The Siremobil C02 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil C02 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Description

The Siremobil C02 is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a trolley which consists of the image memory device, image monitor(s), and user interface. The Siremobil C02 is designed to meet the monitor(s), and user interface. The Siremobil Councilled onvironments identified below.

AI/ML Overview

This document is a 510(k) Summary for the Siemens Siremobil C02 Mobile X-ray System. It describes the device, its intended use, and technological characteristics. Crucially, it is a submission for regulatory clearance and focuses on establishing substantial equivalence to a predicate device, not on presenting a study to prove acceptance criteria through performance metrics. As such, the information you've requested about specific performance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not present in this type of document.

Here's an explanation of why the requested information isn't available in this document and how a 510(k) works:

510(k) Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or, if there are different technological characteristics, that these do not raise new questions of safety and effectiveness.
Performance Data in a 510(k): While a 510(k) may include performance data, it's typically to support the claim of substantial equivalence (e.g., showing that the new device performs at least as well as the predicate device in relevant aspects). It's not usually a comprehensive study designed to meet pre-defined acceptance criteria as one might see for a novel device or a PMA (Pre-Market Approval) study.
"Acceptance Criteria" for a 510(k): The "acceptance criteria" for a 510(k) are largely regulatory: satisfying the FDA that the device is safe and effective and substantially equivalent to a predicate device. It's not about quantitative performance metrics in the same way your request implies.

Given the nature of the provided document, I cannot fulfill your request for the specific details outlined (Table of acceptance criteria and performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC or standalone studies, training set details). The document simply doesn't contain that level of detail about a performance study.

The document does provide the following:

Device Name: Siremobil C02 (Mobile X-ray System)
Manufacturer: Siemens Medical Systems, Inc.
Intended Use: Mobile x-ray system for use in operating rooms, traumatology, endoscopy, intensive care, pediatrics, ambulatory patient care, and veterinary medicine. It supports various modes like Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping for procedures such as bile duct display, intra-medullary nail implant display, low dose fluoroscopy in pediatrics, pain therapy techniques, and catheter/probe positioning.
Technological Characteristics:
- Isocentric C-arm
- Expanded orbital angle of 190°
- Increased distance between X-ray tube and image intensifier (SID)
- Electromagnetic brakes (instead of manual)
- Concealed, integrated cable routing
- Optimized for use with other medical systems.

To reiterate, the requested information elements related to a study proving acceptance criteria are not present in this 510(k) summary.

Summary

{0}------------------------------------------------

Attachment O: 510(k) Summary

। 1

= 17

510(k) Summary

GENERAL INFORMATION: I. Establishment:

Address: .

NOV 10 1997

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Registration Number: .
Contact Person: ●

2240869

Kathleen Rutherford Manager, Regulatory Submissions Telephone: (732) 321- 4779 Telefax: (732) 321 - 4841

Date of Summary Preparation:

Device Name:

●

Trade Name: ●

Common Name: .

Siremobil C02

Mobile X-ray System

Classification: ●
Classification Name:

Class II 21 CFR, Subchapter J

Performance Standards:

All system components to which the above standard applies are certified
ed the supportunity of the text

All System with 21 CFR subchapter J

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE I

SSEE CAND EFFECTIVEN FENCE DETERMINATION SAFETY AND EFFECT VALANCE DETERMINATION.

Device Description:

The Siremobil C02 is a mobile x-ray C-ram which consists of a high
er and the first and the successions weblic, images intensifier. TV can The Siremobil C02 is a mobile x-ray tube assembly, image intensifier, TV camera,
frequency generator, X-ray tube assembly, image intension a frequency generation, A-ray tube assences), electronics cabinet and a
film cassette attachment, Laser light localizers, electronics cabinet image film cassette attachinent, Laser infinitionshipsion memory device, image monitor frolley which consists of the Siremobil C02 is designed to meet the monitor(s), and user interface. The Siremobil Councilled onvironments identified below.

{1}------------------------------------------------

SIEMENS

The Siremobil C02 is designed for easy maneuverability, durability and The Sirentoon Co2 15 designed to: The system operation is designed to high efficiency and performance. This of ically optimized interface. The provide the user with an eigeneme on Fluoroscopy with Last Image Siremobil Co2 can operate in 3x mounge Hold, Disjital Radiography, Hold, Pulsed Truoroscopy Will East Inc. and Roadmapping. The user can
Cassette Exposures, Digital Subtraction, and Roadmapping, filtration Cassette Exposures, Digital Subtitle: Such techniques as recursive filtration, process the images unnzing Such lecture, spatial frequency filtration,
summation or spatial noise suppression, spatial frequency filtration, Summation of Spatial Reise support and contrast enhancement.

Intended Use:

The Siremobil C02 is a mobile x-ray system intended for use in operating in
ternation in the mobile commiss are station, nediatrics The Siremobil Co2 is a moone x fay byeies care station, pediatrics, room, traumatology, encoscopy, incensive medicine. The Siremobil C02
ambulatory patient care and in veterinary medicine. The Siremont Pulsed ambulatory patient care and in vecessary with Last Image Hold, Pulsed
can operate in six modes: Fluoroscopy with Last Image Hold, Cassette can operate in SIX modes. Fractord, Digital Radiography, Cassette Fluoroscopy with Last intage Frond, Digital Project of the are necessary in
Exposures, Digital Subtraction, and Roadman, succh as introperative bill Exposures, Digital Subtractioni, and novements, such as intraoperative bile
performing wide variety of clinical procedures, such as intraoperative bile performing wide variety of cinical processededlary nail implants in
duct display, fluoroscopic display of a intractions, fluoroscopic duct display, nuoroscopic display or an are and in pediatrics, fluoroscopic various positions, low dose nuoroscopy in positions,
techniques utilized in pain therapy and positioning of catheters and probes.

Technological Characteristics:

The Siremobil C02 is designed for an optimal range of movement. The The Siremobil Co2 is designed 100 and the angulation movement range is
orbital range for the C-arm is 190° and the angulation in the horizontal orbital range for the C-affirst 170 - under is ±12.5°. The horizontal
±190°. The horizontal swivel (rotational) range in clipical £190°. The nortzonial Swives (readsming optimized for use in clinical
and vertical movement of the C-arm is optimized travel in The horizontal travel is 20 cm and the vertical travel is 40 applications. applications. The norizonial traver as as as an 20 cm, 74 cm, provides the
cm. The large C-arm depth or interior width of C-arm, 74 cm, provides the chi. The large & arm aight access during examinations.

Isocentric C-arm .
Expanded orbital angle of 190° ●
Increased distance between X-ray tube and image intensifier (SID) .
Electromagnetic brakes, instead on manual brakes .
Concealed, integrated cable routing ●
Conceated, and growth of the use of the C-arm system with other . interraces available medical systems. The premarket approval of commercially avanable incured by obtained in a separate filing to FDA prior to commercialization.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three overlapping human profiles facing to the right, with flowing lines suggesting movement or progress.

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

NOV 1 7 2011

Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830

Re: K973598

Trade/Device Name: Sireobil C02 (Mobile X-ray System) Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: September 19, 1997 Received: September 22, 1997

Dear Ms. Rutherford:

This letter corrects our substantially equivalent letter of November 10, 1997.

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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

{3}------------------------------------------------

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

Mahal D. O'Shea for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): Siremobil C02 Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Girid C. Siyum
(Division Sign Off)

vision Sign-Off ion of Reproductive, Abdominal, EN Radiological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.