UROVIEW 2800

K993687 · Ge Dec Medical Systems · OWB · Dec 21, 1999 · Radiology

Device Facts

• Record ID: K993687
• Device Name: UROVIEW 2800
• Applicant: Ge Dec Medical Systems
• Product Code: OWB · Radiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.

Device Story

UroView 2800 is a fluoroscopic X-ray system; comprises tilting patient-support table, overhead X-ray tube assembly, high-voltage generator, image intensifier, and video display. Separate mobile workstation provides digital image processing and storage. Used in hospitals/clinics by physicians, surgeons, radiologists, and technologists for diagnostic, surgical, and interventional procedures (e.g., urologic, endoscopic). System captures X-ray signals; processes and displays images for real-time visualization. Output assists clinicians in guiding procedures and diagnostic assessment; facilitates minimally invasive interventions. Requires operator training in medical X-ray equipment use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics, design specifications, and adherence to recognized safety and performance standards for diagnostic X-ray systems.

Technological Characteristics

Fluoroscopic X-ray system; includes tilting table, overhead tube, high-voltage generator, image intensifier, and digital workstation. Complies with 21 CFR 1020.30-32, UL 2601, CSA-C22.2 No. 601.1-M90, and IEC 60601 series (1, 1-2, 1-3, 1-4, 2-7, 2-28, 2-32, 2-46). Features digital image processing and storage. Programmable electrical medical system.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, and interventional procedures requiring fluoroscopic and spot-film imaging, including urologic and endoscopic applications. Intended for use by trained healthcare professionals (medical doctors, surgeons, radiologists, technologists) in hospital or clinical settings.

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

• OEC UroView 2600 (K940295)
• Liebel-Flarsheim Hydradjust IV (K943581)
• Liebel-Flarsheim HydraVision (K004145)

Submission Summary (Full Text)

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K993687

DEC 21 1999

Image /page/0/Picture/2 description: The image shows the logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" stacked on top of the words "OEC MEDICAL SYSTEMS, INC". The letters "OEC" are in a bold, sans-serif font, and the words "OEC MEDICAL SYSTEMS, INC" are in a smaller, serif font.

384 WRIGHT BROTHERS DRIVE SALT LAKE CITY, UTAH 84116 801 - 328 - 9 300 FAX [phone]

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| Date: | October 25, 1999 | |
|--------------------------|-------------------------------------------------------------------------------------------------------|-----------|
| Name of Submitter: | OEC Medical Systems, Inc.<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116<br>801-328-9300 | |
| Corresponding Official: | Ted L. Parrot, Vice President,<br>Quality Assurance & Regulatory Affairs | |
| Device Proprietary Name: | UroView 2800 | |
| Classification Name: | Image Intensified Fluoroscopic X-ray System | |
| Common/Usual Names: | Fluoroscopic Imaging System<br>Urology Table | |
| Substantial Equivalence: | The UroView 2800 is substantially equivalent to the following<br>devices that are currently marketed: | |
| | • OEC UroView 2600 | (K940295) |
| | • Liebel-Flarsheim Hydradjust IV | (K943581) |
| | • Liebel-Flarsheim HydraVision | (K004145) |

Device Description:

General Description

The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support table with overhead x-ray tube assembly, high-voltage x-ray generator, image intensifier, and video image display. A separate mobile workstation provides digital image processing, image storage capability, and additional video display.

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## Indications for Use

The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.

User Characteristics

The device is used by health care professionals such as medical doctors, surgeons, radiologists and technologists in a hospital or clinical environment. In addition to being qualified within their respective medical fields, users must be trained in the use of medical x-ray equipment. OEC applications specialists train the user in the proper use of this product. The device labeling stipulates that only properly trained persons operate this equipment.

## Standards:

The UroView 2800 is designed in accordance with product safety and performance requirements established in the following standards:

| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|-------------------------|------------------------------------------------------------------------|
| ANSI/NFPA 70 & 99 | National Electrical Code and Standard for Health Care Facilities |
| UL 2601 | Medical Electrical Equipment |
| CSA-C22.2 No. 601.1-M90 | Medical Electrical Equipment |
| IEC 60601-1 | Medical Electrical Equipment, General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment, Electromagnetic Compatibility |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical Systems |
| IEC 60601-2-7 | Medical Electrical Equipment, Safety of HV/X-ray Generators |
| IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tubes and X-ray Source Assemblies |
| IEC 60601-2-32 | Medical Electrical Equipment, Safety of Associated X-ray Equipment |
| IEC 60601-2-46 | Medical Electrical Equipment, Safety of Operating Tables |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |

This concludes this 510(k) Summary.

OEC, MEDICAL SYSTEMS, INC.

Hamo

Ted L. Parrot Vice President, Quality Assurance & Regulatory Affairs

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle or bird-like figure with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 1999

Ted L. Parrot Vice President, Quality Assurance/ Regulatory Affairs and Official Correspondent OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, Utah 84116

Re:

K993687 UroView 2800 Dated: October 25, 1999 Received: November 1, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 876.4890/Procode: 78 KQS

Dear Mr. Parrot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use Statement

OEC Medical Systems, Inc. Applicant:

510(k) No. (if known):

UroView 2800 Device name:

- The UroView 2800 is designed to provide fluoroscopic and spot-film Indications for use: imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ﮐﮯ (Per 21 CFR 801.109)

OR

Over-The-Counter

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number