The Vereos PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and Xray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The Philips Vereos PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Device Description

The proposed Vereos PET/CT system is an integrated diagnostic X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) system designed for a wide range of diagnostic applications. Computerized Tomography (CT) is a medical imaging technique that uses X-rays to obtain cross sectional images of the head or body. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images provide useful diagnostic information. Positron Emission Tomography (PET) uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional imaqes of biochemical and metabolic processes of organs within the body.

The proposed Vereos PET/CT system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for therapeutic planning. The system also provides tools for quantifying results from the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.

The system is comprised of the following system components/subsystems: positron emission tomography (PET); X-ray computed tomography (CT); a patient table; Operating station; Reconstruction Servers. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. These components of the proposed Vereos PET/CT are identical to the currently marketed and predicate device, Vereos PET/CT (K210880) with respect to technological specifications.

The proposed Vereos PET/CT System includes a modification to the currently marketed and predicate device, Vereos PET/CT (K210880). The modification is limited to the addition of an optional Adaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions. The interface of the PET AR with the Vereos system is additional protocols available to the user in the PET recon tool. In addition, a Software patch was released which limits the use of the PET AR reconstruction protocols for the scan type it's compatible with and enables identifying the PET AR reconstructed images with visual identifier to differentiate them from regular PET results.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Vereos PET/CT with PET Adaptive Reconstruction (AR) software application

Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list a table of quantitative acceptance criteria. Instead, it describes general compliance with standards and the adequacy for intended use. The core acceptance criteria for the PET AR software are that it provides low noise and improves low contrast detectability as compared to OSEM (Ordered Subsets Expectation Maximization). The overall acceptance is based on demonstrating substantial equivalence to the predicate device (Vereos PET/CT K210880) in terms of design features, indications for use, fundamental scientific technology, safety, and effectiveness.

Acceptance Criterion (Implicit)	Reported Device Performance
Compliance with International and FDA-recognized consensus standards and FDA guidance documents	Demonstrated compliance with a list of standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-44, IEC 60825-1, IEC 62366-1, IEC 62304, ISO 10993-1, ISO 14971) and guidance documents. Specifically, the software modification complies with IEC 62304.
Adequacy for intended use	Non-clinical design validation testing demonstrates the system can be used as defined in its clinical workflow and intended use.
Low noise as compared to OSEM	PET AR is described as an "Artificial Intelligence-powered reconstruction algorithm that provides low noise" compared to OSEM.
Improved low contrast detectability as compared to OSEM	PET AR is described as an "Artificial Intelligence-powered reconstruction algorithm that ... improves low contrast detectability as compared to OSEM."
No new risks or impact on safety and effectiveness	The PET AR modification "does not impact safety and effectiveness" and "does not introduce any new risks nor impact the safety and effectiveness" of the system.
Maintain good image quality	Sample clinical images were reviewed and evaluated by certified radiologists, and all images were found to have good image quality.

Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "sample clinical images" and that "External clinical images [were] reviewed by certified board radiologists." However, it does not specify the exact number of images or cases used in this external review.
- Data Provenance: Not explicitly stated. The document refers to "External clinical images," implying real patient data, but does not mention the country of origin or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Certified board radiologists" reviewed the external clinical images. The exact number of radiologists is not specified.
- Qualifications of Experts: "Certified board radiologists." No further details on years of experience or sub-specialty are provided.
Adjudication method for the test set:
- Not specified. The document only states that images were "reviewed and evaluated by certified radiologists" and that "All images were evaluated to have a good image quality." There is no mention of a consensus process (e.g., 2+1, 3+1) or any adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states: "The proposed Vereos PET/CT system did not require any clinical study." The evaluation was described as "simulated use testing" and "non-clinical testing." Therefore, an MRMC study and
  effect size on human readers are not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance claims regarding "low noise" and "improved low contrast detectability" compared to OSEM are inherent characteristics of the algorithm itself. While radiologists reviewed images, the performance characteristics of the reconstruction algorithm (PET AR vs. OSEM) are evaluated independently of human interpretation in terms of these intrinsic image quality metrics. The "internal PET AR image evaluation" mentioned falls under this category.
The type of ground truth used:
- For the "external clinical images reviewed by certified board radiologists," the implicit ground truth appears to be expert consensus/evaluation of image quality by these radiologists. They evaluated "good image quality."
- For the claims of "low noise" and "improved low contrast detectability," the ground truth likely involves quantitative metrics derived from phantoms or known datasets, compared against OSEM reconstructions. This is part of the "internal PET AR image evaluation." The document doesn't explicitly state pathology or outcomes data as ground truth for this software modification.
The sample size for the training set:
- Not specified. The document states PET AR is an "Artificial Intelligence-powered reconstruction algorithm" but provides no details on any training data or its sample size.
How the ground truth for the training set was established:
- Not specified. Since no training set details are provided, the method for establishing its ground truth is also not mentioned.

Summary

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August 6, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and consists of a stylized human figure. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Philips Medical Systems Nederland B.V. % Carmit Shmuel Regulatory Affairs Specialist Veenpluis 6 Best. 5684 PC NETHERLANDS

Re: K211764

Trade/Device Name: Vereos PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: June 3, 2021 Received: June 8, 2021

Dear Carmit Shmuel:

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 avare 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 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-reporting

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combination-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 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,

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) K211764

Device Name Vereos PET/CT

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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PHILIPS BG Diagnostic lmaging

SECTION 5 510(K) SUMMARY

HA300-006-05 Revision: 01 Status: Approved Page: 1 of 5

CT/AMI

SECTION 5 510(K) SUMMARY

510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	June 3, 2021
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 6,5684 PC BESTThe NetherlandsEstablishment Registration Number: 3015777306
Primary Contact Person:	Carmit ShmuelRegulatory Affairs SpecialistPhone: 972-54-2109-054E-mail: carmit.shmuel@philips.com
Secondary Contact Person:	Douglas KentzDirector of Regulatory AffairsPhone: (262) 389-7369E-mail: douglas.kentz@philips.com
Device:
Trade Name:	Vereos PET/CT
Common name:	Positron Emission Computed Tomography,Computed Tomography X-Ray
Classification Name:	Emission Computed Tomography Systems,X-Ray Computed Tomography
Classification Regulation:	21 CFR 892.120021 CFR 892.1750
Classification Panel:	Radiology
Device Class:	II
Primary Product Code:	KPS
Secondary Product Code:	JAK
Predicate Device:
Trade Name:	Vereos PET/CT
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) Clearance:	K210880 (Predicate)
Classification Name:	Emission Computed Tomography Systems,X-Ray Computed Tomography
Classification Regulation:	21 CFR 892.120021 CFR 892.1750
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	KPS
Secondary Product Code:	JAK

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PHILIPS BG Diagnostic Imaging

SECTION 5 510(K) SUMMARY

CT/AMI

Reference Device:	Trade Name:	Discovery PET/CT 710 Clarity Edition
	Manufacturer:	GE Medical Systems LLC
	510(k) Clearance:	K133657
	Classification Name:	Emission Computed Tomography Systems,X-Ray Computed Tomography
	Classification Regulation:	21 CFR 892.1200
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	KPS

The proposed Vereos PET/CT system is an integrated diagnostic X-Ray Computed Device Description: Tomography (CT) and Positron Emission Tomography (PET) system designed for a wide range of diagnostic applications. Computerized Tomography (CT) is a medical imaging technique that uses X-rays to obtain cross sectional images of the head or body. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images provide useful diagnostic information. Positron Emission Tomography (PET) uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional imaqes of biochemical and metabolic processes of organs within the body.

The proposed Vereos PET/CT system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for therapeutic planning. The system also provides tools for quantifying results from the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.

The system is comprised of the following system components/subsystems: positron emission tomography (PET); X-ray computed tomography (CT); a patient table; Operating station; Reconstruction Servers. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. These components of the proposed Vereos PET/CT are identical to the currently marketed and predicate device, Vereos PET/CT (K210880) with respect to technological specifications.

The proposed Vereos PET/CT System includes a modification to the currently marketed and predicate device, Vereos PET/CT (K210880). The modification is limited to the addition of an optional Adaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions. The interface of the PET AR with the Vereos system is additional protocols available to the user in the PET recon tool. In addition, a Software patch was released which limits the use of the PET AR reconstruction protocols for the scan type it's compatible with and enables identifying the PET AR reconstructed images with visual identifier to differentiate them from regular PET results.

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PHILIPSBG DiagnosticImagingCT/AMI	SECTION 5 510(K) SUMMARY	HA300-006-05 Revision: 01 Status: Approved Page: 3 of 5
Indications for Use /Intended Use:	Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x- ray transmission data. The PET subsystem images the distribution of PET anatomy- specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.
	The indication for use/intended use for the proposed Vereos PET/CT is identical to the currently marketed and predicate device. Vereos PET/CT (K210880) with respect to technological specifications.
TechnologicalCharacteristics	The Vereos PET/CT system with the PET AR algorithm employs the same fundamental technology as the currently marketed and predicate device, Vereos PET/CT (K210880).
	The proposed Vereos PET/CT is a modification to the currently marketed and predicate device, Vereos PET/CT (K210880) that introduces a new optional Adaptive reconstruction algorithm called PET Adaptive Reconstruction (AR). This method iteratively reconstructs PET images to full convergence (Regularized Reconstruction). All other system components are identical to the currently marketed and predicate device, Vereos PET/CT (K210880) and have the same functionality and performance. Hence, the device description hasn't changed from the currently marketed and predicate device (K210880), other than the addition of the PET AR algorithm.
	This 510(k) submission addresses the addition of a new optional Adaptive reconstruction software application being implemented in the currently marketed and predicate device, Vereos PET/CT system (K210880). The PET AR is an Artificial Intelligence-powered reconstruction algorithm that provides low noise and improves low contrast detectability as compared to OSEM (Ordered Subsets Expectation Maximization).
	PET AR modification of the proposed Vereos PET/CT System does not impact safety and effectiveness.
Summary of Non-Clinical PerformanceData:	Non-clinical performance testing has been performed on the proposed Vereos PET/CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s). Design Verification activities demonstrate that the proposed Vereos PET/CT meets the established design input requirements. Design Verification also included image quality verification and risk analysis risk mitigation testing.
	The following tests were performed on the currently marketed and predicate device, Vereos PET/CT (K210880) according to the following international standards and FDA recognized consensus standards and FDA guidance documents;
	IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1: 2012: Medical electrical equipment - Part 1: General requirements for safety

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and essential performance (FDA Recognition Number: 19-4) (Including US Differences: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012)

IEC 60601-1-2:2014: Medical electrical equipment Part 1-2: General . requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests (FDA Recognition Number: 19-8)
IEC 60601-1-3:2008+A1:2013: Medical electrical equipment Part 1: ● General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (FDA Recognition Number: 12-269)
. IEC 60601-1-6:2010 +A1: 2013: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability (FDA Recognition Number: 5-89)
IEC 60601-2-28:2017: Medical electrical equipment Part 2-28: Particular . requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (FDA Recognition Number: 12-309)
IEC 60601-2-44:2009/AMD1:2012 and AMD2:2016: Medical electrical . equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (FDA Recognition Number: 12-302)
. IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirements (FDA Recognition Number 12-273 and FDA laser notice No. 56 on IEC 60825-1 Ed. 3 issued on May 8, 2019).
. IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices (FDA Recognition Number: 5-114)
IEC 62304:2006 + A1: 2015: Medical device software Software life-cycle . processes (FDA Recognition Number: 13-79)
ISO 10993-1:2018: Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process (FDA Recognition Number: 2-258)
. ISO 14971:2007 Medical devices - Application of risk management to medical devices (FDA Recognition Number: 5-40)

The software modification introduced in this application complies with IEC 62304:2006+A1;2015- see Section 17_002_D000812275- PET AR IEC 62304-1 Test Report.

There are no hardware changes from the currently marketed and predicate device, Vereos PET/CT (K210880), therefore, system-level testing done earlier are still applicable.

Device-Specific Guidance Document:

Guidance for the Submission of Premarket Notifications for Emission . Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems (issued December 3, 1998)
. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).

CT/AMI

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CT/AMI

The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and hazard mitigation. The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report. Non-clinical design validation testing demonstrates that the proposed Vereos PET/CT system can be used as defined in its clinical workflow and intended use. This testing includes internal PET AR image evaluation as well as External clinical images reviewed by certified board radiologists. All the testing described above were used to support the substantial equivalence of the proposed Vereos PET/CT with PET Adaptive Reconstruction software application and demonstrate that the proposed Vereos PET/CT with PET Adaptive Reconstruction software application: Complies with the aforementioned international and FDA-recognized ● consensus standards and/or FDA device specific guidance document, and; Meets the acceptance criteria and is adequate for its intended use. ● Therefore, the proposed Vereos PET/CT is substantially equivalent to the currently marketed and predicate device, Vereos PET/CT (K210880) in terms of safety and effectiveness. The proposed Vereos PET/CT system did not require any clinical study. The clinical Summary of Clinical Performance Data: evaluation was conducted via simulated use testing and is accounted in the summary of "Non-Clinical Testing" section of the summary. The substantial equivalence to the currently marketed and predicate device, Vereos PET/CT (K210880) was demonstrated with the following attributes: Design Features ● Indication for use ● Technological characteristics ● Safety and effectiveness . Sample clinical images were provided with this submission, which were reviewed and evaluated by certified radiologists. All images were evaluated to have a good image quality. Substantial The proposed Vereos PET/CT System with PET AR software application is substantially equivalent to the currently marketed and predicate device, Vereos Equivalence PET/CT (K210880), in terms of design features, indications for use, fundamental Conclusion: scientific technology and safety and effectiveness. The PET Adaptive Reconstruction software application for the proposed Vereos PET/CT System does not introduce any new risks nor impact the safety and effectiveness of the proposed Vereos PET/CT System. Additionally, substantial equivalence was demonstrated by non-clinical (verification and validation) performance tests provided in this 510(k) premarket notification. These tests demonstrate that the proposed Vereos PET/CT system complies with the design input requirements and the international and FDA-recognized consensus standards and that it is as safe and effective as the currently marketed and predicate device, Vereos PET/CT (K210880) without raising any new safety and/or

effectiveness concerns.

Regulation Number and Section

§ 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.