ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM

K123529 · Siemens Medical Solutions USA, Inc. · OWB · Feb 26, 2013 · Radiology

Device Facts

• Record ID: K123529
• Device Name: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OWB · Radiology
• Decision Date: Feb 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuroangiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. Artis can also support the acquisition of position triggered imaging for spatial data synthesis. The Artis Q and Artis Q.zen include also the software option DynaCT with following IFU: DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Device Story

Artis Q and Artis Q.zen are modular angiographic X-ray systems; evolution of Artis zee/zeego platforms. System comprises C-arm, X-ray tube, flat panel detectors, generator, and digital imaging workstation. Used in clinical settings (OR, interventional suites) by healthcare professionals for diagnostic imaging and image-guided interventions. Inputs include X-ray projections acquired during C-arm rotation; system processes data to produce 2D fluoroscopic/radiographic images or 3D volumes via DynaCT software. DynaCT reconstructs 2D projections into 3D formats for surgical planning and treatment follow-up. Output displayed on monitors for real-time clinical decision-making, navigation, and image fusion. Benefits include enhanced visualization of anatomy and pathology during minimally invasive procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through hazard analysis, software verification, and validation testing of system components.

Technological Characteristics

Modular angiography system featuring C-arm, X-ray tube, flat panel detectors, collimator, and generator. Digital imaging system supports 2D and 3D (DynaCT) reconstruction. Components are either commercially available or modified versions of existing Siemens hardware. System is designed for diagnostic and interventional X-ray imaging.

Indications for Use

Indicated for single and biplane diagnostic imaging and interventional procedures, including pediatric and obese patients. Procedures include cardiac, neuro, general, rotational, and multipurpose angiography, whole-body radiographic/fluoroscopic imaging, and image-guided surgery. DynaCT software is indicated for 3D reconstruction of 2D angiographic images for diagnosis, surgical planning, interventional procedures, and treatment follow-up of hard and soft tissues.

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

• Artis zee and Artis zeego - Modular Angiographic System (K090745)

Submission Summary (Full Text)

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Ki2 3529

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· Special 510(k) Submission: Artis Q and Artis Q zen

# 510(k) Summary: Artis Q and Artis Q.zen

FEB 2 6 2013

Siemens Medical Systems, Inc. Company: 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: November 14, 2012

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. General Information:
lmporter / Distributor: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site: SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany Establishment Registration Number: 2240869

#### 2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device Name and Classification: Trade Name: Artis Q and Q.zen - Modular Angiographic System Classification Name: Angiographic X-Ray System Image intensified fluoroscopic x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1600 21 CFR §892.1650

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Image /page/1/Picture/14 description: The image shows the word "SIEMENS" in a bold, outlined font. The letters are filled with a textured pattern, giving them a three-dimensional appearance. The word is horizontally oriented and centered in the image. The background is plain and light, which makes the word stand out.

Special 510(k) Submission: Artis Q and Artis Q zen

Device Class: Product Code: Class II OWB, JAA, IZI

- 4. Legally Marketed Predicate Device Trade Name: Angiographic System 510(k) Clearance K090745 Clearance Date June 18, 2009 Angiographic X-Ray System Classification Name:
Classification Panel: CFR Section: Device Class: Product Code:

Artis zee and Artis zeego - Modular Radiology 21 CFR §892.1600 Class II 90 IZI

#### 5. Device Description:

The Artis Q and Artis Q.zen Modular Angiography System is a further development of the Artis zee / zeego Modular Angiography System. It is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. New Flat Panel detectors, a new x-ray tube are implemented and system improvements were performed to the systems.

The Artis Q and Artis Q.zen Modular Angiography System is substantially equivalent to the Artis zee / zeego Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.

#### 6. Indication for Use:

Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis family include cardiac neuro-angiography, general angiography, angiography, rotational angiography. multipurpose angiography and whole bodv radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

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Special 510(k) Submission: Artis Q and Artis Q zen

Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

#### 7. Substantial Equivalence:

SIEMENS

The Artis Q and Artis Q.zen Modular Angiography System is a modification of a legally marketed device and substantial equivalent to Artis zee, Artis zeego systems as listed below.

| 510(k)<br>Number | Date of<br>Clearance | Device Name |
|------------------|----------------------|-------------------------------------------------------|
| K090745 | June 18, 2009 | Artis zee, Artis zeego Angiographic X-<br>ray Systems |

### Summary of Technological Characteristics of the Subject Device as 8. Compared with the Predicate Device:

Artis Q and Artis Q.zen Modular Angiography System is designed as a set of components (C-arm, X-ray tube and housing, flat detector, digital imaging system, collimator, generator etc.) that may be combined into different configurations to provide specialized angiography systems. Many of the components used with Artis Q and Artis Q.zen are either commercially available with current Siemens systems or include minor modifications to existing components. New or modified features provided with Artis Q and Artis Q.zen are provided in the Device Description.

#### 9. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care

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# SIEMENS

## Special 510(k) Submission: Artis Q and Artis Q zen

professionals familiar with and responsible for the evaluating and post processing of X-ray images.

#### 10. Conclusion as to Substantial Equivalence:

The Artis Q and Artis Q.zen Modular Angiography System has the same indication for use as the predicate device Artis zee / zeego with software VC14 and SW VD10. The new detectors are designed to provide fluoroscopic and spot-film radiographic images of human anatomy during diagnostic, surgical and interventional procedures.

The functionality of Artis Q and Artis Q.zen Modular Angiography System is similar to the predicate device. It is Siemens opinion, that the Artis Q and Artis Q.zen Modular Angiography System is substantially equivalent to the Artis zee / zeego Modular Angiography System (K090745).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 26, 2013

Siemens Medical Solutions USA, Inc. C/O Patricia D. Jones 51 Valley Stream Parkway, D-02 Malvern, PA 19355

Re: K123529

Trade/Device Name: The Artis O and O.zen - Modular Angiographic System Regulation Number: 21 CFR 892.1600 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: February 4, 2013 Received: February 5, 2013

Dear Ms. Jones:

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 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 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

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Page 2 - Ms. Jones

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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,

Image /page/5/Figure/5 description: The image shows a logo that appears to be for the FDA. The logo is stylized and abstract, with the letters "FDA" incorporated into the design. The letters are interconnected and have a geometric appearance. The logo is black and white.

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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SIEMENS

Special 510(k) Submission: Artis Q and Artis Q zen

# Indications for Use Statement

510(k) Number (if known): K123529

Device Name: Artis Q and Artis Q.zen - Modular Angiographic System

Indications for Use:

Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis family include cardiac angiography, neuroangiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

The Artis Q and Artis Q.zen include also the software option DynaCT with following IFU:

DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

FmIDA

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K123529