(28 days)
Not Found.
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description of the device and testing focuses on standard imaging and software validation.
No.
This device is an imaging system designed to provide X-ray images for diagnosis and procedural guidance, not to directly treat a condition.
No
The device is described as an X-ray imaging system used to provide images of anatomical structures during clinical applications. While imaging can be a part of the diagnostic process, the device itself is not described as performing any analysis or interpretation of these images to arrive at a diagnosis. Its function is to acquire images, not to diagnose.
No
The device description clearly states it is a "mobile fluoroscopic C-arm X-ray System" consisting of a C-arm with an X-ray source and detector, and an image display station with a trolley. This indicates significant hardware components beyond just software.
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 device is designed to provide X-ray imaging of anatomical structures of the patient during clinical applications. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details a mobile X-ray system with a C-arm and a flat panel detector, used for acquiring images of the patient. It does not mention any components or processes related to analyzing biological samples.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the body, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system used for direct patient examination.
N/A
Intended Use / Indications for Use
The Cios Spin is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
The Cios Spin (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
- a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
- b) The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.
Mentions image processing
Yes, "the image display station with a moveable trolley for the image processing and storage system".
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
X-Ray
Anatomical Site
anatomical structures of patient
Indicated Patient Age Range
pediatric patients.
Intended User / Care Setting
Not Found. (Implied healthcare professionals in a surgical environment, critical care, and emergency room procedures).
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 Spin (VA30) during product development. The Cios Spin (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with a list of standards for Electrical safety, performance and Electromagnetic Compatibility.
The modifications described in this Premarket Notification are supported with verification and validation testing.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Spin (VA30) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
The Cios Spin software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form.
Performance tests were conducted to test the functionality of Cios Spin (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 5, 2021
Siemens Medical Systems USA, Inc. % Mr. Cordell Fields, Esq. Technical Specialist, Regulatory Submissions 40 Liberty Blvd., 65-1A MALVERN PA 19355
Re: K210054
Trade/Device Name: Cios Spin 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 7, 2021 Received: January 8, 2021
Dear Mr. Fields:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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
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
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K210054
Device Name Cios Spin
Indications for Use (Describe)
The Cios Spin is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
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510(k) Summary: Cios Spin
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: January 07, 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.
-
- General Information: lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Roentgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018
- General Information: lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
2. Contact Person:
Mr. Cordell Fields, Esq. Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 306-3167 Email: cordell.fields@siemens-Healthineers.com
3. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes: Subsequent Product Code:
Cios Spin Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO JAA
Legally Marketed Primary Predicate Device Trade Name: Cios Spin 510(k) Clearance K181550 Clearance Date October 30, 2018
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| Classification Name: | Image-intensified fluoroscopic x-ray System |
|---|---|
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, OXO |
| Subsequent Product Codes: | JAA |
| Total Product Life Cycle: | All product Recall incidents are considered during the |
| Design Input phase of development to ensure the latest | |
| models will not be affected by any of the applicable | |
| issue. |
| Legally Marketed Secondary 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 Codes: | OWB, OXO |
| Subsequent Product Codes: | JAA |
| Total Product Life Cycle: | All product Recall incidents are considered during th |
| Design Input phase of development to ensure the latest | |
| models will not be affected by any of the applicable | |
| issues |
4. Device Description:
The Cios Spin (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
- a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
- b) The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.
The following modifications were made to the predicate device the Cios Spin (K181550). Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device Cios Spin (VA30) for the following device modifications made to the Predicate Device Cios Spin (VA30 - K181550).
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This 510(k) submission, Subject Device "Cios Spin" with software version VA30" the following categories of modifications made to the Subject Device in comparison to Predicate Devices:
Modified Software:
- Table 1: Overview of Software Modifications supported by Software Version VA30 .
Table 1. Software Modifications for Cios Spin
| Software changes specific to New System Software VA30 | |
|---|---|
| Device Software Modification | |
| 1. | Target Pointer |
| 2. | Interactive User Touch Control (Software component of VA30) |
| A. Collimation Controls | |
| B. Brightness Contrast Controls | |
| C. Rotate and Flip Controls | |
| D. Zoom and Pan Controls | |
| E. Spot Adapt | |
| 3. | Dose Regulation Indicator |
| 4. | New Sound Radiation Delay |
| 5. | New Product Software Security |
| 6. | Screw removal button for Screw Scout |
| Other Device Modifications | |
|---|---|
| 7. | Update 510(k) Information |
6. Indications for Use:
The Cios Spin is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
7. Substantial Equivalence:
The Cios Spin (VA30) system is substantial equivalent to the legally marketed predicates listed in Table 2 below:
Table 2: Predicate Device Comparable Properties for Subject Device Modifications:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|-------------------------------------------|------------------|-------------------|-----------------------|
| Primary Predicate | | | |
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| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|-------------------------------------------|------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Siemens' Cios Spin | K181550 | 10/30/2018 | • Indications for use
• System for Image Acquisition
• Post-processing Software
• Examination Settings
• Screw Scout |
| Secondary Predicate
Siemens' Cios Flow | K203504 | 12/22/2020 | • Target Pointer
• Interactive User Touch Control
• Dose Regulation Indicator
• Sound Radiation Delay
• Product Software Security |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Cios Spin (VA30) System is designed as a set of components (floor stand, C-arm, Xray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that is combined to provide a mobile Interventional Fluoroscopic X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Components used with Cios Spin (VA30) System are either commercially available with current Siemens systems or include updated modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in Table 3 below for all modifications.
| | Subject Device
Cios Spin (VA30)
Modifications | Primary Predicate Device
Cios Spin
K181550
Secondary Predicate Device
Cios Flow
K203504
(modifications 1 to 5 derived
from secondary predicate
device Cios Flow) | Comparison
Results |
|----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Target Pointer | Target Pointer | Same: Target Pointer has the
same functionality as cleared in
the Secondary Predicate
Device Cios Flow K202504.
There are no technological
differences in these features
and the functionality of these
features have not changed. |
| 2. | Interactive User Touch Control
(Software components of VA30)
A. Collimation Controls
B. Brightness Contrast Controls
C. Rotate and Flip Controls
D. Zoom and Pan Controls
E. Spot Adapt (Dose regulation with | Interactive User Touch Control
A. Collimation Controls
B. Brightness Contrast Controls
C. Rotate and Flip Controls
D. Zoom and Pan Controls
E. Spot Adapt (Dose regulation with | Same: 2.A-E has the same
functionality as cleared in the
Secondary Predicate device.
The functionality of these
features has not changed from
the Secondary Predicate
device Cios Flow K203504. |
| | movable circle) | movable circle) | |
Table 3: Summary of Comparison of Technological Characteristics
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| Comparison of Modifications to Predicate Devices | |||
|---|---|---|---|
| 3. | New Dose Regulation Indicator | Dose Regulation Indicator | Same: |
| The Dose regulation is equal to | |||
| the Secondary Predicate | |||
| Cios Flow K203504 | |||
| 4. | New Sound during Radiation Delay | Sound during Radiation Delay | Same: |
| The Sound during Radiation | |||
| Delay is equal to the | |||
| Secondary Predicate Cios | |||
| Flow K203504 | |||
| 5. | New Product Software Security | Product Software Security | Same: |
| The updated Product Software | |||
| Security functionality is the | |||
| same as cleared in the | |||
| Secondary Predicate device | |||
| Cios Flow K203504. | |||
| 6. | Screw removal button for Screw Scout | Primary Predicate Device | |
| Cios Spin | |||
| K181550 | |||
| Screw Scout without Screw | |||
| removal button | Similar: The feature Screw | ||
| Scout provides the same | |||
| functionality as cleared in the | |||
| Primary Predicate device | |||
| Cios Spin K181550. Only a | |||
| button has been made | |||
| available to remove recognized | |||
| screws. |
Nonclinical Performance Testing: 9.
Non-clinical tests were conducted for the Cios Spin (VA30) during product development.
The Cios Spin (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
- AAMI ANSI ES60601-1:2005/(R)2012 ●
- IEC 60601-1-2:2014
- IEC 60601-1-3:2013 ●
- IEC 60601-1-6:2010/A1:2013 ●
- IEC 60825-1:2014 ●
- IEC 62304:2015 ●
- IEC 60601-2-28:2010 ●
- IEC 60601-2-43:2010
- IEC 60601-2-54:2009/A1:2015 ●
- ISO 14971:2019 ●
- IEC 62366-1:2015/ Cor.1:2016 .
Table 4: 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 |
8
| FDA Guidance Document and Effective Date | |
|---|---|
| 3. | Guidance for Industry and FDA Staff: The Special 510(k) Program |
| Document issued on September 13, 2019 | |
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change |
| to an existing device. | |
| Document issued on October 25, 2017 | |
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: |
| Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | |
| Document Issued on July 28, 2014 | |
| 6. | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid |
| State X-ray Imaging Devices | |
| Document issued on September 1, 2016 | |
| 7. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket |
| Submission for Software in Medical Devices | |
| Document issued on May 11, 2005 | |
| 8. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in |
| Medical Devices | |
| Document issued on September 27, 2019 | |
| 9. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability |
| Engineering to Medical Devices. | |
| Document issued February 3, 2016 | |
| 10. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device |
| Premarket Notifications. | |
| Document issued on November 28, 2017 | |
| 11. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for |
| Management of Cybersecurity in Medical devices. | |
| Document issued on October 2, 2014 | |
| 12. | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary Consensus |
| Standards in Premarket Submission for Medical Devices | |
| Document issued on September 14, 2018 | |
| 13. | Guidance for Industry and FDA Staff: Medical Device Accessories - Describing |
| Accessories and Classification Pathways | |
| Document issued on December 20, 2017 | |
| 14. | Guidance for Industry and FDA Staff: Recommended Content and Format of Non- |
| Clinical Bench Performance Testing Information in Premarket Submissions | |
| Document issued on December 20, 2019 |
The modifications described in this Premarket Notification are supported with verification and validation testing.
Verification and Validation:
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Spin (VA30) during product development.
The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
The Cios Spin software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation
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process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.
Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. Compliance with IEC 80001-1-2010 is the responsibility of the hospital. Provided in the Software Section is the required cybersecurity information.
Summary:
Performance tests were conducted to test the functionality of Cios Spin (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
10. General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore, the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Spin (VA30) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.