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.

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 Description

The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a vascular table, an X-RAY system and a digital detector.

AI/ML Overview

The GE Medical Systems Digital Fluoroscopic Imaging System (Innova 4100) was studied for its diagnostic capabilities compared to a predicate device, the Innova 2000. The primary goal was to demonstrate equivalent image diagnostic capability.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Equivalent image diagnostic capability	"found that the digital images from the Innova 4100 had equivalent image diagnostic capability."

2. Sample Size and Data Provenance

Test Set Sample Size: 11 pairs of patient sequences. This relatively small number suggests a comparative efficacy study.
Data Provenance: The study was conducted at three hospitals:
- Saint-Luke's Hospital (Bethlehem, Pennsylvania - US)
- Saint-Francis Hospital (Peoria, Illinois - US)
- Centre Paris Nord (Sarcelles - France)
  This indicates a mix of retrospective and prospective data, given the comparison of existing Innova 2000 images with new Innova 4100 images. The involvement of different hospitals across different countries suggests a more diverse dataset than if it were confined to a single institution or country.

3. Number of Experts and Qualifications

Number of Experts: 6 radiologists.
Qualifications: Not explicitly stated beyond "radiologists." It's implied they are qualified to interpret angiographic images for diagnostic purposes.

4. Adjudication Method

The document describes the radiologists "compared digital images" and "found that the digital images from the Innova 4100 had equivalent image diagnostic capability." This phrasing suggests a consensus or majority opinion among the radiologists, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Yes, a clinical comparison study was done with 6 radiologists evaluating images.
Effect Size of Human Readers with vs. without AI: Not applicable. This study does not involve AI assistance to human readers. It's a comparison of two different fluoroscopic imaging systems (Innova 2000 vs. Innova 4100) and their inherent diagnostic image quality.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a medical device clearance for an imaging system, not an artificial intelligence algorithm. The device itself is the entire system outputting images.

7. Type of Ground Truth Used

Expert Consensus/Clinical Agreement: The "gold standard" for determining equivalent diagnostic capability was the collective evaluation and agreement of the 6 radiologists. There's no mention of pathology or long-term outcomes data being used as ground truth for this particular comparison.

8. Sample Size for the Training Set

Not applicable. This device is a digital fluoroscopic imaging system, not an AI algorithm that requires a distinct training set. The "training" for the device would be its engineering and design, informed by established medical imaging principles and prior device iterations (like the Innova 2000).

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no specific "training set" in the context of an AI algorithm. The device's fundamental design is based on known physics, engineering principles, and clinical requirements for fluoroscopic imaging.

Summary

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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.Senior Regulatory Programs ManagerGE Medical SystemsTel. (414) 544-3894Summary prepared: 17 September 2002
Identification of Product:Classification Name:Manufacturer:	Digital Fluoroscopic Imaging SystemStationary X-ray SystemGE Medical Systems Europe283, rue de la Minière78530 Buc Cedex, France
Distributed by:	GE Medical Systems, Milwaukee, WI
Marketed Devices:	The Digital Fluoroscopic Imaging System is substantiallyequivalent to the currently marketed cardiographic systemLCV+ Version 2 so-called Innova 2000 introduced in 2000(K993037) that complies with the same or equivalentstandards. The collimator used (Siemens model # 0468264G052G) was introduced in the Siemens angiographic deviceSireskop (version SX ou SD cleared under K971452) in1997. The Review station used so-called AdvantageWorkstation 4.1 was introduced in 2000 (K020483).
Device Description:	The Digital Fluoroscopic Imaging System is designed toperform fluoroscopic x-ray examinations. The detector iscomprised of amorphous silicon with a cesium iodidescintillator. The resulting digital image can be sent through aFiber Channel link to an acquisition equipment then tonetwork (in using DICOM) for applications such as post-processing, printing, viewing and archiving. DigitalFluoroscopic Imaging System consists of an angiographicmonoplane positioner, a vascular table, an X-RAY system anda 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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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 (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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STATEMENT OF INTENDED USE

510(k) Number (if known): _K

Device Name: Digital Fluoroscopic Imaging System - Innova 4100

Indications for Use

. .

(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

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.