(255 days)
No
The document describes image processing and reconstruction techniques (like DynaCT and DSA) but does not mention AI, ML, or related terms in the device description, intended use, or testing summaries. The testing focuses on functional and image quality aspects of standard angiography system components and algorithms.
No
The device is an angiography system used for diagnostic imaging and image-guided procedures, not directly for therapy. Its purpose is to visualize internal body structures for diagnosis, surgical planning, and to guide interventions, but it does not provide treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is developed for "diagnostic imaging" and that DynaCT, a software option, is "intended for imaging... for diagnosis".
No
The device description explicitly lists numerous hardware components including a floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, and patient table. While it includes software options, 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:
- 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, monitoring, or screening.
- Device Function: The ARTIS system is an angiography system that uses X-rays to image internal body structures in vivo (within the living body). It is used for diagnostic imaging and interventional procedures directly on the patient.
- Intended Use: The intended use clearly describes procedures performed on the patient, such as cardiac angiography, neuro-angiography, and image-guided surgery.
- Device Description: The device components (C-arm, X-ray tube, detector, patient table) are all designed for direct patient imaging and intervention, not for analyzing in vitro specimens.
Therefore, the ARTIS system falls under the category of medical imaging devices used for in vivo procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ARTIS is a family of dedicated angiography systems developed for single plane 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 angtography, 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.
The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS systems include also the software option DynaCT with 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 for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Product codes
OWB, JAA
Device Description
The ARTIS pheno (VE30A) is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, and minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal, and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE30A) is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, and available for the support of dedicated clinical workflows.
The ARTIS pheno (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, radiographic/fluoroscopic procedures.
The following components are configured to create the floor 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, collimator, and imaging system
Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts.
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 pheno (VE30A) is capable of 2D and 3D imaging.
Other systems and software synqo Application Software, syngo X Workplace, Sensis Vibe, and or third-party systems may also be integrated into the ARTIS pheno (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination room and the control room.
The 510(k) submission, Subject Device "ARTIS pheno with software version VE30A" will support the following modifications made to the Subject Device in comparison to the Predicate Device:
- Updated system Software from VE21A to VE30A
A. Added an optional Second Workplace
B. Updated memory data storage to 600K
C. Updated NOMSIE DSA (IQ) for Perivision organ program
D. Updated Roadmap Phase 3
E. Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, and Bismuth
F. Updated Usability Features:
- Updated Case Flow feature to include Editing
- Updated Body Region to include Editing
- Updated Procedure Name to include Editing
- On Screen Display Reconfiguration
- Updated Favorites on the Pilot Module to include protocols, frame and pulse rates
- Updated Direct Access Bar on the Pilot Module to include Editing
- Updated Favorites on the Pilot Module to include List & Icon View
- Updated ARTIS Profiles to include User Profile
- Updated Pilot Module to lock
- Updated Image Directory to include Custom Filter possible as default
- Additional Display Layouts for Cockpit
- Added "Inactive" as a function for Dynamic Viewer during PT registration and after the system restarts.
- New PC for imaging System due to obsolescence
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Hard and soft tissues as well as other internal body structures.
Indicated Patient Age Range
pediatric and obese patients.
Intended User / Care Setting
Healthcare professionals in an operating room, for diagnosis, surgical planning, interventional procedures, and treatment follow-up.
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
Non-clinical tests were conducted for the ARTIS pheno (VE30A) during product development. The following non-clinical testing was conducted on the presented modifications and relied on: Software functional, verification, and System validation testing with passing results. NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing were conducted for the Updated NOMSIE DSA (IQ) for the Perivision. Configuration, DSA Roadmap, Subtracted Fluoro and transfer images testing was conducted in support of the Updated roadmap Phase 3. CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the ARTIS pheno (VE30A) during product development. The following non-clinical testing was conducted on the presented modifications and relied on: Software functional, verification, and System validation testing with passing results. NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing were conducted for the Updated NOMSIE DSA (IQ) for the Perivision. Configuration, DSA Roadmap, Subtracted Fluoro and transfer images testing was conducted in support of the Updated roadmap Phase 3. CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Performance tests were conducted to test the functionality of the ARTIS pheno (VE30A). These tests have been performed to assess the functionality of the subject device. The results of all conducted testing and clinical assessments were found acceptable and did not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
December 15, 2023
Image /page/0/Picture/1 description: The image shows the text "Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard". The text appears to be an address or contact information for Siemens Medical Solutions USA, Inc. with Patricia Jones listed as a Regulatory Affairs Professional. The address is 40 Liberty Boulevard.
Re: K230949
MALVERN, PA 19355
Trade/Device Name: ARTIS pheno (VE30A) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: November 30, 2023 Received: December 1, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230949
Device Name ARTIS pheno (VE30A)
Indications for Use (Describe)
ARTIS is a family of dedicated angiography systems developed for single plane 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 angtography, 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.
The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS systems include also the software option DynaCT with 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 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/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 cluster of orange dots.
510(k) Summary: ARTIS pheno (VE30A) 510(k) #: K230949
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
December 7, 2023 Date Prepared:
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: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Reqistration 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: Regulation Number: Device Class: Product Codes:
ARTIS pheno (VE30A)
Image-intensified fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II OWB, JAA
Legally Marketed Primary Predicate Device 4.
- Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: Regulation Number: Device Class:
ARTIS pheno (VE21) K220409 June 29, 2022 Image-intensified fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II
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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
Product Code: Subsequent Product Code : OWB, JAA
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 pheno (VE30A) is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, and minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal, and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE30A) is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, and available for the support of dedicated clinical workflows.
The ARTIS pheno (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, radiographic/fluoroscopic procedures.
The following components are configured to create the floor 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, collimator, and imaging system
lmages and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts.
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 pheno (VE30A) is capable of 2D and 3D imaging.
Other systems and software synqo Application Software, syngo X Workplace, Sensis Vibe, and or third-party systems may also be integrated into the ARTIS pheno (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination room and the control room.
The 510(k) submission, Subject Device "ARTIS pheno with software version VE30A" will support the following modifications made to the Subject Device in comparison to the Predicate Device:
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Image /page/5/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 arranged in a circular pattern.
| Table 1. Modifications for ARTIS pheno (VE30A) | |
|---|---|
| List of Modifications: | |
| 1. | Updated system Software from VE21A to VE30A |
| A. | Added an optional Second Workplace |
| B. | Updated memory data storage to 600K |
| C. | Updated NOMSIE DSA (IQ) for Perivision organ program |
| D. | Updated Roadmap Phase 3 |
| E. | Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, and |
| Bismuth | |
| F. | Updated Usability Features: |
| 1) | Updated Case Flow feature to include Editing |
| 2) | Updated Body Region to include Editing |
| 3) | Updated Procedure Name to include Editing |
| 4) | On Screen Display Reconfiguration |
| 5) | Updated Favorites on the Pilot Module to include protocols, frame and pulse rates |
| 6) | Updated Direct Access Bar on the Pilot Module to include Editing |
| 7) | Updated Favorites on the Pilot Module to include List & Icon View |
| 8) | Updated ARTIS Profiles to include User Profile |
| 9) | Updated Pilot Module to lock |
| 10) | Updated Image Directory to include Custom Filter possible as default |
| 11) | Additional Display Layouts for Cockpit |
| 12) | Added "Inactive" as a function for Dynamic Viewer during PT registration and after the system restarts. |
| 2. | New PC for imaging System due to obsolescence |
6. Indications for Use:
ARTIS is a family of dedicated angiography systems developed for single-plane 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.
The ARTIS systems can also support the acquisition of position-triggered imaging for spatial data synthesis.
The ARTIS systems also include the software option DynaCT with the 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 three-dimensional image format.
6
Image /page/6/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. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
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 pheno (VE30A) is substantially equivalent to the legally marketed predicate listed in Table 2 below:
| Predicate Device Name
| and Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|---|---|---|---|
| Primary Predicate | |||
| ARTIS pheno (VE21) | K220409 | 06/29/2022 | Indications for use Software Version VE21 PC Usability Features Image Quality (NOMSIE) Workplace Station Data Memory Storage Roadmap Feature Structure Scout |
Table 2: Predicate Device Comparable Properties for Subject Device Modifications
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The ARTIS pheno (VE30A) is designed as a set of components (floor stand, C-arm, the X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, etc.) that is combined to provide a specialized angiography system. Components used with ARTIS pheno (VE30A) 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 Table 3 below for all modifications.
| Table 3: Summary of Comparison of Technological Characteristics | |||
|---|---|---|---|
| Modifications | Subject Device | ||
| ARTIS pheno (VE30A) | Predicate Device | ||
| ARTIS pheno (VE21A) | |||
| K220409 | Comparison | ||
| Results | |||
| New System | |||
| Software/ | |||
| Hardware | |||
| Changes | 1. Updated system Software | ||
| from VE21A to VE30A | System software version | ||
| VE21 | System software | ||
| VE30A was updated | |||
| to support | |||
| modifications 1A – 2. | |||
| A. Added an optional 2nd | |||
| Workplace | ARTIS pheno offered | ||
| only 1 Workplace | All System Software | ||
| modifications conform | |||
| to "Guidance for the | |||
| content of Premarket | |||
| submission for | |||
| software in Medical | |||
| Devices" | |||
| B. Updated memory data | |||
| storage to 600K | Memory data storage is | ||
| 400K | |||
| C. Updated NOMSIE DSA | |||
| (IQ) for Perivision | |||
| organ program | NOMSIC customization | ||
| of contrast in DSA | |||
| images | |||
| D. Updated of Roadmap | |||
| Phase 3 | Roadmap with 4 phases | ||
| E. Added new elements for | |||
| Organ Program | |||
| "Structure Scout": | Structure Scout cleared | ||
| elements are platinum, | |||
| tantalum, iron, iodine. | These software and | ||
| hardware changes do | |||
| Modifications | Subject Device | ||
| ARTIS pheno (VE30A) | Predicate Device | ||
| ARTIS pheno (VE21A) | |||
| K220409 | Comparison | ||
| Results | |||
| Calcium, Gadolinium, | |||
| and Bismuth | steel and nitinol, and CO2 | not raise any new | |
| risks or any issues | |||
| regarding the safety or | |||
| effectiveness of the | |||
| device. | |||
| F. Updated Usability Features: | |||
| 1) Updated Case | |||
| Flow feature to | |||
| include Editing | Editing of the Case Flow | ||
| was not available. | |||
| 2) Updated Body | |||
| Region to include | |||
| Editing | Editing of the Body | ||
| Region was not | |||
| available. | All test results met all | ||
| acceptance criteria. | |||
| 3) Updated | |||
| Procedure Name | |||
| to include Editing | Editing of the Procedure | ||
| Name was not available. | |||
| 4) On Screen | |||
| Display | |||
| Reconfiguration | Reconfiguring of the On- | ||
| Screen Display was not | |||
| available. | |||
| 5) Updated | |||
| Favorites on the | |||
| Pilot Module to | |||
| include protocols, | |||
| frame and pulse | |||
| rates | Favorites on PM did not | ||
| include protocols, frame, | |||
| and pulse rates. | |||
| 6) Updated Direct | |||
| Access Bar on | |||
| the Pilot Module | |||
| to include Editing | Editing of the Direct | ||
| Access Bar was not | |||
| available. | |||
| 7) Updated Favorite | |||
| on the Pilot | |||
| Module to include | |||
| List & Icon View | Favorites on PM with list | ||
| & Icon View were not | |||
| available. | |||
| 8) Updated ARTIS | |||
| Profiles to | |||
| include User | |||
| Profile | ARTIS Profiles to | ||
| include user Profile was | |||
| not available. | |||
| 9) Updated Pilot | |||
| Module to lock | Locking PM was not | ||
| available. | |||
| 10) Updated Image | |||
| Directory to | |||
| include Custom | |||
| Filter possible as | |||
| default | Image Directory to | ||
| include Custom Filters | |||
| as default was Body | |||
| Region was not | |||
| available. | |||
| 11) Additional | |||
| Display Layouts | |||
| for Cockpit | Additional Display | ||
| Layouts for cockpit were | |||
| not available. | |||
| 12) Added "Inactive" | |||
| as a function for | |||
| Dynamic Viewer | |||
| during PT | |||
| registration and | |||
| after system | |||
| restarts. | Dynamic Viewer was | ||
| Active during PT | |||
| registration and after | |||
| system restarts. Inactive | |||
| was not available. | |||
| New PC | 2. New PC for Imaging System | ||
| due to obsolescence | PC for Imaging System | ||
| 3. NFJ- 0157: Modifications for | |||
| the ARTIS pheno for | NFJ- 0157: | ||
| Modifications for the | |||
| Modifications | Subject Device | ||
| ARTIS pheno (VE30A) | Predicate Device | ||
| ARTIS pheno (VE21A) | |||
| K220409 | Comparison | ||
| Results | |||
| inclusion of the new ARTIS | |||
| Transfer Solution in | |||
| combination with MR Nexaris | |||
| Dockable Table for system | |||
| MAGNETOM Vida / Sola | ARTIS pheno for | ||
| inclusion of the new | |||
| ARTIS Transfer Solution | |||
| in combination with MR | |||
| Nexaris Dockable Table | |||
| for system MAGNETOM | |||
| Vida / Sola | |||
| 4. NFJ #0163-Introduction of | |||
| optional AVVIGOTM | |||
| Guidance System II to the | |||
| Artis Family of Medical | |||
| Devices. The AVVIGO | |||
| Guidance System II is a 3rd | |||
| Party 510(k) cleared device | |||
| (K212490) that is integrated | |||
| (connected) with the ARTIS | |||
| system. | NFJ #0163-Introduction | ||
| of optional AVVIGOTM | |||
| Guidance System II to | |||
| the Artis Family of | |||
| Medical Devices. The | |||
| AVVIGO Guidance | |||
| System II is a 3rd Party | |||
| 510(k) cleared device | |||
| (K212490) that is | |||
| integrated (connected) | |||
| with the ARTIS system. |
Summary of Comparison of Technological Characteristics
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Nonclinical Performance Testing: 9.
Non-clinical tests were conducted for the ARTIS pheno (VE30A) during product development. The following non-clinical testing was conducted on the presented modifications and relied on: Software functional, verification, and System validation testing with passing results. NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing were conducted for the Updated NOMSIE DSA (IQ) for the Perivision. Configuration, DSA Roadmap, Subtracted Fluoro and transfer images testing was conducted in support of the Updated roadmap Phase 3. CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed.
The ARTIS pheno (VE30A) 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 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 ●
- ISO 15223-1:2021 ●
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- ISO 17664:2018
- ISO 17664-2:2021 ●
- IEC 60601-2-35:2020 ●
- IEC 62366-1:2020
- IEC 62563-1:2021 ●
- NEMA PS 3.1:2022
- ANSI UL 2900-1:2017 ●
- ANSI UL 2900-2-1:2017 ●
- AAMI TIR57:2016 ●
- ISO 14155:2020 ●
The modifications described in this Premarket Notification are supported with verification and validation testing.
Verification and Validation:
Non-clinical tests were conducted on ARTIS icono software (VE30A) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
ARTIS pheno software (VE30A) 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 trained in the use of this equipment.
Siemens conforms to the cybersecurity requirementing 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 the ARTIS pheno (VE30A). These tests have been performed to assess the functionality of the subject device. The results of all conducted testing and clinical assessments were found acceptable and did 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 safely and effectively.
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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 practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and postprocessing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. Non-clinical test results demonstrate that the ARTIS pheno (VE30A) 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 Device that is currently marketed for the same intended use.