(125 days)
No
The document describes standard medical imaging techniques (SPECT and CT) and software for image display and analysis. There is no mention of AI or ML in the intended use, device description, or performance studies. The software updates and quantification features described are based on established calibration and correction methods, not AI/ML algorithms.
No.
This device is an imaging system intended for detection, localization, diagnosis, staging of lesions, tumors, disease, and evaluation of organ function, not for treating diseases or disorders.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function."
No
The device description clearly states it consists of SPECT scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners, which are hardware components. While it includes software for image display and analysis, it is not solely software.
Based on the provided text, the Siemens Symbia Intevo Bold is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic purposes.
- Symbia Intevo Bold Function: The Symbia Intevo Bold is an imaging system (SPECT/CT) that uses radionuclides and X-rays to create images of the inside of the human body. It detects the distribution of radiopharmaceuticals within the body and uses X-ray transmission data to create anatomical images.
- Intended Use: The intended use clearly states it's for "detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function" by imaging the body directly, not by analyzing specimens taken from the body.
Therefore, the Siemens Symbia Intevo Bold falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Siemens Symbia Intevo Bold 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, 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 take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT 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.
Product codes
KPS, JAK
Device Description
The Siemens Symbia Intevo Bold consist of Sinqle 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 standalone diagnostic imaging devices.
Symbia Intevo Bold implements software version syngo MI Applications VB20A.
Modifications include:
- Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)
- Software updates include modifications to support features available with the CT and SPECT subsystems
- Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes
- Four additional touchpad sensors to cover detectors' light rails and L-arms.
Commercially available xSPECT Quant (Symbia 5.0 K131634) was expanded to support quantification of additional isotopes such as I-123 and In-111. For these isotopes, dose calibrator independent quantification is enabled by a NIST traceable sensitivity calibration method. In addition, cross calibration capabilities were added to remove dose calibrator biases and variations in SUV calculations. The system allows cross calibration of multiple dose calibrators and, once calibrated, automatically adjusts for their biases.
In addition to dose calibrator independent quantification for I-123 and In-111 support for dose calibrator dependent quantification was added for a broad range of SPECT isotopes and collimators (Broad Quantification). Dose calibrator dependent quantification neither supports NIST traceable calibration nor cross calibration and relies on sensitivity measurements based on a local dose calibrator.
Mentions image processing
Yes
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
Performance testing is conducted according to NEMA NU-1:2012 including:
- intrinsic spatial resolution;
- intrinsic spatial linearity -
- intrinsic energy resolution; -
- intrinsic flood field uniformity; -
- multiple window spatial registration
- intrinsic count rate performance in air; -
- system spatial resolution with LEHR
- -SPECT reconstructed spatial resolution
- System Performance Testing at high count rates: ●
- Intrinsic flood field uniformity at 25% busy time -
- Intrinsic enerqy resolution at 25% busy time -
- -Energy peak position stability
- System spatial resolution at 25% busy time -
Testing includes image quality performance and integration testing for the new CT subsystem. All Performance testing met the predetermined acceptance values.
Broad Quantification and xSPECT Quant Testing :
The absolute quantitative accuracy of xSPECT Quant was verified in phantoms for the isotope-collimator combinations shown in Table 1. The acceptance criterion for xSPECT Quant is a quantitative error of smaller or equal to 10% in reference to the National Institute of Standards and Technology (NIST), i.e. when the system is calibrated with the NIST traceable precision source.
The reproducibility of dose calibrator dependent Broad Quantification was verified for isotope collimator combinations shown in Table 2. The reproducibility was verified to be within 10%.
Standard quality control phantoms such as the NEMA NU 2-1994 Test Phantom and the NEMA IEC Body Phantom were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols. All tests met specifications.
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 modifications from the original FDA clearance (K151749) that affect device performance.
Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment.
Performance testing is conducted according to NEMA NU-1:2012 covering various intrinsic and system spatial resolution, linearity, energy, flood field uniformity, and count rate performance. All Performance testing met the predetermined acceptance values.
The absolute quantitative accuracy of xSPECT Quant was verified in phantoms for isotope-collimator combinations (Tc99m-LEHR, Tc99m-LPHR, I123-LPHR, I123-MELP, In111-MELP). The acceptance criterion for xSPECT Quant is a quantitative error of smaller or equal to 10% in reference to the National Institute of Standards and Technology (NIST), which was met for all listed isotopes.
The reproducibility of dose calibrator dependent Broad Quantification was verified for isotope collimator combinations (Ga67-MELP, I131-HE) and met the acceptance criterion of being within 10%.
Standard quality control phantoms such as the NEMA NU 2-1994 Test Phantom and the NEMA IEC Body Phantom were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols. All tests met specifications.
Conclusion: The quantitative error for all supported isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative error
§ 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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them, creating a sense of movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
Siemens Medical Solutions, USA, Inc. % Ms. Cynthia Busch Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K162483
Trade/Device Name: Symbia Intevo Bold Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: November 28, 2016 Received: November 29, 2016
Dear Mr. Busch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Symbia Intevo Bold
Indications for Use (Describe)
The Siemens Symbia Intevo Bold 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, 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 take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT 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.
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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3
510(k) Summary
as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c)
| Identification of the Submitter | |
|---|---|
| Submitter: | Cynthia Busch |
| 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: | (847) 304-7095 |
| Fax Number: | (847) 304-6023 |
| Date of Submission: | September 2, 2016 |
| Identification of the product | |
| Device Proprietary Name: | Symbia Intevo Bold |
| Common Name: | Single-photon emission computed tomography (SPECT) |
| 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 |
| Class: | II |
4
Marketed Devices to which Equivalence is claimed
| Predicate: | ||
|---|---|---|
| Device Proprietary Name: | Symbia Intevo 16 |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| 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 |
| Device Class: | II |
| 510(k) Number: | K142006 |
Reference Device(s):
| Device Name(s): | SOMATOM Scope Power (with SOMARIS/5 VC30) |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Classification Name: | Computed Tomography X-Ray System per 21 CFR 892.1750 |
| Product Code: | JAK |
| Device Class: | II |
| 510(k) Number(s): | K151749 |
Reference Device(s):
| Device Name(s): | Symbia 5.0 |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| 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 |
| Device Class: | II |
| 510(k) Number(s): | K131634 |
5
Device Description:
The Siemens Symbia Intevo Bold consist of Sinqle 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 standalone diagnostic imaging devices.
Symbia Intevo Bold implements software version syngo MI Applications VB20A.
Modifications include:
-
Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)
-
Software updates include modifications to support features available with the CT and SPECT subsystems
-
Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes
-
Four additional touchpad sensors to cover detectors' light rails and L-arms.
Commercially available xSPECT Quant (Symbia 5.0 K131634) was expanded to support quantification of additional isotopes such as I-123 and In-111. For these isotopes, dose calibrator independent quantification is enabled by a NIST traceable sensitivity calibration method. In addition, cross calibration capabilities were added to remove dose calibrator biases and variations in SUV calculations. The system allows cross calibration of multiple dose calibrators and, once calibrated, automatically adjusts for their biases.
In addition to dose calibrator independent quantification for I-123 and In-111 support for dose calibrator dependent quantification was added for a broad range of SPECT isotopes and collimators (Broad Quantification). Dose calibrator dependent quantification neither supports NIST traceable calibration nor cross calibration and relies on sensitivity measurements based on a local dose calibrator.
Intended Use:
The Symbia Intevo Bold is a radioloqical imaqing system that combines a sinqle photon emission computed tomography (SPECT) camera system for nuclear medicine images. and a computed tomography (CT) camera system for x-ray images.
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 imaqes
6
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.
Indications for Use:
The Siemens Symbia Intevo Bold 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 imaqes produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: To detect or imaqe the distribution of radionuclides in the body or organ, usinq the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV
CT: The CT component is intended to produce 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.
SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
Technological Characteristics:
Symbia Intevo Bold is based on the commercially available Symbia Intevo 16 of the Symbia SPECT/CT scanners (K142006, Symbia 6.0). Symbia Intevo Bold incorporates the SOMATOM Scope Power CT (K151749). Updates to xSPECT quantitative software are based on the same fundamental technology of the xSPECT quantification in Symbia SPECT/CT predicate components. The SPECT detector, existinq collimators, and CT performance specifications do not chanqe between the commercially available Symbia Intevo 16 and proposed system, Symbia Intevo Bold.
7
| Feature /
Characteristic | Proposed Device: Symbia
Intevo Bold | Predicate Device: Intevo 16 | Difference |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner Models | Symbia Intevo Bold | Symbia Intevo 16 | New model Symbia
Intevo Bold, the subject
of this 510K application |
| Target Population | General use | General use | Same |
| Tracer Support | TI-201, Xe-133, Co-57, Tc-
99m, I-123, In-111, Ga-67, I-
131, F-18. | TI-201, Xe-133, Co-57, Tc-
99m, I-123, In-111, Ga-67, I-
131, F-18 | Same |
| Collimators | LEHS, LEAP, LEHR, LEUHR,
LEFB, ME, HE, UHE, Pinhole,
SMARTZOOM, LPHR | LEHS, LEAP, LEHR, LEUHR,
LEFB, ME, HE, UHE, Pinhole,
SMARTZOOM, LPHR | Same |
| Optional Pallets | Pediatric,
Scintimammography,
Radiation therapy | Pediatric,
Scintimammography,
Radiation therapy | Same |
| Accessories | Head Holder, Body Wrap, Arm
Rest, Cushions | Head Holder, Body Wrap,
Arm Rest, Cushions | Same |
| Software Version | syngo MI Applications VB20 | syngo MI Applications VB10 | MI Applications upgrade
for new features,
updates and defect fixes. |
| Somaris Version
(CT Software) | VC30 | VC20 | CT software
(commercially available
for Scope Power
(K151749) upgrade due
to new features and
updates. |
| CT Software
Features | | | |
| | CARE Dose 4D, SureView,
Workstream4D, HeartView CT,
syngo Care Bolus, syngo
Pulmo, syngo Fly through,
syngo Calcium Scoring,
Asynchronous Recon,
Multiplanar Reconstruction
(MPR), Syngo 3D SSD,FAST
Planning, FAST Spine, IRIS,
Fast kV, Fast 3D Align, multi-
series CTAC, SAFIRE, iMAR,
IVR, SSDE | CARE Dose 4D, SureView,
Workstream4D, HeartView
CT, syngo Care Bolus, syngo
Pulmo, syngo Fly through,
syngo Calcium Scoring,
Asynchronous Recon,
Multiplanar Reconstruction
(MPR), Syngo 3D SSD,FAST
Planning, FAST Spine, IRIS. | |
| | | Fast kV- CT feature
allows the system to
automatically adapt
mAs once the scan
kV has been set for a
patient in order to
keep the right
correlation between
these scan
parameters. Fast 3D Align - CT
feature which
provides automatic
centering and
aligning of the
reconstruction
volumes. Multi series CT AC-
enables the use of
multiple CT scans for
attenuation
correction SAFIRE – (Sinogram
Affirmed Iterative
Reconstruction) a CT
iterative
reconstruction
method which helps
lower the noise and
enhance sharpness
in CT images. iMAR- Metal Artifact
Reduction Metal
Artifact
Reconstruction
software designed to
reduce metal
artifacts caused by
large and/or dense
metal objects in
computed
tomography images. IVR- Interleaved
Volume
Reconstruction uses
measured data by
reconstructing
overlapping slices
from up to 32 slices.
This improves the
spatial resolution in
the Z-direction. | |
| Feature /
Characteristic | Proposed Device: Symbia
Intevo Bold | Predicate Device: Intevo 16 | Difference |
| Advanced
Reconstruction | IQ•SPECT Reconstruction
xSPECT Reconstruction | IQ•SPECT Reconstruction
xSPECT Reconstruction | Same |
| Quantification | xSPECT Quantification (Bq/ml)
Broad Quantification
PET SUV Quantification
(Bq/ml) | xSPECT Quantification
(Bq/ml)
PET SUV Quantification
(Bq/ml) | xSPECT Quantification
expands features to
include standardized
quantification of
isotopes In-111 and
I-123 and software
improvements to
support the detectors'
high-count rate
quantitative imaging.
Broad Quantification is
an expanded offering of
xSPECT Quantification
for Tc99m from
commercially marketed
Symbia 5.0 (K131634). |
Essential Characteristics Comparison with Predicate Device:
8
9
Siemens believes that the Symbia Intevo Bold is substantially equivalent to the predicate device. There are no differences in the Indications for Use or Fundamental Technological Characteristics of the Symbia Intevo Bold as compared to the commercially available Symbia Intevo 16. Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate devices.
Performance Testing:
Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no modifications from the original FDA clearance (K151749) that affect device performance.
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
10
Symbia Intevo Bold is designed in accordance with the 60601-1 series including all relevant collateral standards qeneral and specific (see standards table in Safety and Effectiveness section of this document).
Performance testing is conducted according to NEMA NU-1:2012 including:
- intrinsic spatial resolution;
- intrinsic spatial linearity -
- intrinsic energy resolution; -
- intrinsic flood field uniformity; -
- multiple window spatial registration
- intrinsic count rate performance in air; -
- system spatial resolution with LEHR
- -SPECT reconstructed spatial resolution
- System Performance Testing at high count rates: ●
- Intrinsic flood field uniformity at 25% busy time -
- Intrinsic enerqy resolution at 25% busy time -
- -Energy peak position stability
- System spatial resolution at 25% busy time -
Testing includes image quality performance and integration testing for the new CT subsystem. All Performance testing met the predetermined acceptance values.
Broad Quantification and xSPECT Quant Testing :
The absolute quantitative accuracy of xSPECT Quant was verified in phantoms for the isotope-collimator combinations shown in Table 1. The acceptance criterion for xSPECT Quant is a quantitative error of smaller or equal to 10% in reference to the National Institute of Standards and Technology (NIST), i.e. when the system is calibrated with the NIST traceable precision source.
The reproducibility of dose calibrator dependent Broad Quantification was verified for isotope collimator combinations shown in Table 2. The reproducibility was verified to be within 10%.
Standard quality control phantoms such as the NEMA NU 2-1994 Test Phantom and the NEMA IEC Body Phantom were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols. All tests met specifications.
| Isotope | Collimator | Acceptance:
Quantitative
error | Verification
Result |
|-------------------------------------------------------------|------------|--------------------------------------|------------------------|
| Tc99m | LEHR |