(30 days)
Not Found
No
The document describes a standard mobile X-ray system with digital imaging processing. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is an X-ray imaging system used for diagnosis and image-guided procedures, not for direct therapeutic treatment.
No
The device is described as an X-ray imaging system used to perform various clinical procedures such as fluoroscopic display of implants and positioning of catheters. It is used to visualize internal structures during procedures, but it is not explicitly stated to be used for diagnosing a condition or disease.
No
The device description explicitly states it is a "Mobile X-ray System" consisting of two mobile units: a mobile acquisition unit (containing the X-ray control, C-arm, generator/X-ray tube, and flat panel detector) and a monitor cart. This clearly indicates the presence of significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cios Select is a mobile X-ray system. It uses X-rays to create images of the inside of the body. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use clearly describes its use in various clinical procedures involving imaging the body directly (e.g., intraoperative bile duct display, fluoroscopic display of implants, positioning of catheters).
The device description and intended use clearly indicate that the Cios Select is an imaging device used on patients, not a device that analyzes samples taken from patients.
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, JAA
Device Description
The Cios Select (VA21) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K181767 on August 17, 2018.
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 (DVD, USB).
The following modifications were made to the predicate device the Cios Select Mobile X-ray System cleared under Premarket Notification K181767 on August 17, 2018. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21) in comparison to the Predicate Device.
- 1.) Upgraded software to version VA21.
- 2.) New optional Cios OpenApps
- 3.) New optional Target pointer.
- 4.) New optional tube side green laser aimer
- 5.) New optional flat detector side green laser aimer
- 6.) Enhanced Cybersecurity
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatrics, adult
Intended User / Care Setting
Operating room, Traumatology, Endoscopy, Intensive Care Station, Ambulatory patient care, Veterinary Medicine. Intended users are healthcare professionals.
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 (VA21) during product development. 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, 1020.31 - Radiographic equipment, 1020.32 Fluoroscopic Equipment, 1040.10 Laser products. The Cios Select (VA 21) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with standards for Electrical safety, performance and Electromagnetic Compatibility (e.g., AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3).
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 VA21 during product development.
Bench testing in the form of Unit, Subsystem and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
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 software (VA21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form.
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. X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed with acceptable results.
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
Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355
Re: K210309
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: January 27, 2021 Received: February 3, 2021
Dear Cordell Fields:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
March 5, 2021
1
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 medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: 06/30/2023 | |
| See PRA Statement on last page. |
| 510(k) Number ( if known ) | K210309 |
|---|---|
| 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, 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. |
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) Subpart C) | □ Over-The-Counter Use (21 CFR 801 |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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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 (6/20) | Page 1 of 1 |
|---|---|
| PSC Publishing Services(301)443-6740 EF |
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Image /page/3/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.
510(k) Summary: Cios Select
Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: January 27, 2021
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information: Importer / Distributor: Siemens Medical 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
Contact Person: 2.
Cordell Fields Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 306-3167 Email: cordell.fields@siemens - healthineers.com
3. Device Name and Classification:
Cios Select
Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:
Image-Intensified Fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO, JAA
Legally Marketed Primary Predicate Device 4.
Trade Name: Cios Select 510(k) Clearance K181767 Clearance Date August 17. 2018 Classification Name: Image-intensified fluoroscopic x-ray System Classification Panel: Radiology
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Image /page/4/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is an orange graphic of several dots.
| Regulation 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. |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Legally Marketed Secondary Predicate Device | |
| Trade Name: | Cios Spin |
| 510(k) Clearance | K181550 |
| Clearance Date | October 30, 2018 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Codes: | OWB |
| Subsequent Product Codes: | JAA, OXO |
| Total Product Life Cycle: | All product Recall incidents are considered
during the Design Input phase of development
to ensure the latest models will not be affected
by any of the applicable issues. |
| Legally Marketed Predicate Device | |
| Trade Name: | Cios Flow |
| 510(k) Clearance | K203504 |
| Clearance Date | December 22, 2020 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB |
| Subsequent Product Codes: | JAA, OXO |
| Total Product Life Cycle: | There are no Recalls nor MDR incidents for this
cleared device |
Device Description: 1.
The Cios Select (VA21) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K181767 on August 17, 2018.
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.
5
Image /page/5/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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 following modifications were made to the predicate device the Cios Select Mobile X-ray System cleared under Premarket Notification K181767 on August 17, 2018. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21) in comparison to the Predicate Device.
- 1.) Upgraded software to version VA21.
- 2.) New optional Cios OpenApps
- 3.) New optional Target pointer.
- 4.) New optional tube side green laser aimer
- 5.) New optional flat detector side green laser aimer
- 6.) Enhanced Cybersecurity
2. 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.
3. Substantial Equivalence:
The Cios Select (VA21) system is substantial equivalent to the legally marketed predicates listed in Table 1 below:
| Predicate Device Name and
| Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|---|---|---|---|
| Primary Predicate | |||
| Cios Select (VA20) w/Flat | |||
| Panel Detector | |||
| Siemens Shanghai Medical | |||
| Equipment Ltd. | K181767 | 8/17/2018 | Indications for use X-ray technology Image processing Mechanical design Cybersecurity Software |
| Predicate Device | K181550 | 10/30/2018 | Tube Side Laser |
Table 1: Predicate Device Comparable Properties for Subject Device Modifications:
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Image /page/6/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a pattern.
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|-------------------------------------------------------------------------|------------------|-------------------|-------------------------------------|
| Cios Spin (VA30)
SIEMENS AG Sector
Healthcare | | | • FD Side Laser |
| Predicate Device
Cios Flow (VA30)
SIEMENS AG Sector
Healthcare | K203504 | 12/22/20 | • Target Pointer
• Cios OpenApps |
4. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Cios Select (VA21) System is designed as a set of components (floor stand, Carm, 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 (VA21) 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 is provided in the Table 2 below for all modifications.
| | Subject Device
Cios Select (VA21) System
Modifications | Primary Predicate Device
Cios Select VA20
(K181767) | Comparison
Results |
|------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Updated System Software to
VA21 with modifications/features | Secondary Predicate Device
Cios Flow (VA30)
(K203504) | Same: The system software was upgraded to support new software features (1-3). |
| 1.A
1.B | New Optional Cios OpenApps
New optional Target pointer. | Optional Cios OpenApps
New optional Target pointer. | Upgraded software VA21 with Cios Open Apps and Target Pointer. There are no technological differences in these features and the functionality of these features have not changed except for better visualization of moving k-wires. These features are the exact same features cleared in the Secondary Predicate Device Cios Flow (VA30) K1203504. Software Testing was conducted per Software Guidance. |
| 1.C | Enhanced Cybersecurity | Primary Predicate Device
Cios Select (VA20)
(K181767)
Enhanced Cybersecurity | Same: Cybersecurity features are the same features cleared in Cios Select VA20 (K181767) |
| 2. | New Optional tube side green
laser aimer | Secondary Predicate Device
Cios Spin (VA30) (K181550)
Optional tube side green laser
aimer | Same: The green laser aimers on the side of the tube and flat detector is the same exact laser aimer cleared in the Secondary Predicate |
| 3. | New Optional flat detector side
green laser aimer | Optional flat detector side
green laser aimer | the Secondary Predicate |
Table 2: Summary of Comparison of Technological Characteristics
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Image /page/7/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
| Device Cios Spin (VA30)
| K181550. |
|---|
| ------------------------------------- |
Nonclinical Performance Testing: 5.
Non-clinical tests were conducted for the Cios Select (VA21) during product development. 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.
Code of Federal Requlations Title 21 Subchapter J- Radiological Health, applicable sections include:
- 1020.30 Diagnostic X-Ray Systems and their major components ●
- 1020.31 - Radiographic equipment
- 1020.32 Fluoroscopic Equipment ●
- 1040.10 Laser products ●
The Cios Select (VA 21) 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 60825-1:2007 ●
- TR 60878:2015 ●
- IEC 62304:2015 ●
- IEC 80001-1:2010 ●
- IEC 60601-2-28:2017 ●
- IEC 60601-2-43:2017
- IEC 60601-2-54:2009/A1:2015 ●
- ISO 10993-1:2009 ●
- ISO 14971:2007 ●
Table 3: FDA Guidance Documents
| FDA Guidance Document and Effective Date | ||
|---|---|---|
| 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket | |
| Notification Submissions 510(k) | ||
| Document issued on October 2, 2017 | ||
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy | |
| for 510(k)s | ||
| Document issued on September 13, 2019 | ||
| 3. | Guidance for Industry and FDA Staff: The Special 510(k) Program | |
| Document issued on September 13, 2019 | ||
| FDA Guidance Document and Effective Date | ||
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change | |
| to an existing device. | ||
| Document issued on October 25, 2017 | ||
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | ||
| Document Issued on July 28, 2014 | ||
| 6. | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid | |
| State X-ray Imaging Devices | ||
| Document issued on September 1, 2016 | ||
| 7. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket | |
| Submission for Software in Medical Devices | ||
| Document issued on May 11, 2005 | ||
| 8. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in | |
| Medical Devices | ||
| Document issued on September 27, 2019 | ||
| 9. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability | |
| Engineering to Medical Devices. | ||
| Document issued February 3, 2016 | ||
| 10. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device | |
| Premarket Notifications. | ||
| Document issued on November 28, 2017 | ||
| 11. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for | |
| Management of Cybersecurity in Medical devices. | ||
| Document issued on October 2, 2014 | ||
| 12. | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary Consensus | |
| Standards in Premarket Submission for Medical Devices | ||
| Document issued on September 14, 2018 | ||
| 13. | Guidance for Industry and FDA Staff: Medical Device Accessories - Describing | |
| Accessories and Classification Pathways | ||
| Document issued on December 20, 2017 | ||
| 14. | Guidance for Industry and FDA Staff: Recommended Content and Format of Non- | |
| Clinical Bench Performance Testing Information in Premarket Submissions | ||
| Document issued on December 20, 2019 | ||
| 15. | Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in | |
| Medical Device | ||
| Document issued on August 14, 2007. | ||
| 16. | 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 |
8
Image /page/8/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
The modifications described in this Premarket Notification are supported with verification and validation testing.
Verification and Validation:
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select software version VA21 during product development.
9
Image /page/9/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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 was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
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 software (VA21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
Siemens conforms to the cybersecurity requirementing 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. 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 (VA21). 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.
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6. 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 post processing of X-ray images.
7. 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 the 510(k) submission that the Cios Select does not introduce any new potential safety risks and is substantially equivalent, and performs as well as the predicate devices.