UROVANTAGE

K053279 · Pck Electronic Industry & Trade Co., Ltd. · OWB · Dec 22, 2005 · Radiology

Device Facts

• Record ID: K053279
• Device Name: UROVANTAGE
• Applicant: Pck Electronic Industry & Trade Co., Ltd.
• Product Code: OWB · Radiology
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical publications may include but are not limited to urologic and endoscopic procedures. applications may be used for other imaging applications at physician's discretion

Device Story

UroVantage is an image-intensified fluoroscopic X-ray system and radiological table. It consists of a tilting patient support table, X-ray generator, X-ray tube assembly, collimator, image intensifier, and TV system with monitor. The device features an isocentric C-arm that allows for controlled movement of the X-ray tube and image intensifier around the patient. Operated by clinicians in clinical settings, the system provides real-time fluoroscopic and radiographic images to assist in diagnostic, surgical, and interventional procedures. The output is displayed on a monitor for the physician to visualize internal anatomy, facilitating clinical decision-making during procedures. It is a modification of the UROlogic device, incorporating an isocentric C-arm and updated software to support the new imaging geometry.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to the predicate device.

Technological Characteristics

Image-intensified fluoroscopic X-ray system. Components: tilting patient support table, X-ray generator, X-ray tube assembly, collimator, image intensifier, TV system, and monitor. Features an isocentric C-arm for imaging geometry. Software updated to accommodate C-arm movement. System is an over-table X-ray tube assembly design.

Indications for Use

Indicated for patients requiring fluoroscopic and radiographic imaging during diagnostic, surgical, and interventional procedures, including urologic and endoscopic applications.

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

• UROlogic (K011311)

Submission Summary (Full Text)

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# K053279

## DEC 2 2 2005

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness is being submitted in accordance rins summary or enters of SMDA 1990 and 21 CFR 807.92.

#### Applicant 1.

PCK Electronic Industry and Trade Company, LTD, Inc. PCK Electrome Industry and Prade Seland.
1 Organize Sanayi Bolgesi Orhan Isik Cad. No: 4 Sincan 06935 Ankara TURKEY

Phone: [phone] Fax: [phone] Contact Person: Cengiz Kabakci, General Manager

### Device Identification 2.

| Proprieatary Device Name: | UroVantage |
|-----------------------------|-------------------------------------------------------------------|
| Common/Generic Device Name: | Urological Table |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System<br>Radiological Table |
| Product Code: | JAA, IXR |
| Regulatory Class: | Class II, Class II 510(k) Exempt |
| Regulation Number: | 21 CFR § 892.1650, 21 CFR § 892.1980 |

#### Substantial Equivalence 3.

The UroVantage Urological Table is substantially equivalent to the following currently marketed device:

- o UROlogic, (K011311), PCK Electronic Industry and Trade Company, LTD
### Description of Device 4.

The UroVantage is an Image-Intensified Fluoroscopic X-Ray System and radiological table. The device consists of: a tilting patient support table; x-ray radinogical adolo: "The ol panel; remote control panel, x-ray tube assembly, collimator, image intensifier, television ("TV") system with monitor; tableside continator, mage mosticol, control. The Isocentric C-arm of the UroVantage ensures easy control and issues intensifier and x-ray tube around the patient. The device s movement of x-ray stand with a tilting table also provides support for both the thou modition is as a m. Standard and optional accessories also are supplied.

The UroVantage is a modification to PCK's UROlogic device that has already been The Orovide fluoroscopic and radiographic imaging of the patient

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during diagnostic, surgical and interventional procedures (K011311). The during diagnootic, barger intended use and fundamental scientific technology as the Orovantage nas the battle interations are: (1) replacement of the fixed imaging arm ("U" arm) with an Isocentric C-Arm; (2) the fixation of the Isocentric C-arm to the support table; (3) minor changes in the dimensions of the support table; and (4) changes in the software to accommodate the use of the Isocentric C-arm.

### Intended Use 5.

The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical publications may include but are not limited to urologic and endoscopic procedures. applications may be used for other imaging applications at physician's discretion

### Technological Characteristics 6.

UroVantage Urological Table employs the samc technological characteristics as the UROlogic. The UroVantage has the same intended use and indications for use as the UROlogic. Both systems are image intensified x-ray imaging systems with an overtable x-ray tube assembly. Like the UROlogic, the UroVantage consists of a over and suport table, and standard system components: x-ray generator, x-ray tube, Image Intensifier, TV system and monitor(s).

#### 7. Conclusion

The UroVantage has the same intended use and indications for use as the predicate I the Oro rantage also has very similar technological characteristics, and principles of operation as its predicate. Although there are minor differences between the UroVantage and UROlogic, those differences do not raise any new questions of safety or efficacy. Thus, the UroVantage is substantially equivalent to the UROlogic product.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the USA. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 23 2013

PCK Electronic Industry and Trade Co., Ltd % Mr. Jonathan S. Kahn, Esq. Hogan & Hartson, L.L.P. 555 13th Street, NW WASHINGTON DC 20004

Re: K053279

Trade/Device Name: UROVantage (Urology x-ray table) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: November 23, 2005 Received: November 30, 2005

Dear Mr. Kahn:

This letter corrects our substantially equivalent letter of December 22. 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 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 Statement

510(k) Number (if known):

Device Name: UROVANTAGE

・・

Indications for Use: The UroVantage is intended to provide fluoroscopic and Indications for Use: The Oro valient during diagnostic, surpical and interventional
radiographic imaging of the patient during and Imited to Urologic and radiographic imaging of the patient duing and limited to Urologic and procedures. Clinical applications may merade but are marring applications at physician's discretion

YESV Prescription Use _ (Per 21 C.F.R. 801.109)

ANDIOR

Over-The-Counter Use_NO (Per 21 C.F.R. 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leyon

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number .

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