(82 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is an angiography system used for diagnostic imaging and interventional procedures, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that Artis zee / zeego systems are developed for "single and biplane diagnostic imaging."
No
The device description explicitly states it is a "Modular Angiography System" and lists various hardware components and configurations, indicating it is a physical medical device, not software-only.
Based on the provided information, the Artis zee / zeego device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as an angiography system for diagnostic imaging and interventional procedures performed on patients. This involves imaging the inside of the body using X-rays and contrast agents.
- Device Description: The description confirms it's an angiography system, a type of medical imaging equipment used directly on patients.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The Artis zee / zeego does not perform this function. It directly images the patient's internal structures.
Therefore, the Artis zee / zeego is a medical device used for in-vivo imaging and procedures, not an in-vitro diagnostic device.
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, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
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
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. These models now will be equipped with a new user interface. In addition a new multi-anis. stand will be offered.
The Artis zee / zeego Modular Angiography System is basically equal to the AXIOM Artis Modular Angiography System family with all its components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various anatomical regions of the body
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)
Not Found
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
SECTION 5
510(K) SUMMARY FOR
SIEMENS ARTIS ZEE FAMILY
FES 11
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
November 19, 2007
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. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions 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: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Artis zee - Modular Angiographic System Angiographic X-ray System Radiology 21 CFR §892.1600 Class II 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, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
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 have minor changes from its predicate device the AXIOM Artis Modular Angiographic System.
1
4. 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. These models now will be equipped with a new user interface. In addition a new multi-anis. stand will be offered.
The Artis zee / zeego Modular Angiography System is basically equal to the AXIOM Artis Modular Angiography System family with all its components.
5. Substantial Equivalence:
The Artis zee/zeego configurations are designed for fluoroscopy and acquisition of radiographic exposures of various anatomical regions of the body. They are substantially equivalent to the following Medical Devices:
| 510(k) Number | Date of Clearance | Device Name |
|---|---|---|
| K021021 | June 06, 2002 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS |
| K052202 | March 07, 2006 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM |
The Indication for use of the Artis zee/zeego does not change from the above-mentioned Medical Devices.
A detailed Substantial Equivalence Comparison is provided in Section 12.
Summary of Technological Characteristics of the Principal Device as compared with the 6. Predicate Device:
Artis zee / zeego Modular Angiography System is designed as a set of components (C-arm, Xray 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.
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 ware 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 crror message will be displayed. Furthermore the operators are health care professionals familiar with and responsible for the Xray 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like symbol with three stylized lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple and monochromatic, with a focus on the symbol and the department's name.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 2008
Mr. Gary Johnson Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MS E-50 MALVERN PA 19355-1406
Re: K073290
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: January 21, 2008 Received: January 23, 2008
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 v adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4
INDICATIONS FOR USE
510(k) Number (if known): K013290
Device Name: _________________________________________________________________________________________________________________________________________________________________
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, neuroangiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Aran M. Wry
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number