(90 days)
Not Found
No
The document describes a software update (VC14) for an existing angiography system. The new features mentioned are related to hardware (wide screen display, OR table, laser light crosshair) and extending the intended use to surgical angiography. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is described as an angiography system used for diagnostic imaging and interventional procedures, which are primarily for diagnosis and visualization, not direct treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "diagnostic imaging" as a function of the device.
No
The device description explicitly states it is a "Modular Angiography System" and lists hardware components like an "examination table" and "laser light crosshair" as part of the system, even though a new software version is being introduced.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for diagnostic imaging and interventional procedures using X-ray technology. This involves imaging the inside of the body, not analyzing samples taken from the body.
- Device Description: The description details an angiography system with components like software, displays, and an examination table. This aligns with an imaging system, not a device for in vitro analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
The Artis zee / zeego is an imaging device used for visualizing blood vessels and other structures within the body for diagnostic and interventional purposes.
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, 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.
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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI, IZI
Device Description
The Artis zee / zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. For these models, a new SW version VC14 will be available. The new SW version VC14 will allow additional functionality of currently used applications and is extended with new features (i.e. a wide screen display, a new OR table, and laser light crosshair). SW VC14 also includes an extension of the intended use to surgical angiography, including general surgical use for patients in the OR. The Artis zee / zeego Modular Angiography System with SW VC14 is substantially equivalent to the AXIOM Artis Modular Angiography System VC13 with all its components as described in the Device Description, Section 11 and the Substantial Equivalence Section 12.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and obese patients
Intended User / Care Setting
health care professionals
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)
Applicable testing was performed to evaluate the modifications to the Artis zee / zeego family. The test results were found to be acceptable as required by the respective test plans and protocols.
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K090745
Page 1 of 3
JUN 18 2009
SECTION 5
510(K) SUMMARY
FOR
SIEMENS ARTIS ZEE / ZEEGO FAMILY VC14
Submitted by: Siemens AG, Healthcare Sector, USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
March 17, 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Mr. Garv Johnson Technical Specialist, Regulatory Affairs Submissions Siemens AG, Healthcare Sector, USA, Inc 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1778 Fax: (610) 448-1787
Device Name and Classification 2.
| Product Name: | Artis zee and Artis zeego - Modular Angiographic System | |
|---|---|---|
| Classification Name: | Angiographic X-ray System | |
| Classification Panel: | Radiology | |
| CFR Section: | 21 CFR §892.1600 | |
| Device Class: | Class II | |
| Product Code: | 90 IZI |
3. Intended 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, 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 X-ray imaging,
1
KC9C745
Page 2 of 3
Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the Artis zee / zeego VC14 have minor changes from its predicate device the Artis zee / zeego VC13, K073290
Device Description: 4.
The Artis zee / zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. For these models, a new SW version VC14 will be available. The new SW version VC14 will allow additional functionality of currently used applications and is extended with new features (i.e. a wide screen display, a new OR table, and laser light crosshair). SW VC14 also includes an extension of the intended use to surgical angiography, including general surgical use for patients in the OR. The Artis zee / zeego Modular Angiography System with SW VC14 is substantially equivalent to the AXIOM Artis Modular Angiography System VC13 with all its components as described in the Device Description, Section 11 and the Substantial Equivalence Section 12.
5. Substantial Equivalence:
The Artis zee / zeego Modular Angiography System SW VC14 is a modification of a legally marketed device and substantial equivalent to Artis zee, Artis zeego SW VC13 as listed below.
| 510(k) Number | Date of Clearance | Device Name |
|---|---|---|
| K073290 | February 11th, 2008 | Artis zee, Artis zeego Angiographic X-ray Systems |
A detailed Substantial Equivalence Comparison is provided in Section 12.
6. Summary of Technological Characteristics of the Principal Device as compared with the Predicate Device:
Artis zee / zeego Modular Angiography System is designed as a set of components (Carm, 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. Many of the components used with Artis zee / zeego are either commercially available with current Siemens systems or include minor modifications to existing components. New or modified features provided with Artis zee/zeego SW VC 14 are provided in the Executive Summary as well as in the Device Description.
2
KC9C745.
Page 3 of 3
7. 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. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Artis zee / zeego Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Performance Data:
Applicable testing was performed to evaluate the modifications to the Artis zee / zeego family. The test results were found to be acceptable as required by the respective test plans and protocols.
Conclusion:
The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 18 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Garv Johnson
Technical Specialist, Regulatory Affairs, Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K090745
Trade/Device Name: Artis zee / zeego Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: June 5, 2009 Received: June 9, 2009
Dear Mr. Johnson:
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.
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
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4
Indications For Use
510(k) Number (if known): 090 745 Device Name: Artis zee / zeego
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 linited to, pedication and obese patients.
Procedures that can be performed with the Artis zee / zeego 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.
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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
Prescription Use
(Part 21 CFR 801 Subpart D)
C)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart
(Please do not write below this line - continue on another page if needed)
Concyrrence of the CDRH, Office of Device Evaluation (ODE)
HoguhkPh
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KO90745 510(k) Number
510(k) Artis zeelzeego
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Siemens AG Healthcare Sector