(260 days)
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, 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.
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.
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. A new Flat Panel detector has been added to the systems.
The Artis zee / zeego Modular Angiography System with the new Flat Panel detector is substantially equivalent to the AXIOM Artis Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.
The provided text is a 510(k) summary for a medical device (Artis zee/zeego with CSX-10 Detector SW VC21), which is a regulatory submission to the FDA. It declares substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Artis zee, Artis zeego SW VC14, K090745) rather than establishing and reporting against new performance acceptance criteria for the modified device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The submission details modifications to an existing system, including a new flat panel detector. It doesn't describe a specific "test set" in the context of clinical performance evaluation for acceptance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided. As no specific study with a "test set" and ground truth establishment is detailed, this is not applicable here.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on technological characteristics and substantial equivalence, not comparative clinical effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an angiography system with a new detector, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable in this context. The document describes a medical imaging system that produces images for human interpretation.
7. The Type of Ground Truth Used:
This information is not provided. No specific "ground truth" is described in the context of device performance evaluation. The device is intended to produce images for diagnostic, surgical planning, interventional procedures, and treatment follow-up, implying that the output (images) would be interpreted by healthcare professionals.
8. The Sample Size for the Training Set:
This information is not provided. The device is an imaging system, not an AI system that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. This concept is not applicable to the type of device described.
Summary of Information from the Provided Text:
The document is a 510(k) submission, specifically a "510(k) Summary," which aims to demonstrate that a modified device (Artis zee/zeego with CSX-10 Detector SW VC21) is "substantially equivalent" to a legally marketed predicate device (Artis zee, Artis zeego SW VC14).
- Device Name: Artis zee/zeego with CSX-10 Detector SW VC21
- Predicate Device: Artis zee, Artis zeego SW VC14 (K090745, cleared June 18, 2009)
- Basis for Equivalence: The document states that the new device is a modification of the predicate device, primarily adding a new Flat Panel detector. It asserts that the functionality and indications for use are similar.
- Safety and Effectiveness Concerns: Siemens states that instructions for use are included, risk management is ensured via hazard analysis and V&V testing, and adherence to recognized industry practices minimizes electrical, mechanical, and radiation hazards. Operators are expected to be healthcare professionals.
- Conclusion: Siemens states that the Artis zee/zeego Modular Angiography System with the new detector is substantially equivalent to the predicate device because it has the same indication for use and similar functionality.
The 510(k) process typically relies on demonstrating equivalence to an already cleared device, potentially through performance differences that do not raise new questions of safety and effectiveness, rather than a detailed study against specific, novel acceptance criteria as might be expected for entirely new technology or PMA submissions.
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SIEMENS
MAY 1 6 2013
510(k) Summary: Artis zee/zeego with CSX-10 Detector VC21
Company:
Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: May 14, 2013
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 Vallev Stream Parkway Malvern, PA 19355 Establishment Registration 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. Requlatory 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
3. 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 Angiographic X-Ray System Image intensified fluoroscopic x-ray system Radiology 21 CFR §892.1650 Class II OWB, JAA, IZI JAK
{1}------------------------------------------------
SIEMENS
- Legally Marketed Predicate Device 4. Trade Name:
510(k) Clearance Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
· Artis zee and Artis zeego - Modular Angiographic System K090745 June 18, 2009 Angiographic X-Ray System Radiology 21 CFR §892.1600 Class II 90 İZİ
5. 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. A new Flat Panel detector has been added to the systems.
The Artis zee / zeego Modular Angiography System with the new Flat Panel detector is substantially equivalent to the AXIOM Artis Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.
6. 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 multipurpose anqiography, whole bodv 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 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.
{2}------------------------------------------------
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 body structures for diagnosis, surgical planning, interventional internal procedures and treatment follow-up.
7. Substantial Equivalence:
The Artis zee / zeego Modular Angiography System with CSX-10 Panel detector is a modification of a legally marketed device and substantial equivalent to Artis zee, Artis zeego SW VC14 as listed below. .
| 510(k) Number | Date of Clearance | Device Name |
|---|---|---|
| K090745 | June 18, 2009 | Artis zee, Artis zeego Angiographic X-ray Systems |
Summary of Technological Characteristics of the Subject Device as 8. 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. 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 and the new Flat Panel detector are provided in the Device Description.
9. General Safetv 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.
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.
{3}------------------------------------------------
SIEMENS
10. Conclusion as to Substantial Equivalence:
The Artis zee / zeego Modular Angiography System with CSX 10 Flat Panel detector has the same indication for use as the predicate device Artis zee / zeego with software VC14. The new detector is designed to provide fluoroscopic and spot-film radiographic images of human anatomy during diagnostic, surgical and interventional procedures.
The functionality of Artis zee / zeego Modular Angiography System is similar to the predicate device. It is Siemens opinion, that the Artis zee / zeego Modular Angiography System with the new detector is substantially equivalent to the Artis zee / zeego Modular Angiography System (K090745).
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing growth and vitality. The figure is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2013
Siemens Medical Solutions, Inc. % Ms. Patricia D. Jones Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway MALVERN PA 19355
Re: K122644
Trade/Device Name: Artis zee/zeego with CSX-10 Detector SW VC21 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: May 3. 2013 Received: May 6, 2013
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); medical device reporting (reporting of medical 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.
{5}------------------------------------------------
Page 2 - Ms. Jones
Enclosure
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.h.7)
. for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
{6}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Artis zee and Artis zeego with CSX 10 Detector VC21
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, 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.
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.
| Prescription Use__________ | AND/OR | Over-The-Counter Use__________ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Smir. Fil
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K122644 510(k)________________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
§ 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.