ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)

K042793 · Siemens Medi Cal Solutions, Inc. · OWB · Oct 29, 2004 · Radiology

Device Facts

• Record ID: K042793
• Device Name: ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: OWB · Radiology
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures. The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.

Device Story

Arcadis Orbic is a mobile C-arm X-ray system for surgical/interventional imaging. Inputs: X-ray radiation; outputs: fluoroscopic and digital spot-film images. System includes high-frequency generator, X-ray tube, image intensifier, CCD camera, laser target devices, and digital storage/monitor trolley. Operated by clinicians in OR/clinical settings via footswitch/hand switch. Five modes: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, roadmapping. 3D option provides intraoperative 3D reconstruction of high-contrast structures; 3D Navigation Interface assists instrument positioning. Output viewed on flat-screen monitors to guide surgical procedures, potentially improving accuracy and patient outcomes. Includes uninterruptible power supply for data safety.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Mobile C-arm X-ray system. High-frequency generator, X-ray tube, image intensifier, CCD camera. 1024-squared image processing. Flat-screen monitors. Uninterruptible power supply. Connectivity: digital image storage system. Sterilization: N/A (external use).

Indications for Use

Indicated for patients undergoing surgical and interventional procedures requiring fluoroscopic and digital spot-film imaging, including cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. 3D imaging option indicated for intraoperative visualization of high-contrast objects and anatomical structures. 3D Navigation Interface indicated for instrument planning and positioning.

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

• Siemens SIREMOBIL ISO-C (K973598)
• Siemens SIREMOBIL ISO-C 3D (K040347)
• 3D Navigation Interface for SIREMOBIL ISO-C 3D (K022337)
• Siemens Arcadis Varic (K040066)

Submission Summary (Full Text)

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1804 2793

# OCT 2 9 2004

510(k) Summary for the Arcadis Orbic

Submitted by:

Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

October 01, 2004

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

- 1. Contact Person: Ms. Debbie Peacock 51 Valley Stream Parkway E-50 Malvern, PA 19355 Phone: [phone] Fax: [phone]
- 2. Device Name and Classification: Trade Name: Arcadis Orbic Classification Name: Mobile X-Ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1720 Device Classification: Class II Product Code: OWB, OXO, JAA

3. Substantial Equivalence:

The Arcadis Orbic is substantially equivalent to the following devices:

| Predicate Device<br>Name | 510(k)<br>Number | Clearance<br>Date | Comparable Properties |
|-----------------------------------------------------------------|------------------|-------------------|-------------------------------------------------|
| Siemens<br>SIREMOBIL ISO-C<br>(Cleared as the<br>SIREMOBIL CO2) | K9735<br>98 | 11/10/<br>1997 | Hardware<br>Control<br>Software<br>Intended use |
| Siemens SIREMOBIL ISO-C<br>3D | K0403<br>47 | 03/09/<br>2004 | Hardware<br>Control<br>Software<br>Intended use |

Sicmens Medical Solutions, Inc. USA

Page CONFIDENTIAL

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| 3D Navigation Interface for<br>SIREMOBIL ISO-C 3D | K0223<br>37 | 08/13/<br>2002 | Hardware<br>Control<br>Software<br>Intended use |
|---------------------------------------------------------|-------------|----------------|-------------------------------------------------|
| Siemens Arcadis Varic (Cleared<br>as the SIREMOBIL CO6) | K0400<br>66 | 02/12/<br>2004 | Hardware<br>Control<br>Software |

#### 4. Device Description:

The Arcadis Orbic is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, CCD camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitors, and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.

### Intended Use of the Device:

The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.

The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.

Summary of Technological Characteristics of the Devices Compared to the Predicate:

The Arcadis Orbic is a modification to the SIREMOBIL ISO-C (K973598, cleared by CDRH as the SIREMOBIL C02 on November 10, 1997). Mechanically the changes are minor in design and style. The X-ray generator, X-ray tube and Image Intensifier are identical with the currently cleared product.

The 3D imaging option is similar to the SIREMOBIL. ISO-C 3D (K040347 cleared by CDRH on March 9, 2004).

The 3D navigation interface is similar to the 3D Navigation Interface (Navilink) software for the SIREMOBIL ISO C (K022337, cleared by CDRH on August 13, 2002).

The imaging chain reflects the current standard of 1024° image processing and display with flat screen monitors originally cleared with the Arcadis Varic and in clinical operation for

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more than 10 months. An uninterruptable power supply provides additional safety to image and demographic data in the event of a power outage.

Siemens Medical Solutions, Inc. USA

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CONFIDENTIAL Page

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure embracing or protecting another figure, possibly representing health and human services.

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

Ms. Debbie Peacock Technical Specialist, Regulatory Affairs Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway E-50 MALVERN PA 19355

MAY 22 2012

Re: K042793 Trade/Device Name: ARCADIS ORBIC Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, and JAA Dated: October 4, 2004 Received: October 7, 2004

Dear Ms. Peacock:

This letter corrects our substantially equivalent letter of November 14, 2011.

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 pactice 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 nredicate 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

The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.

The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.

| 510(k) Number (if known): | K042793 |
|---------------------------|---------------|
| Device Name: | ARCADIS ORBIC |

Indications For Use:

(Please do not write below this line - continue on another page if needed)

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use_ OR (Per 21 CFR 801.109)

Nancy C. Gordon

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Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042793