GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ

K092004 · GE Healthcare · OWB · Aug 25, 2009 · Radiology

Device Facts

• Record ID: K092004
• Device Name: GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
• Applicant: GE Healthcare
• Product Code: OWB · Radiology
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

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 Story

Innova 4100 IQ, 3100 IQ, and 2100 IQ systems are x-ray angiographic imaging devices modified with an optional software feature, StentViz. StentViz processes video image sequences recorded during fluoroscopic guidance to produce an enhanced static image of a stent. The device is used in clinical settings (e.g., interventional suites) by physicians to improve stent visibility during procedures. StentViz does not provide real-time guidance; it generates a post-processed static image. By enhancing stent visualization, the device assists clinicians in evaluating stent placement, potentially improving procedural outcomes. The system operates as an integrated component of the existing Innova fluoroscopy platform.

Clinical Evidence

No clinical studies were required. Substantial equivalence was supported by bench testing using a library of clinical images to compare stent visibility enhancement between the subject device and the predicate StentOp feature.

Technological Characteristics

X-ray angiographic system with optional StentViz software. StentViz is a non-real-time image processing feature that derives enhanced static images from fluoroscopic video sequences. The system complies with voluntary standards for safety and performance. Development followed quality assurance measures including risk analysis, module verification, system integration testing, and final validation.

Indications for Use

Indicated for patients undergoing vascular angiography, cardiology, diagnostic, and interventional procedures requiring fluoroscopic imaging. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Innova 4100 IQ, 3100 IQ, 2100 IQ (K052412, K050489, K060259, K061163)
• IC-PRO device (K083745)
• Philips Fresco release 1 (K031836)

Submission Summary (Full Text)

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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 Totah<br>Regulatory Affairs Director, Pre-market<br>GE Healthcare<br>(262) -544-3424<br>(262) -544-3202 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact Person: | Philip Malca<br>Interventional Regulatory Affairs Director<br>GE Healthcare GE Medical Systems SCS.<br>33 1 30 70 42 07<br>33 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 ^IQ<br>K052412, K050489, K060259, K061163<br>IC-PRO device (K083745) featuring StentOp<br>Philips Fresco release 1 (featuring StentBoost) (K031836) |
| Device Description: | The Innova 4100 ^IQ , 3100 ^IQ , 2100 ^IQ Systems are modified with an<br>optional software feature called StentViz. The StentViz feature<br>enhances the visibility of stents in the x-ray images produced by<br>the Innova systems. Specifically, StentViz provides an enhanced<br>static image of the stent that is derived from the video image<br>sequence 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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