(90 days)
AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis U include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures eg. Gastro-intestinal imaging, Skeletal imaging etc.
The AXIOM Artis U Angiography System is designed of components used from existing The RATOM Artis O Angloguphy Systems (i.e., AXIOM Iconos R200, Powermobil, AXIOM Artis FC). AXIOM Artis U covers the complete range of angiographic applications which are ATTOM Tamber with commercially available Siemens Angiography systems. AXIOM Artis U system consists of a mobil C-arm upon connected with other components (i.e. generator, x-ray tube, collimator, image intensifier, television system, digital imaging system, etc). Many of the components used in AXIOM Artis U are either digital maging system, cool many of include minor modifications to conniciently a venuelo with a mobile C-arm which allows manual angulations and movements. The vertical lift is the only motorized movement.
The provided text is a 510(k) summary for the AXIOM Artis U angiography system, submitted by Siemens Medical Systems, Inc. It establishes substantial equivalence to existing predicate devices without presenting new performance data or a specific study. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established from a study proving the device meets acceptance criteria.
The information below reflects what could not be extracted from the provided text.
Acceptance Criteria and Device Performance Study Information
The provided 510(k) summary for the AXIOM Artis U angiography system focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself. The document states that the AXIOM Artis U is "designed of components used from existing ATOM Artis O Angloguphy Systems" and that "many of the components used in AXIOM Artis U are either commercially available with Mary OF are systems or include minor modifications to existing components."
Therefore, the submission does not include a detailed study with acceptance criteria and reported device performance metrics in the format requested. The claim of substantial equivalence is based on the system's intended use, technological characteristics (being composed of existing, cleared components), and comparison to predicate devices, rather than new clinical performance data.
Here's a breakdown of why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) relies on the performance of its predicate devices, not new performance data for the AXIOM Artis U.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is provided for the AXIOM Artis U.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set data requiring ground truth establishment is presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data requiring adjudication is presented.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC study was not performed or referenced in this document. The device is an angiography system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is an imaging system and not designed for standalone algorithmic performance in the context of diagnostic interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study data requiring ground truth is presented for the AXIOM Artis U.
- The sample size for the training set: Not applicable, as there is no mention of a training set or machine learning components.
- How the ground truth for the training set was established: Not applicable, as there is no mention of a training set.
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510(K) SUMMARY
Submitted by: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
March 1, 2004
This 510(k) summary of safety and effectiveness information is being submitted in I ms - 510(R) Summary - 8 - Banty - 1 - Banty - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - -
Contact Person 1.
Ms. Debra Peacock Technical Specialist Phone: (610) 448-1773 Fax:: (610) 448-1787
Device Name and Classification 2.
| Trade Name: | AXIOM Artis U |
|---|---|
| Classification Name: | Angiographic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1600, 392.1720 + 892.1650 |
| Device Class: | Class II |
| Device Code: | OWB, OKO, JAA, & I2I |
Intended Use 3.
AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures.
Intel ventional procedures: revocanes that can be performed wraphy, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures eg. Gastro-intestinal imaging, Skeletal imaging etc.
Substantial Equivalence 4.
Substantial Equivalentially equivalent to the currently, commercially available The AXION Press C is CONOS R200 (URF Digital OT), the Powermobil and the AXIOM Artis FC.
The URF Digital OT, market as AXIOM ICONOS R200 was described in premarket notification K992660 and received FDA clearance on April 21, 1997. The Siremobil C02, market as Powermobil was described in premarket notification K973598 which received FDA Clearance on November 10, 1997. The AXIOM Artis FC was described in received i DA Clearance on 121 which received FDA Clearance on March 30, 2001.
Information that substantiates this claim of equivalence is provided throughout this Information and specific equivalence information is provided in Attachment 4.
.
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Device Description ર.
Device Description
The AXIOM Artis U Angiography System is designed of components used from existing The RATOM Artis O Angloguphy Systems (i.e., AXIOM Iconos R200, Powermobil, AXIOM Artis FC).
AXIOM Artis U covers the complete range of angiographic applications which are ATTOM Tamber with commercially available Siemens Angiography systems.
AXIOM Artis U system consists of a mobil C-arm upon connected with other components (i.e. generator, x-ray tube, collimator, image intensifier, television system, digital imaging system, etc). Many of the components used in AXIOM Artis U are either digital maging system, cool many of include minor modifications to conniciently a venuelo with a mobile C-arm which allows manual angulations and movements. The vertical lift is the only motorized movement.
Summary of Technological Characteristics of the Principal Device as Compared 6. with the Predicate Device
while in recomponents used in AXIOM Artis U are either commercially available with Mary OF are 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 with chicked the trained the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize with and responsible for the diation 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 Systems, Inc., the hardware and software documentation and the substantial equivalence comparison matrix proves that the AXIOM Artis U system is substantially equivalent to the Siemens Medical Systems, Inc. Predicate Angiography systems - the AXIOM ICONOS R200 (URF Digital OT), the Powermobil and the AXIOM Artis FC.
Debra Peacock
March 1, 2004
Date
Debra Peacock
TECHNICAL SPECIALIST, REGULATORY AFFAIRS
Siemens Medical Systems, Inc.
000123
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Debra A. Peacock Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355
MAY 22 2012
Re: K040675
Trade/Device Name: AXIOM Artis U Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, JAA, and IZI Dated: March 8, 2004 Received: March 12, 2004
Dear Ms. Peacock:
This letter corrects our substantially equivalent letter of November 14, 2011.
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 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
Janine M. Mo 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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INDICATIONS FOR USE
| 510(k) Number (if known): | K040675 |
|---|---|
| --------------------------- | --------- |
AXIOM Artis U Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis U include cardiac angiography, Procedures that can be performed with the AXIOM and milipunose anglography.
neuro-angiography, general angiography, operating room angiography, multipungsing etc. Provotatiography, general angiography, operating room anglogaphy, info.iperpool and more of any and
| Concurrence of the CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use _(per 21 CFR 801.10Attachment 2 | OR Over-The-Counter Use _ |
David R. Lyman
Division Sign-Off
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§ 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.