INNOVA 4100

K023178 · Ge Medical Systems, Inc. · OWB · Nov 26, 2002 · Radiology

Device Facts

• Record ID: K023178
• Device Name: INNOVA 4100
• Applicant: Ge Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K023178 · Nov 26, 2002	INNOVA 4100	Ge Medical Systems, Inc.	Clinical procedure recordings; Hospital-based clinical evaluations	Radiologists evaluated the diagnostic capability of the device by comparing images from patient sequences and performing real-time clinical procedure assessments in hospital settings.	Clinical evaluation; Diagnostic capability; Real-time clinical procedures

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical comparison study; Retrospective comparison of patient image sequences	Patients undergoing diagnostic and interventional angiography; Sample Size: 11 pairs of patient sequences; Number of Sites: 3	Innova 2000 (predicate device)	Equivalent image diagnostic capability
Non-comparative clinical evaluation; Clinical evaluation of real-time procedures	Patients undergoing clinical procedures; Number of Sites: 1 (Saint-Luke's)	Not applicable for this study	Diagnostic capability of fluoroscopy in all FOV

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.

Device Story

Digital Fluoroscopic Imaging System (Innova 4100) performs fluoroscopic X-ray examinations; replaces image intensifier technology. System components: angiographic monoplane positioner, vascular table, X-ray system, amorphous silicon detector with cesium iodide scintillator. Input: X-ray signals; Output: digital images. Data transmitted via Fiber Channel to acquisition equipment and networked via DICOM for post-processing, printing, viewing, and archiving. Used in clinical settings by physicians for diagnostic and interventional angiography. Hardware/software redundancies prevent single-point failures during motion. Output assists clinicians in visualizing anatomy for diagnostic/interventional decision-making, potentially improving procedural outcomes compared to traditional image intensifiers.

Clinical Evidence

Clinical comparison study involving 6 radiologists across 3 hospitals (US and France) evaluated 11 pairs of patient sequences. Results showed Innova 4100 digital images had equivalent diagnostic capability to the Innova 2000 predicate. Additional non-comparative clinical evaluations were conducted for the 40 cm Large Field of View diagnostic capability and real-time fluoroscopy across all fields of view.

Technological Characteristics

Amorphous silicon detector with cesium iodide scintillator. Materials compliant with UL 187 and UL 2601. Energy source: 480 VAC 50/60Hz. Connectivity: Fiber Channel link, DICOM networking. Hardware/software redundancies for motion control. System includes angiographic monoplane positioner, vascular table, X-ray system, and digital detector.

Indications for Use

Indicated for diagnostic and interventional angiographic procedures of human anatomy. 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 2000 (LCV+ Version 2) (K993037)

Reference Devices

• Siemens Sireskop (K971452)
• Advantage Workstation 4.1 (K020483)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The logo is black and white and has a vintage look.

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201

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## 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 Medical Systems<br>Tel. [phone]<br>Summary prepared: 17 September 2002 |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product:<br>Classification Name:<br>Manufacturer: | Digital Fluoroscopic Imaging System<br>Stationary X-ray System<br>GE Medical Systems Europe<br>283, rue de la Minière<br>78530 Buc Cedex, France |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
| Marketed Devices: | The Digital Fluoroscopic Imaging System is substantially<br>equivalent to the currently marketed cardiographic system<br>LCV+ Version 2 so-called Innova 2000 introduced in 2000<br>(K993037) that complies with the same or equivalent<br>standards. The collimator used (Siemens model # 0468264<br>G052G) was introduced in the Siemens angiographic device<br>Sireskop (version SX ou SD cleared under K971452) in<br>1997. The Review station used so-called Advantage<br>Workstation 4.1 was introduced in 2000 (K020483). |
| Device Description: | The Digital Fluoroscopic Imaging System is designed to<br>perform fluoroscopic x-ray examinations. The detector is<br>comprised of amorphous silicon with a cesium iodide<br>scintillator. The resulting digital image can be sent through a<br>Fiber Channel link to an acquisition equipment then to<br>network (in using DICOM) for applications such as post-<br>processing, printing, viewing and archiving. Digital<br>Fluoroscopic Imaging System consists of an angiographic<br>monoplane positioner, a vascular table, an X-RAY system and<br>a digital detector. |

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Materials: All construction and materials are compliant with UL 187 for the existing parts of the product and with UL 2601 for the new parts.

- Design: There are hardware and software redundancies to prevent from single point failures that could cause unintended motion.
Energy Source: 480 VAC 50/60Hz.

Indications for Use: The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications.

Comparison with The 41 cm Digital Fluoroscopic Imaging System is Predicate: substantially equivalent to the 20 cm Fluoroscopic system socalled Innova 2000 (Originally Cleared as the LCV+ Version 2; K993037).

- Summary of Studies: A clinical comparison study: 6 radiologists from 3 � hospitals: Saint-Luke's Hosp. (Bethlehem, Pennsylvania - US), Saint-Francis Hospital, (Peoria, Illinois - US); Centre Paris Nord (Sarcelles - France) compared digital images recorded on Innova 2000 and Innova 4100 from 11 pairs of patient sequences and found that the digital images from the Innova 4100 had equivalent image diagnostic capability.
◆ A non-comparative clinical evaluation of the Large Field of View (40 cm) image diagnostic capability has been conducted by the same group of radiologists as well.

◆ A non-comparative clinical evaluation of fluoroscopy in all FOV conducted in real time of the clinical procedures by three radiologists of Saint-Luke's.

Conclusions: GE considers the 41 cm Digital Fluoroscopic Imaging System to be equivalent with the predicate device. The 41 cm Digital Fluoroscopic Imaging System provides fluoroscopic images that result in equivalent diagnostic capabilities than the 20 cm images. The potential hazards, e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:

- · A hazard identification
- · A risk evaluation
- · A Software Development and Validation Process

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right, and its head is slightly tilted upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### 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

JUL 3 Ú 2012

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 MILWAUKEE WI 53201

Re: K023178

Trade/Device Name: Innova 4100 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: September 20, 2002 Received: September 23, 2002

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of November 26, 2002.

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 (OS) 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): _K

Device Name: Digital Fluoroscopic Imaging System - Innova 4100

# 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.

. .

### (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. Gardner

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023178