(28 days)
No
The summary does not mention AI, ML, or related terms in the device description, intended use, or performance studies. The focus is on standard SPECT and CT imaging technologies and their integration.
No.
The device is described as an imaging system used for detection, diagnosis, and planning purposes, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders."
No
The device description clearly states that the Siemens Symbia systems consist of SPECT scanners and integrated hybrid X-Ray CT and SPECT scanners, which are hardware components. While the software component (syngo MI Applications) is mentioned, it is part of a larger system that includes physical imaging hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions.
- Device Function: The Siemens Symbia series is an in vivo imaging system. It uses SPECT and CT technologies to image the distribution of radionuclides and anatomical structures within the patient's body.
- Intended Use: The intended use clearly describes aiding in the detection, localization, diagnosis, staging, and evaluation of diseases and disorders by producing images of the body and organ function. This is consistent with in vivo imaging, not in vitro testing of samples.
- Device Description: The description reinforces that the system images and measures the distribution of radiopharmaceuticals in humans and produces cross-sectional images of the body.
Therefore, the Siemens Symbia series falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
The following statement applies only to Siemens Symbia Intevo 16, and Symbia Intevo Bold systems:
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.
Product codes
KPS, JAK
Device Description
The Siemens Symbia systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand-alone diagnostic imaging devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, CT, PET
Anatomical Site
Body, Organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing.
Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment.
Symbia VB23 is designed in accordance with the 60601-1 series including all relevant collateral standards general and specific. Collimator performance testing is conducted according to NEMA NU-1:2018. All Performance testing met the predetermined acceptance values.
NEMA performance testing results demonstrate accurate quantification in phantoms for all the isotopes and collimators tested. NEMA and high count performance results meet specifications.
The quantitative error for all isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria.
Existing NEMA detector and collimator performance specifications do not change between the commercially available Symbia 6.7 systems and proposed Symbia VB23 systems. There are no changes in the system design that could impact the SPECT performance specifications and the commercially available NEMA NU1:2018 specifications still apply.
Performance testing performed on the CT subsystem is conducted in accordance with IEC 60601-2-44 and in accordance with US regulations including 21 CFR 1020.33, Computed Tomography (CT) equipment. This is unchanged from the FDA clearance via CT 510(k) SOMARIS VC50 (K183548).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative error Tc99m LEHR/LPHR: ≤10%
Quantitative error I123 LPHR/MELP: ≤10%
Quantitative error In111 MELP: ≤10%
Quantitative error Lu177 MELP: ≤10%
Quantitative error Lu177 MELP at 310kcps: ≤10%
Quantitative error I131 HE: ≤10%
(Quantitative error is stated for phantoms with negligible partial volume effect, and for incident count rate for Lu177 and I131)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2024
Siemens Healthineers Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive Knoxville, Tennessee 37938
Re: K241898
Trade/Device Name: Symbia SPECT and SPECT/CT Systems Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: June 28, 2024 Received: June 28, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
FDA
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Symbia SPECT and SPECT/CT Systems
Indications for Use (Describe)
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
The following statement applies only to Siemens Symbia Intevo 16, and Symbia Intevo Bold systems:
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K241898
510(k) Summary
as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c)
Identification of the Submitter
| Submitter: | Tabitha Estes |
|---|---|
| Regulatory Technical Specialist | |
| Siemens Medical Solutions USA, Inc. | |
| 2501 N. Barrington Road | |
| Hoffman Estates, IL 60192 | |
| USA | |
| Name / Address of | |
| Manufacturer: | Siemens Medical Solutions USA, Inc |
| Molecular Imaging | |
| 2501 N. Barrington Road | |
| Hoffman Estates, IL 60192 | |
| USA | |
| Telephone Number: | (865) 804-4553 |
| Date of Submission: | June 28th, 2024 |
| Identification of the product | |
| Device Proprietary Name: | Symbia VB23 |
| Common Name: | Single-photon emission computed tomography (SPECT) |
| system | |
| Computed Tomography (CT) System | |
| Classification Name: | Emission Computed Tomography per 21 CFR 892.1200 |
| Computed Tomography X-Ray System per 21 CFR | |
| 892.1750 | |
| Product Code: | KPS and JAK |
| Classification Panel: | Radiology |
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| Class: | II | |
|---|---|---|
| Marketed Devices to which Equivalence is claimed | ||
| Predicate: | ||
| Device Proprietary Name: | Symbia 6.7 (VB22) | |
| Common Name: | Single-Photon Emission Computed Tomography (SPECT) | |
| System | ||
| Computed Tomography (CT) System | ||
| Classification Name: | Emission Computed Tomography System per 21 CFR | |
| 892.1200 | ||
| Computed Tomography X-Ray System per 21 CFR | ||
| 892.1750 | ||
| Manufacturer: | Siemens Medical Solutions USA, Inc. | |
| Product Code: | KPS and JAK | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| 510(k) Number: | K200474 | |
| Reference Device: | ||
| Device Name and 510(k) | ||
| numbers: | SOMATOM Scope/Scope Power, and SOMATOM | |
| Emotion 16 with VC50 | ||
| Common Name: | Computed Tomography X-Ray System | |
| Classification Name: | Computed Tomography X-Ray System per 21 CFR | |
| 892.1750 | ||
| Manufacturer: | Siemens Healthcare GmbH | |
| Product Code: | JAK |
Classification Panel: Radiology
Device Class: Class II
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510(k) Number: K183548
Device Description:
The Siemens Symbia systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand-alone diagnostic imaging devices.
| Symbia VB23 Family | ||
|---|---|---|
| SPECT Only Systems | Symbia S | variable angle dual detector SPECT system |
| Symbia Evo | variable angle dual detector SPECT system | |
| Symbia Evo Excel | variable angle dual detector SPECT system | |
| SPECT/CT Systems | Symbia T | SPECT/CT system with non-diagnostic CT support for only attenuation correction and anatomical localization |
| Symbia T2, T6, T16 | a variable angle dual detector SPECT with a 2, 6, or 16-slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications | |
| Symbia Intevo Excel | SPECT/CT system with non-diagnostic CT support for only attenuation correction and anatomical localization | |
| Symbia Intevo 2, Intevo 6, Intevo 16, Intevo Bold | variable angle dual detector SPECT and 2, 6, or 16-slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications |
All systems implement a new software version syngo MI Applications VB23.
Figure 1: Symbia models
7
Modifications in Symbia VB23 include:
- a) Software:
- upgrade to Windows® 10 LTSC 2021 Operating System for syngo MI ● Applications
- updated version of syngo software: VZ30
- Somaris 5 VC51 based on Somaris VC50 (K183548)
- 3rd party software applications; Corridor 4DM, Cedars, Scenium and TrueD are updated for continued support
- b) Hardware:
- Updated computer models for obsolescence
- Updated versions of printed circuit board assemblies (PCBAs) AEB3 and . LVA2/HVA2 due to obsolescence
- Addition of SLD/LLD (linear) brakes ●
Intended Use:
The Symbia Intevo Excel, Symbia Intevo series and Symbia T series are radiological imaging systems that combine a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The Symbia S. Symbia Evo, and Symbia Evo Excel systems are SPECT camera systems.
The SPECT system is intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data, and the CT system is 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. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (that is, distribution of radiopharmaceuticals).
The SPECT and CT portions of the system may be used independently or in combination, and may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. The SPECT and CT images may be transferred to other systems for radiation therapy planning or additional uses.
8
Indications for Use:
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.
The following statement applies only to Siemens Symbia Intevo 16, and Symbia Intevo Bold systems:
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.
Technological Characteristics:
Symbia VB23 systems are based on the commercially available Symbia 6.7 (VB22) (K200474). SPECT detector, existing collimators, and CT performance specifications do not change between the commercially available Symbia 6.7 systems.
Performance Testing:
9
Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing.
Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment:
- · 21 CFR 1020.30 (a) Applicability
- · 21 CFR 1020.30 (b)(36)(iii)-(v) Technique Factors
- · 21 CFR 1020.30 (b)(58)-(62) CT, Scan, Scan Time, Tomogram, Dose
- · 21 CFR 1020.30 (h)(3)(vi)-(viii) Information to be provided for users
- · 21 CFR 1020.33 Computed Tomography (CT) equipment
- ・21 CFR 1040.10 Laser Products
- · 21 CFR 1040.11 Specific purpose laser products
Symbia VB23 is designed in accordance with the 60601-1 series including all relevant collateral standards general and specific (see standards table in Safety and Effectiveness section). Collimator performance testing is conducted according to NEMA NU-1:2018. All Performance testing met the predetermined acceptance values.
Figure 2 below Depicts Detector Specifications which are valid for Symbia VB23. Specifications have not changed from the predicate device.
| Detector Specifications | 3/8" |
|---|---|
| Intrinsic Spatial Resolution | |
| FWHM in CFOV | ≤3.8 mm |
| FWHM in UFOV | ≤3.9 mm |
| FWTM in CFOV | ≤7.5 mm |
| FWTM in UFOV | ≤7.7 mm |
| Intrinsic Spatial Linearity | |
| Differential in CFOV | ≤0.2 mm |
| Differential in UFOV | ≤0.2 mm |
| Absolute in CFOV | ≤0.4 mm |
| Absolute in UFOV | ≤0.7 mm |
| Intrinsic Energy Resolution | |
| FWHM in CFOV | ≤9.9% |
| Intrinsic Flood Field Uniformity | |
| (Uncorrected) | |
| Differential in CFOV | ≤2.5% |
| Differential in UFOV | ≤2.7% |
| Integral in CFOV | ≤2.9% |
| Integral in UFOV | ≤3.7% |
| Multiple Window Spatial Registration | ≤0.6 mm |
| Intrinsic Count Rate Performance in Air | |
| Maximum Count Rate | 310 kcps |
| Intrinsic Spatial Resolution at 75 kcps | |
| FWHM in UFOV | ≤4.1 mm |
| FWTM in UFOV | ≤7.8 mm |
| Intrinsic Flood Field Uniformity at 75 kcps | |
| Differential in CFOV | ≤2.5% |
| Differential in UFOV | ≤2.7% |
| Integral in CFOV | ≤2.9% |
| Integral in UFOV | ≤3.7% |
| System Spatial Resolution Without Scatter | |
| (LEHR at 10 cm) | |
| FWHM in CFOV | ≤7.5 mm |
| FWTM in CFOV | ≤13.6 mm |
| System Spatial Resolution With Scatter | |
| (LEHR at 10 cm) | |
| FWHM in CFOV | ≤8.3 mm |
| FWTM in CFOV | ≤18.6 mm |
| System Planar Sensitivity (LEHR at 10 cm) | |
| Absolute | 202 cpm/µCi |
| System Planar Sensitivity (ME at 10 cm) | |
| Absolute 111In | 430 cpm/µCi |
| Average Volume Sensitivity per axial | |
| centimeter | |
| LEHR Tc99m | 12,000 |
| (cts/sec)/(MBq/cm2) | |
| Detector-Detector Sensitivity Variation | |
| (LEHR, 99mTc) | ≤5.0% |
| Whole-Body System Spatial Resolution | |
| Without Scatter at 10 cm/min Scan Speed | |
| (LEHR at 10 cm) | |
| FWHM Perpendicular | ≤7.5 mm |
| FWHM Parallel | ≤7.9 mm |
| FWTM Perpendicular | ≤14.0 mm |
| FWTM Parallel | ≤14.2 mm |
10
Figure 2 Detector Specifications
11
Image Quality
Figure 3 below shows NEMA performance testing results demonstrate accurate quantification in phantoms for all the isotopes and collimators tested. NEMA and high count performance results meet specifications.
| Summary of Quantitative accuracy
| specifications* | |
|---|---|
| Quantitative error Tc99m LEHR/LPHR | ≤10% |
| Quantitative error I123 LPHR/MELP | ≤10% |
| Quantitative error In111 MELP | ≤10% |
| Quantitative error Lu177 MELP | ≤10% |
| Quantitative error Lu177 MELP at 310kcps** | ≤10% |
| Quantitative error I131 HE ** | ≤10% |
Figure 3 Quantitative Accuracy Specifications
- In phantoms for objects with negligible partial volume effect
- ** incident count rate
The quantitative error for all isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria.
Existing NEMA detector and collimator performance specifications do not change between the commercially available Symbia 6.7 systems and proposed Symbia VB23 systems. There are no changes in the system design that could impact the SPECT performance specifications and the commercially available NEMA NU1:2018 specifications still apply.
Performance testing performed on the CT subsystem is conducted in accordance with IEC 60601-2-44 and in accordance with US regulations including 21 CFR 1020.33, Computed Tomography (CT) equipment. This is unchanged from the FDA clearance via CT 510(k) SOMARIS VC50 (K183548).
Risk analyses performed at Siemens Medical Solutions USA; Inc. are in compliance with the requirements of:
- IEC/ISO 14971 Medical Devices Application of Risk Management to Medical ● Devices
- IEC 62304 Medical Device Software - Software Life-cycle Processes
There is no significant difference in the risks imposed by this system and the risks associated with the predicate devices. The product Risk Management Team has reviewed and verified that all risks identified in the Symbia VB23 Product Risk Analysis has been
12
adequately mitigated and the individual and overall residual risks are reduced as far as possible.
Verification and validation of Siemens software is performed in accordance with documented procedures, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software verification, and system testing.
System and System Integration testing (validation) was carried out for all features of the project, and all planned test cases were executed.
Verification and Validation is performed to:
- ensure the functionality described in the specifications are met, ●
- . ensure the quality in the planning documentation is adhered to,
- ensure mitigations required by risk analysis are implemented, and appropriate ●
- identify additional issues that may be related to patient / operator safety, or ● effectiveness
- assure that the specifications are appropriate to fulfill the intended use of the . system.
Safety and Effectiveness:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.
Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.
Siemens claims compliance with the following product standards for the Symbia systems:
- IEC 60601-1: 2005+ A1:2012 .
- IEC 60601-1-2: 2014 ●
- IEC 60601-1-3: 2013 ●
- IEC 60601-1-6:2010 +A1:2013 ● +A1:2020
- IEC 60601-2-28:2017 ●
- IEC 60601-2-44: 2016 ●
- IEC 61223-3-5:2019 .
- IEC 62366-1:2020 ●
- IEC 62304:2015 ●
- NEMA XR 25: 2019
- NEMA XR 28: 2018 ●
- NEMA PS3.1-3.20: 2023e ●
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- IEC 61223-2-6:2006 ●
Symbia VB23 conforms to applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as required by the respective SPECT FDA Guidance Documents. SPECT detector and CT performance is conducted according to NEMA NU1:2018, and the performance does not change from the predicate device.
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Cybersecurity features have been assessed according to FDA Guidance issued September 27, 2023 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'.
The Symbia systems' software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Symbia systems and external devices.
Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
Substantial Equivalence:
Symbia VB23 has the same intended use and utilizes the same fundamental scientific technology as the predicate device. There have been no changes implemented in the modifications of the Symbia systems that impact the fundamental technology or the indications for use. Siemens considers Symbia VB23 to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.