

January 8th, 2013 Date:

Submitter: GE Healthcare, (GE Medical Systems SCS) 283 rue de la MINIERE 78530 Buc, FRANCE

Primary Contact Person: Ning WEN Regulatory Affairs Leader GE Healthcare, (GE Medical Systems SCS) Tel: (+33)-1-3070-5668 Fax: (+33) 1-3070-4670

Secondary Contact Person: Carol ALLOIAN Regulatory Affairs Leader GE Healthcare Tel: (224) 280-1008 Fax: (847) 589-8524

Device: Trade Name: Innova EPVision 2.0 Common/Usual Name: Picture Archiving and Communications System Classification Names: 21CFR 892.2050, Class II Product Code: LLZ

Predicate Device(s): K092639, Innova Vision Applications (including Innova EPVision)

Reference Device(s): K111200, CardioLab System (from GE Healthcare)

Device Description: Innova EPVision 2.0 is the new version of Innova EPVision software, which is part of the Innova Vision Applications [K092639] software. Innova EPVision 2.0, as all Innova Vision Applications image processing algorithms, is executed on a hardware called Advantage platform Workstation (AW) [K110834].
It can perform the following functions:

Image /page/0/Picture/14 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The logo is black and white.

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510(k) Premarket Notification Submission

Functions inherited from Innova EPVision:

Superimpose the segmented DICOM 3D XA, CT, MR dataset on radioscopic or radiographic image of the same anatomy, obtained on an Innova Fluoroscopic X-ray system [K113034].
. Register the segmented DICOM 3D XA. CT. MR dataset with radioscopic or radiographic images obtained on an Innova Fluoroscopic X-ray system for interventional procedures.
. Image stabilization features such as ECG gated display or motion tracking in the image.
. Capability to load planning data, deposited on the 3D model in Volume Viewer [K041521], such as 3D landmarks, ablations lines, and to display them on the 3D-2D fused image to support the physician during procedures.
. Marking points of interest of different size and color during the procedures.
. The frequently used functions are also available from tableside on the Innova Central Touch Screen to provide efficient workflow during the interventional procedures.

Innova EPVision 2.0 can perform additionally the following functions:

Import electrophysiology (EP) data digitized and processed . on the CardioLab system [K111200] and use them to colorcode EP recording points on 3D model of the visualized anatomy in order to support catheter/device guidance during cardiac electrophysiology interventional procedures.
. Catheter tip detection to help locate the catheter tip on the 2D X-ray image. The user can modify or correct the automatically proposed tip location anytime.
. 3D side viewer allowing the user to freely rotate the 3D model independently from the Fluoro image and the gantry angulation.

Innova EPVision 2.0, as Innova EPVision targets clinical indication for interventional cardiology procedures and in particular cardiac electrophysiology procedures.

Intended Use: Innova EPVision 2.0 software application is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

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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 letters and the border are black, creating a high-contrast design.

GE Healthcare 510(k) Premarket Notification Submission

Indication for Use: Innova EPVision 2.0 software application is intended to enable users to load, overlay and register in real time 3D datasets with radioscopic or radiographic images of the same anatomy. Electrophysiological signal information is imported and used to color-code these 3D datasets in order to support catheter/device during cardiac electrophysiology guidance interventional procedures.
- Same as predicate device, Innova EPVision 2.0 is a software Technology: application that executes on the Advantage Workstation (AW) review workstation [K110834]. The live Innova fluoroscopic images, as well as the necessary exam data, are transmitted from the Innova Digital Fluoroscopic Imaging System [K113034] to the AW through a dedicated link. The 3D datasets previously acquired (from XA, CT and MR) are loaded from the AW database. The application fuses the live fluoroscopic images with the 3D dataset. The 3D-2D fusion and the user interface of the application are displayed on the AW main screen, which is distributed identically in Control Room and in Exam Room by a video splitter of Innova system.

Additionally, upon request Innova EPVision 2.0 can receive digitized electrophysiology signals from the CardioLab recording system [K111200] and display them in its signal window. Innova EPVision 2.0 performs automatic measurements on the received mapping channel signal (local activation time [ms] (LAT) and/or voltage amplitude [mV]) and allows the user to manually adjust the measurements with the mouse. Innova EPVision 2.0 marks the point of measurement on the 3D model and color-codes its surrounding area based on the measurement values and thereby allows the user to create step by step 3D electroanatomical maps of cardiac arrhythmias.

Same as predicate device, the frequently used functions are available from the exam room on the Innova Central Touch Screen. This user interface is controlled by the application through the Innova Ethernet network.

The Innova EPVision 2.0 application employs the same fundamental scientific technology as its predicate device.

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GE Healthcare

510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Innova EPVision 2.0 complies with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set and with voluntary standards IEC 60601-1-4 (2000), IEC 62304 (2006) and IEC 62366 (2007).

The following quality assurance measures were applied to the development of the software application:

Risk Management .
. Requirements Reviews
◆ Design Reviews
Performance and Safety testing (Verification) 4

The Verification Tests of the Innova EPVision 2.0 were performed in accordance with device Design Verification Plan and with device Verification Procedure, at 3 levels:

Software Unit Testing (Unit Test Verification) -
-Software Integration Testing (Integration Verification)
-System Testing (System Verification)

The verification tests were performed to check whether the application works as required and whether the risk mitigations have been correctly implemented. Performance testing consists of tests which measured the features and functions behavior supporting the user needs and ensured the physical characteristics of the proposed device. The Verification confirms that the Design Output meets the Design Input (Product Specifications) requirements.

Final acceptance testing (Validation)
The Validation Tests of the Innova EPVision 2.0 were executed in accordance with device Design Validation Plan and with device Validation Procedure. The Validation tests ensure that the proposed device fulfills the requirement of the user needs and intended use, the risk mitigation and the product labeling are effective.

Summary of Clinical Tests:

The subject of this premarket submission, Innova EPVision 2.0, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Innova EPVision 2.0 to be as safe and as effective as its predicate device, and its performance is substantially equivalent to the predicate device.

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GE Healthcare 510(k) Premarket Notification Submission

This conclusion is based on:

Innova EPVision 2.0 application does not introduce . substantially new indications for use. Innova EPVision 2.0 application works within the predicate's Intended Use and Indication for Use.
. Innova EPVision 2.0 application does not raise new issues of safety and effectiveness.
Innova EPVision 2.0 application does not introduce new . fundamental scientific technology.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2013

NING WEN REGULATORY AFFAIRS LEADER GE HEALTHCARE 283 RUE DE LA MINIERE BUC 78530 FRANCE

Re: K130069

Trade/Device Name: Innova EPVision 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 27, 2013 Received: March 29, 2013

Dear Mr. Wen:

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. Iisting 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 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.

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Page 2-Mr. Wen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

SmhP)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130069

Device Name: Innova EPVision 2.0

Indications for Use:

Innova EPVision 2.0 software application is intended to enable users to load, overlay and register in real time 3D datasets with radioscopic or radiographic images of the same anatomy. Electrophysiology signal information is imported and used to color-code these 3D datasets in order to support catheter/device guidance during cardiac electrophysiology interventional procedures.

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

Over-The-Counter Use (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 Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130069 510(k)

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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).