(57 days)
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-Rav 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)
The Biograph 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 PET/CT 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 VK10 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 PET/CT systems which are the subject of this application are substantially equivalent to the commercially available Biograph Vision family of PET/CT systems (K193248). Differences compared to the Biograph Vision systems include:
- The PET system is an air cooled SiPM system. The detectors, electronics, etc. are similar to the Biograph Vision. Modifications have been made to produce a costeffective SiPM system while bringing high end features to that market.
- . Commercially available go. systems (K211373) have been incorporated as the CT system. This provides for updated workflows, interfaces, etc. to allow the health personnel interact more closely with the patients.
- The software integrated into the system is a combination of the CT software (K211373) with PET software with features similar to / based on the Biograph Vision systems (K193248).
- . The Patient Handling System has been updated to increase the weight limit allowing access to more bariatric patients.
The Biograph VK10 is designed as a scalable system with varying PET axial FoV's and different CT configurations. Hardware and software upgrades are available.
The provided text is a 510(k) summary for the Siemens Biograph VK10 PET/CT system. It focuses on demonstrating substantial equivalence to a predicate device and includes performance testing results based on NEMA NU 2:2018 standards. However, it does not provide information about a study proving the device meets acceptance criteria related to AI/algorithm performance with human users or standalone AI performance, ground truth establishment for a test set, expert involvement, or MRMC studies.
The "Performance Testing / Safety and Effectiveness" section explicitly states: "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 NU 2: 2018 was conducted on the system." This indicates the performance data relates to the physical imaging capabilities of the PET/CT system, not an AI component.
Therefore, many of the requested details, particularly those related to AI model evaluation (e.g., sample size for test/training sets for an AI model, expert ground truth, MRMC studies, standalone algorithm performance), cannot be extracted from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is available for the PET system's physical performance, based on NEMA NU 2:2018.
| Performance Criteria | Reported Performance (Results) | Acceptance Criteria (Values) |
|---|---|---|
| Resolution - Full Size | ||
| Transverse Resolution FWHM @ 1 cm | Pass | ≤ 4.5 mm (Axial FoV 1) |
| Transverse Resolution FWHM @ 10 cm | Pass | ≤ 5.0 mm (Axial FoV 1) |
| Transverse Resolution FWHM @ 20 cm | Pass | ≤ 5.8 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 1 cm | Pass | ≤ 4.7 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 10 cm | Pass | ≤ 5.5 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 20 cm | Pass | ≤ 6.1 mm (Axial FoV 1) |
| Sensitivity @435 keV LLD | Pass | ≥ 6.7 cps/kBq (Axial FoV 1), ≥ 12.0 cps/kBq (Axial FoV 2) |
| Count Rate peak NECR | Pass | ≥60 kcps @ ≤ 25 kBq/cc (Axial FoV 1), ≥110 kcps @ ≤ 25 kBq/cc (Axial FoV 2) |
| Count Rate peak trues | Pass | ≥180 kcps @ ≤ 35 kBq/cc (Axial FoV 1), ≥320 kcps @ ≤ 35 kBq/cc (Axial FoV 2) |
| Scatter Fraction at peak NECR | Pass | ≤43% (Axial FoV 1) |
| Co-Registration Accuracy | Pass | ≤ 5 mm |
| Time of Flight Resolution at 5.3kBq/cc | Pass | ≤ 274 ps |
| 10mm sphere (Contrast / Background Variability) | Pass | ≥ 30% / ≤ 9% |
| 13mm sphere (Contrast / Background Variability) | Pass | ≥ 40% / ≤ 8% |
| 17mm sphere (Contrast / Background Variability) | Pass | ≥ 55% / ≤ 6% |
| 22mm sphere (Contrast / Background Variability) | Pass | ≥ 65% / ≤ 5% |
| 28mm sphere (Contrast / Background Variability) | Pass | ≥ 70% / ≤ 4% |
| 37mm sphere (Contrast / Background Variability) | Pass | ≥ 80% / ≤ 3% |
| Lung Residual Error | Pass | ≤ 10% |
The study that proves the device meets the acceptance criteria:
The document states: "PET Testing in accordance with NEMA NU 2: 2018 was conducted on the system. All Performance testing met the predetermined acceptance values." This indicates that a testing procedure following the NEMA NU 2:2018 standard was performed to verify the physical performance characteristics of the PET component of the Biograph VK10.
Regarding AI/Software performance specific to the detailed criteria (2-9):
The provided document does not contain the necessary information to answer these questions, as it describes the 510(k) clearance process for a PET/CT imaging system based on its hardware and basic software functionalities (image reconstruction, archival, evaluation), rather than an AI/ML-driven diagnostic or assistive algorithm. The "software integrated into the system is a combination of the CT software (K211373) with PET software with features similar to / based on the Biograph Vision systems (K193248)". This suggests conventional software, not an AI model that would require training sets, expert ground truth for test sets, MRMC studies, etc.
Therefore, for questions 2 through 9, the answer based on the provided text is: Information not provided in this document.
To reiterate: This 510(k) summary focuses on the substantial equivalence of a medical imaging device (PET/CT scanner) based on its hardware specifications and traditional software functions, as evaluated against established performance standards (NEMA NU 2:2018). It does not discuss the evaluation of an AI or machine learning component that would necessitate the types of studies outlined in your detailed request (MRMC, standalone algorithm performance, specific ground truth methods, training/test set details for AI).
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January 12, 2024
Siemens Medical Solutions USA, Inc. Alaine Medio Manager, Regulatory Affairs 810 Innovation Drive Knoxville, Tennessee 37932
Re: K233677
Trade/Device Name: Biograph VK10 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: November 16, 2023 Received: November 16, 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 (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 (OS) 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,
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
Biograph VK10
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-Rav 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)
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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K233677
510(k) Summary
as required by 21 CFR Part 807.87(h)
Identification of the Submitter
| Submitter: | Alaine MedioRegulatory Affairs ManagerSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932 |
|---|---|
| Alternative Contact: | Tabitha EstesRegulatory Affairs |
| Manufacturer: | Siemens Medical Solutions USA, Inc.Molecular Imaging2501 North Barrington RoadHoffman Estates, IL 60192 |
| Telephone Number: | (865)206-0337 |
| Fax Number: | (865)218-3019 |
| Date of Submission: | November 15, 2023 |
| Identification of the product | |
| Device ProprietaryName: | Biograph VK10 PET/CT |
| Common Name: | Positron Emission Tomography (PET) SystemComputed Tomography (CT) System |
| Classification Name: | Emission Computed Tomography System per 21 CFR892.1200Computed Tomography X-Ray System per 21 CFR 892.1750 |
| Product Code: | KPS and JAK |
| Classification Panel: | Radiology |
| Device Class: | Class II |
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Marketed Devices to which Equivalence is claimed
| Primary PredicateDevice: | |
|---|---|
| Device ProprietaryName: | 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 Predicate Devices:
| SOMATOM go.Alland go.Top | Biograph Horizon | MI View &Go | |
|---|---|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. | ||
| Product Code: | JAK | KPS | QIH |
| Device Class: | Class II | ||
| 510(k) Number: | K211373 | K193178 | K222172 |
Device Description:
The Biograph 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 PET/CT 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 VK10 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 PET/CT systems which are the subject of this application are substantially equivalent to the commercially available Biograph Vision family of PET/CT systems (K193248). Differences compared to the Biograph Vision systems include:
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- The PET system is an air cooled SiPM system. The detectors, electronics, etc. are similar to the Biograph Vision. Modifications have been made to produce a costeffective SiPM system while bringing high end features to that market.
- . Commercially available go. systems (K211373) have been incorporated as the CT system. This provides for updated workflows, interfaces, etc. to allow the health personnel interact more closely with the patients.
- The software integrated into the system is a combination of the CT software (K211373) with PET software with features similar to / based on the Biograph Vision systems (K193248).
- . The Patient Handling System has been updated to increase the weight limit allowing access to more bariatric patients.
The Biograph VK10 is designed as a scalable system with varying PET axial FoV's and different CT configurations. Hardware and software upgrades are available.
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.
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There is no change to the Intended Use / Indications for use as compared to the commercially available Biograph Vision PET/CT Scanners.
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 NU 2: 2018 was conducted on the system.
| Performance Criteria | Results | Acceptance | |
|---|---|---|---|
| Resolution - Full Size | Axial FoV 1 | Axial FoV 2 | |
| Transverse Resolution FWHM @ 1 cm | Pass | ≤ 4.5 mm | |
| Transverse Resolution FWHM @ 10 cm | Pass | ≤ 5.0 mm | |
| Transverse Resolution FWHM @ 20 cm | Pass | ≤ 5.8 mm | |
| Axial Resolution FWHM @ 1 cm | Pass | ≤ 4.7 mm | |
| Axial Resolution FWHM @ 10 cm | Pass | ≤ 5.5 mm | |
| Axial Resolution FWHM @ 20 cm | Pass | ≤ 6.1 mm | |
| Sensitivity @435 keV LLD | Pass | ≥ 6.7 cps/kBq | ≥ 12.0 cps/kBq |
| Count Rate peak NECR | Pass | ≥60 kcps @ ≤ 25kBq/cc | ≥110 kcps @ ≤ 25kBq/cc |
| Count Rate peak trues | Pass | ≥180 kcps @ ≤ 35kBq/cc | ≥320 kcps @ ≤ 35kBq/cc |
| Scatter Fraction at peak NECR | Pass | ≤43% | |
| Co-Registration Accuracy | Pass | ≤ 5 mm | |
| Time of Flight Resolution at 5.3kBq/cc | Pass | ≤ 274 ps | |
| 10mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 30% / ≤ 9% | |
| 13mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 40% / ≤ 8% | |
| 17mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 55% / ≤ 6% | |
| 22mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 65% / ≤ 5% | |
| 28mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 70% / ≤ 4% | |
| 37mm sphere (Contrast / BackgroundVariability) | Pass | ≥ 80% / ≤ 3% | |
| Lung Residual Error | Pass | ≤ 10% |
Table 1 PET NEMA 2018 Performance
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.
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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 Medical Solutions USA, Inc claims compliance with the following product standards for the Biograph VK10 PET/CT Systems:
- IEC 60601-1: 2005+ A1:2012 +A2:2020-- [Rec #19-49]
- o IEC 60601-1-2: 2020 – [Rec #19-36]
- 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]
- o ISO 10993-1: 2018 – [Rec # 2-258]
- o IEC 61223-3-5:2019 – [Rec # 12-328]
- NEMA NU 2: 2018 – [Rec # 12-326]
- NEMA XR 25: 2019 – [Rec #12-325]
- o NEMA PS3.1-3.20 2021e -- [Rec # 12-342]
Additionally, the Biograph 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 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 systems and external devices.
Verification and validation of Siemens Medical Solutions USA, Inc. systems is performed in accordance with documented procedures, design and code reviews, test plans and
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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 Biograph system that impacts either the fundamental technology or the indications for use as compared to the predicate. The Biograph PET/CT systems outlined in this Premarket Notification are substantially equivalent to the currently commercially available predicate devices.
§ 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.