INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ

K052412 · GE Healthcare · OWB · Sep 16, 2005 · Radiology

Device Facts

Record IDK052412
Device NameINNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
ApplicantGE Healthcare
Product CodeOWB · Radiology
Decision DateSep 16, 2005
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1650
Device ClassClass 2
Attributes3rd-Party Reviewed

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 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.

Device Story

Digital Fluoroscopic Imaging System (Innova 4100, 4100IQ, 3100, 3100IQ, 2100IQ) utilizes amorphous silicon detector with cesium iodine scintillator to capture X-ray signals. System includes monoplane positioner, vascular/cardiac table, X-ray source, and digital detector. Data transmitted via Fiber Channel to acquisition system and network (DICOM) for processing, viewing, and archiving. Innova 3D software option reconstructs 3D volumes from rotational fluoroscopy acquisitions to assist physicians in diagnosis, surgical planning, and treatment follow-up. InnovaSpin software option enables fast-spin rotational angiography. Used in clinical settings by physicians for interventional and diagnostic procedures. Replaces traditional image intensifier technology; provides digital images to support clinical decision-making and improve diagnostic/interventional accuracy.

Clinical Evidence

No new clinical data provided. Substantial equivalence relies on clinical data previously submitted for predicate devices: Advantage 3D XR (K954355) for Innova 3D, and LCV+ Version 2 (K993037) for InnovaSpin. Devices are considered equivalent in image quality and diagnostic capabilities.

Technological Characteristics

Digital fluoroscopic system; amorphous silicon detector with cesium iodine scintillator. Power: 480 VAC 50/60Hz. Connectivity: Fiber Channel link, DICOM network. Compliance: UL 187, UL 2601, IEC 60601-1. Software options: Innova 3D (3D volume reconstruction), InnovaSpin (rotational angiography).

Indications for Use

Indicated for human patients requiring vascular, cardiac, diagnostic, and interventional angiography procedures. Supports rotational imaging. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K0524/2 SEP 1 6 2005 Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate corporation. P.O. Box 414, W-400 GE Healthcare Milwaukee, WI 53201 USA ## 1. 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.<br>Senior Regulatory Programs Manager<br>GE Healthcare<br>Tel. (262) 544-3894<br>Summary prepared: July 11, 2005 | |----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Identification of Product:<br>Classification Name:<br>Manufacturer:<br>Distributed by: | Digital Fluoroscopic Imaging System<br>Fluoroscopic X-ray System<br>GE Medical Systems SCS.<br>283, rue de la Minière<br>78530 Buc Cedex, France<br>GE Medical Systems, LLC, Milwaukee, WI | | Marketed Devices: | The GE Healthcare Innova 3D option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715). | | | The GE Healthcare InnovaSpin option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ devices is substantially equivalent to the currently marketed InnovaSpin option of the Vascular Angiographic system Innova 2100IQ (2100-IQ) (K050489). | | | The GE Healthcare Innova 4100IQ and Innova 3100IQ devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. | | | This opinion is based on the information contained in the comparison table and the product data sheets. | | Device Description: | The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under | {1}------------------------------------------------ K031637), Innova 2100''' (2100-IQ) aiready cleared under K050489), Innova 4100''' and Innova 3100'''. The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9. The Digital Fluoroscopic Imaging Systems Innova 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 an a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector. - Materials: All construction and materials are compliant with UL 187 and IEC 60601-1 for the existing parts of the product and with UL 2601 and IEC 60601-1 for the new parts. - Design: The design is validated through Failures Modes Effects Analysis (FMEA) process, which allows managing the risks. - Energy Source: 480 VAC 50/60Hz. Indications for Use: For Innova 4100, Innova 410019, Innova 3100, Innova 310019, Innova 2100'9 with Innova 3D or InnovaSpin 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 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. 2/4 {2}------------------------------------------------ Comparison with The GE Healthcare Innova 3D option for Innova 4100, Innova 410010, Innova 3100, Innova 310010, Innova 210019 devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715). The GE Healthcare InnovaSpin option for Innova 4100, Innova 41000, Innova 3100, Innova 31000 devices is substantially equivalent to the currently marketed InnovaSpin option of the (K050489). The GE Healthcare Innova 4100'0 and Innova 3100'0 devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. The indications of use for the predicative devices are given below: - Advantage 3D XR indications for use: The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuroangiographic cases. - Innova 21000 (2100-IQ) Indications for Use: The Innova 21000 (2100-1Q) 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. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. - Innova 3100 indications for use: 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 to mammography applications. - Innova 4100 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. {3}------------------------------------------------ This opinion is based on the information contained in the comparison table and the product data sheets. Summary of the Studies: For the Innova 3D option: Clinical data have been submitted been submitted in the Advantage 3D XR 510K (K954355). For the InnovaSpin option: Clinical data have been submitted in the LCV+ Version 2 system 510K (K993037), which indications for use is cardiac angiography. Innova 2000 "Fast Spin Rotational Angiography" option has been submitted in 2002, cleared under K022322, without clinical data based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037). Innova 4100, Innova 41000, Innova 3100, Innova 310000 and Innova 2100'0 with InnovaSpin and Innova 3D options are considered substantially equivalent to the predicates in terms of image quality and diagnostic capabilities. Therefore, previously submitted clinical data are applicable for this submission. ## Conclusions: GE Healthcare considers that the Innova 3D and Innova Spin options for Digital Fluoroscopic Imaging Systems Innova 4100, Innova 41000, Innova 3100, Innova 31000 and Innova 21000 to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova 3D and InnovaSpin options are controlled by a risk management plan including: - . A hazard identification - A risk evaluation . - A Software Development and Validation Process . {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service JUL 30 2012 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 GE Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719 ## Re: K052412 Trade/Device Name: Digital Fluoroscopic Imaging Systems-Innova 4100, Innova 41000 Innova 3100. Innova 310010. Innova 210010 with optional Innova 3D or optional InnovaSpin Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 31, 2005 Received: September 2, 2005 Dear Mr. Lehtonen: This letter corrects our substantially equivalent letter of September 16, 2005. 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ ## Indications for Use 2. 510(k) Number (if known): Device Name: K.052412 Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 41000, Innova 3100, Innova 310010, Innova 210019 with optional Innova 3D or optional InnovaSpin. Indications for 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 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. Over-The-Counter-Use AND/OR Prescription Use x (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Broadm (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K052417 Posted 13 Nov 2003
Innolitics
510(k) Summary
Decision Summary
Classification Order
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