The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended for mammography applications.

Device Description

The Innova 3100 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. The Innova 3100 consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector. The SuperFast Gantry (InnovaTrace) includes capacitive sensor technology and optimized collision avoidance software that permits an increase of pivot and C-arm speed of up to 20°/sec.

AI/ML Overview

The provided document for the GE Innova 3100 Digital Fluoroscopic Imaging System is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel algorithm.

Therefore, the requested information, particularly regarding specific acceptance criteria, a standalone study with defined performance thresholds, and details on ground truth establishment and expert adjudication for a new AI-based device, is not present in this document.

Instead, the document states:

"Summary of Studies: Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."

This indicates that extensive new clinical performance studies to establish specific acceptance criteria for a novel device, as might be done for an AI algorithm, were not conducted or deemed necessary for this 510(k) clearance due to direct comparison and equivalence to existing, already cleared devices.

However, I can extract information related to the device and its comparison to predicates.

Here's a breakdown of what can be inferred or is directly stated, with explicit mention of what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable thresholds for a novel device's performance. The "acceptance criteria" here is met by demonstrating substantial equivalence to predicate devices.
Reported Device Performance: The primary "performance" reported is its equivalence to the predicate in "image quality and diagnostic capabilities." No specific metrics (e.g., sensitivity, specificity, AUC) are provided.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable/Not provided. No separate "test set" from a performance study is mentioned because the submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable/Not provided. Ground truth establishment for a test set is not mentioned as part of this equivalence submission.

4. Adjudication Method for the Test Set:

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This is not an AI device, and no MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This is an imaging system, not an AI algorithm.

7. The Type of Ground Truth Used:

Not applicable/Not provided. For substantial equivalence, the "ground truth" is that the predicate device is safe and effective.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This is an imaging system, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided.

Summary based on the provided document:

The GE Innova 3100 Digital Fluoroscopic Imaging System sought 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices:

Innova 4100 (K023178) for the overall system and image quality/diagnostic capabilities.
Innova 2000/Innova 2000S (K022322) for the SuperFast Gantry (InnovaTrace) with capacitive sensor feature.

The rationale provided for not needing new clinical performance studies (which would typically define acceptance criteria and collect performance data) is: "Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."

The acceptance criteria are therefore implicitly met by:

The device being designed for the same intended use (fluoroscopic images for vascular/rotational angiography, replacing image intensifier technology).
The device having similar technological characteristics (amorphous silicon detector with cesium iodide scintillator).
The manufacturer's conclusion that the system provides fluoroscopic images "equivalent to the diagnostic capabilities of the predicate images."
Control of potential hazards through a risk management process, including hazard identification, risk evaluation, and a Software Development and Validation Process.

The FDA's clearance letter confirms their review and determination that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The circle has a textured or patterned border, giving it a slightly vintage or classic appearance. The logo is presented in black and white, with the letters and border appearing in black against a white background.

GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

Ko31637

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 Manager GE Medical Systems Tel. 344-3894 Summary prepared: May 2, 2003

(dentification) a varies (1) and 1970) a minute and service the comment of the comments of

Classification Name:	Solid State X-ray Imaging System
Manufacturer:	GE Medical Systems Europe283, rue de la Minière78530 Buc Cedex, France
Distributed by:	GE Medical Systems, Milwaukee, WI

The Innova 3100 is substantially equivalent to the currently Marketed Devices: marketed Vascular Angiographic system Innova 4100 (K023178) and complies with the same or equivalent standards. The SuperFast Gantry (InnovaTrace) with the capacitive sensor feature in the Innova 3100 system is substantially equivalent to the Innova 2000/Innova 2000S systems (K022322) for this feature.

The Innova 3100 is designed to perform fluoroscopic x-ray Device Description: 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. The Innova 3100 consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector.
The SuperFast Gantry (InnovaTrace) includes capacitive sensor technology and optimized collision avoidance software that permits an increase of pivot and C-arm speed of up to 20°/sec.

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Kv3162.7

All construction and materials are compliant with UL 2601. Materials:

KO3!637
poyi20f2

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

The Innova 3100 system is indicated for use in generating Indications for Use: fluoroscopic images of human anatomy for vascular optionally, rotational angiography angiography, and procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology.

Comparison with The system is substantially equivalent to the Vascular predicate Angiographic System Innova 4100 system cleared under K023178. The optional SuperFast Gantry (InnovaTrace) with capacitive sensor feature in the Innova 3100 system is substantially equivalent to the Innova 2000/Innova 2000S systems cleared under K022322 for this feature.

Summary of Studies: Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities.
Conclusions: GE considers the system to be equivalent with the predicate devices. The system provides fluoroscopic images that are equivalent to the diagnostic capabilities of the predicate images. The potential hazards, e.g., wrong device measurements, misdiagnosis and increased gantry speeds are controlled by a risk management process 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 of the Department of Health & Human Services. The logo consists of a stylized human figure in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue. The logo is simple and clean, and it is easily recognizable.

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 Systems P.O. Box 414. W-400 MILWAUKEE WI 53201

JUL 30 2012

Re: K031637

Trade/Device Name: Innova 3100 Digital Fluoroscopic Imaging Systems Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: May 23, 2003 Received: May 28, 2003

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of August 22, 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

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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 (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): K131637

Device Name: Digital Fluoroscopic Imaging System - Innova 3100

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
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(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K031637

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.