The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging 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. Those devices are not intended for mammography applications.

Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.

Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.

Innova CT is not intended for mammography applications

Device Description

The Innova CT imaging is offered as an option for Innova 4100 Innova 3100, Innova 2100 IQ (2100-IQ), 4100 IQ and Innova 3100 IQ. The Digital Fluoroscopic Imaging Systems are designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.

AI/ML Overview

The provided text is a 510(k) summary for the GE Healthcare Innova CT option. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on specific acceptance criteria and performance metrics for the Innova CT option itself. Therefore, many of the requested details about acceptance criteria and study design are not explicitly present in the document.

However, based on the information provided, here's what can be extracted and what remains unknown:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device (Siemens DynaCT) based on similar indications for use, design, materials, and energy sources. It does not list quantitative acceptance criteria or performance metrics for the Innova CT option.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: "Sample clinical data for the Innova CT option are included in this submission." The exact sample size is not specified.
Data provenance: The country of origin and whether the data is retrospective or prospective are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document mentions "Sample clinical data" but does not describe the process of establishing ground truth or the involvement of experts for this data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on substantial equivalence to an existing device, not on comparing human reader performance with and without AI assistance. The Innova CT is described as a software option that reconstructs 3D volumes, not an AI for interpretation.

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

The Innova CT is described as a "software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up." This implies it's an algorithm-only function (reconstruction of 3D volumes), designed to provide images for physician use, rather than an AI for diagnostic interpretation that would typically have a "human-in-the-loop" performance study. Therefore, in the context of its function, its performance would inherently be "standalone" for its image reconstruction task. However, a formal "standalone performance study" with specific metrics for image quality or diagnostic accuracy based on the reconstructed images is not detailed in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated. The document mentions "Sample clinical data," but the method for establishing the ground truth for this data is not described.

8. The sample size for the training set

The document does not mention a training set. As this is a 510(k) submission for a device that reconstructs 3D volumes from fluoroscopic acquisitions, it may not involve machine learning in the conventional sense that requires a "training set" for model development. The design validation mentions "Failures Modes Effects Analysis (FMEA) process," which is a risk management tool, not a method for training a machine learning algorithm.

9. How the ground truth for the training set was established

Since a training set is not mentioned, this information is not available.

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 and enclosed within a circle. The logo is in black and white.

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: 上一篇:

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AUG 25 2005

Koszis7

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: July 22, 2005
Identification of Product:	Digital Fluoroscopic Imaging System
Device Trade Name:	Innova CT option for Digital Fluoroscopic Imaging SystemsInnova 4100, Innova 4100 IQ , Innova 3100, Innova 3100 IQ , Innova 2100 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 GE Healthcare Innova CT option is substantially equivalentto the currently marketed DynaCT option of Siemens VascularAngiographic system (K042646). The Innova CT is intended foruse with Innova 4100 (renamed Innova 4100 IQ and previouslycleared under K033244), Innova 3100 (renamed Innova 3100 IQand previously cleared under K031637), and Innova 2100 IQ (or2100-IQ previously cleared under K050489). This opinion isbased on the information included in this premarket notification.
Device Description:	The Innova CT imaging is offered as an option for Innova 4100Innova 3100, Innova 2100 IQ (2100-IQ), 4100 IQ and Innova 3100 IQ .The Digital Fluoroscopic Imaging Systems are designed toperform fluoroscopic x-ray examinations. The detector iscomprised of amorphous silicon with a cesium iodine scintillator.The resulting digital image can be sent through a Fiber Channellink to an acquisition system then to network (in using DICOM)
Innova CT_SumSE revA.doc1/3

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and the was and the states

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for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.

All construction and materials are compliant with UL 187 and IEC Materials: 60601-1 for the existing parts of the product and with UL 2601 and IEC 60601-1 for the new parts.

The design is validated through Failures Modes Effects Analysis Design: (FMEA) process, which allows managing the risks.

Energy Source: 480 VAC 50/60Hz.

Indications for Use: For Innova 4100, Innova 410019, Innova 3100, Innova 310010, Innova 2100'0 with Innova 3T option:

The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging 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. Those devices are not intended for mammography applications.

Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.

Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.

Innova CT is not intended for mammography applications

Comparison with

The GE Healthcare option Innova CT is substantially equivalent to the currently marketed option DynaCT of Siemens Vascular Angiographic system cleared under K042646 .

Dyna CT indications for use: DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic Carm device into a three-dimensional image format.

Innova CT_SumSE revA.doc 2/3

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DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

This opinion is based on the information contained in the comparison table and the product data sheets.

Summary of the Studies:

Sample clinical data for the Innova CT option are included in this submission.

Conclusions:

GE Healthcare considers that the Innova CT option for Digital Fluoroscopic Imaging Systems Innova 2100, Innova 4100, Innova 4100",
Innova 3100, Innova 3100 " and Innova 2100 " to be equivalent with the DynaCT option The potential hazards, related to the use of Innova CT option are controlled by a risk management plan including:

A hazard identification .
A risk evaluation ●
A Software Development and Validation Process

Innova CT_SumSE revA.doc ર્સ્ડ

2017 2017

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.

AUG 25 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Healthcare P.O. Box 414, W-400 MILWAUKEE WI 53201

Re: K052157

Trade/Device Name: Innova CT option for Digital Fluoroscopic Imaging Systems, Innova 4100, Innova 410010, Innova 3100, Innova 3100 10, Innova 210010 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II

Product Code: IZI, JAA, and LLZ Dated: August 5, 2005 Received: August 8, 2005

Dear Mr. Kroger:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maning of substantial equivalence of your device to a legally prematication: "The PDF maing or our device and thus, permits 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 Part 801), please If you desire specific access your of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other	1	240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.77). I ou may ovain one generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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C. Indications for Use

510(k) Number (if known): x 052157

Device Name: Innova CT option for Digital Fluoroscopic Imaging Systems Innova 4100, Innova 410010, Innova 3100, Innova 310019, Innova 210010

Indications for Use:

Indications for USe.
The Innova systems are indicated for use in generating fluoroscopic images of The Innova systems are indicated for doo in genostic and interventional procedures, human analorny for vascular anglography, diagnosticated for generating and optionally, fotational maging procedures. They ar disgnostic, and interventional
fluoroscopic images of human anatomy for cardiology, diagnos abtained through fluoroscopic Infages of numan anatonly for sarensisy).
procedures. They are intended to replace fluoroscopic images obtained through procedures: They are intended is topice is not intended for mammography applications.
applications.
Innova CT is a software option which reconstructs 3D volumes from in diagnosi ପ innova CT IS a soltware option which roosnet assist the physician in diagnosis,
Fluoroscopy acquisition to provide images that assist the physician wa Fluoroscopy acquisition to procedures and treatment follow-up.
surgical planning, interventional procession in the many as well as other internal ロ body structures.
body Structures:
Innova CT is not intended for mammography applications ם

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyl
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052157

AttC_Indications_for_use_revA.doc

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Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.