DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

K033244 · Ge Medical Systems, Inc. · OWB · Oct 16, 2003 · Radiology

Device Facts

• Record ID: K033244
• Device Name: DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
• Applicant: Ge Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Digital Fluoroscopic Imaging System is 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. This device is not intended for mammography applications. The new tilt table will support performing procedures like CO2 studies. Venography.

Device Story

Digital Fluoroscopic Imaging System (Innova 4100) with optional tilt table; used for diagnostic and interventional angiography. Tilt table enables patient positioning for various procedures, including CO2 studies and venography. System generates fluoroscopic images of human anatomy. Operated by clinicians in clinical settings. Hardware and software redundancies prevent single-point failures during table motion. Device replaces existing image intensifier fluoroscopic systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluoroscopic X-ray system; 480 VAC 50/60Hz power. Materials compliant with UL 2601 and IEC 60601-1. Includes hardware and software redundancies for motion control safety.

Indications for Use

Indicated for diagnostic and interventional angiographic procedures of human anatomy, including CO2 studies and venography. 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

• Siemens Axiom Artis (K021021)

Submission Summary (Full Text)

{0}------------------------------------------------

K033244

OCT 1 6 2003

GE Medical Systems 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).

| <b>Identification of Submitter:</b> | Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>GE Medical Systems<br>Tel. [phone]<br>Summary prepared: 5 September 2003 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Identification of Product:</b> | Digital Fluoroscopic Imaging System |
| <b>Classification Name:</b> | Fluoroscopic X-ray system - 21 CFR 892.1650 |
| <b>Manufacturer:</b> | GE Medical Systems Europe<br>283, rue de la Minière<br>78530 Buc Cedex, France |
| <b>Distributed by:</b> | GE Medical Systems, Milwaukee, WI |
| <b>Marketed Devices:</b> | The GE Medical System's Innova 4100, with a new Tilt table<br>option for patient positioning, for diagnostic fluoroscopic<br>imaging is substantially equivalent to Siemens Axiom Artis<br>(K021021). This opinion is based on the information<br>contained in the comparison table (Attachment 3), and the<br>product data sheets (Attachment 4 & 5). |
| <b>Device Description:</b> | The new tilt table is offered as an option for Innova 4100, in<br>place of the existing Omega V table, which is part of the<br>Innova 4100 system already cleared under K023178. |
| <b>Materials:</b> | All construction and materials are compliant with UL 2601 and<br>IEC 60601-1. |
| <b>Design:</b> | There are hardware and software redundancies to prevent<br>from single point failures that could cause unintended motion. |
| <b>Energy Source:</b> | 480 VAC 50/60Hz. |
| <b>Indications for Use:</b> | The Digital Fluoroscopic Imaging System with tilt table option<br>is indicated for use in generating fluoroscopic images of<br>human anatomy for diagnostic and intervention angiography<br>procedures in both normal and tilted condition of patient. This |

104 - Au 1 - Summary - SE Rev-Daloc PAGENBPAGES9/16/2003 PAGE

Image /page/0/Picture/7 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is written in a clear, sans-serif font.

Public Health Service

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

GE Medical Systems % Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719

JUL 30 2012

Re: K033244

Trade/Device Name: Model Innova 4100 with Tilt Table Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: October 6, 2003 Received: October 7, 2003

Dear Mr. Sherratt:

This letter corrects our substantially equivalent letter of October 16, 2003.

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

{2}------------------------------------------------

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

{3}------------------------------------------------

## STATEMENT OF INTENDED USE

510(k) Number (if known): K033244

V

Device Name: Digital Fluoroscopic Imaging System – Innova 4100 with optional Tilt Table

## Indications for Use

The Digital Fluoroscopic Imaging System is 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. This device is not intended for mammography applications.

The new tilt table will support performing procedures like CO2 studies. Venography.

(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_

Nancy. C brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033244