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510(k) Data Aggregation
(28 days)
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.
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 provided text is a 510(k) summary for the Siemens Cios Select (VA21C) with Flat Panel Detector. It describes modifications made to an existing device (Cios Select (VA21) Flat Panel, cleared under K210309) and argues for its substantial equivalence to the predicate device.
Crucially, this document focuses on demonstrating substantial equivalence of a modified medical device to its predicate, rather than providing a detailed study proving the de novo performance of a new device against specific acceptance criteria for a clinical task (e.g., detecting a disease).
The "acceptance criteria" discussed in this document refer to adherence to regulatory standards, successful completion of non-clinical bench testing, software verification and validation, and human factors validation, all geared towards demonstrating that the modified device is as safe and effective as the original, and performs as expected.
Therefore, many of the requested points regarding clinical study design, expert ground truth, MRMC studies, and training set details are not applicable or not explicitly provided in this type of regulatory submission because the demonstrated equivalence is primarily based on engineering and performance testing, not direct clinical efficacy studies for a new diagnostic or therapeutic capability.
Here's a breakdown based on the provided text, addressing the points as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a "Special 510(k)" for modifications, the "acceptance criteria" are primarily related to conforming to recognized standards and ensuring the modifications do not introduce new safety or effectiveness concerns, rather than specific clinical performance metrics. The "reported device performance" is framed in terms of successful completion of tests demonstrating compliance and functional equivalence to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Non-Clinical Performance Testing & Standards Compliance | Compliance with relevant FDA performance standards for diagnostic x-ray systems and fluoroscopic equipment (21 CFR 1020.30, 1020.32, 1040.10). | "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, 1020.32, 1040.10." |
| Compliance with electrical safety, performance, and electromagnetic compatibility (EMC) standards: 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. | "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 [and others listed above]... 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." | |
| Software Verification & Validation | Conformance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and "Off-The-Shelf Software Use in Medical Devices." | |
| All software specifications meet acceptance criteria. | ||
| Successful unit, subsystem, and system integration testing. | ||
| Successful regression testing. | "Software Documentation for a Moderate Level of Concern software... is also included as part of this submission. The performance data demonstrate continued conformance with special controls for medical devices containing software. ...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. ...All testable requirements... have been successfully verified and traced... The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria..." | |
| Risk Management | Identified hazards mitigated through risk control implementation. | "The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. ...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." |
| Cybersecurity | Implement processes preventing unauthorized access, modifications, misuse, or denial of use of information. | "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." |
| Human Factors/Usability | Device is safe and effective for intended users, uses, and use environments. | |
| Human factors addressed in system testing and clinical use tests. | "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." | |
| Overall Equivalence | Device performs as well as the predicate device and does not introduce new safety or effectiveness issues. | "The results of all conducted testing and clinical assessments were found acceptable and do not raise any new safety or effectiveness issues." |
| "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of clinical images or patient data. The testing described is primarily engineering bench testing, software verification/validation, and human factors validation.
- Data Provenance: Not applicable in the context of clinical images/patient data for performance evaluation. Testing was conducted internally by Siemens Healthcare GmbH Corporate Testing Laboratory and through internal product development processes. It is not mentioned whether the human factors validation included users from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission does not involve assessment against a "ground truth" for a specific diagnostic task or clinical condition, as it's a submission for modifications to an existing X-ray system, not a new AI-based diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is mentioned as there's no diagnostic ground truth being established by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is an X-ray imaging system, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an X-ray imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in this context refers to the specifications and requirements the device is designed to meet, as well as adherence to recognized industry standards for medical device safety and performance. No disease-specific "ground truth" derived from expert consensus, pathology, or outcomes data is relevant for this type of submission.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set of data.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or associated ground truth is relevant.
In summary: The K223410 510(k) submission for the Cios Select (VA21C) with Flat Panel Detector focuses on demonstrating that minor modifications (software update, new collimator, new PC hardware) to an already cleared X-ray system do not raise new safety or effectiveness concerns and maintain substantial equivalence to its predicate. The "study" referenced in the document is a compilation of engineering bench tests, software verification and validation activities, and human factors validation, all ensuring compliance with regulatory standards and functional performance of the device's hardware and software components. It does not involve a clinical efficacy study or AI performance evaluation.
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