(246 days)
The Cios Alpha 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.
The Cios Alpha is a mobile fluoroscopy system designed for the surgical environment. The Cios Alpha 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 moved forward/backward by an operator.
b) The monitor trolley providing image processing, review and patient data entry. The monitor trolley may contain an optional hardcopy (paper) printer and navigational equipment as well.
The Siemens Cios Alpha is a mobile fluoroscopic X-ray system that undergone non-clinical and clinical testing to demonstrate its performance and substantial equivalence to a predicate device, the ARCADIS Avantic.
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantitative acceptance criteria for image quality beyond general "Good" or "Very good" ratings. However, it does compare technological characteristics.
| Feature | Subject Device (Cios Alpha) | Predicate Device (ARCADIS Avantic) | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Cios Alpha) |
|---|---|---|---|---|
| Image Quality (Clinical Evaluation) | At least comparable to predicate | Described as "even better, more detailed image quality as compared to the ARCADIS Avantic" for various procedures. | ||
| Spatial Resolution (Clinical Evaluation) | At least comparable to predicate | "Good" to "Very good" | ||
| Motion Resolution (Clinical Evaluation) | At least comparable to predicate | "n.a." (for Carotids and peripheral vascular), "Very good" (for EVAR procedures) | ||
| Contrast (Clinical Evaluation) | At least comparable to predicate | "Acceptable" to "Good" | ||
| Noise (Clinical Evaluation) | At least comparable to predicate | "Low" to "Acceptable" | ||
| Mobile Fluoroscopy C-arm | Yes | Yes | Yes | Yes |
| Tube housing assembly with high frequency generator | Yes | Yes | Yes | Yes |
| kV range | 40 kV - 125 kV | 40 kV - 125 kV | 40 kV - 125 kV | 40 kV - 125 kV |
| Max power output | 12 kW, 25 kW (optional) | 20 kW | At least 20 kW | 12 kW, 25 kW (optional) (an improvement) |
| Pulsed Fluoroscopy (mA) | 3 mA to 120 mA (12kW), 3 mA to 250 mA (25kW) | Up to 70 mA | At least up to 70 mA | Higher (an improvement) |
| X-ray detector | Solid State Detector (20cm x 20cm or 30cm x 30cm) | Image Intensifier (13" diameter) | Not explicitly defined, but solid state detector is a technological advancement | Solid State Detector |
| Dose measurement device | Yes | Yes | Yes | Yes |
| Matrix size | 1536 x 1536 | 1024 x 1024 | At least 1024 x 1024 | 1536 x 1536 (an improvement) |
| Monitors | 19" TFT Flat Screen Display Panels, B/W or Color | 18" TFT Flat Screen Display Panels, B/W or Color | At least 18" | 19" (an improvement) |
| Navigation interface | Yes | Yes | Yes | Yes |
| Image post-processing | Yes | Yes | Yes | Yes |
| DICOM Functionality | Yes | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: More than 70 patients were examined during the clinical evaluation (customer use test).
- Data Provenance: The data was generated during a "customer use test" in a clinical environment. The country of origin is not explicitly stated, but Siemens Medical Systems, Inc. is based in Malvern, PA, USA, and the manufacturing site is in Kemnath, Germany. Given this is a 510(k) submission to the FDA, it is highly likely that at least some, if not all, of the clinical evaluation was conducted in the USA or in a manner compliant with US regulatory requirements. The data is prospective, as it was a specific evaluation conducted for 8 weeks in a clinical environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
The document states: "It was the investigators opinion that in this test phase the new Cios Alpha provided an even better, more detailed image quality as compared to the ARCADIS Avantic (predicate device)."
- Number of Experts: The document refers to "investigators" (plural) but does not specify an exact number.
- Qualifications of Experts: The qualifications of the "investigators" are not explicitly stated, but it is implied they are healthcare professionals who are experienced in evaluating medical imaging devices in a clinical setting ("customer use test," "clinical environment").
4. Adjudication Method for the Test Set:
The document describes the assessment as "the investigator's opinion." This suggests a qualitative assessment by the clinical investigators, rather than a formal, multi-reader adjudication process (e.g., 2+1 or 3+1). It does not mention blinding or independent review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The clinical evaluation was a customer use test where investigators provided an opinion on image quality compared to the predicate, but it does not detail a structured study comparing human reader performance with and without AI assistance or with the new device versus the predicate in a statistically rigorous MRMC design.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Cios Alpha is an imaging device, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance as typically applied to AI/CAD devices is not relevant here. The device's performance is based on its ability to produce images. The non-clinical tests involved compliance with various IEC/ISO standards and X-Ray performance tests, which evaluate the device itself.
7. The Type of Ground Truth Used:
For the clinical evaluation, the "ground truth" for image quality was based on the subjective expert opinion/consensus of the clinical investigators. The document mentions the "investigators opinion" regarding image quality being "even better, more detailed" compared to the predicate. This is a qualitative assessment rather than a definitive objective measure like pathology or clinical outcomes.
8. The Sample Size for the Training Set:
The Cios Alpha is a fluoroscopic X-ray system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The document describes its development as being "based on the ARCADIS Avantic and the experience Siemens has with more than 30 years with predicate mobile fluoroscopy C-arms (SIREMOBILE series)." This refers to product development experience and engineering, not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set was Established:
As the Cios Alpha is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set is not applicable to this submission. The device's design and performance are a result of engineering principles, compliance with standards, and experience with prior generations of fluoroscopy systems.
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SIEMENS
K132094 Cios Alpha: Al / Hold Response
510(k) Summary: Cios Alpha
Company: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
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, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number:
2240869
Manufacturing Site:
SIEMENS AG Sector Healthcare Röntgenstrasse 19 - 21 D-95478 Kemnath, Germany
Establishment Registration Number:
3002466018
Contact Person: 2.
Mr. Darren Dorman Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy · Mail Code D02 · Malvern, PA 19355, USA Phone: +1 610 219-9066 · Fax: +1 610 448-1787 Email: darren.dorman@siemens.com
3. Device Name and Classification:
Trade Name: Cios Alpha Device: Interventional fluoroscopic x-ray system; image-intensified fluoroscopic x-ray system, mobile Regulation Description: Image-intensified fluoroscopic x-ray system; Regulation: Radiology
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STEMENS
Review Panel: Radiology OWB, OXO Product Code: Submission Type: Traditional 510(k) Regulation Number: 892.1650 Device Class: 2
4. Legally Marketed Predicate Device:
Trade Name: ARCADIS Avantic image-intensified fluoroscopic x-ray system, mobile Device: Image-intensified fluoroscopic x-ray system. Regulation Description: Regulation: Radiology Review Panel: Radiology Product Code: ОХО Submission Type: Traditional 510(k) Regulation Number: 892.1650 Device Class: 2
ട്. Device Description:
The Cios Alpha is a mobile fluoroscopy system designed for the surgical environment. The Cios Alpha 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 moved forward/backward by an operator.
- b) The monitor trolley providing image processing, review and patient data entry. The monitor trolley may contain an optional hardcopy (paper) printer and navigational equipment as well.
6. Indication for Use:
The Cios Alpha 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 Alpha is substantially equivalent to the commercially available Siemens ARCADIS Avantic, cleared 06/01/2005 with K051133.
The Indication for use statement is similar to the predicate. The image intensifier has been replaced by a solid state detector. X-ray generation and control used with the
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SIEMENS
Cios Alpha is similar to the technology used with the predicate ARCADIS Avantic. A new GUI (graphical user interface) supports the user in the operation of the system.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The Cios Alpha design is based on the ARCADIS Avantic and the experience Siemens has with more than 30 years with predicate mobile fluoroscopy C-arms (SIREMOBILE series). The advent of solid state detectors created a need to use this technology for mobile fluoroscopic systems too. The detector replaces the image intensifier and the TV camera (1k x 1k pixel matrix). The imaging system was upgraded to support the processing of up to 1536 pixel 16bit image matrix. Full DICOM compatibility and a new graphical user interface provide networking and an intuitive operation. X-ray generation is similar to the predicate with a 25% increase in output power. Pulsed fluoroscopy, similar to the predicate, helps to reduce dose exposure for long procedures.
The following table compares the dominant performance data of the subject device with the predicate device to substantiate equivalence of both devices.
| Feature | Subject DeviceCios Alpha | Predicate DeviceARCADIS Avantic |
|---|---|---|
| Mobile Fluoroscopy C-arm | Yes | Yes |
| Tube housing assemblywith high frequencygenerator | Yes | Yes |
| kV range: 40 kV - 125 kV | Yes | Yes |
| Max power output | 12 kV25 kW (optional) | 20 kV |
| Pulsed Fluoroscopy | 3 mA to 120 mA (12kW)3 mA to 250 mA (25kW) | Up to 70 mA |
| X-ray detector | Solid State Detector20cm x 20cm or30cm x 30cm | Image Intensifier withOptics and TV System 13"diameter |
| Dose measurement device | Yes | Yes |
| Matrix size | 1536 x 1536 | 1024 x 1024 |
| Monitors | 19" TFT Flat Screen DisplayPanels, B/W or Color | 18" TFT Flat ScreenDisplay Panels, B/W orColor |
| Navigation interface | Yes | Yes |
| Image post-processing | Yes | Yes |
| DICOM Functionality | Yes | Yes |
9. Summary of Non-Clinical Tests:
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The Siemens Cios Alpha complies with the following voluntary standards:
| IEC 60601-1 | 60601-2-28 |
|---|---|
| IEC 60601-1-1 | 60601-2-32 |
| IEC 60601-1-3 | 60601-2-54 |
| IEC 62366 | 61910-1 |
| ISO 14971 | 60601-2-43 |
| IEC 62304 | IEC 60825-1 |
| IEC 60601-1-2 | IEC 10993-1 |
| 60601-2-7 | NEMA PS 3.1 - 3.20 (2011) |
| X-Ray performance tests outlined in: 21 CFR 1020.30, 31, and 32 |
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- ◆ Requirement Specification Reviews
- . Design Reviews
- Integration testing (System verification) .
Non-clinical testing was conducted in accordance with Guidance for Submission of 510(k)s for Solid State X-Ray Imaging Devices (issued August 6, 1999). All test results were satisfied.
11. Summary of Clinical Tests:
For the subject of this premarket submission, Siemens did not perform a formal clinical trial but did conduct a customer use test. In this test the Cios Alpha has been evaluated in a clinical environment for 8 weeks. More than 70 patients have been examined. The following table provides a summary of the image quality outcome with different procedures:
| IQ overall | Spatialresolution | Motionresolution | Contrast | Noise | |
|---|---|---|---|---|---|
| Carotids sub | Good | Good | n.a. | Acceptable | Acceptable |
| Vascularperipheral | Very good | Very good | n.a. | Good | Low |
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C. HINS & SONS
K132094 Cios Alpha: Al / Hold Response
| EVAR (AAA) | Very good | Very good | Very good | Good | Acceptable |
|---|---|---|---|---|---|
| EVAR (TAA) | Very good | Very good | Very good | Good | Acceptable |
It was the investigators opinion that in this test phase the new Cios Alpha provided an even better, more detailed image quality as compared to the ARCADIS Avantic (predicate device). This includes the aortic procedures as well as the peripheral vascular structure representation i.e. the vascular representation of the foot. The complete clinical evaluation is included in the attachment.
12. 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. Several safety features including visual and audible wamings are incorporated into the system design. In addition the Cios Alpha is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Conclusion as to Substantial Equivalence: 13.
The Cios Alpha is intended for similar indications for use as the predicate ARCADIS Avantic. The imaging properties (X-ray source, output power and field of view) are similar. The most significant difference is the use of a solid state detector instead of an image intensifier. It is Siemens opinion, that the Cios Alpha is substantially equivalent to the ARCADIS Avantic (K051133, cleared 06/01/2005).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2014
Siemens Medical Solutions USA, Inc. % Mr. Darren Dorman Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K132094
Trade/Device Name: Cios Alpha Regulation Number: 21 CFR 892.1650 Regulation Name: Intensified Fluoroscopic X-Ray System Regulatory Class: II Product Code: OWB, OXO Dated: February 7, 2014 Received: February 11, 2014
Dear Mr. Dorman:
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. 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 (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Darren Dorman
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
ਿ၊
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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K132094 Clos Alpha: Al / Hold Response
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Indications for Use
510(k) Number (il known) KI 37094
Device Name Cios Alpha
Indicalions for Use (Describe)
The Cios Alpha is a mobile X-Ray system designed to provide of the annonical structures of panent during chuical applications. Clinical applications may included to: interventional final fineroscopic. gastro-intestinal. endoscopic. urologic, pain management, orthopedic, vascular, cardine, chical care and emergency room procedures. The patient population may include pediatric parients.
Type of Use (Select one or both, as applicable)
[8] Prescription Use (Part 21 CFR 80 | Subpan D)
Over The Counter Use (2) CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
FORM FDA 3881 (9/13)
Page 1 of 2
N.; 2012. Nature Reviews ; 16(1): 44-48
Siemens Medical Solutions, Inc.
Cios Alpha K132094 Confidential
38 of 1564
Siemens Medical Solutions, Inc.
§ 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.