INNOVA 4100, INNOVA 3100

K042053 · Ge Medical Systems, Inc. · OWB · Aug 26, 2004 · Radiology

Device Facts

• Record ID: K042053
• Device Name: INNOVA 4100, INNOVA 3100
• Applicant: Ge Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.

Device Story

Digital Fluoroscopic Imaging System (Innova 4100/3100) with Bolus Chasing option; performs real-time subtracted angiography of lower limbs. System integrates X-ray imaging, contrast injection, and table motion. Bolus Chasing feature automates tracking of contrast bolus during imaging. Used in clinical settings by physicians for diagnostic and interventional procedures. Safety controls prevent unnecessary X-ray exposure or contrast agent delivery in event of system failure (X-ray, injection, or table motion). Benefits include improved visualization of lower limb vasculature during angiography.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by risk management, hazard identification, and software validation processes.

Technological Characteristics

Digital fluoroscopic X-ray system; 380-480 VAC, 50/60Hz power. Materials and construction compliant with UL 2601 and IEC 60601-1. Features integrated control of X-ray, contrast injection, and table motion for Bolus Chasing sequence. Software-based control for safety and synchronization.

Indications for Use

Indicated for diagnostic and interventional angiographic procedures of human anatomy, including real-time subtracted angiography of lower limbs. Not intended 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

• GE Advantx LCV+ (K960575)

Submission Summary (Full Text)

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Image /page/0/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, while the background is white. The logo is simple and recognizable, representing the well-known multinational conglomerate.

K042053
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GE Healthcare P.O. Box 414, W-400 Milwaukee, WI 53201 USA

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

| Identification of Submitter: | Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>GE Healthcare<br>Tel. [phone]<br>Summary prepared: 5 July 2004 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Digital Fluoroscopic Imaging System |
| Classification Name: | Fluoroscopic X-ray system - 21 CFR 892.1650 |
| Manufacturer: | GE Medical Systems Europe<br>283, rue de la Miniere<br>78530 Buc Cedex, France |
| Distributed by: | GE Healthcare, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 4100 and Innova 3100, with the<br>new Bolus Chasing option for angiography of lower limbs are<br>substantially equivalent to GE Advantx LCV+ (K960575). This<br>opinion is based on the information contained in the<br>comparison table, and the product data sheets. |
| Device Description: | The new Bolus Chasing is offered as an option for Innova<br>4100 and 3100, already cleared under K033244 and<br>K031637. |
| Materials: | All construction and materials are compliant with UL 2601 and<br>IEC 60601-1. |
| Design: | Controls of operation of XRAY, injection and table motion are<br>intended to prevent from useless exposures to XRAY/contrast<br>agent during a Bolus Chasing sequence in case of failure<br>from one of these parameters (i.e., XRAY, injection and table<br>motion). |
| Energy Source: | 380 - 480 VAC; 50/60Hz. |
| Indications for Use: | The Digital Fluoroscopic Imaging System with Bolus Chasing<br>option is indicated for use in generating fluoroscopic images<br>of human anatomy for diagnostic and intervention; the option<br>Bolus enables to perform subtraction angiography of lower |

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limbs. This device is not intended for mammography applications.

K042053
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- Comparison with The GE Healthcare new Bolus Chasing option for Innova 4100, 3100 systems, is substantially equivalent to the GE Health Care Advantx LCV+ Bolus Chasing which is part of the Advantx LCV+ system (K960575).
- GE Healthcare considers that the Bolus Chasing option for Conclusions: their 41 cm and 31 cm Digital Fluoroscopic Imaging Systems Innova 4100 and Innova 3100 to be equivalent with the predicate device. The potential hazards, related to the introduction of new Bolus Chasing option, are controlled by a risk management plan including:
- · A hazard identification
- · A risk evaluation
- · A Software Development and Validation Process

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Public Health Service

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

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical System, Inc. P.O. Box 414, W-400 MILWAUKEE WI 53201

Re: K042053

Trade/Device Name: Innova 4100, Innova 3100 with optional Bolus Chasing Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 29, 2004 Received: July 30, 2004

JUL 30 2012

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of August 26, 2004.

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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## STATEMENT OF INTENDED USE

510(k) Number (if known): ¼o42e53____________________________________________________________________________________________________________________________________________

Device Name: Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 3100 with optional Bolus Chasing.

## Indications for Use

The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801-109) | ✓ | OR Over-The-Counter Use | |
|---------------------------------------|---|-------------------------|--|
|---------------------------------------|---|-------------------------|--|

(Division Sigh-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K042053 |
|---------------|---------|
|---------------|---------|