(113 days)
NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations *.
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.
Scan&GO:
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are using special protocols.
The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.
The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.
The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.
The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient.
The Siemens NAEOTOM Alpha, Scan&GO Software (K220814) is a computed tomography x-ray system that received 510(k) clearance. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics against ground truth.
However, based on the information provided, we can infer acceptance criteria for the non-clinical testing conducted to support the device modifications and their performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes several non-clinical tests performed to demonstrate the functionality and performance of the modified features. The acceptance criteria for these tests are generally stated implicitly as the successful demonstration of the intended function and efficacy.
| Feature/Test | Acceptance Criteria (Inferred from description) | Reported Device Performance (Summary) |
|---|---|---|
| myNeedle Laser Functionality | Achieve defined accuracy level for laser visualization; demonstrate essential workflow steps. | The results of the accuracy test with a close to clinical workflow and test setup show that defined accuracy level can be achieved. The workflow evaluation showed a comparison to the essential workflow steps. |
| Flex 4D Spiral (Neuro & Body Perfusion/Dynamic Angio) | Proper function of dynamic collimation and dose modulation; acceptable image quality on NAEOTOM Alpha. | Demonstrated the proper function of dynamic collimation and dose modulation and assessed acceptable image quality of Flex 4D Spiral on NAEOTOM Alpha. |
| QuantumPlus UHR (Ultra-High Resolution) | Successful reconstruction of spectral images from raw UHR data. | Described the reconstruction of spectral images from raw data acquired in ultra-high resolution (UHR) modes. |
| PURE Calcium | Obtain modified image reconstruction that aims at removing iodine contribution from generated output images using spectrally acquired input data. | Described the feature "PURE Calcium," which uses spectrally acquired input image data to obtain a modified image reconstruction that aims at removing the iodine contribution. |
| Iterative Metal Artifact Reduction (iMAR) | Efficacy in reducing metal artifacts in phantom images. | Evaluation of phantom images demonstrated the efficacy of iMAR to reduce metal artifacts. |
| High Resolution Dual Source Cardiac Modes | Basic image quality and property of ECG gated ultra-high resolution dual-source cardiac acquisition mode. | The basic image quality and the property of the ECG gated ultra-high resolution dual source cardiac acquisition mode were described and found acceptable. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with standards IEC 60601-2-44 and IEC 60601-1-2. | Testing conducted in accordance with standards 60601-2-44, and 60601-1-2. |
| Software Verification and Validation | All software specifications meet acceptance criteria; risk control implemented for identified hazards. | Testing supports that all software specifications have met the acceptance criteria. Risk analysis completed and risk control implemented to mitigate identified hazards. |
| Wireless Coexistence Testing | Safe operation with other systems in a shared environment; successful communication despite potential interference; adherence to IEEE 802.11h for dynamic frequency selection and transmission power control. | Testing considered co-channel, adjacent channel, RF interference, and separation distance/location scenarios. Scan&GO supports dynamic frequency selection and transmission power control. Successfully ensured wireless communications were actively transmitting in situations where possible interference may exist. |
2. Sample size used for the test set and the data provenance
The document specifies "phantom tests" and "bench tests" for non-clinical testing. It does not provide specific sample sizes (e.g., number of phantoms, number of test runs) for these tests, nor does it explicitly state the data provenance in terms of country of origin or whether they were retrospective or prospective, beyond stating they were conducted "during product development." Given these are non-clinical hardware/software tests, the concept of "retrospective or prospective" data provenance (as typically applied to patient data) is not directly applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a ground truth for the test set. The testing described is primarily non-clinical verification and validation of hardware and software modifications against engineering specifications and industry standards.
4. Adjudication method for the test set
As the testing is non-clinical and does not involve human interpretation against a ground truth, an adjudication method like "2+1" or "3+1" is not applicable and therefore not mentioned.
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
The document does not describe an MRMC comparative effectiveness study. The NAEOTOM Alpha and Scan&GO software, as described, do not appear to be an AI-assisted diagnostic tool that would typically undergo such a study. The software is for planning, control, image reconstruction, and post-processing, not for interpretation or AI-driven diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone (algorithm only) performance was assessed through the various non-clinical hardware and software verification and validation tests listed in the table above. These tests evaluate the device's inherent functionality, image quality, and compliance with technical specifications, without direct human interaction for interpretation or decision-making during the test itself.
7. The type of ground truth used
For the non-clinical tests described, the "ground truth" implicitly refers to:
- Engineering Specifications/Requirements: The design and performance targets set for the device's hardware and software features.
- Industry Standards: Compliance with recognized standards like NEMA, IEC, and ANSI AAMI for electrical safety, EMC, and image quality.
- Physical Properties: For tests like myNeedle Laser accuracy or iMAR efficacy, the ground truth would be the known physical characteristics or expected outcomes in phantom models.
There is no mention of "expert consensus, pathology, or outcomes data" as ground truth, which are typically found in clinical validation studies.
8. The sample size for the training set
The document does not provide information on a training set. This is consistent with the nature of the submission (510(k) for a CT system software update) which focuses on demonstrating substantial equivalence and safety/effectiveness through non-clinical testing, rather than developing or validating an AI algorithm that would typically require a training set.
9. How the ground truth for the training set was established
Since no information on a training set is provided, how its ground truth was established is not applicable/not mentioned.
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July 12, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K220814
Trade/Device Name: NAEOTOM Alpha, Scan&GO Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 8, 2022 Received: June 9, 2022
Dear Tabitha Estes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K220814
Device Name NAEOTOM Alpha Scan&GO Software
Indications for Use (Describe) NAEOTOM Alpha
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.
Scan&GO
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are using special protocols.
| 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) |
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510(k) Summary
FOR
NAEOTOM Alpha CT Scanner System SOFTWARE VERSION SOMARIS/10 syngo CT VA50 (K220814) Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive
Knoxville, TN 37932 Date Prepared: March 18, 2022
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
I. Submitter
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number 1034973
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335
Note: Description in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.
Contact Person:
Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) (865) 218-3019 FAX tabitha.estes@Siemens-healthineers.com
II. Device Name and Classification
NAEOTOM Alpha Product Name:
| Trade Name: | NAEOTOM Alpha |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
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| Product Name: | Scan&GO |
|---|---|
| Propriety Trade Name: | Scan&GO |
| Classification Name: | Computed Tomography X-ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |
III. Predicate Device
| Primary Predicate Device: | |
|---|---|
| Trade Name: | NAEOTOM Alpha, Scan&GO |
| 510(k) Number: | K211591 |
| Clearance Date: | September 30, 2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All predicate device recalls have been considered in the subjectdevice design. |
| Secondary Predicate Device: | |
| Trade Name: | SOMATOM X.ceed, Scan&GO |
| 510(k) Number: | K211373 |
| Clearance Date: | August 27, 2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All predicate device recalls have been considered in the subjectdevice design. |
Note: K211373 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed and Scan&GO software.
In this submission, the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40 and the secondary predicate device SOMATOM X.ceed, both including Scan&GO, are being used, to demonstrate substantial equivalence of technological characteristics.
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IV. Device Description
Siemens intends to update software version, SOMARIS/10 synqo CT VA50 for Siemens NAEOTOM Alpha Scanner Systems with unmodified mobile workflow options.
This update also includes optional hardware for CT guided intervention workflow.
Dual Source CT Scanner System:
- NAEOTOM Alpha
- . Scan&GO Mobile Medical Application (optional mobile workflow component)
The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.
The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.
The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.
The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with Wi-Fi connection that meets certain minimum requirements:
- . Selection of patients
- Selection of pre-defined protocols
- Scan parameter display
- Patient table position display and gantry tilt parameter display
- . Tools and instruction message area,
- Patient table position planning area
- . Physiological data display
- . Patient data display (e.g. date of birth, name)
- Display of acquired topogram and tomogram images
- Finalization of exam (close patient)
- Mobile Organizer
- Patient Instruction Language ("API languages")
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- . predefined workflow associated question/answer dialog
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The software version for the NAEOTOM Alpha, syngo CT VA50 (SOMARIS/10 syngo CT VA50), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.
New software version syngo CT VA50 (SOMARIS/10 syngo CT VA50) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the primary predicate device in K211591 and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the primary predicate device.
V. Indications for Use
NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations*.
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Scan&GO:
This in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
VI. Comparison of Technological Characteristics with the Predicate Device
The NAEOTOM Alpha scanner provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the primary predicate device.
The subject device NAEOTOM Alpha is building on the dual-source CT system configuration of the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40.
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The predicate device and the subject device NAEOTOM Alpha features two photon counting detectors built from Cadmium-Telluride (CdTe).
Supported by the subject device, SOMARIS/10 syngo CT VA50 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211591.
lt reuses all unmodified software features of the legacy software syngo CT VA40 as described below in the section "Unmodified Features used in the Subject Devices".
The NAEOTOM Alpha with syngo CT VA50 also supports an optional laser component for a modified CT guided intervention workflow.
As with the primary device NAEOTOM Alpha with syngo CT VA40, the subject device NAEOTOM Alpha is supported by an optional mobile workflow, Scan&GO.
Software version SOMARIS/10 syngo CT VA50 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications. The intended use and fundamental scientific technology for the NAEOTOM Alpha remains unchanged from the cleared primary predicate device.
At a high level, the subject device NAEOTOM Alpha and the primary/secondary predicate device are based on the same subset of technological elements:
- Scanner Principle- Whole body X-Ray Computed Tomography Scanner
- System Acquisition – Continuously rotating tube detector system
- Iterative Reconstruction - Support of various iterative reconstruction principles
- Workplaces – Support of workplaces that include reconstruction and image evaluation software
- . Patient table
- Patient table foot switch for movement
- Tin filtration technology
- Vectron X-ray Tube
- Power Generator
- Mobile Medical application Software functionality (Scan&GO)
- Mobile workflow (Tablet)
- . Support 3D Camera operation for fast patient positioning workflow
- Scanner display and control functionality
- Remote Scan Control
- . Long scan range
The following technological differences exist between the subject device NAEOTOM Alpha and the primary predicate device NAEOTOM Alpha with syngo CT VA40 cleared in K211591:
- Software version SOMARIS/10 syngo CT VA50 ●
- . CT guided intervention – modified hardware and software application
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The following technological differences exist between the subject device Scan&GO mobile application software and the predicate device Scan&GO mobile application software cleared in K211591:
- Software version SOMARIS/10 syngo CT VA50 ●
- . CT guided intervention – modified hardware and software application
The NAEOTOM Alpha will support the following modifications/further developments in comparison to the primary/secondary predicate devices as listed in the tables below.
-
- New/Modified Hardware
- Table 1: Overview of hardware modifications .
-
- Software version SOMARIS/10 syngo CT VA50
- Table 2: Overview of software modifications
The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:
Table 1: Overview of term definition.
| Term | Definition |
|---|---|
| N/A | The feature is not supported for the subject device |
| New | The feature is newly supported for Siemens CT Scanners and the subjectdevice |
| Modified | This feature is modified from the predicate / reference devices |
| Enabled | This feature is currently supported by other cleared Siemens CT systems orcleared Siemens stand-alone software applications. This feature will besupported for the subject device with software version SOMARIS/10 syngo CTVA50 and is substantially equivalent compared to the cleared version. |
New/modified hardware features:
Table 2: Overview of hardware modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.
| Hardware properties | Subject deviceNAEOTOM AlphaSOMARIS/10 syngo CT VA50 | |
|---|---|---|
| 1. | CT guided intervention – MyNeedle Laser | enabled |
| 2. | Tablet dock for patient table | enabled |
| 3. | Interventional Joystick (IVJ) | enabled |
| 4. | Integrated Injector Arm | enabled |
| 5. | Tablet hardware for Scan&GO | modified |
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New/modified software features:
Table 3: Overview of software modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.
| Software properties | NAEOTOM Alpha | |
|---|---|---|
| SOMARIS/10 syngo CT VA50 | ||
| (subject device) | ||
| 1. | CT guided intervention – MyNeedle Guide | enabled |
| 2. | Flex 4D Spiral – Neuro & Body Perfusion/ DynamicAngio | modified |
| 3. | Quantum 70 kV | modified |
| 4. | QuantumPlus UHR | modified |
| 5. | Flash Phase Spiral | modified |
| 6. | PURE Calcium | new |
| 7. | Iterative Metal Artifact Reduction (iMAR) | enabled |
| 8. | Automated Patient Instructions | modified |
| 9. | QuantumPlus Topo (Spectral Topo) | modified |
| 10. | Multi-Threshold Acquisition | modified |
| 11. | High Resolution Dual Source Cardiac Modes | modified |
| 12. | Additional ex-factory exam protocols | modified |
A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VA50 and primary/secondary predicate device are listed in Table 4 and Table 5 below (modifications are in gray shaded sections).
Table 4: Technical hardware characteristics for subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VA50) compared to the predicate devices.
| Hardwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
|---|---|---|---|
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| Scanner | whole body X-raycomputed tomographyscanner | whole body X-raycomputed tomographyscanner | whole body X-raycomputed tomographyscanner |
| Scan Mode | Dual Source Dual Energy | Dual Source Dual Energy | Single Source DualEnergy |
| Hardwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| Generatormax. power | 2x 120 kW | 2x 120 kW | 105 kW/ 120 kW |
| DetectorTechnology | QuantaMaxDirect Conversion with"Quantum Technology" | QuantaMaxDirect Conversion with"Quantum Technology" | StellarinfinityEnergy integrating |
| Detectorvolumecoverage | 2 x 57.6 mm | 2 x 57.6 mm | 38.4 mm |
| Detectorphysical rows | 2x 288 | 2x 288 | 64 |
| Detector slicewidth | 0.2 mm | 0.2 mm | 0.6 mm |
| Detectorchannel No. | 2752 (A system)1984 (B system) | 2752 (A system)1984 (B system) | 920 |
| X-ray Tube | VECTRON | VECTRON | VECTRON |
| TubekV steps | 70 kV, 90 kV, 100 kV,120 kV, 140 kV | 90 kV, 100 kV, 120 kV,140 kV | 70 kV to 150 kV(in 10 kV steps) |
| Tubemax. current | 2 x 1300 mA | 2 x 1300 mA | 1200 mA; for 105 kW1300 mA; for 120 kW |
| Tubetube focus | 0.4 mm x 0.5 mm0.6 mm x 0.7 mm0.8 mm x 1.1 mm(for both tubes) | 0.4 mm x 0.5 mm0.6 mm x 0.7 mm0.8 mm x 1.1 mm(for both tubes) | min. 0.6 mm x 0,7 mm(w/o comb)min. 0.4 mm x 0.5 mm(with comb) |
| Tubeheat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| Gantrybore size | 82 cm | 82 cm | 82 cm |
| GantryScan FoV | 50 cm | 50 cm | 50 cm |
| Gantryrotation time [s] | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.3 s, 0.5 s, 1.0 s |
| GantryTilt [degree] | N/A | N/A | +/- 25+/- 30 (only with Vitus) |
| Hardwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| Patient Tabletype | Vario 2.DVitus | Vario 2.DVitus | Vario 2.DVitusVario RT |
| Max. ScanlengthTopogram | Vario 2.D: 2080 mmVitus: 2080 mm | Vario 2.D: 2080 mmVitus: 2080 mm | Vario 2.D: 2080 mmVitus: 2080 mmVario RT: 1680 mm |
| Max. ScanlengthImageacquisition | Vario 2.D: 2000 mmVitus: 2000 mm | Vario 2.D: 2000 mmVitus: 2000 mm | Vario 2.D: 2000 mmVitus: 2000 mmVario RT: 1600 mm |
| SpectralfiltrationOption* | Tin Filter for both tubes | Tin Filter for both tubes | Combined Split Filter /Tin Filter supported, plusextra Tin Filter |
| 3D Camerafor patientpositioning | option for patientpositioning with 3DCamera | option for patientpositioning with 3DCamera | option for patientpositioning with 3DCamera |
| Tablet dock forpatient table | Option for mounting ofthe tablet on the patienttable. | N/A | Option for mounting ofthe tablet on the patienttable. |
| InterventionalJoystick (IVJ) | Option to support thetablet mobile workflowincluding an electricalconnection for the tabletdock which allowscharging the tabletwhen mounted. | N/A | Option to support thetablet mobile workflowincluding an electricalconnection for the tabletdock which allowscharging the tabletwhen mounted. |
| Laser supportedworkflow | Laser in combinationwith FAST Isocenteringvisualize coordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions | N/A | Laser in combinationwith FAST Isocenteringvisualize coordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions |
| Softwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| OperatingSystem | Windows basedSOMARIS/10 syngo CTVA50 | Windows basedSOMARIS/10 syngo CTVA40 | Windows basedSOMARIS/10 syngo CTVA40 |
| AcquisitionWorkplace | syngo AcquisitionWorkplace named as"myExam Console"syngo Viewing, syngoFilming and syngoArchiving & Networking2nd AcquisitionWorkplace named as"myExam Satellite" | syngo AcquisitionWorkplace named as"myExam Console"syngo Viewing, syngoFilming and syngoArchiving & Networking2nd AcquisitionWorkplace named as"myExam Satellite" | syngo AcquisitionWorkplace named as"myExam Console"syngo Viewing, syngoFilming and syngoArchiving & Networking2nd AcquisitionWorkplace named as"myExam Satellite" |
| IRS | Image Reconstructionfor QuantumTechnology | Image Reconstructionfor QuantumTechnology | Image Reconstructionfor classic Siemenssingle source CT scanner |
| Detector | QuantaMax detectorfirmware supported | QuantaMax detectorfirmware supported | Stellar detectorfirmware supported |
| Teamplay | Support teamplayProtocols | Support teamplayProtocols | Support teamplayProtocols |
| Protocols | Support of:Protocol supportingcontrast bolus-triggered dataacquisitionContrast mediaprotocols (includingcoronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual EnergyacquisitionDynamic imaging(Flex 4D Spiral) | Support of:Protocol supportingcontrast bolus-triggered dataacquisitionContrast mediaprotocols (includingcoronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual EnergyacquisitionProtocols supportingCardiac Scanning,Spectral imaging for | Protocols forRadiation TherapyPlanning supportpatient markingProtocols that allowscanning withsupport of anexternal respiratorygating system(ANZAI, Varian RGSC)Protocol supportingcontrast bolus-triggered dataacquisition |
| Softwareproperty | Subject device | Primary predicate device | Secondary predicate device |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| various i-spiral scan protocols and FAST i-sequence(applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV Protocols supporting Intervention, Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution | child examination, Spectral imaging with high resolution | Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Dynamic imaging (Flex 4D Spiral) various i-spiral scan protocols and FAST i-sequence(applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV Protocols supporting Intervention | |
| AdvancedReconstruction | Recon&GO: Spectral Recon (Dual Energy Reconstruction from photon counting data) / including Virtual Unenhanced, Monoenergetic plus Inline Results DE SPP (Spectral Post-Processing with photon counting image data) | Recon&GO: Spectral Recon (Dual Energy Reconstruction from photon counting data) / including Virtual Unenhanced, Monoenergetic plus Inline Results DE SPP (Spectral Post-Processing with photon counting image data) | Recon&GO: Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-Processing) / including Virtual Unenhanced, Monoenergetic plus |
| Post- ProcessingInterface | Recon&GO Inline Results: | Recon&GO Inline Results: | Recon&GO Inline Results: |
| Softwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| Software interface topost-processingalgorithms which areunmodified whenloaded onto the CTscanners and 510(k)cleared as medicaldevices in their ownright. | Software interface topost-processingalgorithms which areunmodified whenloaded onto the CTscanners and 510(k)cleared as medicaldevices in their ownright. | Software interface topost-processingalgorithms which areunmodified whenloaded onto the CTscanners and 510(k)cleared as medicaldevices in their ownright. | |
| • softwareinterfaces for post-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose. | • softwareinterfaces for post-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose. | • softwareinterfaces for post-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose. | |
| Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition. | Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition. | Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition. | |
| These advancedvisualization tools aredesigned to support thetechnician & physicianin the qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regardingthe points of interfaceand inputs for thisfeature is provided inSection 16. | These advancedvisualization tools aredesigned to support thetechnician & physicianin the qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regardingthe points of interfaceand inputs for thisfeature is provided inSection 16. | These advancedvisualization tools aredesigned to support thetechnician & physicianin the qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regardingthe points of interfaceand inputs for thisfeature is provided inSection 16. | |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| Softwareproperty | Subject device | Primary predicatedevice | Secondary predicatedevice |
| NAEOTOM AlphaSOMARIS/10 syngo CTVA50 | NAEOTOM AlphaSOMARIS/10 syngo CTVA40(K211591) | SOMATOM X.ceedSOMARIS/10 syngo CTVA40(K211373) | |
| Standardtechnologies | FAST Features CARE Features GO technology CARE keV | FAST Features CARE Features GO technology CARE keV | FAST Features CARE Features GO technology CARE kV |
| IterativeReconstructionMethods | Quantum IterativeReconstructioniMAR | Quantum IterativeReconstruction | ADMIREiMAR |
| Precision Matrix | Precision Matrixresolutionsupport image matrixsizes of 512x512,768x768 pixels and1024x1024 pixel (automode supported) | Precision Matrixresolutionsupport image matrixsizes of 512x512,768x768 pixels and1024x1024 pixel (automode supported) | image matrix sizes256x256, 512x512 and768x768 pixels |
| CaScoring | Photon countingtechnology offersmonoenergetic imageswhich can be used as abase for calcium scoringindependent from tubevoltage kV and beamfiltration settings. | Photon countingtechnology offersmonoenergetic imageswhich can be used as abase for calcium scoringindependent from tubevoltage kV and beamfiltration settings. | Classic SOMATOMX.ceed technology offersimages which can beused for calciumscoring, independentfrom tube voltage kVand beam filtrationsettings based on adedicated single energyimage reconstructionmethod. |
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Table 5: Software characteristics for subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VA50) compared to the predicate devices.
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Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, the NAEOTOM Alpha with syngo CT VA50, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
VII. Performance Data
Non-Clinical Testing
Non-clinical testing, (integration and functional) including phantom tests were conducted for the NAEOTOM Alpha during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
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The general purpose of each test is to verify and validate the functionality of the subject device modifications.
Testing covered all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
System Validation test:
- Acceptance test (workflow and user manual test) ●
- Legal and Regulatory test
System Verification test:
- System Integration Test (functional) ●
- . Functionality verification
- . Image Quality (IQ) Evaluation
Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented, and traced by hazard keys.
Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 6 below.
| Feature/Non-clinicalsupportive testing | Testing performed |
|---|---|
| myNeedle Laser | The performed bench test covers the laser accuracy evaluation.The results of the accuracy test with a close to clinical workflowand test setup show that defined accuracy level can be achieved. |
| myNeedle Laser | The performed bench test report covers the workflow evaluation.A comparison to the essential workflow steps is performed. |
| Flex 4D Spiral – Neuro &Body Perfusion/ DynamicAngio | The performed bench test describes the technical background ofFlex 4D Spiral and added functionalities with NAEOTOM Alpha(dynamic collimation and dose modulation), demonstrates theproper function of those and assesses the image quality of Flex 4DSpiral on NAEOTOM Alpha at all. |
| QuantumPlus UHR | The performed bench test describes the reconstruction of spectralimages from raw data acquired in ultra-high resolution (UHR)modes. |
| PURE Calcium | The performed bench test describes the feature "PURE Calcium",which uses spectrally acquired input image data generated by thesubject device NAEOTOM Alpha to obtain a modified image |
Table 6: Non-clinical performance testing
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| Feature/Non-clinicalsupportive testing | Testing performed |
|---|---|
| reconstruction that aims at removing the iodine contribution fromthe generated output images. | |
| Iterative Metal ArtifactReduction (iMAR) | The performed bench test covers evaluation of phantom images todemonstrate the efficacy of iMAR to reduce metal arti-facts. |
| High Resolution Dual SourceCardiac Modes | The performed bench test describes the basic image quality andthe property of the ECG gated ultra-high resolution dual sourcecardiac acquisition mode introduced in NAEOTOM Alpha withsoftware version syngo CT VA50. |
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device NAEOTOM Alpha in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table 7 and Table 8 below.
Table 7: Recognized Consensus Standards
| Date ofRecognition | RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
|---|---|---|---|---|
| 06/27/2016 | 12-300 | NEMA | PS 3.1 - 3.20 (2016) | Digital Imaging andCommunications in Medicine(DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed Tomography DoseCheck |
| 01/27/2015 | 12-287 | NEMA | XR 28-2013 | Supplemental Requirementsfor User Information andSystem Function Related toDose in CT |
| 06/27/2016 | 5-40 | ANSI AAMIISO | 14971:2007/(R)2010(Corrected 4October 2007) | Medical Devices - ApplicationsOf Risk Management ToMedical Devices |
| ISO | 14971 Secondedition 2007-03-01 | Medical Devices - ApplicationsOf Risk Management ToMedical Devices | ||
| 01/14/2019 | 13-79 | IEC | 62304 Edition 1.12015-06CONSOLIDATEDVERSION | Medical Device Software -Software Life Cycle Processes |
| 07/09/2014 | 19-4 | ANSI AAMI | ES60601-1:2005/(R)2012 AndA1:2012, | C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) Medicalelectrical equipment - Part 1:General requirements for basicsafety and essential |
| Date ofRecognition | RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
| 09/17/2018 | 19-8 | ANSI AAMIIEC | 60601-1-2:2014 | Medical electrical equipment -Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances -Requirements and tests |
| 12/23/2016 | 5-114 | ANSI AAMIIEC | 62366-1:2015 | Medical devices - Part 1:Application of usabilityengineering to medical devices |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.02007-03 | Safety Of Laser Products - Part1: Equipment Classification,And Requirements [Including:Technical Corrigendum 1(2008), Interpretation Sheet 1(2007), Interpretation Sheet 2(2007)]Note: Requirements accordingto IEC 60825-1:2014 (Ed.3.0)are implemented. |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition3.2: 2016 | Medical electrical equipment -Part 2-44: Particularrequirements for the basicsafety and essentialperformance of x-rayequipment for computedtomography |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition2.1 2013-04 | Medical electrical equipment -Part 1-3: Generalrequirements for basic safetyand essential performance -Collateral Standard: Radiationprotection in diagnostic X-rayequipment |
| 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition3.1 2013-10 | Medical Electrical Equipment -Part 1-6: GeneralRequirements For Basic SafetyAnd Essential Performance -Collateral Standard: Usability |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 SecondEdition 2006-11 | Evaluation and routine testingin medical imagingdepartments - Part 2-6:Constancy tests - Imaging |
| Date ofRecognition | RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
| performance of computedtomography X-ray equipment | ||||
| 01/30/2014 | 12-270 | IEC | 61223-3-5 FirstEdition 2004-08 | Evaluation and routine testingin medical imagingdepartments - Part 3-5:Acceptance tests - Imagingperformance of computedtomography X-ray equipment[Including: TechnicalCorrigendum 1 (2006)] |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition2.0 2019-09 | Evaluation and routine testingin medical imagingdepartments - Part 3-5:Acceptance tests - Imagingperformance of computedtomography X-ray equipment[Including: TechnicalCorrigendum 1 (2006)] |
| 06/07/2018 | 12-309 | IEC | 60601-2-28 Edition3.0 2017-06 | Medical Electrical Equipment -Part 2-28: ParticularRequirements For The BasicSafety And EssentialPerformance Of X-Ray TubeAssemblies For MedicalDiagnosis |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical electrical equipment -Medical image display systems- Part 1: Evaluation methods |
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Table 8: General Use Consensus Standards
| Standard DevelopingOrganization | Standard DesignationNumber and Date | Title of Standard | How was StandardUsed |
|---|---|---|---|
| IEC | 60601-1:2005+A1:2012 | Medical electricalequipment - part 1:general requirementsfor basic safety andessential performance | Covered by ANSI AAMIES60601-1:2005/(R)2012 andA1:2012 as part ofEMC testing. |
| IEC/ISO | 17050-1 | ConformityAssessment -Supplier's declarationof conformity - Part 1:General requirements | Declaration ofconformance to FDArecognized consensusstandards. |
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| Standard DevelopingOrganization | Standard DesignationNumber and Date | Title of Standard | How was StandardUsed |
|---|---|---|---|
| IEC/ISO | 17050-2 | Conformityassessment –Supplier's declarationof conformity – Part 2:Supportingdocumentation. | General consensusstandards notcurrently recognizedby FDA. |
A list of applicable guidance documents considered for this submission is provided as Table 9 below.
Table 9: FDA Guidance Document and Effective Date
| 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)sDocument issued on February 21, 2019 |
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA StaffDocument issued on August 12, 2005 |
| 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 Content of Premarket Submission for Software in Medical DevicesDocument issued on May 11, 2005 |
| 7. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical DevicesDocument issued on September 9, 1999 |
| 8. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices.Document issued February 3, 2016 |
| 9. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications. |
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| Document issued on November 28, 2017 | |
|---|---|
| 10. | Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014 |
| 11. | Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical DevicesDocument issued on July 11, 2016 |
| 12. | Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submission recommendations for Interoperable Medical devicesDocument Issued on September 6, 2017 |
| 13. | Guidance for Industry and Food Drug Administration Staff:Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for MedicalDevicesDocument issued on September 14, 2018 |
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 is also included as part of this submission. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.
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. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014″ is included within this submission.
Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.
The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device iPad for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the NAEOTOM Alpha and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance to IEC60601-2-44.
Wireless Coexistence Testing
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Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components in combination with the applicable system supported functionality. Wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.
Testing for co-existence considered for following scenarios:
- Co-Channel Testing
- . Adjacent Channel Testing
- . RF Interference Testing
- Separation Distance/Location Testing
Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.
Summary
The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed, and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the risk management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
VIII. Conclusions
The primary and secondary predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The nonclinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the NAEOTOM Alpha should perform as intended in the specified use conditions. The data included in this submission demonstrates that the NAEOTOM Alpha with described modifications performs comparably to the primary predicate device currently marketed for
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the same intended use. Siemens believes that the data generated from the NAEOTOM Alpha testing supports a finding of substantial equivalence.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.