Who is the manufacturer of ARTIS Icono?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for ARTIS Icono (K193326).

What is the FDA product code for ARTIS Icono?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ARTIS Icono?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ARTIS Icono?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ARTIS Icono

K193326 · Siemens Medical Solutions USA, Inc. · OWB · Apr 16, 2020 · Radiology

Device Facts

Record ID	K193326
Device Name	ARTIS Icono
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	OWB · Radiology
Decision Date	Apr 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended 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, neuro-angiography, 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. This does not include projection radiography. 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 family include also the software option DynaCT with the following indications for use: 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 soft tissues as well as other internal body structures of diagnosis, surgical planning, interventional procedures and treatment follow-up.

Device Story

ARTIS icono (VE2) is a modular angiography system for visualization of vessels and internal structures. Inputs: X-ray signals captured by flat panel detector. Operation: Multi-axis motorized C-arm positions around patient; X-ray generator produces radiation; system performs 2D/3D image reconstruction and post-processing. Used in OR/interventional suites by physicians/technicians. Output: Real-time fluoroscopic/radiographic images and 3D reconstructions on ceiling-mounted displays. Clinical utility: Enables catheter navigation, device placement, and surgical guidance. Benefits: Improved precision, dose reduction via CNR-driven exposure control, and faster workflow for stroke centers.

Clinical Evidence

Bench testing only. Performance validated using phantoms (PMMA/aluminum) to simulate patient thicknesses (2.5-40 cm) and various attenuations. Metrics include dose savings (3-86% depending on procedure/attenuation) and contrast-to-noise ratio (CNR) maintenance compared to detector-driven control. Software verification and validation confirmed performance against specifications.

Technological Characteristics

Modular angiography system; C-arm, X-ray tube, flat panel detector, high-voltage generator, patient table. Connectivity: Networked/integrated with syngo application software. Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62304, ISO 10993-1, ISO 14971. Software: Major level of concern. Sterilization: N/A (non-invasive).

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, and whole-body radiographic/fluoroscopic procedures. Supports image-guided surgery and DynaCT 3D reconstruction for hard/soft tissue imaging, surgical planning, and treatment follow-up.

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 icono (K190768)

Related Devices

K230950 — ARTIS icono (VE30A) · Siemens Medical Solutions USA, Inc. · Dec 14, 2023
K220432 — ARTIS icono (VE21) System · Siemens Medical Solutions USA, Inc. · Jun 29, 2022
K190768 — ARTIS icono · Siemens Medical Solutions USA, Inc. · Sep 12, 2019
K201156 — ARTIS pheno (VE2) · Siemens Medical Solution USA, Inc. · Jun 29, 2020
K133580 — ARTIS ONE · Siemens Medical Solutions USA, Inc. · Apr 28, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words. Siemens Medical Solutions USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355 Re: K193326 Trade/Device Name: ARTIS icono (VE2) System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, JAK, IZI Dated: March 11, 2020 Received: March 12, 2020 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 contract 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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see April 16, 2020 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193326 Device Name ARTIS icono (VE2) System ### Indications for Use (Describe) 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. 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. This does not include projection radiography. 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 Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with the following indications for use: 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 soft tissues as well as other internal body structures of diagnosis, surgical planning, interventional procedures and treatment follow-up. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary: ARTIS icono (VE2) K193326 Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 #### Date Prepared: April 1, 2020 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. - General Information: 1. Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869 Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Ms. Patricia D. Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone : (610) 448-6474 Email : patricia.d.jones@siemens-Healthineers.com #### Device Name and Classification: 3. | Trade Name: | ARTIS icono (VE2) System | |-----------------------|---------------------------------------------| | Classification Name: | Image-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1650 | | Device Class: | Class II | | Product Codes: | OWB, IZI, JAA, JAK | # 4. Legally Marketed Predicate Device | Trade Name: | ARTIS icono (VE2) System | |-----------------------|---------------------------------------------| | 510(k) Clearance | K190768 | | Clearance Date | September 12, 2019 | | Classification Name: | Image-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | {4}------------------------------------------------ Regulation Number: Device Class: Product Code: Total Product Life Cycle: 21 CFR §892.1650 Class II OWB, IZI, JAA, JAK There are no product Recall incidents for this device. ### 5. Device Description: Siemens is introducing a revolutionary new family of angiography systems, the ARTIS icono (VE2) a new modular angiography system designed to help healthcare professionals in today's stroke centers, deal with a double challenge: to treat more patients, and to treat them faster. This is literally expanding percision medicine to advance therapy outcomes. The new ARTIS icono (VE2) system is a medical device that allows visualization of vessels within the human body. It is of the utmost importance to find the right projections so physician can navigate catheters and other devices safely. The ARTIS icono (VE2) system consist of a patient table and a multi-axis motorized c-arm that can be positioned around the patient and angulated in a double-oblique fashion isocentering the region of interest between the x-ray tube and the flat panel detector. The x-ray generator is placed separately. The displays for visualizing the x-ray images are mounted at the ceiling with a movable display suspension system. System operation is executed via control modules table so that the physician can move and position the table and c-arm adequately for best imaging while manipulate the catheters or other devices during x-ray. X-ray release is table side via a footswitch. The ARTIS icono (VE2), modular angiography systems are designed as sets of components that may be combined into two different configurations (Biplane or Floor) to provide specialized angiography systems. In general they are equipped with Carm, stand, flat panel detector, x-rav tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS icono (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, angiography and radiographic/fluoroscopic procedures. The following components are configured to create a Floor or Biplane configuration: - (1) Floor stand with C-arm, X-ray tube assembly and FD - (2) Patient table - (3) Display ceiling suspension with displays - (4) Footswitch for releasing radiation - (5) Control console for controlling the stand, patient table and imaging system Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE2) system configuration, different display variants are used to visualize {5}------------------------------------------------ image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information content in various layouts are used. Post processing can be done in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS icono (VE2) System is capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor and on the ceiling. Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room. The cleared "Predicate Device "ARTIS icono with software version VE2" supports the following product claims. These product claims are specific to cleared product features 510(k) cleared in the "Predicate Device". | Claim | Feature / Component | Labeling Claim | | | |-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | # | | | | | | 1 | Improved Automatic Exposure Control (Structure Scout) | 1a. Dose savings of 32-83% during fluoroscopy at middle and high attenuations, while maintaining the contrast to noise ratio of platinum | | | | | | Disclaimer: | | | | | | The dose reductions were achieved with the CNR-driven exposure control comparing to the detector-driven exposure control. | | | | | | They were obtained using a phantom composed of PMMA and aluminum plates to reproduce x-ray absorption and scattering in 20-40 cm of patient equivalent thickness, here referred as middle and high attenuations. Contrast produced by a 0.01 mm thick platinum foil, located in the isocenter, and the surrounding noise were measured. | | | | | | The contrast to noise ratio was calculated, considering the contrast-reducing (blurring) effects of the tube focus and object motion. Patient equivalent thickness refers to the physical thickness along the x-ray path excluding air cavities of a body having chemical element composition identical to the human body. | | | | | Improved Automatic Exposure Control (Structure Scout) | 1b. Dose savings of 52-86% during radiography at middle and high attenuations, while maintaining the contrast to noise ratio of platinum, | | | | | | Disclaimer: | | | | Claim | Feature / | Labeling Claim | | | | # | Component | | | | | | | The dose reductions were achieved with the CNR-driven exposure control comparing to the detector-driven exposure control. They were obtained using a phantom composed of PMMA and aluminum plates to reproduce x-ray absorption and scattering in 20-40 cm of patient equivalent thickness, here referred as middle and high attenuations. Contrast produced by a 0.01 mm thick platinum foil, located in the isocenter, and the surrounding noise were measured. | | | | | | The contrast to noise ratio was calculated, considering the contrast-reducing (blurring) effects of the tube focus and object motion. Patient equivalent thickness refers to the physical thickness along the x-ray path excluding air cavities of a body having chemical element composition identical to the human body. | | | | | Improved Automatic Exposure Control (Structure Scout) | 1c. Dose savings of 78-81% during fluoroscopy and radiography at medium attenuation, while maintaining the contrast to noise ratio of tantalum* | | | | | | Disclaimer: | | | | | | The dose reductions were achieved with the CNR-driven exposure control comparing to the detector-driven exposure control. | | | | | | They were obtained using a phantom composed of PMMA and aluminum plates to reproduce x-ray absorption and scattering in 20-30 cm of patient equivalent thickness, here referred as medium attenuations. Contrast produced by a 0.01 mm thick tantalum foil, located in the isocenter, and the surrounding noise were measured. | | | | | | The contrast to noise ratio was calculated, considering the contrast-reducing (blurring) effects of the tube focus and object motion. | | | | | Improved Automatic Exposure Control (Structure Scout) | 1d Dose savings of 3-27% during fluoroscopy, while maintaining the contrast to noise ratio of iron *Disclaimer: | | | | | | The dose reductions were achieved with the CNR-driven exposure control comparing to the detector-driven exposure control. | | | | | | They were obtained using a phantom composed of PMMA and aluminum plates to reproduce x-ray absorption and scattering in 2.5-40 cm of patient equivalent thickness. Contrast produced by a 0.25 mm thick iron foil, located in the isocenter, and the surrounding noise were measured. | | | | Claim | Feature / | Labeling Claim | | | | # | Component | | | | | | | The contrast to noise ratio was calculated, considering the contrast- reducing (blurring) effects of the tube focus and object motion. Patient equivalent thickness refers to the physical thickness along the x-ray path excluding air cavities of a body having chemical element composition identical to the human body. | | | | | Improved Automatic Exposure Control (Structure Scout) | 1e. Dose savings of 22-52% during radiography at high attenuations, while maintaining the contrast to noise ratio of iodine | | | | | | Disclaimer: | | | | | | The dose reductions were achieved with the CNR-driven exposure control comparing to the detector-driven exposure control. | | | | | | They were obtained using a phantom composed of PMMA and aluminum plates to reproduce x-ray absorption and scattering in 30-40 cm of patient equivalent thickness, here referred as high attenuations. Contrast produced by a 4 mm thick cavity, filled with iodine-based contrast material, located in the isocenter, and the surrounding noise were measured.…