Cios Connect

K153147 · Siemens Medical Solutions USA, Inc. · OWB · Jan 12, 2016 · Radiology

Device Facts

• Record ID: K153147
• Device Name: Cios Connect
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OWB · Radiology
• Decision Date: Jan 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cios Connect is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Story

Mobile fluoroscopic C-arm system; consists of mobile acquisition unit (X-ray control, C-arm, high-frequency generator, X-ray tube, image intensifier) and monitor cart (TFT displays, digital image processing, storage). Inputs: X-ray radiation; outputs: real-time fluoroscopic images. Used in OR, trauma, endoscopy, ICU, pediatrics, ambulatory, and veterinary settings by clinicians. Operates in six modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, Roadmapping. Supports clinical procedures like bile duct display, implant positioning, pain therapy, and catheter placement. Healthcare providers view images on integrated TFT displays to guide interventional procedures. Benefits include real-time visualization for minimally invasive surgical guidance and diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation performed at unit, subsystem, and system levels to confirm performance against engineering requirements, risk management hazards, and acceptance criteria. Compliance with IEC 60601-1, 60601-2-43, 60601-2-54, and 60601-1-2 standards verified.

Technological Characteristics

Mobile C-arm fluoroscopic X-ray system. Stationary anode X-ray tube (0.6 mm focal spot); 40-110 kV range; 2.3 kW max power. Image Intensifier detector (23 cm field size) with CCD technology. 1024x1024 matrix. 19" TFT color displays. Connectivity: DICOM (wired/wireless), 2D navigation, lithotripsy, 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 use in operating rooms, traumatology, endoscopy, intensive care, pediatrics, ambulatory care, and veterinary medicine for procedures requiring digital radiography, fluoroscopy, pulsed fluoroscopy, cassette exposures, digital subtraction, and roadmapping, including bile duct display, intra-medullary nail positioning, pain therapy, and catheter/probe placement.

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

• Siremobil C-06 (renamed: Arcadis Varic) (K040066)
• Cios Alpha (K132094)

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

January 12, 2016

Siemens Medical Solutions USA, Inc. % Ms. Patricia D. Jones Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355

Re: K153147

Trade/Device Name: Cios Connect Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, JAA Dated: December 17, 2015 Received: December 18, 2015

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

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) K153147

Device Name Cios Connect

### Indications for Use (Describe)

The Cios Connect is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary: Cios Connect

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: December 17, 2015

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 Solutions USA, Inc. 40 Liberty Boulevard; 65-1A Malvern, PA 19355 Establishment Reqistration 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:

Mr. Darren Dorman Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard · Mail Code 65-1A Malvern, PA 19355, USA Phone: [phone] Email: [e-mail]

# Alternate Contact Person :

Ms. Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail code 65-1A

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard Malvern, PA 19355-1406

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Malvern, PA 19355, USA Phone : [phone] Email : [e-mail]

- 3. Subject Device Name and Classification: Trade Name: Cios Connect
Device: Regulation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class

Image-intensified Fluoroscopic X-ray system, Mobile Radiology Radiology OWB OXO, JAA Traditional 510(k) 892.1650 2

- 4. Legally Marketed Predicate Devices: Primary Predicate:
Trade Name: 510(k) Number: Device:

Regulation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class Recall Information:

Siremobil C-06 (renamed: Arcadis Varic) K040066 Image-intensified Fluoroscopic X-ray system, Mobile Radiology Radiology ОХО JAA Traditional 510(k) 892.1650 2 Z-0118-06; Z-0123-06; Z-0438/9-06

- Secondary Predicate: Trade Name: 510(k) Number: Device: Requlation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class 2 Recall Information:
Cios Alpha K132094 Interventional Fluoroscopic X-Ray system Radiology Radiology OWB ОХО Traditional 510(k) 892.1650 Z-1958-2015

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#### 5. Device Description:

The Siemens Cios Connect mobile fluoroscopy system is an imageintensified 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 Image Intensifier, 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).

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 Connect is a mobile x-rav system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

#### 7. Substantial Equivalence:

The new device Cios Connect is within the same classification regulation for the same indication for use as the Primary predicate Siremobil C-06 (Arcadis Varic) (K040066, cleared 2/12/2004). Other comparable properties of the subject device to the Primary predicate include X-Ray technology, Mechanical design, and the Detector technology. Similarly, the Indication for Use, X-Ray technology, Image processing, and Mechanical design are compared to the Secondary predicate Cios Alpha (K132094, cleared 3/11/2014). 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 Devices:

The Siemens Cios Connect design is based on the Siemens Siremobil C 06 (ARCADIS Varic) (K040066) including the mechanical design, X-ray generator, the Image Intensifier, pulsed fluoroscopy, upgraded to integrate the latest control and image processing functions from the Siemens Cios Alpha (K132094).

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The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table in 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.

| Features /<br>Technology | Subject Device :<br>Cios Connect | Primary Predicate:<br>Siremobil C-06<br>(renamed: Arcadis<br>Varic) K040066 | Secondary Predicate:<br>Cios Alpha K132094 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Mobile fluoroscopic C-<br>arm | Yes | Yes | Yes |
| X-ray tube | Stationary Anode<br>0.6 mm focal spot | Stationary Anode<br>0.6 mm focal spot | Rotating Anode<br>0.3/0.5 mm focal spot |
| Tube housing assembly<br>with high frequency<br>generator | Yes | Yes | Yes |
| kV Range<br>40 kV to 110 kV | 40 kV to 110 kV | 40 kV to 110 kV | 40 kV to 125 kV |
| Max power output | 2.3 kW | 2.3 kW | 12 kW<br>25 kW (optional) |
| Pulsed fluoroscopy | 3 mA to 25 mA | up to 23 mA | 3 mA to 119 mA (12kW) |
| Beam limiting device | Yes, Iris collimator | Yes, Iris collimator | Yes, rectangular<br>collimator |
| X-Ray detector | Image Intensifier with<br>Optics and Digital<br>Video Imaging<br>system (CCD<br>technology) | lmage Intensifier with<br>Optics and TV System<br>(CCD technology) | Solid State Detector |
| Detector active field size | ø 23 cm | ø 23 cm | 20 cm × 20 cm<br>30 cm × 30 cm (optional) |
| Optional cassette holder | Yes | Yes | N/A |
| Optional integrated dose<br>measurement device | Yes | Yes | Yes |
| Matrix size | 1024 × 1024 | 1024 × 1024 | 1024 × 1024<br>(20 cm × 20 cm detector)<br>1536 × 1536<br>(30 cm × 30 cm detector) |
| Displays | 19" TFT Flat Screen<br>Color Display Panels | 19" TFT Flat Screen<br>Display Panels, B/W<br>or 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, membrane<br>keyboards | Yes, membrane<br>keyboards | Yes, touch panels |
| NaviLink 2D integrated | Yes | Yes | No |

Siemens Medical Solutions USA, Inc.

Tel.: [phone] www.usa.siemens.com/healthcare

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| 510(k) Submission: Cios Connect |
|---------------------------------|
| |

| navigation interface | | | |
|-----------------------|-----|-----|-----|
| Lithotripsy interface | Yes | Yes | No |
| DICOM functionality | Yes | Yes | Yes |

#### 9. Testing to Voluntary Consensus Standards

The Siemens Cios Connect has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Connect 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 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 1:<br>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-<br>2: General requirements for basic<br>safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests | 60601-1- 2:<br>2007 | IEC |
| 12-210 | Radiology | Medical electrical equipment - Part 1-<br>3: General requirements for basic<br>safety and essential performance -<br>Collateral Standard: Radiation<br>protection in diagnostic X-ray<br>equipment | 60601-1-3:<br>2008 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part 2-<br>28: Particular requirements for the<br>basic safety and essential<br>performance of X-ray tube assemblies<br>for medical 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<br>basic safety and essential<br>performance of X-ray equipment for<br>radiography and radioscopy | 60601-2-54:<br>2009 | IEC |
| 5-40 | General I | Medical devices - Application of risk | 14971:2007 | ISO |

Siemens Medical Solutions USA, Inc.

Tel.: [phone] www.usa.siemens.com/healthcare

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# Healthcare

510(k) Submission: Cios Connect

| | (QS/RM) | management to medical devices | | |
|--------|--------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------|
| 12-238 | Radiology | Digital Imaging and Communications<br>in 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:<br>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<br>devices | 62366:2007 | AAMI<br>ANSI<br>IEC |
| 12-229 | Radiology | Medical electrical equipment -<br>Radiation dose documentation - Part<br>1: Equipment for radiography and<br>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:

Validation activities have been performed at the System test level on production prototype devices by appropriately trained and knowledgeable 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.

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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 Connect performs as designed and does not raise new questions regarding safety and effectiveness. Therefore, when compared to the predicate devices the Cios Connect supports a determination of substantial equivalence to the predicate devices.

#### 13. Electrical Safety and Electromagnetic Compatibility (EMC):

Electrical safety and EMC testing were conducted on the Cios Connect, 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.

#### 14. Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for 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.

#### 15. Conclusion as to Substantial Equivalence:

The Cios Connect 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 Connect does not introduce any new potential safety risks is substantially equivalent to, and performs as well as the predicate devices.