(107 days)
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 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 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.
The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.
The provided text describes the ARTIS pheno device and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
The document states that "Non-clinical tests were conducted for ARTIS pheno, during product development" and that "The modifications described in this Premarket Notification were supported with verification and validation testing." It also mentions "The performance data demonstrates continued conformance with special controls for medical devices containing software" and "The testing results support that all the software specifications have met the acceptance criteria."
However, it does not provide the actual acceptance criteria or the specific numerical performance results achieved by the device in a table format. It only lists various standards the device complies with (e.g., ES60601-1:2005/(R)2012) and general statements about the tests being passed.
Therefore, I cannot populate the requested table or provide detailed answers to questions 2 through 9 based on the provided text. The document refers to "non-clinical performance testing" and "verification and validation testing" but does not elaborate on the specific methodologies, sample sizes, ground truth establishment, or expert involvement for these tests.
Summary of available information regarding performance:
- Acceptance Criteria/Reported Performance: Not explicitly stated in a quantifiable manner or table. The document generally states that "all tests were passed" and that "all the software specifications have met the acceptance criteria."
- Sample size for test set and data provenance: No information provided.
- Number of experts and qualifications for ground truth: No information provided.
- Adjudication method: No information provided.
- MRMC comparative effectiveness study: No information provided.
- Standalone (algorithm only) performance: No information provided the software is a component of the interventional fluoroscopic x-ray system, not a standalone AI device with specific algorithmic performance metrics.
- Type of ground truth used: "Non-clinical performance testing" and "software specifications" are mentioned, suggesting internal validation against defined functional requirements and safety standards. No mention of expert consensus, pathology, or outcomes data for performance evaluation in the context of diagnostic accuracy.
- Sample size for training set: No information provided.
- How ground truth for training set was established: No information provided.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, adherence to safety and performance standards for an interventional fluoroscopic x-ray system, and successful completion of verification and validation activities. It does not provide the kind of detailed study results one might expect for a novel AI/CAD device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
Siemens Medical Solution USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355
Re: K163286
Trade/Device Name: ARTIS pheno Regulation Number: 21 CFR 892.1650 Regulation Name: Interventional fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: February 10, 2017 Received: February 13, 2017
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
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
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Indications for Use
510(k) Number (if known) K163286
Device Name ARTIS pheno
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 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 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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510(k) Summary: ARTIS pheno
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
February 10, 2017 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.
1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Fax: (610) 640-4481 Email: patricia.d.jones@siemens.com
3. Device Name and Classification:
| Trade Name: | ARTIS pheno |
|---|---|
| Classification Name: | Interventional fluoroscopic X-RaySystem |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Primary Product Codes: | OWB |
| Secondary Product Code: | JAA |
- Legally Marketed Primary Predicate Device 4. Trade Name: Artis Q and Artis Q.zen - Modular Angiographic System K123529 510(k) Clearance
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Clearance Date Classification Name:
Classification Panel: CFR Section: Device Class: Product Codes: Total Product Life Cycle: February 12, 2013 Interventional fluoroscopic X-Ray System Radiology 21 CFR §892.1650 Class II OWB, JAA, IZI 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:
510(k) Clearance Clearance Date Classification Name:
Classification Panel: CFR Section: Device Class: Product Code: Total Product Life Cycle:
Artis zee/zeego with CSX-10 Detector SW VC21 K122644 May 16, 2013 Interventional fluoroscopic X-Ray System Radiology 21 CFR §892.1650 Class II OWB Recall product incidents All 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: 510(k) Clearance Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Total Product Life Cycle: syngo Application Software K162541 November 16, 2016 System, Image processing, Radiological Radiology 21 CFR §892.2050 Class II LLZ There are no Recalls for this Predicate Device
5. Device Description:
The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.
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The following modifications are made to the cleared Artis Q and Artis Q.zen - Modular Angiography System, software version VD10 which created the Subject Device.
Proposed Device Modifications:
- Newly designed C-arm and stand. 1)
-
- Optional Anti-Microbial Coating on surface of C-arm, stand and table
- Newly designed table. 3)
- Newly designed tableside control modules (TCM) 4)
-
- New Flat Panel detector Canon CSX-30
- Newly designed collimator for both angiography and cardiology 6)
- New System Software Version VE10 7)
-
- Integration of the post-processing syngo Application Software VD20
-
- Preparation for ACUSON Freestyle Elite w. Artis Access
-
- Modified image processing
-
- Modified dose regulation
- New Display EIZO MX242W 12)
- Modified Display Ceiling Suspension 13)
-
- Proposed product claims associated with the above device modifications
- Updated 510(k) information 15)
The ARTIS pheno is substantially equivalent to the Artis Q and Artis Q.zen - Modular Angiography System VD10 with all its components as described in the Device Description, and the Substantial Equivalence sections.
6. Indication 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 multipurpose angiography and www.whole angiography, an 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 X-ray imaging, surgery and interventions.
ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.
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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 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 pheno is substantial equivalent to the legally marketed predicates listed in the table below:
| Predicate Device Nameand Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|---|---|---|---|
| Primary PredicateArtis Q and Q.zen -Modular AngiographicSystem | K123529 | 02/12/2013 | • Indications for use• System for Image Acquisition• System for post processing |
| Secondary PredicatesArtis zee/zeegow/CSX10syngo ApplicationSoftware | K122644K162541 | 05/16/201311/16/2016 | • Detector CSX-10• VD11 Post-ProcessingSoftware Features |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
ARTIS pheno is designed as a set of components (C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, etc.) that may be combined into different configurations to provide specialized angiography systems. Components used with ARTIS pheno are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in the table below for all modifications.
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| Modification | Subject DeviceARTIS phenowith SW VE10 | Predicate DeviceArtis Q and ArtisQ.zen ModularAngiography SystemVD10 (K123529) | ComparisonResults |
|---|---|---|---|
| Newlydesigned C-arm and stand | Stand with C-armdiameter 100-130cm | Stand with C-armdiameter 90-110cm | Increased C-armdiameter forsteeperangulations |
| Optional Anti-MicrobialCoating onsurface of C-arm, standand table | Surface of C-arm,stand and table withAnti-Microbial Paintadditive | Surface of C-arm, standand table without Anti-Microbial Paint additive | Less risks ofinfection due toAnti-MicrobialPaint additive |
| Newlydesignedtable | Improved patient tableup to 280kg / 617lbspatient weight motor-assisted longitudinaland transversal travelin leveled and tiltedposition | Standard patient tableup to 250kg / 550lbspatient weight motor-assisted longitudinaltravel in tilted position | Improved patienttable due toincreased patientload and higherflexibility inpositioning |
| Newlydesignedtablesidecontrolmodules | TCM (Table ControlModule)PCM (Pilot ControlModule)CCM (CollimatorControl Module)Consolidation oftableside controlsresulting in reduceddistance for operationHygienic optimizationdue to sealed joysticks,inner dead manswitches and lesscorrugated gaiters. | TCM (Table ControlModule)ECC (ExaminationControl Console)CCM (CollimatorControl Module) | Newly designedwith similarfunctionalityConsolidation oftableside controlsresulting inreduced distancefor operationHygienicoptimization dueto sealedjoysticks, innerdead manswitches and lesscorrugatedgaiters. |
| New flat paneldetectorCanon CSX-30 | CSX-302496 x 1856 pixels forLive 2k imaging1024 x 1024 pixels for1k imagingInput fields 50 cm, 42cm, 32 cm, 22 cm, 16cm, 11 cm | CSX-101792 x 1632 pixels896 x 816 pixels with2x2 binningInput fields 39 cm, 32cm, 26 cm, 20 cm, 16cm, 10 cm | Similar resolutionwith similar inputfields |
| Newlydesignedcollimator forbothangiographyandcardiology | One collimator for bothangiography andcardiology | One dedicatedangiography and onededicated cardiologycollimator | The newlydesignedcollimatorcombines thefunctionality ofboth the |
| angiography andcardiology | |||
| New SoftwareVersion VE10 | Communicationplatform for C-Arm,table movements,tableside controlmodules, detector,collimator, Integrationof the syngoApplication SoftwareVD20, imageprocessing, doseprocessing via Profinetprotocol (industrialstandard) | Communicationplatform for C-Arm,table movements,tableside controlmodules, detector,collimator, Interface tothe syngo ApplicationSoftware, imageprocessing, doseprocessing via CANprotocol (ControllerArea Network) | CAN protocol(Controller AreaNetwork) haschanged to theProfinet protocol(industrialstandard) |
| Integration ofthe post-processingsyngoApplicationSoftwareVD20 | syngo ApplicationSoftware available onARTIS pheno PChardware | syngo ApplicationSoftware available onseparate syngo XWorkplace or onseparate PC hardware | Functionality ofsyngo ApplicationSoftwareremains the sameand runs on onePC hardware |
| Preparationfor ACUSONFreestyleUltrasoundSystemArtisFreestyleAccess | Preparation forACUSON FreestyleUltrasound SystemArtis Freestyle Access.The interface will allowfor viewing ofultrasound images atthe Large Display ofthe Artis system | Preparation forACUSON FreestyleUltrasound SystemArtis Freestyle Accessfiled via NFJ. Theinterface will allow forviewing of ultrasoundimages at the LargeDisplay of the Artissystem | Mechanicaladaptation forACUSONFreestyle. Use ofexisting interfaceof the ARTISsystem |
| Modifiedimageprocessing | -2k image matrix withup to 15f/s- Advanced noisereduction algorithm- Automated contrastand brightnessadjustment-spatial modulationtransfer function up to16 frequency hands | -1k image matrix withup to 15f/s- noise reductionalgorithm- Manual contrast andbrightness adjustment(windowing)--spatial modulationtransfer function up to 3frequency bands | Increased imagematrixMore precisecontrol of the finalimagepresentation |
| Modified Doseregulation | constant signal to noiseratio (image quality) | constant system dose(entrance dose to thedetector) | Optimizedcomposition of X-ray spectrum independency ofwater values |
| New DisplayEIZO MX242W | Use of 24" display | Use of 19", 21", 22"displays | Increased size ofdisplay |
| ModifiedDisplayCeilingSuspension | DCS pivot mountedDCS rail mounted | DCS rail mounted | Enhancedpositioning range |
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SIER
9. Nonclinical Performance Testing:
Non-clinical tests were conducted for ARTIS pheno, during product development.
The ARTIS pheno was 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 ●
All tests were passed.
The modifications described in this Premarket Notification were supported with verification and validation testing.
Verification and Validation:
Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 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 pheno during product development.
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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 pheno was tested 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 safety relevant functions that need to be revalidated. Further risk mitigations have been defined in a corrective action plan to inform and train the current users of Artis pheno VE10. Users understanding of warnings were founded during testing. Warnings were updated in the documentation and the summative usability validation with two different samples of representative users was performed.
The ARTIS pheno VE10 has been found to be safe and effective for the intended users, uses and use environments, based on the results ascertained at the two clinical use test sites in Frankfurt and Hannover.
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 pheno. 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
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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 device was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrrates that the ARTIS pheno acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data, clinical images 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.
§ 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.