(132 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description of the device and testing focuses on standard imaging system performance and software validation.
No
This device is an X-ray imaging system, which is used for diagnosis and visualization, not for treating diseases or conditions.
Yes
The device is described as providing "X-ray imaging of the anatomical structures of patient," and while it's also used for "interventional fluoroscopic" procedures, the primary function of "imaging" to visualize structures implies a diagnostic capability.
No
The device description clearly outlines hardware components, specifically a C-arm with an X-ray source and flat panel detector, and an image display station with a trolley. The software is part of a larger hardware system.
Based on the provided information, the Cios Alpha is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide X-ray imaging of the anatomical structures of a patient during clinical applications. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details a mobile X-ray system with a C-arm and an image display station. This is consistent with an in-vivo imaging device, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cios Alpha's function is to create images of the inside of the patient's body using X-rays.
N/A
Intended Use / Indications for Use
The Cios Alpha 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
Device Description
The Cios Alpha mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes. The system consists of two major components:
- a) The C-arm with an 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 lifted vertically, shifted to the side and moved forward/backward by an operator.
- b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.
The main C-arm component 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 Alpha. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device the Cios Alpha (VA30) for the following device modifications made to the Predicate Device (Cios Alpha (VA10).
The following software and hardware modifications are included in the Subject Device, Cios Alpha (VA30):
A new system software version (VA30) contains new software and hardware features for a new flat panel detector; new features Target Pointer, Cios Open Apps and Digital Cine Mode.
In addition to software changes this submission contains the following new hardware features: a remote control unit mounted on the cart; an anti-microbial coating on the C-arm and trolley, a wireless footswitch and a proposed claims list.
The modified Subject Device Cios Alpha is within the same classification regulation with the same indication for use as the predicate devices.
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
The patient population may include 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
Non-clinical tests were conducted on the Subject Device Cios Alpha software version VA30 during product development. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conduct to test the functionality of the Cios Alpha (VA30). Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness.
Non-clinical tests were conducted on the Subject Device Cios Alpha software version VA30 during product development. 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 was found acceptable to support the claims of substantial equivalence.
All new software functions present in the Subject Device (Cios Open-Apps, Target Pointer, and Digital Cine Mode) have been validated through detailed software testing and it was founded they worked as intended. 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.
Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation.
With regards to the flat panel detector (SSXI), the test documentation provided in this submission demonstrates compliance of the Cios Alpha to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices". The evaluation includes but is not limited to the following performance specifications identified in the SSXI guidance, showing comparable or better performance of the Cios Alpha to its predicate and referenced devices.
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.
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
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Siemens Medical Systems USA, Inc. Patricia Jones Sr. Regulatory Affairs Technical Specialist 40 Liberty Boulevard, 65-1A Malvern, Pennsylvania 19355
October 24, 2018
Re: K181560
Trade/Device Name: Cios Alpha Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO Dated: June 12, 2018 Received: June 14, 2018
Dear Patricia 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
Image /page/1/Picture/7 description: The image shows the name "Michael D. O'hara -S" in a large font. To the right of the name is a digital signature block that includes information such as the date, time, and other details related to the digital signature. The date of the signature is 2018.10.24 at 07:53:42 -04'00'.
Robert A. 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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Traditional 510(k) Submission: Cios Alpha (VA30)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K181560 |
|---|---|
| Device Name | Cios Alpha |
| Indications for Use (Describe) | The Cios Alpha 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) | 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
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"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 |
|---|---|
| ---------------------- | ------------- |
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Image /page/3/Picture/0 description: The image displays the Siemens Healthineers logo, with "SIEMENS" in teal and "Healthineers" in orange. To the right of the logo are orange dots arranged in a pattern. Below the logo, the text "510(k) Summary: Cios Alpha" is written in bold.
Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Date Prepared: October 2, 2018
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: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site/Manufacturer: SIEMENS AG Sector Healthcare Röntgenstrasse 19 - 21 D-95478 Kemnath, Germany Establishment Registration Number: 3002466018
- General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.jones@siemens-healthineers.com
3. Device Name and Classification:
Trade Name: Cios Alpha Classification Name: Image-intensified Fluoroscopic X-Ray
System
System
Classification Panel: Requlation Number: Device Class: Product Code:
Radiology 21 CFR §892. 1650 Class II OWB, OXO
-
- Legally Marketed Predicate Devices Trade Name: Cios Alpha 510(k) Clearance K132094 Clearance Date 03/11/2014
4
| Classification Name: | Image-intensified Fluoroscopic X-Ray |
|---|---|
| System | |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, OXO |
| Recall Information: | 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. | |
| Trade Name: | ARTIS pheno |
| 510(k) Clearance | K163286 |
| Clearance Date | 03/09/2017 |
| Classification Name: | Image-intensified Fluoroscopic X-Ray |
| System | |
| Classification Panel: | Radiology |
| Regulation Number | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA |
| Recall Information: | 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. | |
| Trade Name: | ARCADIS Avantic |
| 510(k) Clearance | K051133 |
| Clearance Date | 03/09/2017 |
| Classification Name: | Image-intensified Fluoroscopic X-Ray |
| System | |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA |
| Recall Information: | No recalls |
5. Device Description:
The Cios Alpha mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes. The system consists of two major components:
- a) The C-arm with an 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 lifted vertically, shifted to the side and moved forward/backward by an operator.
- b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.
5
ineers
The main C-arm component 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 Alpha. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device the Cios Alpha (VA30) for the following device modifications made to the Predicate Device (Cios Alpha (VA10).
The following software and hardware modifications are included in the Subject Device, Cios Alpha (VA30):
A new system software version (VA30) contains new software and hardware features for a new flat panel detector; new features Target Pointer, Cios Open Apps and Digital Cine Mode.
In addition to software changes this submission contains the following new hardware features: a remote control unit mounted on the cart; an anti-microbial coating on the C-arm and trolley, a wireless footswitch and a proposed claims list.
The modified Subject Device Cios Alpha is within the same classification regulation with the same indication for use as the predicate devices.
6. Indications for Use:
The Cios Alpha 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 Alpha (VA30) is substantially equivalent to the commercially available primary predicate device Siemens Cios Alpha (VA10), cleared 11/03/2014 with K132094.
Indication for use remains unchanged the technology is similar. The predicate Flat Panel detector (a-Si technology) has been replaced by a CMOS Flat Panel detector. X-ray generation and control used with the Cios Alpha is similar to the technology used with the primary predicate device Cios Alpha. Table 1 provides primary and secondary Predicate Device comparable information.
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance Date | Comparable Properties |
|-------------------------------------------------|------------------|----------------|-----------------------|
| Siemens : Cios Alpha
Product Codes: OWB, OXO | K132094 | March 11, 2014 | -Indications for Use |
Table 1: Primary and Secondary Comparable Properties
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| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance Date | Comparable Properties |
|---------------------------------------------------------------------------------------------------------------|------------------|-------------------|-------------------------------------------------------------------------------------|
| Primary Predicate | | | -System for Image Acquisition
- Post processing software
-Detector |
| Siemens: ARTIS pheno
Product Codes: OWB, JAA
Secondary Predicate | K163286 | March 09, 2017 | -Anti-Microbial Coating
-Anti-Microbial Coating Claims
-Cleaning Instructions |
| Siemens : ARCADIS Avantic
Product Codes: OXO
Secondary Predicate | K051133 | June 01, 2005 | -Digital Cine Mode (DCM) |
| Reference 510(k) Information | | | |
| ZIEHM IMAGING GMBH
Reference 510(k): ZIEHM
Vision RFD Product Codes:
OWB, OXO JAA | K132904 | December 12, 2013 | -Detector Information |
| ZIEHM IMAGING GMBH
Reference 510(k):
Solo FD Mobile Imaging
System
Product Codes:
OWB, OXO JAA | K161976 | October 6, 2016 | -Detector Information |
8. Summary of Technological Characteristics of the Subject Device as Compared to the Predicate Devices:
The Subject Device Cios Alpha (VA30) is substantially equivalent to the commercially available Siemens Cios Alpha (VA10), cleared 03/11/2014 with K132094 since the Indications for Use remains unchanged and technology and design of the Cios Alpha (VA30) is based on the Cios Alpha (VA10).
The predicate Flat Panel detector (a-Si technology) has been replaced by a CMOS Flat Panel detector and an optional available wireless footswitch is being introduced.
An anti-microbial coating is being added to the Cios Alpha (VA30) trolley. The anti-microbial coating and associated claims were cleared in the secondary Predicate Device the ARTIS pheno (K163286) on March 9, 2017.
A software function, Digital Cine Mode (DCM) the same function as the DCM Mode that was cleared in the secondary predicate device the ARCADIS Avantic (K051133) on June 1, 2005, was also added.
Table 2 below provides comparison of the Subject Device modification to the Predicate Devices.
7
SIEMENS Healthineers
Comparison of Technological Characteristics Table 2:
| Subject Device
Cios Alpha (VA30)
Indications For Use Statement | | | Primary Predicate Device
Cios Alpha (VA10) K132094
Indications For Use Statement | | | | Comparison
Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| The Cios Alpha 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 Cios Alpha 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. | | | | Same |
| Property | Subject Device
Cios Alpha
(VA30) | Primary
Predicate
Device
Cios Alpha
(VA10)
K132094 | Secondary
Predicate
Device
Artis Pheno
K163286 | Secondary
Predicate
Device
ARCADIS
Avantic
K051133 | Comparison Results | | |
| 1. System
Software | New Software
Version VA30 | Version
VA10 | N/A | N/A | VA30 was developed to
support identified
modifications (a-d).
Testing requirements are
acceptable per Software
and SSXI guidance
requirements. | | |
| | a) Two New Flat
Panel
Detectors New
Detector
XINEOS-
3030HS and
XINEOS
2222HS
(Software &
Hardware) | a-Si
technology | CSX-30
Detector
CMOS
Technology | N/A | Equivalent image quality
does not raise any new
issues of safety of
effectiveness. Non-
clinical testing was
conducted and is
acceptable per SSXI
Guidance Document | | |
| | b) Target Pointer
(Software)
This
application
enables the
automatic
detection of
K-wires and
displays the
trajectory as
a projection
to the
opposite
edge of the
image.
Displaying
the trajectory
is intended to
help the
surgeon to
better predict
the position
of the K-wire | N/A | N/A | N/A | Testing requirements are
acceptable per Software
Guidance, does not raise
any new issues of safety
of effectiveness. | | |
| Property | Subject Device
Cios Alpha
(VA30) | Primary
Predicate
Device
Cios Alpha
(VA10)
K132094 | Secondary
Predicate
Device
Artis Pheno
K163286 | Secondary
Predicate
Device
ARCADIS
Avantic
K051133 | Comparison Results | | |
| | | in an early
phase of the
insertion. | | | | | |
| | | c) Cios Open
Apps –
(Hardware &
Software) | N/A | N/A | N/A | Testing requirements are
acceptable per Software
Guidance, does not raise
any new issues of safety
of effectiveness. | |
| | | d) Digital Cine
Mode (DCM)
(Software) | | | Software
function DCM
mode | Same functionality as
cleared in the secondary
Predicate Device. Does
not raise any new safety
or effectiveness issues | |
| 2. | Remote
control
Unit | Remote control
unit available
(unmodified); may
be mounted on
table or
additionally on
remote control unit
cart | Remote
control unit
available; may
be mounted
on patient
table | N/A | N/A | Does not raise any new
safety or effectiveness
issues | |
| 3. | Additional
of Optional
Anti-
Microbial
Coating | Optional Anti-
Microbial Coating
(C-arm & Trolley)
w/ cleaning
instructions | N/A | Optional Anti-
Microbial
Coating (C-
arm & Table
Base) | N/A | Same Coating and
Cleaning Instructions
cleared in Artis pheno
510(k) K163286 | |
| 4. | Footswitch | Wired footswitch | Wired
footswitch | N/A | N/A | Same | |
| | | Optional wireless
footswitch | Wired
footswitch | N/A | N/A | Optional wireless
footswitch with same
functionality like wired
footswitch. Wireless
version does not raise
any new safety or
effectiveness issues. | |
| 5. | Product Claims List: Product claims list along with supportive information. | | | | | | |
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The subject device modifications do not alter the fundamental scientific technology from the 510(k) cleared primary predicate device Siemens Cios Alpha (VA10), K132094 and secondary predicate devices Siemens ARTIS pheno K163286 and Siemens ARCADIS Avantic K051133.
9. Non-Clinical Performance Testing :
The Cios Alpha is certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following voluntary standards listed in Table 3 below:
Table 3: Conformance Standards
Standards Development Organization Standards Development Organization Reference Number and Date Reference Number and Date
9
SIEMENS .::
| Standards Development Organization
Reference Number and Date | | Standards Development Organization
Reference Number and Date | |
|-----------------------------------------------------------------|----------------------------------------|-----------------------------------------------------------------|------------------------------------------|
| 1 | AAMI ANSI ES60601-1:2005/
(R)2012 | 7 | IEC 60601-2-28:2010 |
| 2 | AMI ANSI IEC 60601-1-2:2014 | 8 | IEC 60601-2-43:2017
(recognized 2010) |
| 3 | IEC 60601-1-3:2013 | 9 | IEC 60601-2-54:2009/A1:2015 |
| 4 | IEC 60601-1-6:2010/A1:2013 | 10 | ISO 14971:2007 |
| 5 | IEC 60825-1:2014
(recognized: 2007) | 11 | IEC 62366-1:2015/Cor1:2016 |
| 6 | IEC 62304:2015 | | |
Table 4: FDA Guidance Documents
| FDA Guidance Documents 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 January 30, 2018 | |
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated |
| 510(k)s - Guidance for Industry and FDA Staff | |
| Document issued on August 12, 2005 | |
| 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 (SSXI) 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 9, 1999 | |
| 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: Radio Frequency Wireless Technology |
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| FDA Guidance Documents and Effective Date | |
|---|---|
| in Medical Device | |
| Document issued on August 14, 2007. | |
| 13. | Guidance for Industry and FDA Staff: Information to Support a Claim of |
| Electromagnetic Compatibility (EMC) of Electrically-Powered Medical | |
| Devices |
Document issued on July 11, 2016
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. Non-clinical tests were conducted on the Subject Device Cios Alpha software version 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 was found acceptable to support the claims of substantial equivalence.
The Cios Alpha 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. All new software functions present in the Subject Device (Cios Open-Apps, Target Pointer, and Digital Cine Mode) have been validated through detailed software testing and it was founded they worked as intended. 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. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.
Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation.
With regards to the flat panel detector (SSXI), the test documentation provided in this submission demonstrates compliance of the Cios Alpha to "Guidance for the
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SIEMENS Healthineers
Submission of 510(k)'s for Solid State X-ray Imaging Devices". The evaluation includes but is not limited to the following performance specifications identified in the SSXI guidance, showing comparable or better performance of the Cios Alpha to its predicate and referenced devices. Provided in Table 5 is comparative information showing the equivalence between the Subject and Predicate Device detectors.
| Table 5: SSXI Specifications | ||
|---|---|---|
| -- | -- | ------------------------------ |
| Cios Alpha Performance compared to Predicate and Reference Devices | ||||
|---|---|---|---|---|
| SSXI Metrics | Subject Device | |||
| Cios Alpha | ||||
| (VA30) | Predicate | |||
| Device Cios | ||||
| Alpha (VA10) | ||||
| K132094 | Reference | |||
| Device | ||||
| Ziehm Vision | ||||
| RFD | ||||
| K132904 | Reference Device | |||
| Ziehm Solo FD | ||||
| K161976 | ||||
| Imaging | ||||
| Modes | Pulsed | |||
| fluoroscopy | Pulsed | |||
| fluoroscopy | Pulsed | |||
| Fluoroscopy | Pulsed Fluoroscopy |
Digital Spot |
| DQE | Single images
75% (small)
72% (large) | Single images
76% | Digital Spot
Information Not
Available | 70% |
| Dynamic
Range | 96dB | 94dB | Information Not
Available | Equivalent |
| Modulation
Transfer
Function
(MTF) | 60% at 1 lp/mm
(small)
58% at 1 lpmm
large) | 55% at 1 Lp/mm | Information Not
Available | 4lp/mm |
| Digitization
depth | 16 bit | 16 bit | 16 bit | 16 bit |
| Pixel Pitch | 152 μm | 194μm | 194 μm | 100 μm |
| Field of View | Small FD:
- 20 cm x 20 cm
- 15 cm x 15 cm
- 10 cm x 10 cm
Large FD: - 30 cm x 30 cm
- 20 cm x 20 cm | Small FD:
- 20 cm x 20 cm
- 15 cm x 15 cm
- 10 cm x 10 cm
Large FD: - 30 cm x 30 cm
- 20 cm x 20 cm | FPD 20 cm:
• 20 cm
• 15 cm
• 10 cm | FPD 20 cm:
• 20 cm
• 15 cm
• 10 cm |
Since Cios Alpha's' new flat panel detector does not change the system's intended use and was found to be equivalent in technological characteristics, with the predicate device after conducting the test in the SSXI Guidance, clinical images are not required.
Summary:
Performance tests were conduct to test the functionality of the Cios Alpha (VA30). Results of all conducted testing 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 in the device labeling section. The labeling information provided will enable the user to operate the device in a safe and
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effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Cios Alpha is continually monitored and if an error occurs, the system functions will be blocked and an error message will be displayed.
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.
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 Alpha (VA30) acceptance criteria are adequate for the intended use of The comparison of technological characteristics, non-clinical the device. performance data and software validation demonstrates that the Subject Devices are as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use.