ARCADIS AVANTIC

K051133 · Siemens Medical Solutions USA, Inc. · OXO · Jun 1, 2005 · Radiology

Device Facts

• Record ID: K051133
• Device Name: ARCADIS AVANTIC
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OXO · Radiology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping, which are necessary to perform a wide variety of clinical procedures. Clinical applications may include, but are not limited to, card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures

Device Story

Mobile C-arm x-ray system; includes high-frequency generator, x-ray tube, image intensifier, TV camera, laser target devices, electronics cabinet, monitor trolley, and digital storage. Operated by clinicians in clinical settings (OR, ER, etc.) via footswitch or hand switch. Transforms x-ray inputs into 1024x1024 digital images displayed on flat-screen monitors. Supports six modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping. Provides real-time visualization for surgical and diagnostic guidance; assists in clinical decision-making during minimally invasive procedures. Includes uninterruptible power supply for data safety.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Mobile C-arm x-ray system; high-frequency generator; image intensifier; 1024x1024 digital image processing; flat-screen monitors; uninterruptible power supply. Connectivity includes digital image storage. System operates in six modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode, Subtraction, and Roadmapping.

Indications for Use

Indicated for patients requiring mobile x-ray imaging during clinical procedures including card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatric, endoscopic, pain therapy, and emergency room interventions. No specific age or gender contraindications stated.

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 C06 (ARCADIS Varic) (K040066)
• Siemens AXIOM Artis U (K040675)

Submission Summary (Full Text)

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## KOS 1133 510(K) SUMMARY FOR THE SIREMOBIL C 06

### Submitted by:

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

## April 18, 2005

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:

Michael J. Andrews 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Phone: [phone] Fax: [phone]

#### 2. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:

ARCADIS Avantic Mobile X-Ray System Radiology 21 CFR §892.1720 Class II 0x0

#### 3. Substantial Equivalence:

The ARCADIS Avantic is substantially equivalent to the following devices:

| Predicate Device Name | 510(k) Number | Clearance Date | Comparable Properties |
|-------------------------------------------------------|---------------|----------------|------------------------------------------------------|
| Siemens Siremobil C06<br>Trade name:<br>ARCADIS Varic | K040066 | 02/12/2004 | • Hardware<br>• Control Software<br>• Imaging system |
| Siemens AXIOM Artis U | K040675 | 06/10/2004 | • X-ray features<br>• Intended use |

#### 4. Device Description:

The ARCADIS Avantic is an x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release.

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# KOSII33

#### ડ. Intended Use of the Device:

The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode DCM,

Subtraction, and Roadmapping, which are necessary in performing a wide variety of clinical procedures. Clinical applications may include, but are not limited to card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures

#### ર્ભ. Summary of Technological Characteristics of the Devices Compared to the Predicate:

The ARCADIS Avantic is a modification to the ARCADIS Varic. Mechanically the changes are minor in design and style. The X-ray generator and X-ray tube are designed to provide the increased power.

The imaging chain reflects the current standard of 10244 image processing and display with flat screen monitors. An uninterruptable power supply provides additional safety to image and demographic data in the event of a power outage.

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

Michael J. Andrews, Ph.D. Senior Manager, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

NOV 1 4 2011

Re: K051133

Trade/Device Name: ARCADIS Avantic Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: April 29, 2005 Received: May 3, 2005

Dear Dr. Andrews:

This letter corrects our substantially equivalent letter of June 1, 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 (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

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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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

Michael D'Oker 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

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## INDICATIONS FOR USE

**510(k) Number (if known):** K051133
**Device Name:** ARCADIS Avantic

Indications For Use:

The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping, which are necessary to perform a wide variety of clinical procedures. Clinical applications may include, but are not limited to, card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Rate A. Pally

OR

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