(45 days)
Not Found
No
The document mentions "Digital Imaging Processing System" and "image processing" but does not mention AI, ML, or any related terms like deep learning or neural networks. The description of testing focuses on standard software and hardware validation, not AI/ML model training or evaluation.
No.
The device is an X-ray imaging system, not a therapeutic device. It is used for diagnostic imaging procedures, such as displaying intraoperative bile ducts or positioning catheters, rather than for treating diseases or conditions.
No
The device is an X-ray imaging system that captures images for clinical procedures but does not inherently analyze or interpret those images to provide a diagnosis.
No
The device description clearly states it is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart, which are hardware components. The summary also mentions hardware updates and testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a mobile X-ray system used for imaging procedures in various clinical settings. This involves generating and displaying X-ray images of the body.
- Device Description: The device description details the components of an X-ray imaging system (X-ray control, C-arm, generator, detector, monitor cart, image processing).
- Functionality: The described modes (Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy) are all related to generating and displaying X-ray images.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to detect diseases, conditions, or infections. This device is an imaging system used to visualize internal structures of the body in vivo (within the body).
N/A
Intended Use / Indications for Use
The Cios Select 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 Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO
Device Description
The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (DVD, USB).
The new detector PaxScan 2121DXV is a new component to the subject device Cios Select. This is a hardware change that impacts the system software VA20. The essential performance of the detector is to generate (a sequence of) digital images in which the digital pixel values are representative of the intensity of the spatially distributed X-Ray radiation at the position of the detector. All the non-clinical performance data demonstrate that the detector PaxScan 2121DXV for Cios Select VA20 does not raise any new issues of safety or effectiveness and is as safe, and effective when compared to the secondary predicate devices Cios Fusion (K153244) that is currently marketed for the detector technology.
Interfaces are provided for optional devices such as external monitors, thermal printers, as well as wired and wireless DICOM network interfaces.
The following modifications are incorporated to create the Subject Device the Cios Select (VA20):
- Updated the Indications for Use Statement with minor changes
- Upgraded software, from Version VA10 to Version VA20:
a. New User Interface touch panel (software)
b. New flat detector (PaxScan 2121DXV) (software)
c. (OTS) software from Windows 7 to Windows 10. (software)
d. Updated Image storage to a maximum of 300000 frames (software)
e. Optional Metal Artifact Reduction Software (cleared in Secondary Predicate Cios Fusion K153244) - New user interface in-touch panel for navigating and operating the system. (Hardware)
- New optional wireless LAN for network connectivity (Hardware)
- New optional wireless footswitch in addition to the wired footswitch. (Hardware)
- New flat detector (PaxScan 2121DXV) to replace image intensifier for image receptor.(Hardware)
Mentions image processing
Yes, "Digital Imaging Processing System", "image processing functions"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The operators are health care professionals familiar with and responsible for the evaluating and postprocessing of X-ray images.
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
Bench testing in the form of Unit, Subsystem and System Integration testing were 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 have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
Electrical safety and EMC testing were conducted on the Cios Select, consisting of the acquisition unit (C-arm system) and the image processing and display station.
The Cios Select software (VA20) 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 (New User Interface touch panel, New flat detector (PaxScan 2121DXV), (OTS) software from Windows 7 to Windows 10 and Updated Image storage to a maximum of 300000 frames) 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 nonclinical 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. X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed with acceptable results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the Cios Select (VA20). These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing and clinical assessments 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
August 17, 2018
Siemens Medical Solutions USA, Inc. % Ms. Patricia Jones Senior Regulatory Affairs Technical Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355
Re: K181767
Trade/Device Name: Cios Select Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO Dated: July 02, 2018 Received: July 03, 2018
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. 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 (QS) 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.
Hol. 2. Nils
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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| 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 below. | |
| 510(k) Number (if known) | K181767 | |
| Device Name | Cios Select | |
| Indications for Use (Describe) | The Cios Select 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 Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants 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) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human Services | ||
| Food and Drug Administration | ||
| Office of Chief Information Officer | ||
| Paperwork Reduction Act (PRA) Staff | ||
| PRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
3
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Section 7 510(k) Summary
The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website.
4
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510(k) Summary: Cios Select
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: August 16, 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: 1.
lmporter / Distributor:
Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Reqistration Number: 2. 2240869
Manufacturing Site:
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318, China Establishment Registration Number: 3003202425
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 Select |
|---|---|
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1650 |
| Submission Type: | Traditional 510(k) |
| Device Class: | Class II |
| Product Code: | OWB |
| Subsequent Product Code: | OXO |
5
SIEMENS Healthineers
-
- Legally Marketed Predicate Device: Primarv Predicate: Cios Select Trade Name: K153232 510(k) #: Clearance Date: February 10, 2016 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: Class II Product Code: OWB Subsequent Product Code: JAA, OXO Recall Information: No Recalls Secondary Predicate: Trade Name: Cios Fusion 510(k) #: K153244 March 07, 2016 Clearance Date: Classification Name: Image-intensified fluoroscopic x-ray svstem Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: Class II Product Code: OWB Subsequent Product Code: ОХО No Recalls Recall Information:
5. Device Description:
The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (DVD, USB).
The new detector PaxScan 2121DXV is a new component to the subject device Cios Select. This is a hardware change that impacts the system software VA20. The essential performance of the detector is to generate (a sequence of) digital images in which the digital pixel values are representative of the intensity of the spatially distributed X-Ray radiation at the position of the detector. All the non-clinical performance data demonstrate that the detector PaxScan 2121DXV for Cios Select VA20 does not raise any new issues of safety or effectiveness and is as safe, and effective when compared to the secondary predicate devices Cios Fusion (K153244) that is currently marketed for the detector technology.
6
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Interfaces are provided for optional devices such as external monitors, thermal printers, as well as wired and wireless DICOM network interfaces.
The following modifications are incorporated to create the Subject Device the Cios Select (VA20):
-
- Updated the Indications for Use Statement with minor changes
-
- Upgraded software, from Version VA10 to Version VA20:
- a. New User Interface touch panel (software)
- b. New flat detector (PaxScan 2121DXV) (software)
- (OTS) software from Windows 7 to Windows 10. (software) C.
- d. Updated Image storage to a maximum of 300000 frames (software)
- e. Optional Metal Artifact Reduction Software (cleared in Secondary Predicate Cios Fusion K153244)
-
- New user interface in-touch panel for navigating and operating the system. (Hardware)
-
- New optional wireless LAN for network connectivity (Hardware)
-
- New optional wireless footswitch in addition to the wired footswitch. (Hardware)
-
- New flat detector (PaxScan 2121DXV) to replace image intensifier for image receptor.(Hardware)
6. Indication for Use:
The Cios Select 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 Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
7. Substantial Equivalence:
The Cios Select (VA20) is substantially equivalent to the commercially available primary predicate device Siemens Cios Select (VA10), cleared February 10, 2016, with K153232.
The Indications for Use was slightly modified, however, the change does not impact the Intended Use of the device. Table 1 provides primary and secondary Predicate Devices comparable information:
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The Cios Select is substantially equivalent to the following predicate devices:
Table 1: Predicate Device Comparable Properties:
| Predicate Device(s) Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|--------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|--------------------------------------------------------------------------------------------------|
| Primary Predicate Device
Cios Select (VA10)
Product Code: OWB, OXO,
JAA
Siemens Shanghai Medical
Equipment Ltd. | K153232 | 2/10/2016 | ●
ndications for use
●
-ray technology
●
mage processing
●
echanical design |
| Secondary Predicate Device
Cios Fusion (VA20)
Product Code:
OWB, OXO
Siemens Healthcare GmbH | K153244 | 3/07/2016 | ●
etector Technology |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Subject device Cios Select design is based on the Siemens Cios Select(K153232) including the system control, mechanical design and image processing functions. The flat panel detector technology is based on the Cios Fusion (K153244).
The subject device has the same fundamental scientific technologies as the
predicate devices. The modifications do not affect the intended use of the device. Table 2 has Subject Device characteristics compared to the Predicate Device.
| Modifications | Subject Device
Cios Select
(VA20) | Primary
Predicate Device
Cios Select
(VA10) K153232 | Secondary
Predicate Device
Cios Fusion
(VA20) K153244 | Comparison Results |
|---------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Software | Upgraded
software, from
Version VA10 to
Version VA20. | Software Version
VA10 | N/A | System Software
upgraded to VA20 to
support new software /
hardware modifications
and tested per software
and guidance and SSXI
Guidance. All test
results passed. |
| User
Interface | New user
interface in a
touch panel for
navigating and
operating the | Keyboard button
based User
interface | N/A | The functionality of the
device remains the
same as the predicate
device except for the
new User Interface with |
| Modifications | Subject Device
Cios Select
(VA20) | Primary
Predicate Device
Cios Select
(VA10) K153232 | Secondary
Predicate Device
Cios Fusion
(VA20) K153244 | Comparison Results |
| | system. | | | Touchscreen panel. |
| WLAN | New optional
wireless LAN for
network
connectivity. | N/A | N/A | The WLAN network
connectivity feature is in
compliance with the
Wireless Guidance
document. |
| Footswitch | Wired
Optional
Wireless
footswitch | Wired Only | N/A | Optional wireless
footswitch with the same
functionality as a wired
footswitch. Wireless
version does not raise
any new safety or
effectiveness issue.
This feature is in
compliance with the
Wireless Guidance
document. |
| Image
Receptor | New flat
detector
PaxScan
(2121DXV) | Image Intensifier | Detector
PaxScanTM 2020X
and PaxScanTM
3030X Detector
was cleared in the
predicate | Detector technology is
comparable to
secondary predicate
device Cios Fusion
(K153244) per the SSXI
Guidance document and
does not raise any new
safety or effectiveness
issues. |
| Off The Shelf
Software | Upgraded Off-
the-Shelf (OTS)
software from
Windows
version 10. | Windows 7 | N/A | Tested per Software
Guidance and Off the
Shelf Software
Guidance. |
| Image
Storage | Updated Image
storage to a
maximum of
300000 frames. | 150000 frames | N/A | Increased system
capability for image
storage. This
modification does not
raise new issues of
safety or effectiveness. |
Table 2: Comparison of Technological Characteristics
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9. Non-Clinical Testing
The Siemens Cios Select has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select complies with the following 21 CFR Federal Performance Standards:
1020.30 Diagnostic X-Ray Systems and their major components 1020.32 Fluoroscopic equipment
1040.10Laser products
and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
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Table 3: Voluntary Conformance Standards:
| Recog-
nition
Number | Product
Area | Title of Standard | Reference Number
and Date | Standards
Development
Organization |
|----------------------------|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------|
| 19-4 | General | Medical Electrical Equipment - Part
1: General Requirements for
Safety, 2005 | 60601-1:2012, ed. 3.1 | IEC |
| 19-8 | General | Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance -
Collateral Standard:
Electromagnetic disturbances -
Requirements and tests | 60601-1-2 Edition 4.0
2014-02 | IEC |
| 12-269 | Radiology | Medical electrical equipment - Part
1-3: General requirements for basic
safety and essential performance -
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment | 60601-1-3 Edition 2.1
2013-04 | IEC |
| 5-114 | General | Medical devices - Part 1:
Application of usability engineering
to medical devices [Including
CORRIGENDUM 1 (2016)] | 62366-1 Edition 1.0
2015-02 | IEC |
| 5-70 | General I
(QS/RM) | Medical devices – application of
risk management to medical
devices | 14971:2012 | ISO |
| 13-32 | Software | Medical device software - Software
life cycle processes | 62304 Ed. 1.0
2006 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part
2-28: Particular requirements for
the basic safety and essential
performance of X-ray tube
assemblies for medical diagnosis | 60601-2-28 Edition
2.0 2010-03 | IEC |
| 12-202 | Radiology | Medical electrical equipment- Part
2-43: Particular requirements for
the basic safety and essential
performance of X-ray equipment for
interventional procedures | 60601-2-43
2010 | IEC |
| 12-274 | Radiology | Medical electrical equipment - Part
2- | 60601-2-54: | IEC |
| Recog-
nition
Number | Product
Area | Title of Standard | Reference Number
and Date | Standards
Development
Organization |
| | | 54: Particular requirements for the
basic safety and essential
performance of X-ray equipment for
radiography and radioscopy | 2009 | |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.20 (2011) | NEMA |
| 12-273 | Radiology | Safety of laser products - Part 1:
Equipment classification, and
requirements | 60825-1 Edition 2.0
2007-03 | IEC |
| 12-290 | Radiology | Medical electrical equipment -
Radiation dose documentation -
Part
1: Equipment for radiography and
radioscopy | 61910-1 Edition 1.0
2014-09 | IEC |
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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 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 |
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| FDA Guidance Documents and Effective Date | |
|---|---|
| Management of Cybersecurity in Medical devices. | |
| Document issued on October 2, 2014 | |
| 12. | Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology 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 Select software version VA20 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.
Bench testing in the form of Unit, Subsystem and System Integration testing were 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 have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
Electrical safety and EMC testing were conducted on the Cios Select, 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 the standard for EMC.
The Cios Select software (VA20) 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 (New User Interface touch panel, New flat detector (PaxScan 2121DXV), (OTS) software from Windows 7 to Windows 10 and Updated Image storage to a maximum of 300000 frames) have been validated through detailed software testing and it was
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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 nonclinical 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. X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed with acceptable results.
Summary:
Performance tests were conducted to test the functionality of the Cios Select (VA20). These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing and clinical assessments 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 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 postprocessing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The Cios Select 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 Select does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as the
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predicate devices even though the Subject Device is using a different detector.