SmartCT assists physicians during vascular and non-vascular procedures, with diagnosis, treatment planning, interventional procedures and treatment follow-up by creating 3D views from sets of 2D images created during rotational acquisitions.

SmartCT provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures.

SmartCT provides live image guidance for navigating endovascular structures anywhere in the body.

SmartCT helps to assess anatomical intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures.

SmartCT is intended to be used for human patients that have been elected for the procedures as described in the Indications for Use.

Device Description

SmartCT is a 3D image visualization and analysis software product (Interventional Tool) intended to provide fast and high-resolution 3D visualization of vasculature, hemorrhages, soft tissue and bone structures, thereby helping the physician to identify pathologies and supporting the physician to define and plan the intervention strategy.

SmartCT runs on a software platform called the Interventional Workspot, and is intended to be used with a Philips Interventional X-Ray System.

SmartCT supports 3D Rotational Angiography (3DRA), Cone Beam CT (CBCT) and VasoCT acquisition protocols, and it includes 3D roadmap functionality. The CBCT and VasoCT protocols are only available for the 20" detector of the Interventional X-Ray system. The 3DRA protocols are available for all detectors.

The 3DRA protocols are available with SmartCT Angio, the CBCT protocols with SmartCT Soft Tissue and the VasoCT protocols with SmartCT Vaso. The 3D roadmap functionality (SmartCT Roadmap) comes in combination with SmartCT Angio, SmartCT Soft Tissue or SmartCT Vaso.

SmartCT includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of X-ray radiation.

SmartCT provides overlays of live 2D fluoroscopic images with a 3D reconstruction of the vessel tree.

SmartCT offers tools to manually measure sizes and volumes of anatomical structures such as lesions, aneurysms or vessels. It also offers a vessel analysis tool that provides semi-automatic measurements of the diameter of a segmented vessel.

SmartCT can be controlled from both the control room and the examination room.

SmartCT provides workflow guidance to support the physician in the workflow of acquiring and processing 3D images.

AI/ML Overview

The Philips Medical Systems SmartCT device did not require a clinical study to demonstrate substantial equivalence. Instead, equivalence was established through non-clinical performance testing and comparison to predicate devices. Therefore, the information provided below is derived from the non-clinical performance testing and usability validation described in the 510(k) summary.

Acceptance Criteria and Device Performance for SmartCT (K201583)

The provided documentation does not include a specific table of acceptance criteria with corresponding device performance metrics in quantitative terms for the SmartCT device. Instead, it describes general compliance with recognized standards and successful completion of various tests.

However, based on the non-clinical performance testing and validation activities, the acceptance criteria implicitly relate to:

Compliance with recognized standards: The device must comply with a list of FDA-recognized consensus standards (e.g., IEC 62304 for software life cycle, IEC 62366-1 for usability, ISO 14971 for risk management, NEMA PS 3.1 - 3.20 DICOM).
Functional and non-functional requirements: All requirements specified in the System Requirements Specification must be met.
Safety risk control measures: All safety risk control measures from the Detailed Risk Management Matrix must be implemented.
Privacy and Security requirements: All privacy and security requirements and mitigations must be implemented.
Usability: The device must be safe and effective for the intended use, users (physicians and nurse/technicians), and use environment.
Intended use and claims: The device must conform to its intended use, claims, and user needs, as demonstrated through simulated use and expert opinion.

Reported Device Performance (Implicit):

The documentation states that:

"Results demonstrated that all executed verification tests were passed."
"SmartCT was found to be safe and effective for the intended use, users and use environment." (From Usability validation)
"Results demonstrated that all executed validation protocols were passed." (From Simulated use design validation)
"Results demonstrated that these commercial claims and user needs were successfully validated." (From Clinical experience/expert opinion evaluation)
"All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartCT: complies with the afore mentioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use."

Detailed Study Information (Based on Non-Clinical & Usability Validation):

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Regulatory Compliance	Complies with IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, ISO 15223-1, UL 2900-1, NEMA PS 3.1-3.20, IEC 80001-1.
Functional & Non-Functional Requirements	All executed verification tests were passed to verify functional and non-functional requirements, performance, reliability, and safety.
Safety Risk Control	All safety risk control measures from the Detailed Risk Management Matrix were implemented; verification tests passed.
Privacy & Security	All privacy and security requirements and mitigations were implemented; verification tests passed.
Usability	Found to be safe and effective for the intended use, users (physicians, nurse/technicians), and use environment. Validation protocols in the form of a clinical workflow were passed by participants who fulfill the intended user profile.
Intended Use & Claims	Conforms to intended use, claims, and user needs. Commercial claims and user needs regarding clinical functionality were successfully validated by assessing clinical images.

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, it refers to:
  - "Representative clinical users (both physicians and nurse/technicians)" for usability validation. The exact number is not provided.
  - "Participants who fulfill the intended user profile" for simulated use validation. The exact number is not provided.
  - "Clinical images" for expert opinion evaluation. The number of images is not provided.
- Data Provenance: The document does not specify country of origin for the data used in these non-clinical tests. It refers to a "simulated use environment" and "clinical images," implying retrospective or simulated data rather than prospective patient data.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: The document refers to "representative clinical users (both physicians and nurse/technicians)" for usability validation and suggests "expert opinion" for clinical experience evaluation. The exact number of experts is not quantified in the provided text.
- Qualifications of Experts: The experts were identified as "physicians and nurse/technicians." Specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth or evaluating performance in the context of the described non-clinical tests. The tests focused on compliance with requirements, usability, and claims validation, often through successful completion of tasks or expert feedback, rather than a diagnostic accuracy assessment requiring multi-reader adjudication.
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 MRMC Study: A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The 510(k) summary explicitly states that the proposed SmartCT "did not require clinical study since substantial equivalence... was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness." The SmartCT device is described as "3D image visualization and analysis software" and an "Interventional Tool," suggesting it enhances existing capabilities rather than being a standalone diagnostic AI. Therefore, no effect size of human reader improvement with/without AI assistance is provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The SmartCT device is designed as an "Interventional Tool" that "assists physicians" and "provides live image guidance for navigating endovascular structures." Its description emphasizes visualization, analysis, and guidance for physicians during procedures. While it includes "implementing algorithm on Vessel Analysis tool," the testing described (usability, simulated workflow) inherently involves human interaction. Therefore, a standalone (algorithm only) performance study in the absence of a human operator was not conducted or reported as such. The focus appears to be on human-in-the-loop performance and interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical validation activities, the "ground truth" was established through:
  - Expert Opinion/Feedback: For Usability validation and Clinical experience evaluation, "representative clinical users (physicians and nurse/technicians)" and "experts" assessed the device's safety, effectiveness, and ability to meet claims/user needs with "clinical images."
  - System Requirements Specification: For software verification testing, performance was measured against predefined functional and non-functional requirements.
  - Industry Standards: Compliance with recognized international and FDA consensus standards served as a form of ground truth for regulatory and technical performance.
The sample size for the training set:
- The document does not provide information regarding a specific "training set" sample size. Given that the SmartCT is described as "3D image visualization and analysis software" that utilizes existing acquisition protocols (3DRA, CBCT, VasoCT) and includes "filters to improve the image quality of the reconstruction" and an "implementing algorithm on Vessel Analysis tool," it's possible that internal development and optimization (which might involve training data) occurred. However, the FDA submission focuses on validation and verification against established standards and predicate devices rather than the specifics of machine learning model training.
How the ground truth for the training set was established:
- As no information on a specific "training set" is provided, the method for establishing its ground truth is also not available in the supplied text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo 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 the square. The full name of the agency is "U.S. Food & Drug Administration".

Philips Medical Systems, Nederland B.V. % Maria Silos Viu Regulatory Affairs Specialist Veenpluis 4-6 Best. Noord-Brabant 5684 PC THE NETHERLANDS

February 9, 2021

Re: K201583

Trade/Device Name: SmartCT Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAK, LLZ, Dated: January 12, 2021 Received: January 15, 2021

Dear Maria Silos Viu:

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 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

{1}------------------------------------------------

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 (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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201583

Device Name SmartCT

Indications for Use (Describe)

SmartCT provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures.

SmartCT provides live image guidance for navigating endovascular structures anywhere in the body.

SmartCT helps to assess anatomical intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures.

SmartCT is intended to be used for human patients that have been elected for the procedures as described in the Indications for Use.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K201583

510(k) Summary SmartCT

The 510(k) Summary of the proposed SmartCT is provided in the following pages.

{4}------------------------------------------------

510(k) Summary

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

Date Prepared:	June 08, 2020
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	María Silos ViuRegulatory Affairs SpecialistPhone: +31 618596430E-mail: maria.silos@philips.com
Secondary ContactPerson:	Michael KoningsDirector of Regulatory AffairsPhone: +31 646941461E-mail: michael.konings@philips.com
Device:
Trade Name:	SmartCT
Classification Name:	Interventional fluoroscopic x-ray system
Classification Regulation:	21CFR §892.1650
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	Primary Code: OWBSubsequent Codes: JAK, LLZ
Primary PredicateDevice:
Trade Name:	XperCT
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) Clearance:	K130893 (September 6, 2013)
Classification Name:	Interventional fluoroscopic x-ray system
Classification Regulation:	21CFR §892.1650
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	Primary Code: OWBSubsequent Code: JAK

{5}------------------------------------------------

Additional PredicateDevices:	Trade Name:	Allura 3D-RA
	Manufacturer:	Philips Medical Systems Nederland B.V
	510(k) Clearance:	K121772 (March 21, 2013)
	Classification Name:	Interventional fluoroscopic x-ray system
	Classification Regulation:	21CFR §892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
		Product Code:
	Trade Name:	3D Roadmap
	Manufacturer:	Philips Medical Systems Nederland B.V
	510(k) Clearance:	K121772 (March 21, 2013)
	Classification Name:	Interventional fluoroscopic x-ray system
	Classification Regulation:	21CFR §892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	Primary Code: OWBSubsequent Codes: JAK, LLZ

{6}------------------------------------------------

Device description: SmartCT is a 3D image visualization and analysis software product (Interventional Tool) intended to provide fast and high-resolution 3D visualization of vasculature, hemorrhages, soft tissue and bone structures, thereby helping the physician to identify pathologies and supporting the physician to define and plan the intervention strategy.

SmartCT runs on a software platform called the Interventional Workspot, and is intended to be used with a Philips Interventional X-Ray System.

SmartCT includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of X-ray radiation.

SmartCT provides overlays of live 2D fluoroscopic images with a 3D reconstruction of the vessel tree.

SmartCT can be controlled from both the control room and the examination room.

SmartCT provides workflow guidance to support the physician in the workflow of acquiring and processing 3D images.

{7}------------------------------------------------

Indications for Use:	SmartCT assists physicians during vascular and non-vascular procedures, withdiagnosis, treatment planning, interventional procedures and treatment follow-upby creating 3D views from sets of 2D images created during rotationalacquisitions.
	SmartCT provides high-speed and high-resolution 3D visualizations ofvasculature, hemorrhages, soft tissue and bone structures.
	SmartCT provides live image guidance for navigating endovascular devicesthrough vascular structures anywhere in the body.
	SmartCT helps to assess anatomical information intra-procedurally, such as theestimate of a vessel or lesion size, diameter or volume, and anatomical distancesbetween relevant structures.
	SmartCT is intended to be used for human patients that have been elected for theprocedures as described in these Indications for Use.
	The indications for use of SmartCT are similar to the indications for use of thecurrently marketed predicate devices XperCT, Allura 3D-RA and 3D Roadmap.Based on the information provided above, SmartCT is considered substantiallyequivalent to the currently marketed and predicate devices XperCT, Allura 3D-RAand 3D Roadmap in terms of Indications for Use.
Technologicalcharacteristics:	SmartCT has similar technological characteristics compared to the predicatedevices. Similar features are used in the predicate and subject devices, withexception of the following modifications implemented in the SmartCT: 3D acquisition guidance including injector protocols suggestions and acquisition timeline showing the different phases of the 3D acquisition performed via Philips Interventional X-Ray system. Visualization improvements such as skull removal feature, initial viewing settings and 3D volume rendering options. User Interface improvements to enhance the interaction of the user with the Multi-Modality Touch Screen Module at table side and provide workflow guidance, as well as overall usability improvements, including 3D measurements and annotations. Architectural improvements including enhanced interface between SmartCT and Philips Interventional X-Ray system in order to get additional information on specific settings and acquisition protocols required for the enabling the acquisition guidance functionality. Curved and straightened reformat for vessel views and new implementing algorithm on Vessel Analysis tool.
	The differences between SmartCT and the predicate devices do not raise any newquestions regarding safety or effectiveness. Based on the information providedabove, SmartCT is considered substantially equivalent to the currently marketedand predicate devices XperCT, Allura 3D-RA and 3D Roadmap in terms offundamental scientific technology.

{8}------------------------------------------------

Summary of Non-Non-clinical performance testing has been performed on SmartCT and Clinical Performance demonstrates compliance with the following FDA recognized consensus Data: standards:

. IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
. IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0, 2015-02). FDA/CDRH recognition number 5-114.
. IEC 82304-1 Health software – Part 1: General requirements for product safety (Edition 1.0 2016-10), FDA/CDRH recognition number 13-97.
. ISO 14971 Medical devices – Application of risk management to medical devices (Edition 2.0, corrected 2007). FDA/CDRH recognition number 5-40.
ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Third Edition, 2016-11-01). FDA/CDRH recognition number 5-117.
UL 2900-1, Standard For Safety, Standard For Software Cybersecurity . Network-Connectable Products, Part 1: General Requirements, (First Edition, 2017-08), FDA/CDRH recognition number 13-96
NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016-06). FDA/CDRH recognition number 12-300
IEC 80001-1 Application of risk management for IT-networks . incorporating medical devices - Part 1: Roles, responsibilities and activities (Edition 1.0, 2010-10). FDA/CDRH recognition number 13-38.

Software verification testing of the functional and non-functional requirements as well as performance, reliability and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. Results demonstrated that all executed verification tests were passed.

Non-clinical validation testing has been performed to validate that SmartCT conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. The validation consisted of the following activities:

-Usability validation was performed with representative clinical users (both physicians and nurse/technicians) in a simulated use environment. SmartCT was found to be safe and effective for the intended use, users and use environment
A simulated use design validation was undertaken with participants who fulfill the intended user profile. The participants executed validation protocols in the form of a clinical workflow to validate user needs. intended use and claims. Results demonstrated that all executed validation protocols were passed.
A clinical experience (expert opinion) evaluation was performed in order to validate some marketing claims and user needs regarding the clinical

{9}------------------------------------------------

functionality of SmartCT by assessing clinical images. Results demonstrated that these commercial claims and user needs were successfully validated.
All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartCT :
complies with the afore mentioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use.

Therefore, SmartCT is substantially equivalent to the predicate devices XperCT, Allura 3D-RA and 3D Roadmap in terms of safety and effectiveness.

Summary of Clinical The proposed SmartCT did not require clinical study since substantial Performance Data: equivalence to the currently marketed and predicate devices XperCT, Allura 3D-RA and 3D Roadmap was demonstrated with the following attributes:

Indication for use;
. Technological characteristics;
. Non-clinical performance testing; and
Safety and effectiveness. .

Substantial The SmartCT is substantially equivalent to the currently marketed predicate Equivalence devices XperCT (K130893), Allura 3D-RA and 3D Roadmap (K121772) in terms Conclusion: of indications for use, technological characteristics and safety and effectiveness. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) pre-market notification. These tests demonstrate that SmartCT complies with the requirements specified in the international and FDA-recognized consensus standards and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.