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

Device Description

UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor. The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.

AI/ML Overview

This 510(k) submission pertains to the UROlogic Urological Table, an image-intensified fluoroscopic x-ray system. The document provided does not contain specific acceptance criteria, device performance data, details of a clinical study, or information about AI integration.

The submission focuses entirely on demonstrating substantial equivalence to predicate devices (OEC Uroview 2600 and Liebel-Flarsheim Hydradjust IV) based on technological characteristics and intended use. The FDA letter confirms this substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as these are not present in the provided text.

Based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the given 510(k) summary. The submission focuses on substantial equivalence based on the device's technical specifications and intended use, rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not provided. No clinical study data is presented in the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. No clinical study data is presented, and therefore no ground truth establishment for a test set is discussed.

4. Adjudication method for the test set:

This information is not provided. No clinical study data is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided. The device described is an X-ray table, and the submission makes no mention of AI or software for image interpretation, or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided. No AI algorithm is mentioned or evaluated.

7. The type of ground truth used:

This information is not provided. No clinical study data is presented requiring ground truth.

8. The sample size for the training set:

This information is not provided. No AI training is mentioned.

9. How the ground truth for the training set was established:

This information is not provided. No AI training is mentioned.

Summary

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510(k) Application

UROlogic

ÍJÚL 1 0 2001

Image /page/0/Picture/3 description: The image shows a logo with a geometric design on the left and the letters "PCK" on the right. The geometric design resembles a wheel or a stylized flower with six petals or sections. A horizontal line extends from the right side of the geometric design, underlining the letters "PCK". The letters are in a bold, sans-serif font and appear to be a part of the company's name or brand.

×011311

ELECTRONIC INDUSTRY AND TRADE CO, LTD

TURAN GUNES BUL KONRAD AD CAD 59/1 SANCAK, CANKAYA, 06550 ANKARA, TURKEY TEL:+90 312 491 6010 FAX:+90 312 491 601 1

30 APR 2001

510(k) Summary

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

Applicant

PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD TURAN GUNES BUL KONRAD AD CAD 59/1 SANCAK CANKAYA, 06550 ANKARA TURKEY

TEL:+90 312 491 6010 FAX:+90 312 491 6011

CONTACT PERSON: CENGİZ KABAKCI ASSISTANT GENERAL MANAGER

Device Identification

Proprieatary Device Name:	UROlogic Urological Table
Common/Generic Device Name:	Fluorocsopic Imaging System, Urological Table
Classification Name:	SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product Code:	90 JAA
Regulatory Class:	Class II
Regulation Number:	21 CFR 892.1650

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3. Substantial Equivalence

The UROlogic Urological Table is substantially equivalent to the following currently marketed devices:

OEC Uroview 2600 (K940295) ●
Liebel-Flarsheim Hydradjust IV (K943581) .

4. Description of Device

The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.

5. Intended Use

6. Technological Characteristics

URO!ogic Urological Table employs the same technological characteristicsas the predicate devices. This device is intended for the same applications as the currently marketed predicate devices. All systems are image intensified x-ray imaging systems with an overtable x-ray tube assembly. Like the predicate devices, UROlogic Urological Table consists of basic the basic patient suport table, and standard system components: x-ray generator, x-ray tube, Image Intensifier, TV system and monitor(s).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with a curved line representing the forehead, nose, and chin. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

Mr. Cengiz Kabakci Assistant General Manager PCK Electronic Industry and Trade Co, Ltd. Turan Gunes Bul Konrad AD CAD 59/1 Sancak CANKAYA 06550 ANKARA TURKEY

1 6 2012 N VA

Re: K011311

Trade/Device Name: IURO) Logic (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: April 30, 2001 Received: April 30, 2001

Dear Mr. Kabakci:

This letter corrects our substantially equivalent letter of July 10, 2001.

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 (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

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STATEMENT OF INDICATIONS FOR USE

Applicant:

PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD

TURAN GUNES BUL KONRAD ADENAUER CAD 59/1 SANCAK, CANKAYA O6550, ANKARA TURKIYE

510(k) NUMBER: K011311

UROlogic Urological Table DEVICE NAME:

INDICATIONS FOR USE:

UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures

Prescription Use

David A. Seigman

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

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.