Biograph Vision Quadra PET/CT System

K210262 · Siemens Medical Solutions USA, Inc. · KPS · Mar 3, 2021 · Radiology

Device Facts

• Record ID: K210262
• Device Name: Biograph Vision Quadra PET/CT System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 3, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Siemens Biograph Vision Quadra 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 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.

Device Story

Combined PET/CT scanner; provides registered high-resolution physiologic and anatomic images. PET subsystem images radiopharmaceutical distribution; CT subsystem produces cross-sectional X-ray images. Used in clinical settings by trained professionals (physicians, technologists) for oncology, neurology, and cardiology diagnostics, staging, and radiotherapy planning. Features 106 cm axial PET field-of-view; 4x detector density compared to predicate. System includes patient handling, acquisition/processing workstations, and software. Data processed via command-based software for reconstruction, archival, and evaluation. Output used by physicians to inform clinical decisions regarding disease management and interventional procedures. Benefits include extended axial coverage for improved diagnostic assessment.

Clinical Evidence

Bench testing only. Performance evaluated per NEMA NU2-2018 standards. Metrics included transverse/axial resolution, sensitivity, count rate (NECR/trues), scatter fraction, bias, co-registration accuracy, time-of-flight resolution, and contrast/background variability. All results met predetermined acceptance criteria.

Technological Characteristics

Combined PET/CT scanner. PET: 106 cm axial FoV, 4x detector density. CT: Multi-slice X-ray. Connectivity: DICOM compliant. Software: Command-based for scan control, reconstruction, and archival. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, ISO 10993-1, NEMA XR 25/28/29, NEMA PS3.1-3.20. Cybersecurity controls implemented for data protection.

Indications for Use

Indicated for use by trained healthcare professionals to detect, localize, diagnose, stage, and restage lesions, tumors, diseases, and organ function in patients (including cardiovascular, neurological, and oncological conditions). CT component indicated for low-dose lung cancer screening in high-risk populations.

Regulatory Classification

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.

Predicate Devices

• Biograph Vision PET/CT Systems (K193248)

Reference Devices

• SOMATOM Definition CT (K190578)

Submission Summary (Full Text)

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March 3, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE TN 37932

## Re: K210262

Trade/Device Name: Biograph Vision Quadra PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: January 29, 2021 Received: February 1, 2021

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/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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known)

#### K210262

Device Name Biograph Vision Quadra PET/CT System

#### Indications for Use (Describe)

The Siemens Biograph Vision Quadra PET/CT systems are combined Tomography (CT) and Positron 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><span style="font-size: 20px; vertical-align: middle;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><span style="font-size: 20px; vertical-align: middle;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

K210262

as required by 21 CFR Part 807.87(h)

## Identification of the Submitter

| Submitter: | Alaine Medio<br>Regulatory Affairs<br>Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>810 Innovation Drive<br>Knoxville, TN 37932 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Tabitha Estes<br>Regulatory Affairs |
| Manufacturer: | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>2501 North Barrington Road<br>Hoffman Estates, IL 60192 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | January 29, 2021 |
| Identification of the product | |
| Device Proprietary<br>Name: | Biograph Vision Quadra PET/CT System |
| Common Name: | Positron Emission Tomography (PET) System<br>Computed Tomography (CT) System |
| Classification Name: | Emission Computed Tomography System per 21 CFR<br>892.1200<br>Computed 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 Predicate<br>Device: | |
|------------------------------|------------------------------------|
| Device Proprietary<br>Name: | Biograph Vision PET/CT Systems |
| 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 CT | K190578 |
|---------------------------------|-----------------------|---------|
|---------------------------------|-----------------------|---------|

#### Device Description:

The Biograph Vision Quadra 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 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 Quadra 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 Quadra is an extended Field of View scanner based on the Biograph Vision 600 Edge scanner. The system incorporates the same CT on the Biograph Vision 600 Edge but incorporates a 106 cm axial PET FoV. The gantry mechanical frame has been updated to support four (4) times the detectors available on the Biograph Vision 600 systems.

The software for the Biograph Vision Quadra systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision software (K193248). Modifications have been made to the commercially available Biograph

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Vision software to provide for acquisition and reconstruction of the additional detectors associated with the extended axial FoV of the PET system.

Additionally, modifications have been made to the PET computers to ensure that the system computing can handle the amount of data received from the 1 m scan range system.

These changes have no impact on safety or effectiveness.

## Intended Use:

The Siemens Biograph Vision Quadra 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 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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## 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 systems.

| 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 | ≥ 70 cps/kBq |
| Count Rate peak NECR | Pass | ≥1060 kcps @ ≤ 20<br>kBq/cc |
| Count Rate peak trues | Pass | ≥2680 kcps @ ≤ 20<br>kBq/cc |
| Scatter Fraction at peak NECR | Pass | ≤43% |
| Mean bias (%) at NEC of 1060 kcps | Pass | [-6,6] |
| Co-Registration Accuracy | Pass | ≤ 5 mm |
| Time of Flight Resolution at 5.3kBq/cc | Pass | ≤249 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.

### Table 2 PET NEMA 2018 Performance Summary Biograph Vision Quadra with a Maximum Ring Difference (MRD) of 322

| Performance Criteria | Results<br>MRD 322 | Acceptance |
|-------------------------------------------|--------------------|--------------------------|
| Sensitivity @435 keV LLD | Pass | ≥ 150 cps/kBq |
| Count Rate peak NECR | Pass | ≥1940 kcps @ ≤ 20 kBq/cc |
| Count Rate peak trues | Pass | ≥5130 kcps @ ≤ 20 kBq/cc |
| Scatter Fraction at peak NECR | Pass | ≤43% |
| Time of Flight Resolution at<br>5.3kBq/cc | Pass | ≤249 ps |

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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 Quadra systems:

- . IEC 60601-1: 2005+ A1:2012
- IEC 60601-1-2: 2014
- IEC 60601-1-3: 2013
- IEC 60601-1-6:2010 +A1:2013
- IEC 60601-2-28:2017
- IEC 60601-2-44: 2016
- IEC 60825-1: 2014
- IEC 62366-1: 2015
- ISO 10993-1: 2018
- IEC 61223-2-6:2006
- IEC 61223-3-5:2004
- NEMA XR 25: 2019
- NEMA XR 28: 2013
- NEMA XR 29: 2013
- NEMA PS3.1-3.20

Additionally, the Biograph Vision Quadra systems have been developed in accordance with the requirements of the following standards:

- IEC 62304:2006 +A1:2015
- ISO 14971:2019

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 Quadra software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use.

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Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph Vision Quadra 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 Quadra system that impacts either the fundamental technology or the indications for use. The Biograph Vision Quadra PET/CT system outlined in this Premarket Notification is substantially equivalent to the currently commercially available predicate device.