The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

Device Description

The Innova 4100 IQ, 3100 IQ, 2100 IQ Systems are modified with an optional software feature called StentViz. The StentViz feature enhances the visibility of stents in the x-ray images produced by the Innova systems. Specifically, StentViz provides an enhanced static image of the stent that is derived from the video image sequence as recorded during fluoroscopic guidance. It does not provide real-time guidance.

AI/ML Overview

The information provided focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and detailed performance studies for the StentViz feature itself. Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly stated in the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on a qualitative comparison to predicate devices and general statements about image enhancement.

Acceptance Criteria (Implied)	Reported Device Performance
Enhanced visibility of stents (compared to Innova without StentViz)	Bench tests were performed "to assess the enhancement of stent visibility." The text states, "When StentViz is used, the image quality and visibility of the stent is improved."
Comparable image quality/stent enhancement to predicate devices (StentOp and StentBoost)	Bench tests were performed "to compare the performance of the Innova with StentViz to... the performance of the similar feature contained in the predicate device StentOp." The document concludes, "The image quality of the stent is enhanced in a comparable way with StentViz than with StentOp and StentBoost." Its performance is "substantially equivalent to the predicate devices."
No adverse impact on safety or effectiveness	The improvement "does not adversely impact safety or effectiveness."
Compliance with voluntary standards	The Innova systems with StentViz comply with voluntary standards as detailed in Sections 9 and 17 of the premarket submission (details not provided in the extract).

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

Sample Size: "Bench tests were performed based on a library of clinical images." The exact number of images in this "library" is not specified.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "clinical images."

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

This information is not provided in the document. The evaluation of "enhancement of stent visibility" appears to have been part of bench testing, but who performed these assessments and their qualifications are not mentioned.

4. Adjudication method for the test set:

This information is not provided.

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:

A MRMC comparative effectiveness study is not explicitly mentioned. The evaluation described is "bench tests" to assess enhancement and perform comparisons. The document does not discuss human reader performance or improvement with AI assistance (StentViz).

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

The evaluation was a "bench test" comparing the StentViz feature to the Innova without StentViz and to a predicate device's feature (StentOp). While human eyes would ultimately interpret the enhanced images, the description of "bench tests... to assess the enhancement of stent visibility" and compare performance suggests an evaluation of the algorithm's output (the enhanced image) itself, making it akin to a standalone performance assessment of the image enhancement capability. However, it's not explicitly stated as "algorithm only without human-in-the-loop performance" in the strict sense of a diagnostic task.

7. The type of ground truth used:

The document mentions "a library of clinical images" being used for bench tests to assess "enhancement of stent visibility." The "ground truth" for assessing this enhancement is not explicitly defined. It likely relied on a subjective or objective assessment of image clarity and stent outline on the enhanced images compared to unenhanced images or images from predicate devices. There is no mention of pathology, or outcomes data being used as ground truth for this enhancement feature.

8. The sample size for the training set:

The document does not provide information about a specific training set. The StentViz is described as an "optional software feature" that "enhances the visibility of stents." The development process mentioned includes "Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), Safety testing (Verification)." This suggests a standard software development and testing cycle rather than a machine learning model that would typically have a distinct "training set."

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

As no specific training set for a machine learning model is mentioned, this information is not applicable/provided. The feature development would have followed established engineering principles for image processing, not a typical machine learning training paradigm with a labeled ground truth dataset.

Summary

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K092004
P. 1 of 3

AUG 2 5 2009

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

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

1 st July 2009 Date:

Submitter: GE Healthcare {GE Medical Systems, LLC] Doing business with GE Healthcare 3000 N. Grandview Blvd Waukesha, WI 53188

Primary C

Device: Commo

Primary Contact Person:	Alan TotahRegulatory Affairs Director, Pre-marketGE Healthcare(262) -544-3424(262) -544-3202
Secondary Contact Person:	Philip MalcaInterventional Regulatory Affairs DirectorGE Healthcare GE Medical Systems SCS.33 1 30 70 42 0733 1 30 70 43 99
Device: Trade Name:	Innova 4100 IQ , 3100 IQ , 2100 IQ with StentViz
Common/Usual Name:	Innova 4100 IQ , 3100 IQ , 2100 IQ with StentViz
Classification Names:	System X-Ray, Angiographic
Product Code:	OWB, JAA, IZI
Predicate Device(s):	Innova 4100 IQ , 3100 IQ , 2100 IQK052412, K050489, K060259, K061163IC-PRO device (K083745) featuring StentOpPhilips Fresco release 1 (featuring StentBoost) (K031836)
Device Description:	The Innova 4100 IQ , 3100 IQ , 2100 IQ Systems are modified with anoptional software feature called StentViz. The StentViz featureenhances the visibility of stents in the x-ray images produced bythe Innova systems. Specifically, StentViz provides an enhancedstatic image of the stent that is derived from the video imagesequence as recorded during fluoroscopic guidance. It does not

The Innova systems are indicated for use in generating Intended Use: fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to
provide real-time guidance.
replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
optionally,

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K092004
?. 2 of 3

GE Healthcare

510(k) Premarket Notification Submission

Technology:

Determination of Substantial Equivalence:

The Innova 4100'0, 3100'0, 2100'0 with StentViz employs the same fundamental scientific technology as its predicate devices.

The subject device is of a comparable type and substantially equivalent to the unmodified Innova 41000, Innova 310019 Innova 2100 10 devices. For the purpose of comparison, the modified and unmodified devices are identical except for the additional software option (StentViz). When StentViz is used, the image quality and visibility of the stent is improved. This improvement does not adversely impact safety or effectiveness.

Two other predicate devices contain an equivalent feature to the StentViz:

Paieon StentOp feature of the IC-PRO device (K083745)
and Philips Fresco (also known as StentBoost) (K031836).

StentOp is a stand-alone software application that can be used on any fluoroscopy system while StentBoost is a feature embedded in the Philips Fresco fluoroscopy system. Both the StentOp and StentBoost offer the ability to provide an enhanced static image of the stent that is derived from the video image sequence as recorded during fluoroscopic guidance. As these predicate devices. StentViz does not provide real-time quidance.

The image quality of the stent is enhanced in a comparable way with StentViz than with StentOp and StentBoost. From a design validation performance standpoint, bench tests were performed based on a library of clinical images. This library was used to assess the enhancement of stent visibility and to compare the performance of the Innova with StentViz to:

Innova without StentViz applied on the video image sequence as recorded
the performance of the similar feature contained in the predicate device StentOp. The image quality of the stent is enhanced in a comparable way with StentOp.

The Innova 410019, 310019, 2100'9 with StentViz and its applications comply with voluntary standards as detailed in Sections 9 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the svstem:

Risk Analysis .
. Requirements Reviews
Design Reviews .
. Testing on unit level (Module verification)
. Integration testing (System verification)
. Final acceptance testing (Validation)

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K092004 P. 3 of 3

GE Healthcare

510(k) Premarket Notification Submission

Performance testing (Verification) ●
Safety testing (Verification) ●

Summary of Clinical studies:

The subject of this premarket submission, Innova 41000, 310000, 210019 with StentViz, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the Innova 41000, 31000, 21000 with StentViz to be as safe and as effective as the predicate devices, and its performance is substantially equivalent to the predicate devices.

Image /page/2/Picture/9 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' in a stylized, cursive font, enclosed within a circular border. The letters and the border are solid black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the multinational conglomerate company, General Electric.

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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

Mr. Alan Totah Director, RA, PreMarket GE Healthcare Systems 3000 N. Grandview Blvd. WAUKESHA WI 53188

1111 30 2012

Re: K092004

Trade/Device Name: Innova 410010. 310010. 210010 with StentViz Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: July 1, 2009 Received: July 2, 2009

Dear Mr. Totah:

This letter corrects our substantially equivalent letter of August 25, 2009.

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,

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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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined inside a circle. The letters are stylized and appear to be hand-drawn. The logo is black and white.

GE Healthcare 510lk) Premarket Notification Submission

510(k) Number (if known) : _ K09 2004

Innova 4100'0, 3100'0 , 2100'0 with StentViz Device Name :

Indications for Use:

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Abdominal and Radiological Devic

510(k) Number K072004

17/138

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.