INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ

K052157 · Ge Medical Systems, LLC · JAK · Aug 25, 2005 · Radiology

Device Facts

• Record ID: K052157
• Device Name: INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
• Applicant: Ge Medical Systems, LLC
• Product Code: JAK · Radiology
• Decision Date: Aug 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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 Story

Innova CT is a software option for GE Digital Fluoroscopic Imaging Systems (Innova 4100/3100/2100 series). It takes rotational fluoroscopy acquisition data as input; reconstructs 3D volumes of bone, soft tissue, and internal structures. Used in clinical settings (OR/interventional suites) by physicians to assist in diagnosis, surgical planning, interventional procedures, and treatment follow-up. Output is 3D volumetric images viewed by clinicians to guide clinical decision-making and procedural navigation. System hardware includes monoplane positioner, vascular/cardiac table, X-ray source, and amorphous silicon/cesium iodine digital detector.

Clinical Evidence

Sample clinical data included in submission. Bench testing performed via FMEA risk management process. No specific sensitivity/specificity metrics provided.

Technological Characteristics

Amorphous silicon detector with cesium iodine scintillator. Energy source: 480 VAC 50/60Hz. Compliance: UL 187, IEC 60601-1, UL 2601. Software-based 3D reconstruction from rotational fluoroscopy.

Indications for Use

Indicated for patients requiring fluoroscopic imaging for vascular, cardiac, diagnostic, and interventional procedures. Includes rotational imaging for 3D volume reconstruction of bone, soft tissue, and internal structures. Not for mammography.

Regulatory Classification

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.

Predicate Devices

• DynaCT option of Siemens Vascular Angiographic system (K042646)

Submission Summary (Full Text)

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AUG 25 2005

Koszis7

GE Healthcare

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

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### 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).

| <b>Identification of Submitter:</b> | Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>GE Healthcare<br>Tel. [phone]<br>Summary prepared: July 22, 2005 |
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| <b>Identification of Product:</b> | Digital Fluoroscopic Imaging System |
| <b>Device Trade Name:</b> | Innova CT option for Digital Fluoroscopic Imaging Systems<br>Innova 4100, Innova 4100 ^IQ , Innova 3100, Innova 3100 ^IQ , Innova 2100 ^IQ |
| <b>Classification Name:</b> | Fluoroscopic X-ray System |
| <b>Manufacturer:</b> | GE Medical Systems SCS.<br>283, rue de la Minière<br>78530 Buc Cedex, France |
| <b>Distributed by:</b> | GE Medical Systems, LLC, Milwaukee, WI |
| <b>Marketed Devices:</b> | The GE Healthcare Innova CT option is substantially equivalent<br>to the currently marketed DynaCT option of Siemens Vascular<br>Angiographic system (K042646). The Innova CT is intended for<br>use with Innova 4100 (renamed Innova 4100 ^IQ and previously<br>cleared under K033244), Innova 3100 (renamed Innova 3100 ^IQ<br>and previously cleared under K031637), and Innova 2100 ^IQ (or<br>2100-IQ previously cleared under K050489). This opinion is<br>based on the information included in this premarket notification. |
| <b>Device Description:</b> | The Innova CT imaging is offered as an option for Innova 4100<br>Innova 3100, Innova 2100 ^IQ (2100-IQ), 4100 ^IQ and Innova 3100 ^IQ .<br>The Digital Fluoroscopic Imaging Systems are designed to<br>perform fluoroscopic x-ray examinations. The detector is<br>comprised of amorphous silicon with a cesium iodine scintillator.<br>The resulting digital image can be sent through a Fiber Channel<br>link to an acquisition system then to network (in using DICOM) |
| Innova CT_SumSE revA.doc<br>1/3 | |

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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.

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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 [phone] or [phone] 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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