(55 days)
Not Found
No
The document describes a standard angiography system with image processing capabilities but does not mention AI or ML.
No.
The device is an imaging system used for diagnosis, surgical planning, and treatment follow-up, rather than providing direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that ARTIS is a family of angiography systems developed for "single and biplane diagnostic imaging" and "DynaCT is intended for imaging ... for diagnosis".
No
The device description clearly outlines multiple hardware components including a patient table, C-arm, X-ray tube, flat panel detector, generator, displays, footswitch, and control console. While it includes software options and image processing capabilities, it is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an angiography system for diagnostic imaging and interventional procedures. It focuses on visualizing vessels and internal body structures using X-ray technology to guide procedures and aid in diagnosis and treatment planning.
- Device Description: The device description details the physical components of an angiography system (C-arm, table, displays, etc.) and how it is used to acquire X-ray images.
- Lack of In Vitro Activity: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any tests on specimens outside of the body. It directly images the internal structures of the patient.
The device is an in vivo diagnostic and interventional imaging system.
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 (comma separated list FDA assigned to the subject device)
OWB, IZI, JAA, JAK
Device Description
The ARTIS icono (VE23) 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 (VE23) 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 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 (VE23) ceiling mounted system covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, and radiographic/fluoroscopic procedures.
The following components are configured to create the Ceiling configuration:
- (1) Ceiling Mounted 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
- (6) Ceiling Rails (two configurations)
Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE23) 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 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 (VE23) ceiling System is capable of 2D and 3D imaging.
Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE23) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The 510(k) submission. Subject device ARTIS icono with software version VE23 will support the following modifications made to the Subject Device in comparison to the Predicate Device:
List of Modifications
-
- Updated system Software from VE20 to VE23
- NOMSIE DSA (IQ) Customization of Contrast in DSA Images A.
- New Generator (Polydoros ACX) B.
- C. Peristepping / Perivision
-
- Ceiling configuration, new ceiling mounted C-arm
-
- Product Claims List
-
- Update 510(k) Information
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
vessels within the human body, hard and soft tissues as well as other internal body structures
Indicated Patient Age Range
pediatric and obese patients (no specific age range provided)
Intended User / Care Setting
physician; in the 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 (VE23) ceiling system during product development.
The modifications described in this Premarket Notification are supported with verification and validation testing.
Software Documentation for a Moderate 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 (VE23 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 (VE23 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.
Performance tests were conducted to test the functionality of ARTIS icono (VE23 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
July 19, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K221516
Trade/Device Name: ARTIS icono (VE23) 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: May 23, 2022 Received: May 25, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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,
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) K221516
Device Name ARTIS icono (VE23) 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 in teal, and the word "Healthineers" is in orange. To the right of the text is a cluster of orange dots of varying sizes.
510(k) Summary: ARTIS icono (VE23)
Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65 Malvern, PA 19355
Date Prepared: July 7, 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.
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 Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-Healthineers.com
3. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:
ARTIS icono (VE23) System
Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, IZI, JAA, JAK
Legally Marketed Primary Predicate Device 4.
| 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 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 word "Healthineers" is an orange graphic that consists of several orange dots of varying sizes.
Device Class: Product Code: Subsequent Product Codes: Total Product Life Cycle:
Class II OWB IZI, JAA, JAK
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.
Secondary Predicate Device: Trade Name: 510(k) Clearance: Clearance Date: Classification Name: Classification Panel: Regulation Number: Device Class: Product Codes: Subsequent Product Codes : Total Product Life Cycle:
Artis Q/Q.zen System K181407 August 15, 2018 Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB IZI, JAA, JAK 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 (VE23) 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 (VE23) 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 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 (VE23) ceiling mounted system covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, and radiographic/fluoroscopic procedures.
The following components are configured to create the Ceiling configuration:
- (1) Ceiling Mounted C-arm, X-ray tube assembly and FD
- (2) Patient table
- (3) Display ceiling suspension with displays
- (4) Footswitch for releasing radiation
5
Image /page/5/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.
- (5) Control console for controlling the stand, patient table and imaging system
- (6) Ceiling Rails (two configurations)
Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE23) 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 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 (VE23) ceiling System is capable of 2D and 3D imaging.
Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE23) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The 510(k) submission. Subject device ARTIS icono with software version VE23 will support the following modifications made to the Subject Device in comparison to the Predicate Device:
List of Modifications
-
- Updated system Software from VE20 to VE23
- NOMSIE DSA (IQ) Customization of Contrast in DSA Images A.
- New Generator (Polydoros ACX) B.
- C. Peristepping / Perivision
-
- Ceiling configuration, new ceiling mounted C-arm
-
- Product Claims List
-
- 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.
6
Image /page/6/Picture/0 description: The image displays the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, while "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
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.
7. Substantial Equivalence:
The ARTIS icono (VE23) System is substantially equivalent to the following predicate devices comparable properties provided in the below Table 1.
Table 1: Predicate Device Comparable Properties for Subject Device Modifications:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|-----------------------------------------------------------------------------------|------------------|-------------------|------------------------------------------------------------------------------------|
| Primary Predicate
ARTIS icono (VE20)
Siemens | K190768 | 09/12/2019 | • Indications for use
• Software Version VE20
• Image Quality
• Generator |
| Secondary Predicate
Artis Q/Q.zen
(Ceiling configuration)
Siemens | K181407 | 08/15/2018 | • Ceiling configuration
• Peri-Stepping & Perivision |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The ARTIS icono (VE23) ceiling System is designed as a set of components (C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) to provide specialized angiography systems. Components used with ARTIS icono (VE23) 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 are provided in the Table 2 below for all modifications.
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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
| Modifications | Subject Device
ARTIS icono (VE23) | Primary Predicate Device
ARTIS icono (VE20)
K190768 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Software | 1. Updated system Software from VE20 to
VE23
A. NOMSIE DSA (IQ) Customization of
Contrast in DSA Images
B. New Generator (Polydoros ACX) | System Software Version VE20
Classical edge enhancement with filters
automatic windowing was used.
Generator (Polydoros A100G) | |
| Comparison
Results | Comparable:
System software VE23 was updated to support 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 in Volume 016 is all required software testing. Provided in Volume
020 are Bench Test Summaries and Test Reports. These software and hardware
changes do not raise any new risks regarding the safety or effectiveness of the device.
All test results met all acceptance criteria. | | |
| Modifications | Subject Device
ARTIS icono (VE23) | Predicate Device
Artis Q/Q.zen (K181407) | Comparison Results |
| System
Software | C. Added Peristepping
/ Perivision feature | Peristepping / Perivision | Same: |
| Ceiling
Configuration: | 2. Ceiling configuration,
new ceiling mounted C-
arm | Ceiling Configuration | Comparable:
Nonclinical tests have been
performed to assess
the functionality of
the subject device.
Results of all
conducted testing
were found
acceptable and do
not raise any new
issues of safety or
effectiveness. All
test results met all
acceptance criteria. |
| Claims: | 3. Product Claims List | | |
| Update 510(k)
Information: | 4. Updated 510(k) information for predicate devices. | | |
Table 2: Summary of Comparison of Technological Characteristics
Nonclinical Performance Testing: 9.
Non-clinical tests were conducted for the ARTIS icono (VE23) ceiling system during product development.
The ARTIS icono (VE23) 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 60601-1-2:2020 ●
- IEC 60601-1-3:2013
- IEC 60601-1-6:2020 ●
- IEC 60825-1:2021 (Recognized 2007) ●
- TR 60878:2015
8
Image /page/8/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.
- 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 Moderate 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 (VE23 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 (VE23 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.
Summarv:
Performance tests were conducted to test the functionality of ARTIS icono (VE23 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.
9
Image /page/9/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.
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. Similar non-clinical test results demonstrate that the ARTIS icono (VE23) Ceiling 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.