LCV+ VERSION 2

K993037 · Ge Medical Systems, Inc. · OWB · Feb 14, 2000 · Radiology

Device Facts

• Record ID: K993037
• Device Name: LCV+ VERSION 2
• Applicant: Ge Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Feb 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human anatomy for cardiology diagnostic interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.

Device Story

LCV+ Version 2 is a solid-state X-ray imaging system for cardiology. Components include cardiac monoplane positioner, vascular table, X-ray system, and amorphous silicon detector with cesium iodide scintillator. Device captures fluoroscopic X-ray images, converting them to digital format. Data transmitted via fiber channel to acquisition equipment and networked via DICOM for post-processing, viewing, printing, and archiving. Used in clinical settings (hospitals) by trained medical professionals. Output provides real-time or recorded fluoroscopic sequences for diagnostic and interventional guidance, replacing traditional image intensifier technology. System includes hardware and software redundancies to prevent single-point failures during patient positioning.

Clinical Evidence

Clinical study involved 6 cardiologists from 2 hospitals comparing digital and image-intensifier recorded images from 31 patient pairs. Results indicated equivalent image capability and diagnostic performance for the digital system.

Technological Characteristics

Solid-state X-ray imaging system; amorphous silicon detector with cesium iodide scintillator; cardiac monoplane positioner; vascular table. Energy source: 360V-480V AC, 50/60Hz. Connectivity: Fiber channel link, DICOM network. Compliance: UL 187, UL 2601, IEC 601-1. Hardware/software redundancies for motion safety.

Indications for Use

Indicated for cardiology diagnostic and interventional procedures in humans requiring fluoroscopic imaging. Replaces traditional image intensifier technology.

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

• Advantx Cardiography System LC (K890348)
• DLX (K926258)
• DLX (K945459)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be handwritten. The background of the logo is solid black, while the letters are white.

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く993037

GE Medical System

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

## · 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<br>GE Medical Systems<br>Tel. [phone]<br>Summary prepared: 31 August, 1999 |
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| Identification of Product:<br>Classification Name:<br>Manufacturer: | LCV+ Version 2<br>Solid State X-ray Imaging System<br>GE Medical Systems S.A.-Europe<br>283, rue de la Minière<br>78530 Buc, France |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
| Marketed Devices: | The LCV+ Version 2 is substantially equivalent to the currently<br>marketed LC cardiographic system (K890348), which complies<br>with the same or equivalent standards and has the same<br>intended uses. The digital sub-system, called DL; is substantially<br>equivalent to the fluoroscopic digital equipment DLX (K926258<br>and K945459). |
| Device Description: | The LCV+ Version 2 is designed to perform fluoroscopic x-ray<br>examinations. The detector is comprised of amorphous silicon<br>with a cesium iodide scintillator. The resulting digital image can<br>be sent through a fiber channel link to an acquisition equipment<br>then to a network (using DICOM) for applications such as post-<br>processing, printing, viewing and archiving. LCV+ Version 2<br>consists of a cardiac monoplane positioner, a vascular table, an<br>X-RAY system and a digital detector. |
| Materials: | All construction and materials are compliant with UL 187 for the<br>existing components and with UL2601, IEC 601-1 and collateral<br>standards for the new components. |

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There are hardware and software redundancies to prevent single Design: point failures that could cause unintended motion.

Energy Source: 360V to 480V AC, 50/60Hz.

The LCV+ Version 2 is indicated for use in generating Indications for Use: for cardiology of human anatomy images fluoroscopic diagnostic/interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology: ·

It is the opinion of GE Medical Systems that the LCV+ Version 2 Comparison with is of comparable type and substantially equivalent to an Advantx Cardiography System LC (K890348). The LCV+ Version 2 presents no new safety concerns. This system will comply with the x-ray requirements of 21CFR as well as the safety requirements noted above.

Six (6) cardiologists from two (2) hospitals compared digital and Summary of Studies: image-intensifier recorded images from 31 pairs of patients, and found that the digital images had equivalent image capability.

Conclusions: GE considers the LCV+ Version 2 to be equivalent with the predicate device. The LCV+ Version 2 provides recorded fluoroscopic sequences that result in diagnostic capabilities equivalent to Image Intensifier images. The potential hazards. e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:

- · Hazard identification (Attachment 8)
- · Risk evaluation (Attachment 8)
- · Software Development and Validation Process (Attachment 7)
- · External validations of paired sets of Image Intensifier image and digital images by two research hospitals to assess the diagnostic equivalence of the digital images.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized image of a human face in profile, with three blue lines representing the face. To the right of the seal is the word "DEPARTMENT" in blue, sans-serif font.

#### Public Health Service

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

JUL 30 2012

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 MILWAUKEE WI 53201

Re: K993037

Trade/Device Name: LCV+ Version 2 System (SSXI Fluoro Device) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: December 21, 1999 Received: December 22, 1999

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of February 14, 2000.

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 [phone]. 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-[phone] or [phone] 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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#### INDICATIONS FOR USE

510(k) Number (if known): _____ 9930 37

Device Name: LCV+ Version 2 System

# Indications for Use

The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human analomy for cardiology diagnostic interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.

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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, ENT, and Radiological Devices x993037 510(k) Number.