(22 days)
Not Found
No
The document describes a standard mobile fluoroscopic X-ray system with image processing capabilities, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an X-ray imaging system, which is used for diagnosis and visualization, not for therapeutic intervention or treatment.
No
The device is an X-ray imaging system used to acquire images of anatomical structures, which is a tool for obtaining information, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a C-arm with X-ray source and flat panel detector, and an image display station with a moveable trolley. This indicates it is a hardware-based medical device with integrated software.
Based on the provided information, the Cios Flow is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide X-ray imaging of anatomical structures of the patient during clinical applications. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details a mobile fluoroscopic C-arm X-ray system with an X-ray source and detector. This is a medical imaging device used for visualizing internal structures within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The Cios Flow operates by generating and detecting X-rays that pass through the patient's body, which is a fundamentally different mechanism than an IVD.
N/A
Intended Use / Indications for Use
The Cios Flow 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
The Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Flow provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
- a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
- b) The second unit is the image display station with a moveable trolley for t processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.
The following modifications were made to the predicate device the Cios Fusion. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device Cios Flow (VA30) for the following device modifications made to the Predicate Device (Cios Fusion (VA20).
This 510(k) submission, Subject Device "Cios Flow" with software version VA30" will support the following categories of modifications made to the Subject Device in comparison to Predicate Devices: -
- Modified Software:
- Table 1: Overview of Software Modifications supported by Software Version VA30 ●
-
- Modified Hardware/Software:
- Table 2: Overview of Hardware Modifications supported by Software Version VA30 ●
-
- Modified Hardware changes
- . Table 3: Overview of Hardware Modifications
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
anatomical structures of patient
Indicated Patient Age Range
pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the Cios Flow (VA30) during product development.
The Cios Flow (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- AAMI ANSI ES60601-1:2005/(R)2012 ●
- IEC 60601-1-2:2014 ●
- IEC 60601-1-3:2013 ●
- IEC 60601-1-6:2010/A1:2013 ●
- IEC 60825-1:2014 ●
- IEC 62304:2015 ●
- IEC 60601-2-28:2017 ●
- IEC 60601-2-43:2017 ●
- IEC 60601-2-54:2009/A1:2015 ●
- ISO 14971:2014 ●
- . IEC 62366-1:2015
The modifications described in this Premarket Notification are supported with verification and validation testing.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Flow (VA30) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device acceptable to support the claims of substantial equivalence.
The Cios Flow software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
Performance tests were conducted to test the functionality of Cios Flow (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2020
Siemens Medical Solutions USA, Inc. % Cordell Fields, Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355
Re: K203504
Trade/Device Name: Cios Flow Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: November 25, 2020 Received: November 30, 2020
Dear Mr. Fields:
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. Iisting 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 and Part 809); medical device 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
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number ( if known ) | K203504 |
|---|---|
| Device Name | |
| Cios Flow | |
| Indications for Use ( Describe ) | |
| The Cios Flow 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. |
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| Subpart C) | □ Over-The-Counter Use (21 CFR 801 |
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:
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Food and Drug Administration
Office of Chief Information Officer
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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."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301)443-6740 EF |
3
Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.
510(k) Summary: Cios Flow
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: November 25, 2020
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.
- General Information: 1. lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Röntgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018
2. Contact Person:
Mr. Cordell Fields Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 306-3167 Email: cordell.fields@siemens-Healthineers.com
3. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes: Subsequent Product Code:
Cios Flow Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO JAA
Legally Marketed Primary Predicate Device 4.
| Trade Name: | Cios Fusion |
|---|---|
| 510(k) Clearance | K153244 |
| Clearance Date | March 07, 2016 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
4
Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
Classification Panel: Requlation Number: Device Class: Product Codes: Subsequent Product Code: Total Product Life Cycle:
Radiology 21 CFR §892.1650 Class II OWB, OXO JAA
All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.
Legally Marketed Secondary Predicate Device
| Trade Name: | Cios Alpha |
|---|---|
| 510(k) Clearance | K181560 |
| Clearance Date | October 24, 2018 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Codes: | OWB, OXO |
| Subsequent Product Codes: | JAA |
| Total Product Life Cycle: | All product Recall incidents are considered during the |
| Design Input phase of development to ensure the latest | |
| models will not be affected by any of the applicable |
Legally Marketed Secondary Predicate Device Trade Name: Cios Spin 510(k) Clearance K181550 Clearance Date October 30, 2018 Image-intensified fluoroscopic x-ray System Classification Name: Classification Panel: Radiology Regulation Number: 21 CFR §892.1650 Device Class: Class II Product Code: OWB, OXO Subsequent Product Codes: JAA Total Product Life Cycle: All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable
issue.
issues.
5. Device Description:
The Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Flow provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
- a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
5
Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
- b) The second unit is the image display station with a moveable trolley for t processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.
The following modifications were made to the predicate device the Cios Fusion. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device Cios Flow (VA30) for the following device modifications made to the Predicate Device (Cios Fusion (VA20).
This 510(k) submission, Subject Device "Cios Flow" with software version VA30" will support the following categories of modifications made to the Subject Device in comparison to Predicate Devices:
-
- Modified Software:
- Table 1: Overview of Software Modifications supported by Software Version VA30 ●
-
- Modified Hardware/Software:
- Table 2: Overview of Hardware Modifications supported by Software Version VA30 ●
-
- Modified Hardware changes
- . Table 3: Overview of Hardware Modifications
Table 1. Software Modifications for Cios Flow
| Software changes specific to New System Software VA30 | |
|---|---|
| Device Software Modification | |
| 1. | System Software VA30 software modifications/features |
| A. Target Pointer | |
| B. Digital Cine Mode (DCM) | |
| C. Cios OpenApps | |
| 2. | Interactive User Touch Control (Software component of VA30) |
| A. Collimation Controls | |
| B. Brightness Contrast Controls | |
| C. Rotate and Flip Controls | |
| D. Zoom and Pan Controls | |
| E. Spot Adapt | |
| 3. | Dose Regulation Indicator |
| 4. | New Sound Radiation Delay |
| 5. | New Product Software Security |
| 6. | Upgrade to Windows 10 Operating System |
Table 2: Hardware/Software Modifications for Cios Flow
| Software/Hardware changes specific to New System Software VA30 | ||
|---|---|---|
| Device Hardware/Software Modifications | ||
| 7. | System Software VA30 software/hardware modifications/features | |
| A. New CMOS Flat Panel Detector | ||
| B. Wireless Foot Switch |
6
Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
Table 3. Hardware Modifications
| Device Hardware Modifications | ||
|---|---|---|
| 8. | Optional Laser Light Localizer green | |
| 9. | Optional Cart for Remote Control Unit | |
| 10. | Anti-microbial Coating on C-Arm and Trolley | |
| Other Device Modifications | ||
| 11. | Update 510(k) Information |
6. Indications for Use:
The Cios Flow 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 Cios Flow (VA30) system is substantial equivalent to the legally marketed predicates listed in Table 3 below:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|---------------------------------------------|------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Predicate
Siemens' Cios Fusion | K153244 | 03/07/2016 | ● Indications for use
● System for Image Acquisition
● Post-processing Software
● Examination Settings
● Cyber Security Information |
| Secondary Predicates
Siemens' Cios Alpha | K181560 | 10/24/2018 | ● CMOS Flat Panel Detector
- Large Detector:
Xineos-30 cm x 30 cm - Small detector
Xineos-20 cm x 20 cm
● Wireless Foot Switch
● Cart for Remote Control Unit
● Anti-Microbial Coating
● Target Pointer
● Digital Cine Mode
● Cios Open Apps
● Windows 10 |
| Secondary Predicates
Siemens' Cios Spin | K181550 | 10/30/2018 | ● Laser Light Localizer green |
Table 3: Predicate Device Comparable Properties for Subject Device Modifications:
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Cios Flow (VA30) System is designed as a set of components (floor stand, C-arm, Xray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that is combined to provide a mobile Interventional Fluoroscopic X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
7
Image /page/7/Picture/0 description: The image contains the logos for Siemens and Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Components used with Cios Flow (VA30) System are either commercially available with current Siemens systems or include updated modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in Table 4 below for all modifications.
| Table 4. Summary of Comparison of Technological Characteristics
| Comparison of Modifications to Predicate Devices | |||
|---|---|---|---|
| Subject Device | |||
| Cios Flow (VA30 | |||
| Modifications | Primary Predicate Device | ||
| Cios Fusion | |||
| K153244 | Comparison | ||
| Results | |||
| 1. | System Software VA30 software | ||
| modifications/features | |||
| A. Target Pointer | |||
| B. Digital Cine Mode (DCM) | |||
| C. Cios OpenApps | Secondary Predicate Device | ||
| Cios Alpha K181560 | |||
| Target Pointer | |||
| Digital Cine Mode (DCM) | |||
| Cios OpenApps | Comparable: 1.A-C have the | ||
| same functionality as cleared in | |||
| the Secondary Predicate | |||
| Device Cios Alpha K181560. | |||
| The functionality of Target | |||
| Pointer has not changed | |||
| except for better visualization | |||
| of moving k-wires | |||
| 2. | Interactive User Touch Control | ||
| (Software components of VA30) | |||
| A. Collimation Controls | |||
| B. Brightness Contrast Controls | |||
| C. Rotate and Flip Controls | |||
| D. Zoom and Pan Controls | |||
| E. Spot Adapt | Primary Predicate Device | ||
| Cios Fusion | |||
| K153244 | |||
| Collimation Controls | |||
| Brightness Contrast Controls | |||
| Rotate and Flip Controls | |||
| Zoom and Pan Controls | |||
| Spot Adapt | Comparable: 2.A-E has the | ||
| same functionality as cleared in | |||
| the Primary Predicate device, | |||
| with exception to user interface | |||
| is with Touch Control. The | |||
| functionality of these features | |||
| has not changed from the | |||
| Primary Predicate device | |||
| Cios Fusion K153244. | |||
| 3. | New Dose Regulation Indicator | New Dose Regulation Indicator | Comparable: |
| The Dose regulation is equal to | |||
| the primary predicate Cios | |||
| Fusion. While dose regulation | |||
| remains the same, added is a | |||
| visual feedback to the operator | |||
| 4. | New Sound Radiation Delay | New Sound Radiation Delay | Comparable: |
| Comparable to the primary | |||
| predicate Cios Fusion typically | |||
| there is a delay after press of | |||
| button until the radiation starts. | |||
| While the delay will be similar, | |||
| there is now an acoustical | |||
| feedback to the user that the | |||
| button has been pressed, but | |||
| radiation has not yet started. | |||
| 5. | New Product Software Security | New Product Software Security | Comparable: This Product |
| software provides additional | |||
| cybersecurity feature to protect | |||
| product security. The software | |||
| functionality is the same except | |||
| for inclusions of additional | |||
| software security features. | |||
| The updated functionality is the | |||
| same as cleared in the Primary | |||
| Predicate device, Cios | |||
| Fusion K153244. | |||
| 6. | Upgrade to Windows 10 Operating | ||
| System | Upgrade to Windows 10 Operating | ||
| System | Same: The Windows | ||
| Operating System is the same | |||
| as cleared in the Primary | |||
| Predicate Device with | |||
| Image: Healthineers logo | |||
| Comparison of Modifications to Predicate Devices | |||
| 7. | System Software VA30 | ||
| software/hardware | |||
| modifications/features | Secondary Predicate Device | ||
| Cios Alpha K181560 | exception to an upgraded | ||
| version Windows 10. The | |||
| upgraded functionality is the | |||
| same as cleared in the Primary | |||
| Predicate device Cios Fusion | |||
| K153244. | |||
| A. CMOS Flat Panel Detector | CMOS Flat Panel Detector | Same: The CMOS Flat Panel | |
| Detector is the exact same | |||
| detector cleared in the | |||
| Secondary Predicate Device | |||
| Cios Alpha K181560. | |||
| B. Wireless Foot Switch | Wireless Foot Switch | Same: The Wireless Foot | |
| Switch is the same as in the | |||
| Secondary Predicate Device | |||
| Cios Alpha K181560. | |||
| 8 | Optional Laser Light Localizer, green | Secondary Predicate Device | |
| Cios Spin K181550 | |||
| Optional Laser Light Localizer, | |||
| green | Same: The Optional Green | ||
| Laser Light Localizer is the | |||
| same aimer cleared in the | |||
| Secondary Predicate Device | |||
| Cios Spin K181550 | |||
| 9 | Optional Cart for Remote Control Unit | Secondary Predicate Device | |
| Cios Alpha K181560 | |||
| Optional Cart for Remote Control | |||
| Unit | Same: The Optional Cart for | ||
| Remote Control Unit is the | |||
| same cart cleared in the | |||
| Secondary Predicate Device | |||
| Cios Alpha K181560. | |||
| 10 | Anti-microbial Coating on C-Arm and | ||
| Trolley | Anti-microbial Coating on C-Arm | ||
| and Trolley | Same: The Anti-microbial | ||
| Coating on C-Arm and Trolley | |||
| is the same cart cleared in the | |||
| Secondary Predicate Device | |||
| Cios Alpha K181560. |
Table 4: Summary of Comparison of Technological Characteristics
8
Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a pattern.
Nonclinical Performance Testing: 9.
Non-clinical tests were conducted for the Cios Flow (VA30) during product development.
The Cios Flow (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- AAMI ANSI ES60601-1:2005/(R)2012 ●
- IEC 60601-1-2:2014 ●
- IEC 60601-1-3:2013 ●
- IEC 60601-1-6:2010/A1:2013 ●
- IEC 60825-1:2014 ●
- IEC 62304:2015 ●
- IEC 60601-2-28:2017 ●
- IEC 60601-2-43:2017 ●
- IEC 60601-2-54:2009/A1:2015 ●
- ISO 14971:2014 ●
- . IEC 62366-1:2015
Table 5: FDA Guidance Documents
9
Healthine
| FDA Guidance Document and Effective Date | ||
|---|---|---|
| 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket | |
| Notification Submissions 510(k) | ||
| Document issued on October 2, 2017 | ||
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy | |
| for 510(k)s | ||
| Document issued on September 13, 2019 | ||
| 3. | Guidance for Industry and FDA Staff: The Special 510(k) Program | |
| Document issued on September 13, 2019 | ||
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change | |
| to an existing device. | ||
| Document issued on October 25, 2017 | ||
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | ||
| Document Issued on July 28, 2014 | ||
| 6. | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid | |
| State X-ray Imaging Devices | ||
| Document issued on September 1, 2016 | ||
| 7. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket | |
| Submission for Software in Medical Devices | ||
| Document issued on May 11, 2005 | ||
| 8. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in | |
| Medical Devices | ||
| Document issued on September 27, 2019 | ||
| 9. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability | |
| Engineering to Medical Devices. | ||
| Document issued February 3, 2016 | ||
| 10. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device | |
| Premarket Notifications. | ||
| Document issued on November 28, 2017 | ||
| 11. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for | |
| Management of Cybersecurity in Medical devices. | ||
| Document issued on October 2, 2014 | ||
| 12. | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary Consensus | |
| Standards in Premarket Submission for Medical Devices | ||
| Document issued on September 14, 2018 | ||
| 13. | Guidance for Industry and FDA Staff: Medical Device Accessories - Describing | |
| Accessories and Classification Pathways | ||
| Document issued on December 20, 2017 | ||
| 14. | Guidance for Industry and FDA Staff: Recommended Content and Format of Non- | |
| Clinical Bench Performance Testing Information in Premarket Submissions | ||
| Document issued on December 20, 2019 |
The modifications described in this Premarket Notification are supported with verification and validation testing.
Verification and Validation:
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Flow (VA30) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the
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acceptance criteria. Testing for verification and validation for the device acceptable to support the claims of substantial equivalence.
The Cios Flow software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. Compliance with IEC 80001-1-2010 is the responsibility of the hospital. Provided in the Software Section is the required cybersecurity information.
Summary:
Performance tests were conducted to test the functionality of Cios Flow (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
10. 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, 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.
11. Conclusion as to Substantial Equivalence:
The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Flow (VA30) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.