(77 days)
Not Found.
No
The document describes standard angiography system components and software for image processing and reconstruction (DynaCT). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance study summaries.
No
The device is described as an angiography system for diagnostic imaging and interventional procedures, including diagnosis, surgical planning, and treatment follow-up, which are primarily diagnostic and preparatory rather than therapeutic in nature. While it can be used during interventional procedures, its role is for imaging and guidance, not direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that Artis is for "single and biplane diagnostic imaging" and "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."
No
The device is described as a family of angiography systems which include hardware components such as a C-arm, stand, flat panel detector, x-ray tube, high voltage generator, and patient table, in addition to software. While software is a component, it is not the sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Artis system is an angiography system that uses X-rays to create images of blood vessels and other internal body structures. It is used for diagnostic imaging and interventional procedures performed directly on the patient.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The system directly interacts with the patient's body using X-rays.
Therefore, the Artis system falls under the category of medical imaging devices, not in vitro diagnostics.
No
Explanation: The provided text does not contain any indication or mention of the device being authorized under a Predetermined Change Control Plan (PCCP).
# 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, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.
Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
# Product codes (comma separated list FDA assigned to the subject device)
OWB, IZI, JAA, JAK
# Device Description
The Artis Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software.
Siemens currently markets the Artis zee / zeego ([K141574](https://510k.innolitics.com/search/K141574)) and the Artis Q / Q.zen ([K123529](https://510k.innolitics.com/search/K123529)). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen ([K123529](https://510k.innolitics.com/search/K123529)). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality.
Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.
The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions.
This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 ([K141574](https://510k.innolitics.com/search/K141574)) and Artis Q / Q.zen SW Version VD10 ([K123529](https://510k.innolitics.com/search/K123529)). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."
# 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
Not Found.
# 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)
Performance tests were conducted to test the functionality of Artis zee / zeego and Artis Q / Q.zen software VD11D. 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.
[K141574](https://510k.innolitics.com/search/K141574), [K123529](https://510k.innolitics.com/search/K123529)
# 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
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solution USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355
Re: K181407
Trade/Device Name: Artis zee/zeego & Artis O/O.zen Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, IZI, JAA, JAK Dated: May 26, 2018 Received: May 30, 2018
Dear Ms. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.
August 15th, 2018
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Baffaro
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181407
Device Name Artis zee / zeego & Artis Q / Q.zen
Indications for Use (Describe)
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
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 systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
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
SIEMENS
510(k) Summary: Artis zee / zeego & Artis Q / Q.zen
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
August 15, 2018 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: lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site:
Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.jones@siemens-Healthineers.com
3. Device Name and Classification:
| Trade Name: | Artis zee / zeego |
|---|---|
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Codes: | OWB, IZI, JAA, JAK |
| Trade Name: | Artis Q and Artis Q.zen |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1650 |
| Device Class: | Class II |
4
SIEMEN
Product Codes:
OWB, JAA, IZI
-
- Legally Marketed Primary Predicate Device
- Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Subsequent Product Codes: Total Product Life Cycle:
Artis zee/zeego SW VC21 K141574 September 05, 2014 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.
Legally Marketed Secondary Predicate Device
| Trade Name: | Artis Q and Artis Q.zen |
|---|---|
| 510(k) Clearance | K123529 |
| Clearance Date | February 26, 2013 |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Codes: | OWB, |
| Subsequent Product Codes: | IZI, 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 Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software.
Siemens currently markets the Artis zee / zeego (K141574) and the Artis Q / Q.zen (K123529). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen (K123529). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality.
5
SIEMENS
Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.
The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions.
This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 (K141574) and Artis Q / Q.zen SW Version VD10 (K123529). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."
The following modifications/features do not impact any new usage of Contrast Agents.
Proposed Device Modifications for the Artis zee / zeego and the Artis Q / Q.zen Systems:
- Revised Indication for Use Statement applicable to both systems 1. (Artis zee / zeego and Artis Q / Q.zen)
-
- New system software version VD11D supports hardware for both systems (Artis zee / zeego and Artis Q / Q.zen)
- New detector pixium 3040CV (also known as "as40HDR") 3. Software and Hardware modification applicable to the Artis zee / zeego system only. (This detector is already cleared for use in the Predicate Device for the Artis Q /Q.zen System).
-
- New Tube cooling unit for both systems (Artis zee / zeego and Artis Q / Q.zen)
- Product Claims List modification applicable for both systems (Artis 5. zee / zeego and Artis Q / Q.zen)
- Update 510(k) Information provided for all predicate devices. 6.
This 510(k) submission also includes the following modification made to the "Miyabi Angio-CT" configuration, which consists of Artis zee / zeego or Artis Q /Q.zen and a CT system (SOMATOM Family Sliding Gantry). The Miyabi Angio-CT configuration that will include these Subject Device modifications will be marketed as "nexaris Angio-CT."
Proposed Device Modifications for the nexaris Angio-CT configuration:
Note: These modifications are only applicable when the Artis zee / zeego or Artis Q / Q.zen and a CT system (SOMATOM Family Sliding Gantry) are
6
Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The text is a light gray color. The font is sans-serif and the letters are evenly spaced. The background is white.
configured in the nexaris Angio-CT configuration. The nexaris Angio-CT is only an environment which may contain an Angio and CT system in close proximity.
- New software version VD11D interface software component with 7. Angio and CT systems.
- Improved Collision calculation between the Artis zee / zeego or Artis Q / Q.zen and CT Systems.
- .
.
6. Indications for Use:
Artis zee / zeego Indications for Use Statement:
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 angjography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image-quided 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 systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up.
Artis Q / Q.zen Indications for Use Statement:
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 anqiography;
7
Image /page/7/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The letters are a light gray color. The background is white.
multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image-quided 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 systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up.
7. Substantial Equivalence:
The Artis zee / zeego and Artis Q / Q.zen SW VD11D is substantially equivalent to the legally marketed predicates listed in the table below:
| This Tradition Bundled 510(k) Submission Contains Two Angiographic Systems | |||
|---|---|---|---|
| Artis zee / zeego VD11D comparable properties: | |||
| Predicate Device Name | |||
| and Manufacturer | 510(k) | ||
| Number | Clearance | ||
| Date | Comparable Properties | ||
| Primary Predicate | |||
| Artis zee/zeego SW VC21 | K141574 | 09/05/2014 | • Indications for use |
| • System for Image Acquisition | |||
| • System for post-processing | |||
| Secondary Predicates | |||
| Artis Q and Q.zen - Modular | |||
| Angiographic System | K123529 | 02/12/2013 | • Detector Pixium 3040CV |
| (as40HDR) | |||
| • Product Claims | |||
| Artis Q / Q.zen VD11D comparable properties: | |||
| Primary Predicate | |||
| Artis Q and Q.zen - Modular | |||
| Angiographic System | K123529 | 02/12/2013 | • Indications for use |
| • System for Image Acquisition | |||
| • System for post processing | |||
| • Detector Pixium 3040CV | |||
| (as40HDR) | |||
| • Product Claims |
| Table 1: Predicate Comparable Properties | |||
|---|---|---|---|
| -- | -- | ------------------------------------------ | -- |
8
SIEMENS
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
Artis zee / zeego and Artis Q / Q.zen Systems are 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 different configurations to provide specialized angiography systems. Components used with Artis zee / zeego and Artis Q / Q.zen 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 below for all modifications.
| Modification | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison Results |
|---|---|---|---|---|
| Indications | ||||
| For Use | ||||
| Statement | IFU statement | |||
| revised to simplify | ||||
| and improve clarity | ||||
| of content. | Cleared IFU | |||
| Statement for | ||||
| K141574 | Not applicable | See row below | ||
| for results | ||||
| Comparison | ||||
| Result | The revised IFU statement is within the scope of the Intended Use for Interventional | |||
| fluoroscopic X-Ray Systems per 21 CFR §892.1650. The minor modification of the cleared | ||||
| IFU statement has no impact on the intended use of the device. | ||||
| Software | ||||
| Version | New Software | |||
| VD11D supports | ||||
| Artis zee / zeego | ||||
| System with Pixium | ||||
| 3040CV 30cm x | ||||
| 40cm 16 bit detector | ||||
| also known as | ||||
| (as40HDR) | Software VC21 for | |||
| Artis zee/zeego | Not applicable | Compatible for | ||
| both Artis zee / | ||||
| zeego and Artis | ||||
| Q / Q.zen | ||||
| systems | ||||
| meets criteria | ||||
| as tested per | ||||
| Software and | ||||
| SSIX Guidance | ||||
| Flat Panel | ||||
| Detector | Pixium 3040CV | |||
| (as40HDR) | ||||
| 30cm x 40cm | ||||
| 16 bit | Not applicable | Pixium 3040CV | ||
| 30cm x 40cm | ||||
| 16 bit also known as | ||||
| (as40HDR) | Same detector | |||
| as cleared with | ||||
| Artis Q / Q.zen | ||||
| will be used | ||||
| with Artis zee / | ||||
| zeego meets | ||||
| criteria as | ||||
| tested per | ||||
| Software and | ||||
| SSIX Guidance | ||||
| Tube Cooling | ||||
| Unit | New Tube Cooling | |||
| Unit: SMC Tube one | ||||
| for all | Tube Cooling Unit: | |||
| Kluever cooling unit | ||||
| or Lytron cooling | ||||
| system. | Not applicable | Same | ||
| functionality | ||||
| Modification | Subject Device | |||
| Artis Q / Q.zen Systems with | ||||
| SW VD11D | Primary Predicate Device | |||
| Artis Q and Artis Q.zen Modular | ||||
| Angiography System VD10 | ||||
| (K123529) | Comparison | |||
| Results | ||||
| Indications | ||||
| For Use | ||||
| Statement | IFU statement revised to | |||
| simplify and improve clarity of | ||||
| content. | Cleared IFU Statement for K123529 | See row below | ||
| for results | ||||
| Comparison | ||||
| Result | The revised IFU statement (applicable to both Artis zee / zeego and Artis Q / Q.zen | |||
| systems) fall within the scope of the Intended Use for Interventional fluoroscopic X-Ray | ||||
| Systems per 21 CFR §892.1650. The minor modification of the cleared IFU statement has | ||||
| no impact on the intended use of the device. | ||||
| Software | ||||
| Version | New Software VD11D supports | |||
| Artis zee / zeego System with | ||||
| Pixium 3040CV 30cm x 40cm | ||||
| 16 bit detector also known as | ||||
| (as40HDR) | Software Version VD10 cleared with | |||
| Artis Q / Q.zen | Compatible for | |||
| both Artis zee / | ||||
| zeego and Artis | ||||
| Q / Q.zen | ||||
| systems meets | ||||
| criteria as | ||||
| tested per | ||||
| Software and | ||||
| SSIX Guidance | ||||
| Tube Cooling | ||||
| Unit | New Tube Cooling Unit: SMC | |||
| Tube one for all | Lytron cooling unit | Same | ||
| functionality | ||||
| Miyabi Angio CT Configuration new marketing name is the nexaris Angio-CT Configuration which is an | ||||
| environment configured with Angio - CT Systems in close proximity previously marketed as Miyabi Angio | ||||
| CT. | ||||
| Modifications | Subject Device | |||
| Configuration | ||||
| nexaris Angio-CT | ||||
| Configuration | ||||
| with Artis zee / | ||||
| zeego or Artis Q / | ||||
| Q.zen | Predicate Device | |||
| Configuration | ||||
| Miyabi Angio CT | ||||
| Configuration with | ||||
| Artis zee / zeego | Predicate Device | |||
| Configuration | ||||
| Miyabi Angio CT | ||||
| Configuration with | ||||
| Artis Q / Q.zen. | Comparison | |||
| Results | ||||
| Miyabi Angio- | ||||
| CT System | ||||
| Configuration | New nexaris Angio | |||
| CT Configuration | ||||
| with Artis zee / | ||||
| zeego or Artis Q / | ||||
| Q.zen Systems | Miyabi Angio CT | |||
| Configuration with | ||||
| Artis zee / zeego | Miyabi Angio CT | |||
| Configuration with | ||||
| Artis Q / Q.zen | New marketing | |||
| name for the | ||||
| previous Miyabi | ||||
| Configuration will | ||||
| be known as the | ||||
| nexaris Angio-CT | ||||
| Configuration with | ||||
| the Artis zee / | ||||
| zeego or Artis Q / | ||||
| Q.zen system and | ||||
| CT Systems with | ||||
| sliding gantry. | ||||
| Collision | ||||
| Calculation | Collision | |||
| calculation (Smart | ||||
| Collision) of the | ||||
| CT gantry now is | ||||
| based on a CT | ||||
| model | Collision calculation of | |||
| the CT gantry is | ||||
| based on a simulated | ||||
| moving wall | Collision calculation | |||
| of the CT gantry is | ||||
| based on a | ||||
| simulated moving | ||||
| wall | Collision | |||
| calculation has | ||||
| been improved | ||||
| and meets | ||||
| criteria as | ||||
| tested per | ||||
| Software |
Table 2: Comparison of Technological Characteristics
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9. Nonclinical Performance Testing:
Non-clinical tests were conducted for Artis zee / zeego and Artis Q / Q.zen during product development.
The Artis zee / zeego and Artis Q / Q.zen were certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- ES60601-1:2005/(R)2012
- 60601-1-2:2007 ●
- 60601-1-3:2008 ●
- 60601-1-6:2010/A1:2013 ●
- 60825-1:2007 ●
- TR 60878:2015 ●
- 62304:2006
- 80001-1:2010
- 60601-2-28:2010 ●
- 60601-2-43:2010 ●
- 60601-2-54:2009/A1:2015 ●
- 10993-1:2009
- 14971:2007 ●
Table 3: FDA Guidance Documents
| FDA Guidance Document and Effective Date | ||
|---|---|---|
| 1. | Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket | |
| Notification Submissions 510(k) | ||
| Document issued on October 2, 2017 | ||
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept | |
| Policy for 510(k)s | ||
| Document issued on January 30, 2018 | ||
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated | |
| 510(k)s - Guidance for Industry and FDA Staff | ||
| Document issued on August 12, 2005 | ||
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a | |
| change to an existing device. | ||
| Document issued on October 25, 2017 | ||
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | ||
| Document Issued on July 28, 2014 | ||
| 6. | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for |
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SIER
| | Solid State X-ray Imaging Devices
Document issued on September 1, 2016 |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket
Submission for Software in Medical Devices
Document issued on May 11, 2005 |
| 8. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in
Medical Devices
Document issued on September 9, 1999 |
| 9. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability
Engineering to Medical Devices.
Document issued February 3, 2016 |
| 10. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging
Device Premarket Notifications.
Document issued on November 28, 2017 |
| 11. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for
Management of Cybersecurity in Medical devices.
Document issued on October 2, 2014 |
| 12. | Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple
Indications in a Single Submission.
Document issued on June 27, 2007 |
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. The modifications of the Artis zee / zeego and Artis Q / Q.zen, software version VD11D are supported with non-clinical information that demonstrates the software safety through verification and validation testing. Verification and validation testing demonstrate that Artis zee / zeego and Artis Q / Q.zen perform as intended. The non-clinical test data demonstrate that Artis zee / zeego and Artis Q / Q.zen device performance is comparable to the predicate device. Software supports all old and modified hardware components for both subject devices with respect to the intended use. The testing supports that all software specifications have met the acceptance criteria. The verification and validation testing support the claims of substantial equivalence.
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 and do not raise any new issues of safety or effectiveness.
Artis zee / zeego and Artis Q / Q.zen software VD11 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
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tests according to the operator's manual and in clinical use tests with customer report and feedback form.
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 zee / zeego and Artis Q / Q.zen software VD11D. 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 zee / zeego and Artis Q / Q.zen SW VD11D 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 Devices are as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.