The Innova 31310 (3131-IQ) and 21219 (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotation: h angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.

They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

Device Description

The Digital Fluoroscopic Imaging Systems are designed to perform biplane fluoroscopic x-ray examinations. The detectors are comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital images can be sent through a Fiber Channel link to an acquisition system then to network (using DICOM) for applications such as post-processing, printing, viewing and archiving. The Digital Fluoroscopic Imaging System consists of a biplane positioner, a vascular table, an X-ray system, two X-ray generators/sources and two digital detectors.

AI/ML Overview

The provided text describes a 510(k) summary for the GE Healthcare Innova 3131-IQ and Innova 2121-IQ Digital Fluoroscopic Imaging Systems. However, it explicitly states that clinical data was not necessary for these devices due to their substantial equivalence to previously cleared devices in terms of image quality and diagnostic capabilities. Therefore, a study proving device performance against acceptance criteria in the typical sense (e.g., measuring accuracy, sensitivity, specificity) was not performed or provided in this submission.

The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone performance study with acceptance criteria.

Here's a breakdown of the requested information based on the provided text, noting where information is explicitly stated as not applicable or not provided:

Acceptance Criteria and Device Performance Study

As stated in the document: "As Innova 31310 and 21210 are considered by Innova 4100 and LCV+ Version 2 in terms of image quality and diagnostic capabilities, reference to clinical data is not necessary (see attachment F for detailed justifications)". This means a specific performance study with acceptance criteria for the Innova 3131-IQ and 2121-IQ was not provided in this 510(k) submission.

Therefore, the table below will reflect this. The "Reported Device Performance" column cannot be filled with direct performance metrics from a study on these specific devices.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category (Implied)	Specific Acceptance Criteria (Not Explicitly Stated for this Device)	Reported Device Performance (Not Directly Measured for this Device)
Image Quality / Diagnostic Capability	Assumed to be equivalent to predicate devices (Innova 4100 and LCV+ Version 2)	Stated as "equivalent" (by GE) to predicate devices
Safety and Compliance	Compliance with UL 60601, IEC 60601-1, and risk management plan (hazard identification, risk evaluation, software development, and validation)	All construction and materials are compliant with UL 60601 and with IEC 60601-1; software development and validation process in place.
Intended Use	Ability to generate fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and cardiology procedures. Intended to replace image intensifier technology.	Indicated for vascular angiography, diagnostic and interventional procedures, cardiology procedures, and optionally rotational angiography. Intended to replace fluoroscopic images obtained through image intensifier technology.
Material/Design	Redundancies to prevent single point failures; compliant materials.	Hardware and software redundancies to prevent single point failures. Compliant materials.

Note: The acceptance criteria listed are inferred from the claims of substantial equivalence and safety standards mentioned. Specific quantitative performance metrics (e.g., sensitivity, specificity, resolution) for the Innova 3131-IQ and 2121-IQ were not provided as part of a standalone study in this document.

Specific Study Information:

Sample size used for the test set and the data provenance:
- Not applicable / Not provided. No specific test set or clinical study data was presented for these devices as substantial equivalence was claimed based on predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No specific test set requiring ground truth establishment was presented.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No specific test set requiring adjudication was presented.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not provided. This device is a fluoroscopic imaging system, not an AI-assisted diagnostic tool for readers. No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device itself is a standalone imaging system. However, the performance evaluation was not a standalone test against specific clinical metrics but rather a claim of equivalence to existing devices. The document states: "As Innova 31310 and 21210 are considered by Innova 4100 and LCV+ Version 2 in terms of image quality and diagnostic capabilities, reference to clinical data is not necessary". This implies that the performance is assumed to be equivalent to the standalone performance of the predicate devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. No direct ground truth was established for a new study on these devices. The "ground truth" for proving effectiveness relies on the established performance and safety of the predicate devices.
The sample size for the training set:
- Not applicable / Not provided. This is an imaging hardware system, not an AI/algorithm-based diagnostic requiring a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable / Not provided. As above, this is not an AI/algorithm-based diagnostic device requiring a training set with ground truth.

Summary

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

060259

Image /page/0/Picture/1 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 are stylized and connected, creating a distinctive and recognizable emblem for the company.

FEB 2 2 2006

GE Healthcare

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

Executive Summary

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 HealthcareTel. (262) 544-3894Summary prepared: 20 January 2006
Identification of Product:	Innova 3131-IQ and Innova 2121-IQ
Classification Name:	Fluoroscopic X-ray System
Manufacturer:	GE Medical Systems SCS.283, rue de la Minière78530 Buc Cedex, France
Distributed by:	GE Medical Systems, LLC, Milwaukee, WI
Marketed Devices:	The Innova 3131 IQ (3131-IQ) and 2121 IQ (2121-IQ) aresubstantially equivalent respectively to the currently marketedVascular Angiographic systems Innova 3100 IQ (K052412) andInnova 2100 IQ (K050489) and comply with the same orequivalent standards.Biplane feature is substantially equivalent respectively to theAdvantx LCN+ and Advantx LC/LP+ (both cleared underK974367).Tilt table Elegance option is substantially equivalent to the DigitalFluoroscopic Imaging System, Model Innova K033244.
Device Description:	The Digital Fluoroscopic Imaging Systems are designed toperform biplane fluoroscopic x-ray examinations. The detectorsare comprised of amorphous silicon with a cesium iodinescintillator. The resulting digital images can be sent through aFiber Channel link to an acquisition system then to network

AttA_SamSF rev_Ldog

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

(using DICOM) for applications such as post-processing, printing, viewing and archiving. The Digital Fluoroscopic Imaging System consists of a biplane positioner, a vascular table, an X-ray system, two X-ray generators/sources and two digital detectors.

Materials: All construction and materials are compliant with UL 60601 and with IEC 60601-1.

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 313119 (3131-IQ) and 21210 (2121-IQ) biplane Indications for Use: systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.

They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

Comparison with Predicates:

The Innova 31310 (3131-IQ) and 2121-IQ) and 2121-IQ) are substantially equivalent respectively to the currently marketed Vascular Angiographic systems Innova 3100'0 (K052412) and Innova 21000 (K050489) and comply with the same or equivalent standards.

Biplane feature is substantially equivalent respectively to the Advantx LCN+ and Advantx LC/LP+ (both cleared under K974367).

Tilt table Elegance option is substantially equivalent to the Digital Fluoroscopic Imaging System, Model Innova (K033244).

Innova 31310 combines features from Innova 31000 with the biplane positioning system of Advantx LCN+ to enable single plane and biplane cardiac and vascular procedures.

Innova 21210 combines features from Innova 210019 with the biplane positioning system of Advantx LCN+ and Adx to enable single plane and biplane cardiac and vascular procedures.

The indications of use for the predicative devices are given below:

ARA SemStrey I doc

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

The Innova 3100'0 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. It is not intended for mammography applications.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational . angiography. It is not intended for mammography applications.
The Innova 2100'0 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures.

-The Advantx LCN+ is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography and interventional single plane and biplane procedures.

The Advantx LC/LP+ is indicated for use in generating fluoroscopic images of human anatomy for cardiology diagnostic/interventional single plane and biplane procedures.

Figure 1 summarizes the equivalence of Innova 313119 and 21210 (2121-IQ) systems with the various predicates.

Summary of the Studies: References in term of clinical data have been submitted for first digital products in the family introduced by GE Medical Systems-SCS, i.e., LCV+ Version 2 for cardiology diagnostic and interventional procedures, and Innova 4100 for vascular angiography diagnostic and interventional procedures. As Innova 31310 and 21210 are considered by Innova 4100 and LCV+ Version 2 in terms of image quality and diagnostic capabilities, reference to clinical data is not necessary (see attachment F for detailed justifications)

GE considers the 30cm and 20 cm Digital Biplane Fluoroscopic Conclusions: Imaging Systems to be equivalent with the predicate devices. The potential hazards. e.g. wrong measurements and

AUA SumSt rev I doc

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

misdiagnosis, are controlled by a risk management plan including:

A hazard identification (Attachment D) .
A risk evaluation (Attachment D) o

Software Development and A Validation Process . (Attachment F)
AUA_SumSEres 1.doc

ﺗﻬ

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted in blue and consists of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

JUL 30 2012

16 23712

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K060259

Trade/Device Name: Digital Fluoroscopic Imaging Systems-Innova 31311 & Innova 212110 1 2012 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: January 31, 2006 Received: February 1, 2006

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of February 22, 2006.

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. Iisting 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

{5}------------------------------------------------

Page 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 (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

{6}------------------------------------------------

STATEMENT OF INTENDED USE

K ORDERS 510(k) Number (if known):

Device Name: Digital Fluoroscopic Imaging Systems – Innova 313110 & Innova 212110

Indications for Use

They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are 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 hogdon

Division of Reproductive, Abdominal, and Radiological Devices 06025 510(k) Number

Anc 510k Indications for use Res Laloc

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.