(21 days)
No
The document describes standard PET/CT imaging technology and software for image reconstruction and processing, without mentioning AI or ML capabilities.
No
The device is used for diagnostic imaging (detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function) and aiding in treatment planning. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used to "aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease, and organ function."
No
The device is described as a combined CT and PET scanner system, which includes hardware components like the scanners, patient handling system, and workstations, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The Siemens Biograph systems are imaging devices (CT and PET scanners). They work by using external energy sources (X-rays and detecting radiation from radiopharmaceuticals) to create images of the inside of the body. This is an in vivo process, meaning it occurs within the living organism.
- Intended Use: The intended use clearly states that the system is used to "aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease, and organ function" by producing images. This is a diagnostic imaging function, not an in vitro test.
While the system aids in diagnosis, it does so through imaging the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Siemens Biograph systems are combined x-ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of 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 healthcare 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.
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.X and Biograph Vision.X Edge PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems provide registration and fusion of highresolution 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.X and Biograph Vision.X Edge 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 Biograph Vision.X and Biograph Vision.X Edge scanners are based on the Biograph Vision 600 and Biograph Vision 600 Edge scanners. The primary difference between the Bigoraph Vision 600 / Vision 600 Edge and Biograph Vision.X / Vision.X Edge scanners is an update to the PET detector electronics assembly (DEA) to provide for better NEMA Time of Flight Resolution.
The software for the Biograph Vision.X and Biograph Vision.X Edge PET/CT system, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision 600 / Vision 600 Edge software (K193248). Modifications have been made to the commercially available Biograph Vision software to provide for the additional two Biograph Vision configurations. All features and functionality of the Biograph Vision.X and Biograph Vision.X Edge scanners are the commercially available Biograph Vision 600 and Biograph Vision 600 Edge PET/CT scanners (K193248).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Computed Tomography (CT), Positron Emission Tomography (PET)
Anatomical Site
Whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare 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.
PET Testing in accordance with NEMA NU2-2018 was conducted on the Biograph Vision Quadra system.
Performance Criteria / Results / Acceptance:
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
Sensitivity @435 keV LLD / Pass / ≥ 15 cps/kBq
Count Rate peak NECR / Pass / ≥ 250 kcps @ ≤ 36 kBq/cc
Count Rate peak trues / Pass / ≥ 1100 kcps @ ≤ 36 kBq/cc
Scatter Fraction at peak NECR / Pass / ≤43%
Co-Registration Accuracy / Pass / ≤ 5 mm
Time of Flight Resolution at 5.3kBq/cc / Pass / ≤ 214 ps
10mm sphere (Contrast / Background Variability) / Pass / ≥ 55.0% / ≤ 10.0%
13mm sphere (Contrast / Background Variability) / Pass / ≥ 60.0% / ≤ 9.0%
17mm sphere (Contrast / Background Variability) / Pass / ≥ 65.0% / ≤ 8.0%
22mm sphere (Contrast / Background Variability) / Pass / ≥ 70.0% / ≤ 7.0%
28mm sphere (Contrast / Background Variability) / Pass / ≥ 75.0% / ≤ 6.0%
37mm sphere (Contrast / Background Variability) / Pass / ≥ 80.0% / ≤ 5.0%
Lung Residual Error / Pass / ≤ 5.0%
All Performance testing met the predetermined acceptance values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2023
Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Manager 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K231833
Trade/Device Name: Biograph Vision.X and Biograph Vision.X Edge Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: June 21, 2023 Received: June 22, 2023
Dear Alaine Medio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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
Enclosure
2
Indications for Use
510(k) Number (if known) K231833
Device Name Biograph Vision.X and Biograph Vision.X Edge
Indications for Use (Describe)
The Siemens Biograph systems are combined x-ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of 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 healthcare 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.
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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510(k) Summary
as required by 21 CFR Part 807.87(h)
Identification of the Submitter
| Submitter: | Alaine Medio
Regulatory Affairs Manager
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Clayton Ginn
Regulatory Affairs |
| Manufacturer: | Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 North Barrington Road
Hoffman Estates, IL 60192 |
| Telephone Number: | (865)206-0337 |
| Fax Number: | (865)218-3019 |
| Date of Submission: | June 21, 2023 |
| Identification of the product | |
| Device Proprietary
Name: | Biograph Vision.X and Biograph Vision.X Edge |
| 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 system |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | KPS and JAK |
| Device Class: | Class II |
| 510(k) Number: | K193248 |
Reference Devices:
| Device Name and 510(k)
| numbers: | SOMATOM Definition AS and Definition Edge CT System |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | JAK |
| Device Class: | Class II |
| 510(k) Number: | K190578 |
Device Description:
The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems provide registration and fusion of highresolution 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.X and Biograph Vision.X Edge 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 Biograph Vision.X and Biograph Vision.X Edge scanners are based on the Biograph Vision 600 and Biograph Vision 600 Edge scanners. The primary difference between the
5
Bigoraph Vision 600 / Vision 600 Edge and Biograph Vision.X / Vision.X Edge scanners is an update to the PET detector electronics assembly (DEA) to provide for better NEMA Time of Flight Resolution.
The software for the Biograph Vision.X and Biograph Vision.X Edge PET/CT system, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision 600 / Vision 600 Edge software (K193248). Modifications have been made to the commercially available Biograph Vision software to provide for the additional two Biograph Vision configurations. All features and functionality of the Biograph Vision.X and Biograph Vision.X Edge scanners are the commercially available Biograph Vision 600 and Biograph Vision 600 Edge PET/CT scanners (K193248).
Intended Use:
The Siemens Biograph 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 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.
There is no change to the Biograph Vision.X / Biograph Vision.X Edge systems Intended Use / Indications for use as compared to the Biograph Vision PET/CT Scanners.
6
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 the Biograph Vision Quadra system.
| Performance Criteria | Results | Acceptance |
|---|---|---|
| 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 |
| Sensitivity @435 keV LLD | Pass | ≥ 15 cps/kBq |
| Count Rate peak NECR | Pass | ≥ 250 kcps @ ≤ 36 kBq/cc |
| Count Rate peak trues | Pass | ≥ 1100 kcps @ ≤ 36 kBq/cc |
| Scatter Fraction at peak NECR | Pass | ≤43% |
| Co-Registration Accuracy | Pass | ≤ 5 mm |
| Time of Flight Resolution at 5.3kBq/cc | Pass | ≤ 214 ps |
| 10mm sphere (Contrast / Background Variability) | Pass | ≥ 55.0% / ≤ 10.0% |
| 13mm sphere (Contrast / Background Variability) | Pass | ≥ 60.0% / ≤ 9.0% |
| 17mm sphere (Contrast / Background Variability) | Pass | ≥ 65.0% / ≤ 8.0% |
| 22mm sphere (Contrast / Background Variability) | Pass | ≥ 70.0% / ≤ 7.0% |
| 28mm sphere (Contrast / Background Variability) | Pass | ≥ 75.0% / ≤ 6.0% |
| 37mm sphere (Contrast / Background Variability) | Pass | ≥ 80.0% / ≤ 5.0% |
| Lung Residual Error | Pass | ≤ 5.0% |
| Table 1 PET NEMA 2018 Performance Summary Biograph Vision Quadra with a | |
|---|---|
| Maximum Ring Difference (MRD) of 85. |
All Performance testing met the predetermined acceptance values.
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.X and Biograph Vision.X Edge PET/CT Systems:
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- IEC 60601-1: 2005+ A1:2012 -- [Rec #19-4]
- IEC 60601-1-2: 2014 — [Rec #19-8]
- IEC 60601-1-3: 2008 + A1:2013 – [Rec # 12-269]
- . IEC 60601-1-6:2010 +A1:2013 + A2:2020 – [Rec # 5-132]
- IEC 60601-2-28:2017 — [Rec # 12-309]
- IEC 60601-2-44: 2016 -- [Rec # 12-302]
- . IEC 60825-1: 2007 -- [Rec # 12-273]
- IEC 62366-1: 2015 +A1:2020 – [Rec # 5-129]
- ISO 10993-1: 2018 [Rec # 2-258] ●
- IEC 61223-2-6:2006 — [Rec # 12-226]
- IEC 61223-3-5:2019 – [Rec # 12-328]
- NEMA NU 2: 2018 [Rec # 12-326] .
- NEMA XR 25: 2019 - [Rec #12-325]
- NEMA PS3.1-3.20 2021e - [Rec # 12-342]
Additionally, the Biograph Vision.X and Biograph Vision.X Edge systems have been developed in accordance with the requirements of the following standards:
- IEC 62304:2015 -- [Rec # 13-79] ●
- ISO 14971:2019 - [Rec # 5-125]
- ISO 13485:2015
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 has been provided. The Biograph Vision.X and Biograph Vision.X Edge 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.X and Biograph Vision.X Edge 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.
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Statement regarding Substantial Equivalence:
There have been no changes implemented in the modifications to the Biograph Vision.X and Biograph Vision.X Edge system that impacts either the fundamental technology or the indications for use as compared to the predicate. The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems outlined in this Premarket Notification are substantially equivalent to the currently commercially available predicate devices (Biograph Vision 600 and Biograph Vision 600 Edge – K193248).