(119 days)
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.
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).
The document describes the Siemens Cios Fusion, a mobile X-ray system. The acceptance criteria and the study proving the device meets them are detailed in sections 9, 11, 12, 14, 15, and 16 of the 510(k) summary.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Federal Performance Standards (21 CFR) | Conformity to relevant sections | Cios Fusion complies with: - 1020.30 Diagnostic X-Ray Systems and their major components - 1020.31 Radiographic Equipment - 1020.32 Fluoroscopic equipment - 1040.10 Laser products |
| Voluntary Consensus Standards | Conformity to recognized standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, DICOM) | Cios Fusion complies with: - IEC 60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance) - IEC 60601-1-2:2007 (Electromagnetic compatibility) - IEC 60601-1-3:2008 (Radiation protection in diagnostic X-ray equipment) - IEC 60601-2-28:2010 (X-ray tube assemblies for medical diagnosis) - IEC 60601-2-43:2010 (X-ray equipment for interventional procedures) - IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy) - ISO 14971:2007 (Application of risk management to medical devices) - DICOM Set PS 3.1 - 3.20 (2011) - IEC 60825-1:2007 (Safety of laser products) - IEC 62304:2006 (Medical device software life-cycle processes) - IEC 62366:2007 (Usability engineering) - PAS 61910-1:2007 (Radiation dose documentation) |
| Bench Testing (Functional/Performance) | Successful verification of all testable requirements in specifications | Unit, Subsystem, and System Integration testing performed. All testable requirements in Engineering Requirements Specifications, Subsystem Requirements Specifications, and Risk Management Hazard keys were successfully verified and traced. Software verification and regression testing met previously determined acceptance criteria. |
| Non-Clinical Testing (Detector Evaluation) | Conformance to FDA guidance document for solid-state X-ray imaging devices | Detectors evaluated according to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." System-level validation and regression testing performed successfully, demonstrating the device meets acceptance criteria as noted in system test plans. System functions as intended and performs as designed. |
| Clinical Testing (Usability and Image Quality) | Adequate usability and image quality for intended use; improved image quality compared to predicate. | Evaluated in a clinical environment for approximately four weeks. More than 30 patients examined during Ortho/Trauma procedures (upper/lower extremities, shoulder, hip/pelvis, cervical/lumbar spine). Found to provide better, more detailed image quality compared to the Secondary predicate device Arcadis Varic. Usability and image quality confirmed adequate. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with relevant safety and EMC standards | System complies with IEC 60601-1, IEC 60601-2-43, and IEC 60601-2-54 for safety, and IEC 60601-1-2 for EMC. |
| Software Verification and Validation | Documentation provided per FDA guidance; software performs as intended. | Software verification and validation testing conducted, and documentation provided per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. Design requirements fulfilled, system functions as intended. |
| Safety and Effectiveness (General) | No new potential safety risks; safe and effective use. | Instructions for use, cautions, and warnings provided. Risk management via Risk Analysis and hazard analysis. Control through software means, user instructions, verification, and validation. Adherence to recognized industry practice and international standards. Device found substantially equivalent to predicates without new safety risks. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the clinical testing (Section 14), "More than 30 patients" were examined.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It states the testing was done "in a clinical environment," suggesting real-world data. It implies a prospective collection for the purpose of this validation, as it describes the device being evaluated over approximately four weeks with patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth in the clinical study. It mentions that "operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images" (Section 13) and that "usability and image quality are adequate for its intended use" (Section 14), which implies evaluation by clinical professionals. However, specific numbers or qualifications like "radiologist with 10 years of experience" are not provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The clinical testing involved evaluation of image quality and usability, and the conclusion ("Cios Fusion was found to provide a better, more detailed image quality") suggests a consensus or comparison by the evaluating clinicians rather than a specific multi-reader adjudication process.
5. 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
- MRMC Study: No, an MRMC comparative effectiveness study, specifically one evaluating human reader improvement with AI assistance, was not performed.
- Effect Size: Not applicable, as no MRMC study with AI assistance was conducted. The study focused on the device's standalone performance and image quality comparison to a predicate, not on human-AI collaboration.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the testing presented is primarily focused on the standalone performance of the Cios Fusion system. This includes bench testing (unit, subsystem, system integration), non-clinical detector evaluation, electrical safety, EMC, and software verification, as well as a clinical evaluation where the device's image quality and usability were assessed. The device itself is an imaging system, not an AI algorithm, so its "standalone" performance refers to its functional operation as an X-ray system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the clinical testing (Section 14) relating to image quality and usability, the ground truth was based on clinical evaluation and consensus/assessment by healthcare professionals during actual patient examinations. The statement "The Cios Fusion was found to provide a better, more detailed image quality as compared to the Secondary predicate device Arcadis Varic" indicates a qualitative expert assessment of the images produced.
8. The Sample Size for the Training Set
Not applicable. The Cios Fusion is an X-ray imaging system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The document describes traditional medical device validation through engineering, non-clinical, and clinical performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" for an AI algorithm.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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,
{4}------------------------------------------------
| 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 |
-
- 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).
{5}------------------------------------------------
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.
{6}------------------------------------------------
| Features /Technology | Subject DeviceCios FusionSiemens | Primary PredicateCios AlphaK132094Siemens | Secondary PredicateSiremobil C06 -ARCADIS VaricK040066Siemens |
|---|---|---|---|
| Mobile fluoroscopic C-arm | Yes | Yes | Yes |
| X-ray tube | Stationary Anode0.6 mm focal spot | Rotating Anode0.3/0.5 mm focal spot | Stationary Anode0.6 mm focal spot |
| Tube housing assemblywith high frequencygenerator | 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 kW25 kW (optional) | 2.3 kW |
| Pulsed fluoroscopy | 3 mA to 25 mA | 3 mA to 119 mA(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 withOptics and TV System(CCD technology) |
| Detector active field size | 20 cm × 20 cm30 cm × 30 cm(optional) | 20 cm × 20 cm30 cm × 30 cm(optional) | ø 23 cm |
| Optional integrated dosemeasurement device | Yes | Yes | Yes |
| Matrix size | 1024 × 1024(20 cm × 20 cmdetector)1536 × 1536(30 cm × 30 cmdetector) | 1024 × 1024(20 cm × 20 cmdetector)1536 × 1536(30 cm × 30 cmdetector) | 1024 × 1024 |
| Displays | 19" TFT Flat ScreenColor Display Panels | 19" TFT Flat ScreenDisplay Panels, B/W orColor | 19" TFT Flat ScreenDisplay Panels, B/W orColor |
| 2D Image postprocessing | Yes | Yes | Yes |
| Dose optimization /Siemens CARE program | Yes | Yes | Yes |
| User Interface | Yes, touch panels | Yes, touch panels | Yes, membranekeyboards |
| NaviLink 2D integratednavigation interface | Yes | No | Yes |
| Lithotripsy Interface | Yes | No | Yes |
| Injector interface | Yes | Yes | No |
| Features /Technology | Subject DeviceCios FusionSiemens | Primary PredicateCios AlphaK132094Siemens | Secondary PredicateSiremobil C06 -ARCADIS VaricK040066Siemens |
| DICOM functionality | Yes | Yes | Yes |
{7}------------------------------------------------
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-nitionNumber | ProductArea | Title of Standard | ReferenceNumber andDate | Organization |
|---|---|---|---|---|
| 19-4 | General II(ES/EMC) | Medical electrical equipment - Part1:General requirements for basic safetyand essential performance | 60601-1:2005 | AAMIANSI |
| 19-1 | General II(ES/EMC) | Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests | 60601-1- 2:2007 | IEC |
| 12-210 | Radiology | Medical electrical equipment - Part 1-3:General requirements for basic safetyand essential performance - CollateralStandard: Radiation protection indiagnostic X-ray equipment | 60601-1-3:2008 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part 2-28: Particular requirements for the basicsafety and essential performance of X-ray tube assemblies for medicaldiagnosis | 60601-2-28:2010 | IEC |
| 12-202 | Radiology | Medical electrical equipment - Part 2-43: Particular requirements for thesafety and essential performance of X-ray equipment for interventionalprocedures | 60601-2-43:2010 | IEC |
| 12-274 | Radiology | Medical electrical equipment - Part 2-54: Particular requirements for the basicsafety and essential performance of X-ray equipment for radiography andradioscopy | 60601-2-54:2009 | IEC |
{8}------------------------------------------------
| Recog-nitionNumber | ProductArea | Title of Standard | ReferenceNumber andDate | Organization |
|---|---|---|---|---|
| 5-40 | General I(QS/RM) | Medical devices - Application of riskmanagement to medical devices | 14971:2007 | ISO |
| 12-238 | Radiology | Digital Imaging and Communications inMedicine (DICOM) Set | PS 3.1 - 3.20(2011) | NEMA |
| 12-273 | Radiology | Safety of laser products - Part 1:Equipment classification, andrequirements | 60825-1: 2007 | IEC |
| 13-8 | Software/Informatics | Medical device software - Software lifecycle processes | 62304:2006 | IEC |
| 5-67 | General I(QS/RM) | Medical devices - Application ofusability engineering to medical devices | 62366:2007 | AAMI ANSIIEC |
| 12-229 | Radiology | Medical electrical equipment - Radiationdose documentation - Part1: Equipmentfor radiography and radioscopy | PAS 61910-1:2007 | 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
{9}------------------------------------------------
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
{10}------------------------------------------------
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.
§ 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.