Cios Fusion
Device Facts
| Record ID | K153244 |
|---|---|
| Device Name | Cios Fusion |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | OWB · Radiology |
| Decision Date | Mar 7, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K153244 · Mar 7, 2016 | Cios Fusion | Siemens Medical Solutions USA, Inc. | Routine clinical patient examinations (Ortho/Trauma procedures) | The device was evaluated in a clinical environment over four weeks with more than 30 patients to confirm usability and image quality for its intended use. | Clinical environment evaluation; Usability; Image quality; Ortho/Trauma procedures |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical environment evaluation; Follow-up/Duration: 4 weeks | Patients undergoing Ortho/Trauma procedures (upper/lower extremities, shoulder, hip/pelvis, cervical/lumbar spine); Sample Size: >30 patients | Secondary predicate device Arcadis Varic | Usability and image quality |
Indications for Use
The Cios Fusion is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, critical care and emergency room procedures. The patient population may include pediatric patients.
Device Story
Mobile fluoroscopic X-ray system; consists of mobile acquisition unit (C-arm, X-ray tube, generator, flat panel detector) and monitor cart (TFT displays, image processing, storage). Used in OR, clinic, and emergency settings by healthcare professionals. Inputs: X-ray radiation through patient anatomy. Transforms inputs via solid-state detector and digital image processing system. Outputs: 2D fluoroscopic images displayed on monitors. Supports DICOM networking, 2D navigation, and injector interfaces. Benefits: provides real-time visualization for interventional procedures; aids clinical decision-making through high-quality imaging; supports dose optimization via Siemens CARE program.
Clinical Evidence
Clinical evaluation conducted over four weeks with >30 patients undergoing Ortho/Trauma procedures (extremities, shoulder, hip/pelvis, spine). Objective: confirm usability and image quality. Results indicated better, more detailed image quality compared to secondary predicate (Arcadis Varic).
Technological Characteristics
Mobile C-arm fluoroscope; solid-state detector (20x20cm or 30x30cm); stationary anode X-ray tube (0.6mm focal spot); 40-110 kV range; 2.3 kW max power. Connectivity: DICOM (wired/wireless), 2D navigation, lithotripsy, and injector interfaces. Software: moderate level of concern. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-43, 60601-2-54, ISO 14971, IEC 62304, IEC 62366.
Indications for Use
Indicated for X-ray imaging of anatomical structures in patients, including pediatric patients, during interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, critical care, and emergency room procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2016
Siemens Medical Solutions USA, Inc. % Ms. Patricia Jones Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355
Re: K153244
Trade/Device Name: Cios Fusion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO Dated: January 27, 2016 Received: January 28, 2016
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 (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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Robert Ools
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K153244
Device Name
Cios Fusion
### Indications for Use (Describe)
The Cios Fusion is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, critical care and emergency room procedures. The patient population may include pediatric patients.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary: Cios Fusion
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
#### Date Prepared: January 27, 2016
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 USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
## Manufacturing Site:
Siemens AG / Siemens Healthcare GmbH Roentgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018
## Legal Manufacturer:
SIEMENS AG Wittelsbacherplatz 2 80333 Muenchen, Germany
#### 2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Requlatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Fax: (610) 640-4481 Email: patricia.d.iones@siemens.com
#### 3. Subject Device Name and Classification: Trade Name: Cios Fusion Image-Intensified Fluoroscopic X-Ray Device: System,
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| Regulation Medical Specialty: | Radiology |
|-------------------------------|--------------------|
| Review Panel: | Radiology |
| Product Codes: | OWB, OXO |
| Secondary Product Code: | JAA |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 892.1650 |
| Device Class | 2 |
- 4. Legally Marketed Predicate Devices:
| Primary Predicate: | |
|-------------------------------|------------------------------------------|
| Trade Name: | Cios Alpha |
| 510(k) Number: | K132094 |
| Device: | Interventional Fluoroscopic X-Ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OWB |
| Secondary Product Code: | OXO |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 892.1650 |
| Device Class | 2 |
| Recall Information: | Z-1958-2015 |
| | |
| Secondary Predicate: | |
| Trade Name: | Siremobil C-06 (renamed: Arcadis Varic) |
| 510(k) Number: | K040066 |
| Device: | Image-intensified Fluoroscopic X-ray |
| | system, Mobile |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OXO |
| Secondary Product Code: | JAA |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 892.1650 |
| Device Class: | 2 |
| Recall Information: | Z-0118-06; Z-0123-06; Z-0438/9-06 |
| | |
#### 5. Device Description:
The Siemens Cios Fusion mobile fluoroscopy system is an image intensified fluoroscopic X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Image Processing System, user controls and image storage devices (DVD, USB).
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Interfaces are provided for optional devices such as external monitors, thermal printers, MP3 players, connections for 2D navigation systems, lithotripters or injectors, as well as wired and wireless DICOM network interfaces.
#### 6. Indications for Use:
The Cios Fusion is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
#### 7. Substantial Equivalence:
The new device Cios Fusion is within the same classification requlation for the same indications for use as the Primary predicate Cios Alpha (K132094, cleared 3/11/2014). Other comparable properties of the subject device to the Primary predicate include X-Ray technology, Mechanical design, the Detector technology and Image processing. Similarly, the Indications for Use, X-Ray technology/Output power, and Mechanical design are compared to the Secondary predicate Siremobil C-06 (Arcadis Varic) (K040066, cleared 2/12/2004). Documentation is provided to support a claim of substantial equivalence to these Siemens' predicate devices.
### 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Siemens Cios Fusion design is based on the Siemens Cios Alpha (K132094) including the system control, flat panel detector technology and image processing functions. The mechanical design and X-ray technology/Output power is based on the Siemens Siremobil C 06 (ARCADIS Varic) (K040066).
The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The modifications do not affect the intended use of the device.
The table below compares the main performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicates.
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| Features /<br>Technology | Subject Device<br>Cios Fusion<br>Siemens | Primary Predicate<br>Cios Alpha<br>K132094<br>Siemens | Secondary Predicate<br>Siremobil C06 -<br>ARCADIS Varic<br>K040066<br>Siemens |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Mobile fluoroscopic C-<br>arm | Yes | Yes | Yes |
| X-ray tube | Stationary Anode<br>0.6 mm focal spot | Rotating Anode<br>0.3/0.5 mm focal spot | Stationary Anode<br>0.6 mm focal spot |
| Tube housing assembly<br>with high frequency<br>generator | Yes, same design | Yes | Yes, same design |
| kV Range | 40 kV to 110 kV | 40 kV to 125 kV | 40 kV to 110 kV |
| Max power output | 2.3 kW | 12 kW<br>25 kW (optional) | 2.3 kW |
| Pulsed fluoroscopy | 3 mA to 25 mA | 3 mA to 119 mA<br>(12kW) | up to 23 mA |
| Beam limiting device | Yes, rectangular | Yes, rectangular | Yes, Iris collimator |
| X-Ray detector | Solid State Detector | Solid State Detector | Image Intensifier with<br>Optics and TV System<br>(CCD technology) |
| Detector active field size | 20 cm × 20 cm<br>30 cm × 30 cm<br>(optional) | 20 cm × 20 cm<br>30 cm × 30 cm<br>(optional) | ø 23 cm |
| Optional integrated dose<br>measurement device | Yes | Yes | Yes |
| Matrix size | 1024 × 1024<br>(20 cm × 20 cm<br>detector)<br>1536 × 1536<br>(30 cm × 30 cm<br>detector) | 1024 × 1024<br>(20 cm × 20 cm<br>detector)<br>1536 × 1536<br>(30 cm × 30 cm<br>detector) | 1024 × 1024 |
| Displays | 19" TFT Flat Screen<br>Color Display Panels | 19" TFT Flat Screen<br>Display Panels, B/W or<br>Color | 19" TFT Flat Screen<br>Display Panels, B/W or<br>Color |
| 2D Image post<br>processing | Yes | Yes | Yes |
| Dose optimization /<br>Siemens CARE program | Yes | Yes | Yes |
| User Interface | Yes, touch panels | Yes, touch panels | Yes, membrane<br>keyboards |
| NaviLink 2D integrated<br>navigation interface | Yes | No | Yes |
| Lithotripsy Interface | Yes | No | Yes |
| Injector interface | Yes | Yes | No |
| Features /<br>Technology | Subject Device<br>Cios Fusion<br>Siemens | Primary Predicate<br>Cios Alpha<br>K132094<br>Siemens | Secondary Predicate<br>Siremobil C06 -<br>ARCADIS Varic<br>K040066<br>Siemens |
| DICOM functionality | Yes | Yes | Yes |
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#### 9. Testing to Voluntary Consensus Standards
The Siemens Cios Fusion has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Fusion complies with the following 21 CFR Federal Performance Standards:
1020.30 Diagnostic X-Ray Systems and their major components
1020.31 Radiographic Equipment
1020.32 Fluoroscopic equipment
1040.10 Laser products and with
Also, the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| Recog-<br>nition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Organization |
|----------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------|
| 19-4 | General II<br>(ES/EMC) | Medical electrical equipment - Part<br>1:General requirements for basic safety<br>and essential performance | 60601-1:2005 | AAMI<br>ANSI |
| 19-1 | General II<br>(ES/EMC) | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>standard: Electromagnetic compatibility<br>- Requirements and tests | 60601-1- 2:<br>2007 | IEC |
| 12-210 | Radiology | Medical electrical equipment - Part 1-3:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Radiation protection in<br>diagnostic X-ray equipment | 60601-1-3:<br>2008 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part 2-<br>28: Particular requirements for the basic<br>safety and essential performance of X-<br>ray tube assemblies for medical<br>diagnosis | 60601-2-28:<br>2010 | IEC |
| 12-202 | Radiology | Medical electrical equipment - Part 2-<br>43: Particular requirements for the<br>safety and essential performance of X-<br>ray equipment for interventional<br>procedures | 60601-2-43:<br>2010 | IEC |
| 12-274 | Radiology | Medical electrical equipment - Part 2-<br>54: Particular requirements for the basic<br>safety and essential performance of X-<br>ray equipment for radiography and<br>radioscopy | 60601-2-54:<br>2009 | IEC |
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| Recog-<br>nition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Organization |
|----------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------|
| 5-40 | General I<br>(QS/RM) | Medical devices - Application of risk<br>management to medical devices | 14971:2007 | ISO |
| 12-238 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set | PS 3.1 - 3.20<br>(2011) | NEMA |
| 12-273 | Radiology | Safety of laser products - Part 1:<br>Equipment classification, and<br>requirements | 60825-1: 2007 | IEC |
| 13-8 | Software/<br>Informatics | Medical device software - Software life<br>cycle processes | 62304:2006 | IEC |
| 5-67 | General I<br>(QS/RM) | Medical devices - Application of<br>usability engineering to medical devices | 62366:2007 | AAMI ANSI<br>IEC |
| 12-229 | Radiology | Medical electrical equipment - Radiation<br>dose documentation - Part1: Equipment<br>for radiography and radioscopy | PAS 61910-1:<br>2007 | IEC |
#### 10. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk Management is ensured via a Risk Analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice and relevant international standards. The following performance data were provided in support of the substantial equivalence determination:
#### 11. Bench Testing:
Bench testing in the form of Unit, Subsystem and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys. Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
#### 12. Non-Clinical Testing:
The detectors were evaluated according to the FDA guidance document "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"..
Validation activities have been performed at the System test level on production prototype devices by appropriately trained and knowledgeable
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test personnel. System level validation and regression testing has been performed successfully, demonstrating that the device meets the acceptance criteria as noted in the system test plans. The verification and validation activities within the meaning of the Quality Regulation (21 CFR 820.30) confirmed design requirements are fulfilled, system functions as intended and the Cios Fusion performs as designed and does not raise new questions regarding safety and effectiveness. Therefore, when compared to the predicate devices the Cios Fusion supports a determination of substantial equivalence to the predicate devices.
#### 13. 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.
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 and mechanical 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.
#### 14. Clinical Testing:
The Cios Fusion has been tested in a clinical environment with the objective to confirm that usability and image quality are adequate for its intended use. In this test Cios Fusion has been evaluated for about four weeks. More than 30 patients have been examined with the Cios Fusion in the course of Ortho/Trauma procedures. These procedures included examinations of the upper and lower extremities, shoulder, hip/pelvis, cervical spine and lumbar spine.
The Cios Fusion was found to provide a better, more detailed image quality as compared to the Secondary predicate device Arcadis Varic.
#### 15. Electrical Safety and Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing were conducted on the Cios Fusion, consisting of the acquisition unit (C-arm system) and the image processing and display station. The system complies with the IEC 60601-1, IEC 60601-2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.
#### 16. Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for
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Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or latent design flaw in the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
#### 17. Conclusion as to Substantial Equivalence:
The Cios Fusion has the same indications for use, operating environment, and mechanical design as the Primary and Secondary predicates. Siemens concludes via the documentation provided in this 510(k) submission that the Cios Fusion does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as the predicate devices.
