(69 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as an angiography system for diagnostic imaging and interventional procedures, which are used to visualize problems, not treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "diagnostic imaging" as a function of the AXIOM Artis family.
No
The device description explicitly states it is a "Modular Angiography System with Dynamic Flat Panel detector" and describes hardware components like a flat panel detector and monitors, indicating it is a hardware system, not software-only.
Based on the provided information, 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 AXIOM Artis is an angiography system that uses X-rays to image blood vessels within the body. It is used for diagnostic imaging and interventional procedures performed directly on the patient.
- Lack of Mention of Samples: The description focuses on imaging the patient's anatomy directly, not on analyzing samples taken from the patient.
Therefore, the AXIOM Artis falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuroangiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the image intensifier.
Product codes
901ZI, JAA, IZI
Device Description
The AXIOM Artis Modular Angiography System with Dynamic Flat Panel detector is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. It is basically equal to the AXIOM Artis Modular Angiography System family with all its components. A new Flat Panel detector has been adapted to the system. The detector is comprised of a large area amorphous silicon layer. Flat screen monitors for diagnostic review are optional available.
Mentions image processing
AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
AXIOM Artis is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures.
AXIOM Artis can support the acquisition of position triggered imaging for spatial data synthesis. When equipped with the AXIOM OR table from the Koordinat Table family, the Modular Angiography System is suitable for angiographic procedures in operating rooms.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Jun -6 2002
510(K) SUMMARY
Submitted by: Siemens Medical Solutions USA, Inc. 186 Wood Avenue South Iselin, NJ 08830
March 22, 2002
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.
Contact Person 1.
Ms. Sandra Robinson Phone: (732) 321-3243 Fax: (732) 321-4841
- Device Name and Classification
Trade Name: Modular Angiography System AXIOM Artis with Flat Panel Detector Classification Name: Angiographic X-ray System Classification Panel: Radiology CFR Section: 21 CFR § 892.1600 Device Class: Class II Device Cade: 901ZI
3. Intended Use
AXIOM Artis is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures.
AXIOM Artis can support the acquisition of position triggered imaging for spatial data synthesis. When equipped with the AXIOM OR table from the Koordinat Table family, the Modular Angiography System is suitable for angiographic procedures in operating rooms.
4. Substantial Equivalence
AXIOM Artis with Dynamic Flat Panel Detector is substantially equivalent to the current, commercially available Siemens AXIOM Artis and the GB Angiographic systems, the INNOVA 2000. The Flat Panel detector Trixell Pixium 4800 is a joint venture development between Thales, Philips and Siemens. It may be used with the Siemens AXIOM Artis and the Philips Integris Allura.
The AXIOM Artis was described in premarket notification K010721 and received FDA clearance on March 30, 2001. The Philips Integris Allura Flat Detector system with the Trixell Pixium 4800 was described in premarket notification (510(k) number not yet published) and received FDA clearance on March 15, 2002. INNOVA 2000 was described in premarket notification K993037 and received FDA clearance on February 14, 2000.
Information that substantiates this claim of equivalence is provided throughout this 510/k) submission and specific equivalence information is provided in Attachment S.
ട. Device Description
The AXIOM Artis Modular Angiography System with Dynamic Flat Panel detector is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. It is basically equal to the AXIOM Artis Modular Angiography System family with all its components. A new Flat Panel detector has been adapted to the system. The detector is comprised of a large area amorphous silicon layer. Flat screen monitors for diagnostic review are optional available.
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6. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
Many of the components used in AXIOM Artis with Dynamic Flat Panel detector are either commercially available with current Siemens systems or include minor modifications to existing components.
General Safety and Effectiveness Concerns 7.
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. 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.
Substantial Equivalence 8.
In the opinion of Siemens Medical Solutions USA, Inc., the hardware and software documentation and the substantial equivalence comparison matrix proves that the AXIOM Artis with Flat Panel Detector is substantially equivalent to the Siemens Medical Solutions USA, Inc. predicate Angiography systems - the AXIOM Artis family of Modular Angiography systems, the Philips Integris Allura Flat Detector system and the GE's Medical System INNOVA 2000.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Solutions USA, Inc. 186 Wood Avenue South ISELIN NJ 08830
AUG 2 0 2013
Re: K021021
Trade/Device Name: Modular Angiography System AXIOM Artis with Flat Panel Detector Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: March 22, 2002 Received: March 29, 2002
Dear Ms. Rutherford:
This letter corrects our substantially equivalent letter of June 6. 2002.
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 Mav 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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CONFIDENTIAL
Attachment 1
Indications For Use
510(k) Number (if known): Device Name: __ Modular Angiography System AXIOM Artis with Flat Panel Detector
Indications for Use:
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuroangiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the image intensifier.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021021
510(k) for Siemens AXIOM Flat Panel Detector 03/22/02