(134 days)
Not Found.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and standard image processing techniques like 3D reconstruction (DynaCT) and DSA. There is no mention of AI/ML in the intended use, device description, or performance studies.
No.
The device is described as an angiography system for diagnostic imaging and interventional procedures, aiming to visualize vessels and other internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "single and biplane diagnostic imaging" and that DynaCT, a software option, is "intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis".
No
The device description explicitly lists numerous hardware components including a patient table, C-arm, flat panel detector, X-ray tube, generator, displays, and footswitch, indicating it is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, treatment, or prevention of disease. This testing is performed outside of the body (in vitro).
- ARTIS icono Function: The ARTIS icono system is an angiography system that uses X-rays to visualize vessels and internal body structures within the human body (in vivo). It is used for diagnostic imaging, interventional procedures, and surgical guidance.
The device's function and intended use clearly fall under the category of medical imaging and interventional systems, not in vitro diagnostics.
N/A
Intended Use / 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, neuro-angiography, general anglography, 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 following indications for use: DynaCT is an X-ray maging 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.
Product codes
OWB, IZI, JAA, JAK
Device Description
The ARTIS icono (VE21) 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 (VE21) 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 iso-centering 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 side 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 (VE21), 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-ray tube, collimator, high voltage generator, patient table, and image post processing.
The ARTIS icono (VE21) 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 (VE21) system configuration, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information content in variaous 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 (VE21) 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, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The Subject device ARTIS icono with software version VE21 will support the following modifications.
| Software / Hardware changes specific to New System Software VE21 | |
|---|---|
| 1. | Updated system Software from VE20 to VE21 |
| A. Lateral Plane syngo DynaCT (3D with Plane B (Biplane) | |
| B. NOMSIE DSA (IQ) Customization of Contrast in DSA Images | |
| C. Optional New Generator (Polydoros ACX) | |
| 2. | Update 510(k) Information |
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
X-ray
Anatomical Site
Vessels within human body, hard and soft tissues as well as other internal body structures.
Indicated Patient Age Range
Pediatric and obese patients.
Intended User / Care Setting
Physician, health care professionals / Operating room, exam room, control room
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the ARTIS icono VE21) during product development.
The ARTIS icono (VE21) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- AAMI ANSI ES60601-1:2005/(R)2012
- IEC 60601-1-2:2014
- IEC 60601-1-3:2013
- IEC 60601-1-6:2010/A1:2013
- IEC 60825-1:2014
- TR 60878:2015
- IEC 62304:2015
- IEC 80001-1:2010
- IEC 60601-2-28:2017
- IEC 60601-2-43:2019
- IEC 60601-2-54:2018
- ISO 10993-1:2018
- ISO 14971:2019
The modifications described in this Premarket Notification are supported with verification and validation testing.
Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ARTIS icono System software (VE21) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
ARTIS icono System software (VE21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual.
Performance tests were conducted to test the functionality of ARTIS icono (VE21) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
0
June 29, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration" with the word "Administration" on the second line.
Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K220432
Trade/Device Name: ARTIS icono (VE21) System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, IZI, JAA, JAK Dated: June 15, 2022 Received: June 17, 2022
Dear Patricia 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/cfpmn/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
1
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 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 mediation-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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220432
Device Name ARTIS icono (VE21) 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, neuro-angiography, general anglography, 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 following indications for use: DynaCT is an X-ray maging 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.
| 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) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots arranged in a circular pattern.
510(k) Summary: ARTIS icono (VE21)
Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65 Malvern, PA 19355
Date Prepared: June 15, 2022
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: 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 Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-Healthineers.com
Device Name and Classification: 3.
Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Codes:
ARTIS icono (VE21) System
Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, IZI, JAA, JAK
4. Legally Marketed Primary Predicate Device
Trade Name: ARTIS icono (VE20) System 510(k) Clearance K190768 Clearance Date September 12, 2019 Classification Name: Image-intensified fluoroscopic x-ray System Classification Panel: Radiology Regulation Number: 21 CFR §892.1650
4
Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
Device Class: Product Code: Subsequent Product Codes: Class II OWB IZI, JAA, JAK
Total Product Life Cycle:
All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.
5. Device Description:
The ARTIS icono (VE21) 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 (VE21) system consist of a patient table and a multi-axis motorized c-Traditional 510(k) ARTIS icono (VE21) System arm that can be positioned around the patient and angulated in a double-oblique fashion iso-centering 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 side 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 (VE21), 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-ray tube, collimator, high voltage generator, patient table, and image post processing.
The ARTIS icono (VE21) 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 (VE21) system configuration, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information content in variaous layouts are used.
5
Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of several orange dots of varying sizes arranged in a circular pattern.
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 (VE21) 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, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The Subject device ARTIS icono with software version VE21 will support the following modifications.
| Software / Hardware changes specific to New System Software VE21 | |
|---|---|
| 1. | Updated system Software from VE20 to VE21 |
| A. Lateral Plane syngo DynaCT (3D with Plane B (Biplane) | |
| B. NOMSIE DSA (IQ) Customization of Contrast in DSA Images | |
| C. Optional New Generator (Polydoros ACX) | |
| 2. | Update 510(k) Information |
6. 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, 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 following indications for use:
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.
6
Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
Substantial Equivalence: 7.
The ARTIS icono (VE21) System is substantial equivalent to the legally marketed (primary) predicate listed in the table below:
| Predicate Device Name
and Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|-------------------------------------------|------------------|-------------------|-----------------------------------------------------------------------------------------------------|
| ARTIS icono (VE20)
Siemens | K190768 | 09/12/2019 | • Indications for Use
• System Software VE20
• Planes A & B
• Image Quality
• Generator |
Table 3: Predicate Device Comparable Properties for Subject Device Modifications:
Summary of Technological Characteristics of the Subject Device as Compared 8. with the Predicate Device:
The ARTIS icono (VE21) System is designed as a set of components (C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that may be combined into two different configurations (Floor & Biplane to provide specialized angiography systems. Components used with ARTIS icono (VE21) System are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in the Table 4 below for all modifications.
| Modifications | Subject Device
ARTIS icono (VE21) | Predicate Device
ARTIS icono (VE20)
K190768 | Comparison
Results |
|-----------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New System
Software
Changes | 1. Updated system Software
from VE20 to VE21 | System Software
Version VE20 | Comparable:
System software VE21 was
updated to support Lateral
Plane syngo DynaCT (3D
with plane B (Biplane only);
NOMSIE DSA (IQ)
Customization of Contrast in
DSA Images and a new
Generator. System Software
modifications conforms to
"Guidance for the content of
Premarket submission for
software in Medical
Devices". Provided is all
required software testing.
Provided in this submission
are Bench Test Summaries.
These software and
hardware changes do not
raise any new risks or any
issues regarding the safety
nor effectiveness of the |
| | A. Lateral Plane syngo
DynaCT (3D with
plane B (Biplane) | No syngo DynaCT on
Lateral Plane B (Biplane) | |
| | B. NOMSIE DSA (IQ)
Customization of
Contrast in DSA
Images | Classical edge
enhancement with filters
and automatic
windowing was used. | |
| | C. Optional New
Generator
(Polydoros ACX) | Generator (Polydoros
A100G) | |
Table 4: Summary of Comparison of Technological Characteristics
7
Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
| Modifications | Subject Device
ARTIS icono (VE21) | Predicate Device
ARTIS icono (VE20)
K190768 | Comparison
Results |
|------------------------------|--------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------|
| | | | device. All test results met
all acceptance criteria. |
| Update 510(k)
Information | | | 2. Updated 510(k) information for the Primary Predicate Device is provided. |
9. Nonclinical Performance Testing:
Non-clinical tests were conducted for the ARTIS icono VE21) during product development.
The ARTIS icono (VE21) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- AAMI ANSI ES60601-1:2005/(R)2012 ●
- IEC 60601-1-2:2014
- IEC 60601-1-3:2013 ●
- IEC 60601-1-6:2010/A1:2013 ●
- IEC 60825-1:2014 ●
- TR 60878:2015 ●
- IEC 62304:2015 ●
- IEC 80001-1:2010 ●
- IEC 60601-2-28:2017 ●
- IEC 60601-2-43:2019 ●
- IEC 60601-2-54:2018 ●
- ISO 10993-1:2018 ●
- ISO 14971:2019
The modifications described in this Premarket Notification are supported with verification and validation testing.
Verification and Validation:
Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ARTIS icono System software (VE21) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
8
Image /page/8/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a cluster of orange dots of varying sizes, arranged in a circular pattern.
ARTIS icono System software (VE21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual. Customer employees are adequately trained in the use of this equipment.
Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information.
Summary:
Performance tests were conducted to test the functionality of ARTIS icono (VE21) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
10. 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 professionals familiar with and responsible for the evaluating and post processing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the ARTIS icono (VE21) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.