(81 days)
Yes
The device description explicitly lists "OncoFreeze AI (Data Driven Gating)" and "FlowMotion Al (PET FAST Planning)" as new software features, indicating the incorporation of AI/ML technology.
No.
The device is a diagnostic imaging system (PET/CT scanner) used for detecting, localizing, diagnosing, and staging diseases. It does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended to be utilized 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". This directly indicates a diagnostic purpose.
No
The device description explicitly states that the Biograph Vision and Biograph mCT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners, which are hardware devices. While the submission discusses software modifications and features, the core device is a physical scanner.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The description clearly states that the Siemens Biograph Vision and Biograph mCT systems are imaging devices that scan the inside of the human body using X-rays and radiopharmaceuticals.
- The intended use is for in vivo imaging and diagnosis. The text describes the system as providing "registration of high resolution physiologic and anatomic information" and being used to "aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders." This is all done by imaging the living patient.
- The device description focuses on the hardware and software for image acquisition and processing. It talks about CT and PET scanners, patient handling systems, workstations, and software for image reconstruction and evaluation. This is consistent with an imaging device, not a device that analyzes biological samples.
Therefore, the Siemens Biograph Vision and Biograph mCT PET/CT systems are imaging devices used for in vivo diagnosis, not In Vitro Diagnostic devices.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Siemens Biograph Vision and Biograph mCT PET/CT systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information.
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 PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized 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.
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 Biograph Vision and Biograph mCT PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph Vision and Biograph mCT software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The software for the Biograph Vision and Biograph mCT systems which are the subject of this application is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software. Modifications include, corrections to software anomalies and addition of new software features, including:
- OncoFreeze AI (Data Driven Gating)
- FlowMotion Al (PET FAST Planning)
- FAST PET Workflow
- Updates to HD FoV
- . Updates to PET DICOM dose Report
- Whole Body Scatter Correction (for Biograph Vision)
Additionally, minor modifications have been made to the computers due to obsolescence issue. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-Ray Computed Tomography (CT), Position Emission Tomography (PET)
Anatomical Site
Whole body
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
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.
PET Testing in accordance with NEMA NU2-2018 was conducted on two different configurations of the Biograph Vision systems, a 6-ring version and an 8-ring version and on two configurations of the Biograph mCT, a 3-ring version and a 4-ring version.
All features (including the new features listed in the device description) were tested during verification and validation testing and met the predetermined acceptance criteria.
Additionally, the changes below had additional scientific evaluations performed. A brief description of testing activities is provided.
-
OncoFreeze Al (Data Driven Gating) .
An evaluation of change in SUVmax, SUVmean and volume measurement has been performed comparing Anzai based OncoFreeze and OncoFreeze Al. -
FlowMotion AI (PET FAST Planning)
Testing was performed to evaluate the accuracy with which FlowMotion AI correctly defines the bed ranges. Successful identification of all ranges in a FlowMotion Al configuration ranged from 87.1% to 100%, dependent on the configuration set. -
Whole Body Scatter Correction (for Biograph Vision)
An evaluation was performed to evaluate ROI's using single bed scatter compared to whole body scatter.
Key Metrics
For Biograph Vision 6-ring and 8-ring systems:
Resolution - Full Size:
Transverse Resolution FWHM @ 1 cm: Pass (≤ 4.0 mm)
Transverse Resolution FWHM @ 10 cm: Pass (≤ 4.8 mm)
Transverse Resolution FWHM @ 20 cm: Pass (≤ 5.2 mm)
Axial Resolution FWHM @ 1 cm: Pass (≤ 4.3 mm)
Axial Resolution FWHM @ 10 cm: Pass (≤ 5.4 mm)
Axial Resolution FWHM @ 20 cm: Pass (≤ 5.4 mm)
Count Rate / Scatter / Sensitivity:
Sensitivity @435 keV LLD: Pass (≥ 8.0 cps/kBq for 6-ring, ≥ 15.0 cps/kBq for 8-ring)
Count Rate peak NECR: Pass (≥ 140 kcps @ ≤ 32 kBq/cc for 6-ring, ≥ 250 kcps @ ≤ 32 kBq/cc for 8-ring)
Count Rate peak trues: Pass (≥600 kcps @ ≤ 56 kBq/cc for 6-ring, ≥1100 kcps @ ≤ 56 kBq/cc for 8-ring)
Scatter Fraction at peak NECR: Pass (≤ 43%)
Mean bias (%) at peak NEC: Pass (≤ +/- 6%)
Image Quality (4 to 1) - (% Contrast / Background Variability):
10mm sphere: Pass (≥ 55% / ≤ 10%)
13mm sphere: Pass (≥ 60% / ≤ 9%)
17mm sphere: Pass (≥ 65% / ≤ 8%)
22mm sphere: Pass (≥ 70% / ≤ 7%)
28mm sphere: Pass (≥ 75% / ≤ 6%)
37mm sphere: Pass (≥ 80% / ≤ 5%)
Co-Registration Accuracy:
Max Error: Pass (≤ 5 mm)
For Biograph mCT 3-ring and 4-ring systems:
Resolution - Full Size:
Transverse Resolution FWHM @ 1 cm: Pass (≤ 4.7 mm for 3-ring, ≤ 4.0 mm for 4-ring)
Transverse Resolution FWHM @ 10 cm: Pass (≤ 5.4 mm for 3-ring, ≤ 4.8 mm for 4-ring)
Transverse Resolution FWHM @ 20 cm: Pass (≤ 6.3 mm for 3-ring, ≤ 5.2 mm for 4-ring)
Axial Resolution FWHM @ 1 cm: Pass (≤ 4.9 mm for 3-ring, ≤ 4.3 mm for 4-ring)
Axial Resolution FWHM @ 10 cm: Pass (≤ 6.5 mm for 3-ring, ≤ 5.4 mm for 4-ring)
Axial Resolution FWHM @ 20 cm: Pass (≤ 8.8 mm for 3-ring, ≤ 5.4 mm for 4-ring)
Count Rate / Scatter / Sensitivity:
Sensitivity @435 keV LLD: Pass (≥ 5.0 cps/kBq for 3-ring, ≥ 9.4 cps/kBq for 4-ring)
Count Rate peak NECR: Pass (≥ 95 kcps @ ≤ 30 kBq/cc for 3-ring, ≥ 165 kcps @ ≤ 28 kBq/cc for 4-ring)
Count Rate peak trues: Pass (≥350 kcps @ ≤ 46 kBq/cc for 3-ring, ≥575 kcps @ ≤ 40 kBq/cc for 4-ring)
Scatter Fraction at peak NECR: Pass (≤ 40%)
Mean bias (%) at peak NEC: Pass (≤ +/- 6%)
Image Quality (4 to 1) - (% Contrast / Background Variability):
10mm sphere: Pass (≥ 10% / ≤ 10%)
13mm sphere: Pass (≥ 25% / ≤ 10%)
17mm sphere: Pass (≥ 40% / ≤ 10%)
22mm sphere: Pass (≥ 55% / ≤ 10%)
28mm sphere: Pass (≥ 60% / ≤ 10%)
37mm sphere: Pass (≥ 65% / ≤ 10%)
Co-Registration Accuracy:
Max Error: Pass (≤ 5 mm)
For OncoFreeze AI:
ΔSUVmax (relative to static): +27% ± 22%
ΔSUVmean (relative to static): +26% ± 22%
ΔVolume (relative to static): -31% ± 19%
For FlowMotion AI (PET FAST Planning):
Successful identification of all ranges: 87.1% to 100%, dependent on the configuration set.
For Whole Body Scatter Correction (in simulation study of phantom):
Difference from ground truth in representative region of interest close to phantom exhibiting high signal: -2%
Difference from ground truth in representative region of interest close to phantom exhibiting low signal: -3%
Difference from ground truth in representative region of interest inside phantom: -0.4%
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
February 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc % Ms. Tabitha Estes Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE TN 37932
Re: K193248
Trade/Device Name: Biograph Vision PET/CT and Biograph mCT PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: January 16, 2020 Received: January 17, 2020
Dear Ms. 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K193248
Device Name Biograph Vision PET/CT and Biograph mCT PET/CT
Indications for Use (Describe)
The Siemens Biograph Vision and Biograph mCT PET/CT systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information.
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 PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized 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.
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 ) | |
|---|---|
| X 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 - K193248
as required by 21 CFR Part 807.87(h)
Identification of the Submitter
| Submitter: | Tabitha Estes
Regulatory Affairs
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | M. Alaine Medio
Regulatory Affairs |
| Manufacturer: | Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 North Barrington Road
Hoffman Estates, IL 60192 |
| Telephone Number: | (865)804-4553 |
| Fax Number: | (865)218-3019 |
| Date of Submission: | November 22, 2019 |
| Identification of the product | |
| Device Proprietary
Name: | Biograph Vision PET/CT and Biograph mCT PET/CT |
| Common Name: | Positron Emission Tomography (PET) 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 |
| Product Code: | KPS and JAK |
| Classification Panel: | Radiology |
| Device Class: | Class II |
4
Marketed Devices to which Equivalence is claimed
Primary Predicate Device:
| Device Proprietary
| Name: | Biograph Vision PET/CT Systems |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | KPS and JAK |
| Device Class: | Class II |
| 510(k) Number: | K190900 |
Predicate Device:
| Device Proprietary
| Name: | Biograph mCT PET/CT Systems |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | KPS and JAK |
| Device Class: | Class II |
| 510(k) Number: | K173578 |
Reference Devices:
| Device Name and 510(k) numbers: | SOMATOM Definition CT | K190578 |
|---|---|---|
| --------------------------------- | ----------------------- | --------- |
Device Description:
The Biograph Vision and Biograph mCT PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET
5
and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph Vision and Biograph mCT software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The software for the Biograph Vision and Biograph mCT systems which are the subject of this application is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software. Modifications include, corrections to software anomalies and addition of new software features, including:
- OncoFreeze AI (Data Driven Gating)
- FlowMotion Al (PET FAST Planning)
- FAST PET Workflow
- Updates to HD FoV
- . Updates to PET DICOM dose Report
- Whole Body Scatter Correction (for Biograph Vision)
Additionally, minor modifications have been made to the computers due to obsolescence issue. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.
Intended Use:
The Siemens Biograph Vision and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
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 PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized 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
6
system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
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.
7
Performance Testing / Safety and Effectiveness:
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.
PET Testing in accordance with NEMA NU2-2018 was conducted on two different configurations of the Biograph Vision systems, a 6-ring version and an 8-ring version and on two configurations of the Biograph mCT, a 3-ring version and a 4-ring version.
| Performance Criteria | Results | Biograph Vision 6-ring
Acceptance | Biograph Vision 8-ring
Acceptance |
|----------------------------------------------------------------|---------|--------------------------------------|--------------------------------------|
| Resolution - Full Size | | | |
| Transverse Resolution
FWHM @ 1 cm | Pass | ≤ 4.0 mm | ≤ 4.0 mm |
| Transverse Resolution
FWHM @ 10 cm | Pass | ≤ 4.8 mm | ≤ 4.8 mm |
| Transverse Resolution
FWHM @ 20 cm | Pass | ≤ 5.2 mm | ≤ 5.2 mm |
| Axial Resolution FWHM
@ 1 cm | Pass | ≤ 4.3 mm | ≤ 4.3 mm |
| Axial Resolution FWHM
@ 10 cm | Pass | ≤ 5.4 mm | ≤ 5.4 mm |
| Axial Resolution FWHM
@ 20 cm | Pass | ≤ 5.4 mm | ≤ 5.4 mm |
| Count Rate / Scatter / Sensitivity | | | |
| Sensitivity @435 keV LLD | Pass | ≥ 8.0 cps/kBq | ≥ 15.0 cps/kBq |
| Count Rate peak NECR | Pass | ≥ 140 kcps @ ≤ 32 kBq/cc | ≥ 250 kcps @ ≤ 32 kBq/cc |
| Count Rate peak trues | Pass | ≥600 kcps @ ≤ 56 kBq/cc | ≥1100 kcps @ ≤ 56 kBq/cc |
| Scatter Fraction at peak
NECR | Pass | ≤ 43% | ≤ 43% |
| Mean bias (%) at peak
NEC | Pass | ≤ +/- 6% | ≤ +/- 6% |
| Image Quality (4 to 1) - (% Contrast / Background Variability) | | | |
| 10mm sphere | Pass | ≥ 55% / ≤ 10% | ≥ 55% / ≤ 10% |
| 13mm sphere | Pass | ≥ 60% / ≤ 9% | ≥ 60% / ≤ 9% |
| 17mm sphere | Pass | ≥ 65% / ≤ 8% | ≥ 65% / ≤ 8% |
| 22mm sphere | Pass | ≥ 70% / ≤ 7% | ≥ 70% / ≤ 7% |
| 28mm sphere | Pass | ≥ 75% / ≤ 6% | ≥ 75% / ≤ 6% |
| 37mm sphere | Pass | ≥ 80% / ≤ 5% | ≥ 80% / ≤ 5% |
| Co-Registration Accuracy | | | |
| Max Error | Pass | ≤ 5 mm | ≤ 5 mm |
| Performance Criteria | Results | Biograph mCT 3-ring
Acceptance | Biograph mCT 4-ring
Acceptance |
| Resolution - Full Size | | | |
| Transverse Resolution
FWHM @ 1 cm | Pass | ≤ 4.7 mm | ≤ 4.0 mm |
| Transverse Resolution
FWHM @ 10 cm | Pass | ≤ 5.4 mm | ≤ 4.8 mm |
| Transverse Resolution
FWHM @ 20 cm | Pass | ≤ 6.3 mm | ≤ 5.2 mm |
| Axial Resolution FWHM
@ 1 cm | Pass | ≤ 4.9 mm | ≤ 4.3 mm |
| Axial Resolution FWHM
@ 10 cm | Pass | ≤ 6.5 mm | ≤ 5.4 mm |
| Axial Resolution FWHM
@ 20 cm | Pass | ≤ 8.8 mm | ≤ 5.4 mm |
| Count Rate / Scatter / Sensitivity | | | |
| Sensitivity @435 keV LLD | Pass | ≥ 5.0 cps/kBq | ≥ 9.4 cps/kBq |
| Count Rate peak NECR | Pass | ≥ 95 kcps @ ≤ 30 kBq/cc | ≥ 165 kcps @ ≤ 28 kBq/cc |
| Count Rate peak trues | Pass | ≥350 kcps @ ≤ 46 kBq/cc | ≥575 kcps @ ≤ 40 kBq/cc |
| Scatter Fraction at peak
NECR | Pass | ≤ 40% | ≤ 40% |
| Mean bias (%) at peak
NEC | Pass | ≤ +/- 6% | ≤ +/- 6% |
| Image Quality (4 to 1) - (% Contrast / Background Variability) | | | |
| 10mm sphere | Pass | ≥ 10% / ≤ 10% | ≥ 10% / ≤ 10% |
| 13mm sphere | Pass | ≥ 25% / ≤ 10% | ≥ 25% / ≤ 10% |
| 17mm sphere | Pass | ≥ 40% / ≤ 10% | ≥ 40% / ≤ 10% |
| 22mm sphere | Pass | ≥ 55% / ≤ 10% | ≥ 55% / ≤ 10% |
| 28mm sphere | Pass | ≥ 60% / ≤ 10% | ≥ 60% / ≤ 10% |
| 37mm sphere | Pass | ≥ 65% / ≤ 10% | ≥ 65% / ≤ 10% |
| Co-Registration Accuracy | | | |
| Max Error | Pass | ≤ 5 mm | ≤ 5 mm |
8
All features (including the new features listed in the device description) were tested during verification and validation testing and met the predetermined acceptance criteria.
Additionally, the changes below had additional scientific evaluations performed. A brief description of testing activities is provided.
- OncoFreeze Al (Data Driven Gating) .
An evaluation of change in SUVmax, SUVmean and volume measurement has been performed comparing Anzai based OncoFreeze and OncoFreeze Al.
9
| Anzai-based OncoFreeze | OncoFreeze Al | |
|---|---|---|
| ΔSUVmax (relative to static) | +29% ± 22% | +27% ± 22% |
| ΔSUVmean (relative to static) | +27% ± 22% | +26% ± 22% |
| ΔVolume (relative to static) | -34% ± 23% | -31% ± 19% |
-
FlowMotion AI (PET FAST Planning)
Testing was performed to evaluate the accuracy with which FlowMotion AI correctly defines the bed ranges. Successful identification of all ranges in a FlowMotion Al configuration ranged from 87.1% to 100%, dependent on the configuration set. -
Whole Body Scatter Correction (for Biograph Vision)
An evaluation was performed to evaluate ROI's using single bed scatter compared to whole body scatter.
| Difference from ground truth
In simulation study of phantom | Single Bed
Scatter
Correction | Whole Body
Scatter correction |
|------------------------------------------------------------------------------|-------------------------------------|----------------------------------|
| Representative region of interest close to
phantom exhibiting high signal | +87% | -2% |
| Representative region of interest close to
phantom exhibiting low signal | -42% | -3% |
| Representative region of interest inside
phantom | +0.5% | -0.4% |
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 Biograph Vision and Biograph mCT systems:
- IEC 60601-1: 2005+ A1:2012
- IEC 60601-1-2: 2014
- IEC 60601-1-3: 2013
- IEC 60601-1-6:2010 +A1:2013
10
- IEC 60601-2-28:2010 ●
- IEC 60601-2-44: 2009 + A1:2012
- IEC 62366-1:2015
- . IEC 61223-2-6:2006
- IEC 61223-3-5:2004
- NEMA XR 25: 2010
- . NEMA XR 28: 2013
- NEMA XR 29: 2013
- NEMA PS3.1-3.20
Additionally, the Biograph Vision and Biograph mCT systems have been developed in accordance with the requirements of the following standards:
- IEC 62304:2006 +A1:2015
- ISO 14971:2012 (ISO 14971:2007)
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Biograph Vision and Biograph mCT 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 Biograph Vision, Biograph mCT 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.
Statement regarding Substantial Equivalence:
There have been no changes implemented in the modifications to the Biograph Vision and Biograph mCT systems that impact either the fundamental technology or the indications for use. The Biograph Vision and Biograph mCT systems with the modifications outlined in this Premarket Notification are substantially equivalent to the currently commercially available predicate device.