(85 days)
Not Found
No
The document describes a standard angiography system with C-arm CBCT functionality (DynaCT) and quantitative CARE claims. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on hardware and established imaging techniques.
No
The device is described as an angiography system for diagnostic imaging and interventional procedures, with a software option for 3D image reconstruction for diagnosis, surgical planning, interventional procedures, and treatment follow-up. While it assists in procedures and follow-up, its primary function is diagnostic imaging and image guidance, not directly providing therapy or treatment.
Yes
The text explicitly states that the device is developed for "single and biplane diagnostic imaging" and that DynaCT is "intended for imaging both hard soft tissues as well as other internal body structures for diagnosis".
No
The device is described as a "family of dedicated angiography systems" and a "Modular Angiography System," which are hardware-based medical devices. While it includes a software option (DynaCT), the submission describes a complete system, not just the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an angiography system used for diagnostic imaging and interventional procedures. These procedures involve imaging the internal structures of the body using X-rays.
- Device Description: The description reinforces that it's an angiography system with components for imaging and procedures.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device operates in vivo (within the body) by generating and detecting X-rays.
The device is an imaging system used for diagnosis and guiding procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Artis zee / zeego 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 zee / zeego family include cardiac angiography, general angiography. rotational angiography, multipurpose angiography and whole body radiographic fluorossopic 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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a Carm CBCT functionality.
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 (comma separated list FDA assigned to the subject device)
OWB, JAA, IZI, JAK
Device Description
/zeego Modular Anqiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. This submission contains Quantitative CARE claims to be added.
The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems. All components are described in the Device Description Section 10 and the Substantial Equivalence Section 11.
The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Hard soft tissues as well as other internal body structures, patient extremities, whole body
Indicated Patient Age Range
pediatric and obese patients
Intended User / Care Setting
health care professionals / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the Artis zee/zeego configured with software version VC21 during product development. The labeling modifications described in this Premarket Notification are supported with same evidence cleared in the Artis Q./Q.zen 510(k) K123529.
Software documentation for a Major Level of Concern per FDA's Guidance Document "Guidance for the Content of Premarket Submission 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 (integration and functional) were conducted on the Artis zee/ Artis zeego software during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all 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.
EMC/electrical safety was evaluated according to the IEC standards.
Siemens certify to conform to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate devices in terms of safety and effectiveness. All testing and validation have been completed.
Clinical testing was not applicable as the Artis zee/ Artis zeego has no new indication for use nor were new clinical applications introduced to the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Siemens Medical Solutions USA, Inc. % Patricia Jones Technical Regulatory Specialist 51 Vallev Stream Parkwav, D-02 MALVERN, PA 19355
Re: K141574
Trade/Device Name: Artis zee/zeego SW VC21 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, IZI, JAK Dated: August 5, 2014 Received: August 6, 2014
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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/ResourcesforYou/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,
Janine M Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
2
Image /page/2/Picture/0 description: The image features the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light teal. A horizontal black line is located directly underneath the text.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Artis zee and Artis zeego
Indications for Use (Describe)
Artis zee / zeego 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 zee / zeego family include cardiac angiography, general angiography. rotational angiography, multipurpose angiography and whole body radiographic fluorossopic 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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a Carm CBCT functionality.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Image /page/3/Picture/0 description: The image contains the word "SIEMENS" in a bold, sans-serif font. The letters are a light blue color. There is a black line underneath the word.
510(k) Summary: Artis zee/zeego - Modular Angiographic System
Company: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: August 5, 2014
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. Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Reqistration Number: 2240869
Manufacturing Site:
SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany Establishment Registration Number: 2240869
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Phone: (610) 448 -3536 Fax: (610) 448-1787 Email: patricia.d.jones@siemens.com
1. Device Name and Classification: Trade Name:
Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code: Secondary Product Code:
Artis zee and Artis zeego - Modular Angiographic System lmage-Intensified Fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II OWB, JAA, IZI JAK
4
Artis zee/zeego VC21 CARE Claims K141574 Al Response
- Legally Marketed Primary Predicate Device 2.
| Trade Name: | Artis zee/zeego with CSX-10 Detector VC21 |
|---|---|
| 510(k) Clearance | K122644 |
| Clearance Date | May 16, 2013 |
| Classification Name: | Image-Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, IZI |
| Secondary Product Code: | JAK |
Legally Marketed Secondary Predicate Device
| Trade Name: | Artis Q and Q.zen – Modular Angiographic System |
|---|---|
| 510(k) Clearance | K123529 |
| Clearance Date | February 26, 2013 |
| Classification Name: | Image-Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1600 & 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, IZI |
| Secondary Product Code: | JAK |
3. Device Description:
/zeego Modular Anqiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. This submission contains Quantitative CARE claims to be added.
The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems. All components are described in the Device Description Section 10 and the Substantial Equivalence Section 11.
The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
4. Indication for Use:
Artis zee / zeego 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 zee / zeego family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
5
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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a C-arm CBCT functionality.
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.
5. Substantial Equivalence:
The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same as the legally marketed device and substantial equivalent to Artis zee / zeego Modular Angiography System with CSX-10 Panel detector as listed below. The quantitative CARE claims are that have been cleared with Artis Q and Artis Q.zen.
| 510(k) Number | Date of
Clearance | Device Name |
|--------------------------------|----------------------|-----------------------------------------|
| Primary Predicate
K122644 | May 16, 2013 | Artis zee/zeego with CSX-10
Detector |
| Secondary Predicate
K123529 | February 26,
2013 | Artis Q and Artis Q.zen |
Table 5: Predicate Devices
-
- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
Artis zee / zeego Modular Angiography System is designed as a set of components (C-arm, X-ray tube and housing, flat detector, digital imaging system, collimator, generator etc.) that may be combined into different configurations to provide specialized angiography systems. All of the components used with Artis zee / zeego are the same as used with the current available Artis zee/zeego (K122644). The Quantitative CARE claims of the Artis zee/zeego are the same as cleared in 510(k) K123529 (Artis Q and Artis Q.zen) this information is provided in the Device Description.
- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
6
SIEMENS
The components of the subject device have the same technological characteristics as the ones from the predicate device. The technological characteristics do not differ from the predicate device Artis zee/zeego cleared in 510(k) K122644.
The subject device Artis zee/zeego does not affect the indication for use nor the intended use of the device nor does it alter its fundamental scientific technology for the 510(k) cleared predicate device Artis zee/zeego K122644.
7. Non-Clinical Performance Testing
Non-clinical tests were conducted for the Artis zee/zeego configured with software version VC21 during product development. The labeling modifications described in this Premarket Notification are supported with same evidence cleared in the Artis Q./Q.zen 510(k) K123529.
Siemens claims conformance to a signed statement of conformance to performance standards as follows: IEC 60601-1: 60601-1-1; IEC 60601-1-2; IEC 60601-1-3; IEC 60601-1-4 ; IEC 60601-2-43; AAMI ANSI ISO 10993-1. IEC ISO-14971 and NEMA PS 3.1 - 3.20 (2011)
Software documentation for a Major Level of Concern per FDA's Guidance Document "Guidance for the Content of Premarket Submission 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 (integration and functional) were conducted on the Artis zee/ Artis zeego software during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all 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.
EMC/electrical safety was evaluated according to the IEC standards.
Siemens certify to conform to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate devices in terms of safety and effectiveness. All testing and validation have been completed.
Clinical testing was not applicable as the Artis zee/ Artis zeego has no new indication for use nor were new clinical applications introduced to the system.
8. 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.
7
SIEMENS
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.
9. Conclusion as to Substantial Equivalence:
The Artis zee / zeego Modular Angiography System with Quantitative CARE claims have the same indication for use as the predicate device Artis zee / zeego with software VC21. The addition of the Quantitative CARE claims were cleared in the Artis Q and Q.zen 510(k) K123529.
The functionality of Artis zee / zeego Modular Angiography System is the same as the predicate device. It is Siemens opinion, that the Artis zee / zeego Modular Angiography System VC21 is substantially equivalent to the Artis zee / zeego VC21 Modular Angiography System (K122644) and the Quantitative CARE claims is substantially equivalent to the Artis Q and Artis Q.zen Modular Antiography System (K123529)..