(28 days)
Not Found
No
The document describes a standard mobile X-ray system with digital image processing. There is no mention of AI, ML, or related concepts in the intended use, device description, or testing sections.
No
The device is an X-ray imaging system used for diagnosis and visualization during procedures, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that the device performs "Digital Radiography, 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." These are all diagnostic or image-guidance functions. Additionally, the "Description of the training set, sample size, data source, and annotation protocol" section mentions "1020.30 Diagnostic X-Ray Systems".
No
The device description clearly states it is a mobile X-ray system consisting of two physical units: a mobile acquisition unit (including the C-arm, X-ray tube, and flat panel detector) and a monitor cart. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Cios Select is a mobile X-ray system used for imaging procedures in various clinical settings (Operating room, Traumatology, etc.). This involves imaging within the body, not testing samples outside the body.
- Device Description: The description details an X-ray imaging system with a C-arm, X-ray tube, flat panel detector, and monitor cart. This is consistent with an in-vivo imaging device.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the internal structures of the body.
- 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 designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Cios Select is an imaging device used to visualize structures 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, 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
OWB, OXO, JAA
Device Description
The Cios Select (VA21C) with Flat Panel Detector Mobile X-ray System is designed for the surgical environment. The Cios Select FD (VA21) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K210309 on March 5, 2021.
The Cios Select consists of two major units:
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 (USB).
The following modifications were made to the predicate device the Cios Select (VA21) Flat Panel mobile X-ray System cleared under Premarket Notification K210309 on March 5, 2021. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21C) with Flat Panel Detector in comparison to the Predicate Device.
-
- Updated Software from VA21(B) to VA21(C) to support the following hardware changes.
- a. New collimator
- b. New PC hardware
-
- Updated 510(k) Information
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not specified
Indicated Patient Age Range
Pediatrics
Intended User / Care Setting
Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care, and in Veterinary Medicine.
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 Select (VA21C) with Flat Panel Detector during product development. The Siemens Cios Select (VA21C) with Flat Panel Detector has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select (VA21C) with Flat Panel Detector complies with the following 21 CFR Federal Performance Standards: 1020.30 Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic Equipment, 1040.10 Laser products.
The Cios Select (VA 21C) with Flat Panel Detector 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 60601-2-43:2019, IEC 60601-2-54:2018, IEC 62366-1:2015, ISO 14971:2019.
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 demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select with Flat Panel Detector software version VA21(C) during product development.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Bench testing in the form of Unit, Subsystem, and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing 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 standard for EMC.
The Cios Select with Flat Panel Detector software VA21(C) 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 reports and feedback forms.
Additional engineering bench testing was performed including the non-clinical testing identified in the guidelines 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.
Performance tests were conducted to test the functionality of the Cios Select (VA21C) with Flat Panel Detector. These tests have been performed to assess the functionality of the Subject Device. The results of all conducted testing and clinical assessments were found acceptable and do not raise any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
December 7, 2022
Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K223410
Trade/Device Name: Cios Select (VA21) Flat Panel 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 4, 2022 Received: November 9, 2022
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
2022.12.07
17:26:25
Lu Jiang
-05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223410
Device Name Cios Select (VA21) Flat Panel
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, 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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 arranged in a circular pattern.
510(k) Summary: Cios Select (VA21) Flat Panel System Submission Number: K223410
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: December 5, 2022
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
Manufacturing Site:
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318, China Establishment Registration Number: 3003202425
2. Contact Person:
Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-healthineers.com
3. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:
Cios Select (VA21) Flat Panel
Image-Intensified Fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO, JAA
-
- Legally Marketed Predicate Device Cios Select (VA21) Flat Panel Trade Name: 510(k) Clearance K210309 Clearance Date March 5, 2021 Classification Name: Image-intensified fluoroscopic x-ray System Classification Panel: Radiology
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Requlation Number: Device Class: Product Code: Subsequent Product Codes: Total Product Life Cycle:
21 CFR §892.1650 Class II OWB JAA. OXO There are no Recalls nor MDR incidents for this cleared device.
5. Device Description:
The Cios Select (VA21C) with Flat Panel Detector Mobile X-ray System is designed for the surgical environment. The Cios Select FD (VA21) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K210309 on March 5, 2021.
The Cios Select consists of two major units:
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 (USB).
The following modifications were made to the predicate device the Cios Select (VA21) Flat Panel mobile X-ray System cleared under Premarket Notification K210309 on March 5, 2021. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21C) with Flat Panel Detector in comparison to the Predicate Device.
-
- Updated Software from VA21(B) to VA21(C) to support the following hardware changes.
- a. New collimator
- b. New PC hardware
-
- Updated 510(k) Information
6. 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
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 word "Healthineers" is a graphic of orange dots.
pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Substantial Equivalence: 7.
The Cios Select (VA21C) with Flat Panel Detector system is substantially equivalent to the legally marketed predicates listed in Table 1 below:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|---------------------------------------------------------------------------------------------------------------|------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Cios Select (VA21) Flat
Panel
Siemens Shanghai Medical
Equipment Ltd. | K210309 | 3/5/2021 | Indications for use X-ray technology Image processing Mechanical design Cybersecurity Software Collimator PC Hardware |
Table 1: 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 Select (VA21C) with Flat Panel Detector System is designed as a set of components (floor stand, C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that is combined to provide a specialized angiography system. Components used with Cios Select (VA21C) with Flat Panel Detector System are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device are provided in Table 2 below for all modifications.
Table 2: Summary of Comparison of Technological Characteristics
| | Subject Device
Cios Select (VA 21C) with Flat Panel
Detector System
Modifications | Predicate Device
Cios Select (VA21B) Flat
Panel
K210309 | Comparison
Results |
|----|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software update from VA21(B) to
VA21(C) to support the following
new hardware, no new features | VA21B System Software | Comparable:
There are no new functionalities
when compared to the Predicate
Device Cios Select (VA21) Flat
Panel cleared in K210309. The
system software update to
support the new hardware does
not raise any new safety or
effectiveness issues. |
| A. | Replaced Collimator | Collimator | Comparable:
There are no new functionalities
when compared to the Predicate
Device Cios Select (VA21) Flat
Panel cleared in K210309. The |
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Image /page/6/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 arranged in a circular pattern.
| | Subject Device
Cios Select (VA 21C) with Flat Panel
Detector System
Modifications | Predicate Device
Cios Select (VA21B) Flat
Panel
K210309 | Comparison
Results |
|----|--------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | new collimator does not raise any
new safety or effectiveness. |
| B. | Updated PC hardware
"Mini-PC" | PC hardware | Comparable:
There are no new functionalities
when compared to the Predicate
Device Cios Select (VA21) Flat
Panel cleared in K210309. The
new mini-PC does not raise any
new safety or effectiveness issues |
9. Nonclinical Performance Testing:
Non-clinical tests were conducted for the Cios Select (VA21C) with Flat Panel Detector during product development. The Siemens Cios Select (VA21C) with Flat Panel Detector has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select (VA21C) with Flat Panel Detector complies with the following 21 CFR Federal Performance Standards.
Code of Federal Requlations Title 21 Subchapter J- Radiological Health, applicable sections include:
- 1020.30 Diagnostic X-Ray Systems and their major components ●
- 1020.32 Fluoroscopic Equipment .
- 1040.10 Laser products ●
The Cios Select (VA 21C) with Flat Panel Detector 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 60601-2-43:2019 ●
- IEC 60601-2-54:2018 ●
- IEC 62366-1:2015 ●
- ISO 14971:2019
Provided in Table 4 is a list of relevant Guidance Documents that were used in the development of the 510(k) content.
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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: 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 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: Information to Support a Claim of |
| Electromagnetic Compatibility (EMC) of Electrically Powered Medical Devices | |
| Document issued on July 11, 2016 | |
| 13. | Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in |
| Medical Devices | |
| Document issued on August 14, 2007 | |
| 14. | Guidance for Industry and Food and Drug Administration Staff: Pediatric Information |
| for X-ray Imaging Device Premarket Notifications | |
| Document issued on November 28, 2017. | |
| 15. | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary Consensus |
| Standards in Premarket Submission for Medical devices | |
| Document issued on September 14, 2018 | |
| 16. | Guidance for Industry and FDA Staff: Medical Device Accessories – Describing |
| Accessories and Classification Pathways | |
| Document issued on December 20, 2017 | |
| 17. | 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.
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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 demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select with Flat Panel Detector software version VA21(C) during product development.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Bench testing in the form of Unit, Subsystem, and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing 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 standard for EMC.
The Cios Select with Flat Panel Detector software VA21(C) 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 reports and feedback forms. 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 guidelines for submission of 510(k)s for Solid State X-Ray Imaging
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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 (VA21C) with Flat Panel Detector. These tests have been performed to assess the functionality of the Subject Device. The results of all conducted testing and clinical assessments were found acceptable and do not raise any new safety or effectiveness issues.
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 practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and post-processing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The Cios Select (VA21C) with Flat Panel Detector has the same indications for use, operating environment, and mechanical design as the predicate. Siemens concludes via the documentation provided in the 510(k) submission that the Cios Select (VA21C) with Flat Panel Detector does not introduce any new potential safety risks and is substantially equivalent and performs as well as the predicate devices.