The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:

· Vascular, cardiovascular and neurovascular imaging applications, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis.

· Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).

· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

Additionally:

· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.

· Allura Xper FD10 is compatible with specified magnetic navigation systems.

· Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

Device Description

The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-rav images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.

AI/ML Overview

This document describes the Allura Xper FD series and Allura Xper OR Table series by Philips Medical Systems Nederland B.V., specifically focusing on the new marketing claim related to the ClarityIQ technology for neuroendovascular procedures.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The core claim pertains to radiation dose reduction while maintaining procedural performance. Therefore, the "acceptance criteria" can be inferred from the stated marketing claim and the study's primary and secondary endpoints.

Metric (Acceptance Criteria / Claim)	Reported Device Performance (with ClarityIQ vs. without)
Primary Endpoints (Radiation Dose Reduction)
Reduce patient dose (as dose-area product) in routine diagnostic neuroendovascular procedures.	Reduced patient radiation dose by 62% (95% CI of 56%, 68%) for the total procedure.
Reduce patient dose (as dose-area product) in routine interventional neuroendovascular procedures.	Reduced patient radiation dose by 65% (95% CI of 58%, 71%) for the total procedure.
Secondary Endpoints (Procedural Performance - No Detrimental Effect)
Not affecting the procedural performance (fluoroscopy time) as compared to equivalent procedures on an Allura Xper system.	Did not affect procedural performances (fluoroscopy time).
Not affecting the procedural performance (number of DSA images) as compared to equivalent procedures on an Allura Xper system.	Did not affect procedural performances (number of DSA images).
Assess impact on performance of the physician (procedure time, number of acquired exposure images, number of acquired exposure runs).	The study aimed to assess this, and the conclusion states "...without affecting the procedural performances (fluoroscopy time and number of DSA images)..." implying no negative impact on these secondary endpoints. Specific values for these secondary endpoints are not provided in the summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Total eligible patients for analysis: 614
- Allura Xper (without ClarityIQ) group: 302 patients
- AlluraClarity (with ClarityIQ) group: 312 patients
Data Provenance: Single center retrospective historically controlled cohort study from Karolinska Hospital - Solna, Sweden (outside the United States).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The study described is a retrospective historically controlled cohort study involving patient radiation dose and procedural metrics. The "ground truth" here is objective physiological and procedural data (radiation dose measurements, fluoroscopy time, number of DSA images, etc.) recorded during actual clinical procedures, rather than expert interpretation of images for diagnosis or outcomes.

Number of Experts: Not applicable in the context of establishing a "ground truth" for image interpretation. The study collected quantitative procedural data.
Qualifications of Experts: The study was conducted by an "interventional radiologist assisted by a physicist as necessary," but this refers to the appropriate settings for each clinical task, not for establishing a ground truth for the study's endpoints. The data itself (DAP, CAK, times, image counts) serves as the ground truth, presumably recorded by the angiography system and validated by standard hospital protocols.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" consists of objectively measured and recorded clinical metadata (radiation dose, procedure times, image counts), not subjective interpretations requiring adjudication.

5. 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

MRMC Study: No, an MRMC study was not done. This study is an evaluation of the device's technical performance (dose reduction, procedural metrics), not an assessment of human reader performance or the impact of AI assistance on human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Study: Yes, in effect. The study directly measures the performance of the "AlluraClarity system with ClarityIQ technology" (an algorithm/system without human-in-the-loop performance measurement) compared to the "Allura Xper system" (without ClarityIQ). The "procedural performance" metrics (fluoroscopy time, number of DSA images) assess the impact of the technology on the procedure, not the human operator's diagnostic or interventional performance. The primary endpoints (radiation dose) are purely system performance metrics.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth consists of objective clinical (procedural) data for radiation dose metrics (DAP fluoroscopy, DAP exposure, DAP total, Cumulative Air Kerma) and procedural timing/imaging metrics (procedure time, fluoroscopy time, number of acquired exposure images, number of acquired exposure runs). This data was recorded during actual neuroendovascular procedures.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not provide information on the training set for the ClarityIQ technology. The ClarityIQ technology itself was cleared in K130638, suggesting its development and training (if applicable, for its noise reduction algorithms) happened prior to this specific 510(k) submission, which is about a new marketing claim for the already cleared technology within the Allura Xper system.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: Not specified in this document. As mentioned above, this 510(k) is for a new marketing claim for an already cleared technology (ClarityIQ). Information on the training of the ClarityIQ algorithms (if they are AI/ML based) would likely be in the K130638 filing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2016

Philips Medical Systems Nederland BV % Ms. Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 Best, 5684PC NETHERLANDS

Re: K161563

Trade/Device Name: Allura Xper FD Series and Allura Xper OR Table Series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: June 3, 2016 Received: June 6, 2016

Dear Ms. Becker:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161563

Device Name

Allura Xper FD series and Allura Xper OR Table series

Indications for Use (Describe)

The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:

· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

Additionally:

· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.

· Allura Xper FD10 is compatible with specified magnetic navigation systems.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

Date Prepared:	June 03, 2016
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Ms. Jeanette BeckerRegulatory Affairs ManagerPhone: +31 611386380E-mail: jeanette.becker@philips.com
Secondary ContactPerson:	Ms. Liselotte Kornmann, PhDSenior Manager Regulatory AffairsPhone: +31 611621238E-mail: liselotte.kornmann@philips.com
Device:	Trade Name:Allura Xper FD series and Allura Xper ORTable series
	Classification Name:Image-intensified fluoroscopic x-ray system
	Classification Regulation:21CFR §892.1650
	Classification Panel:Radiology
	Device Class:Class II
	Primary Product Code:OWB (Interventional x-ray system)
Predicate Device:	Trade Name:Allura Xper FD series and Allura Xper OR Tableseries
	Manufacturer:Philips Medical Systems Nederland B.V.
	510(k) Clearance:K141979 (August 19, 2014)
	Classification Name:Image-intensified fluoroscopic x-ray system
	Classification Regulation:21CFR §892.1650
	Classification Panel:Radiology
	Device Class:Class II
	Product Code:OWB

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The basis for this 510(k) Premarket Notification is to expand the marketing claims Device description: of the currently marketed Allura Xper FD series and the Allura Xper OR Table series (K141979, August 19, 2014) provided with the ClarityIQ technology with the following marketing claim for the neuroendovascular indications:

In routine neuroendovascular procedures*, the AlluraClarity system with ClarityIQ technology may reduce patient dose (as dose-area product) by as much as 62% (in routine diagnostic neuroendovascular procedures) and as much as 65% (in routine interventional neuroendovascular procedures)** for the total procedure without affecting the procedural performance (fluoroscopy time and number of DSA images) as compared to equivalent procedures on an Allura Xper system, as demonstrated in one single-center study. ***

Routine neuro interventions comprise of DSA and fluoroscopy usage.

** (95% CI 56%, 68% for routine diagnostic neuroendovascular procedures, 95% CI 58%. 71% for routine interventional neuroendovascular procedures). The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional radiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task.

*** Results based on total dose area product from a single center retrospective historically controlled cohort study (Karolinska Hospital - Solna, Sweden) on 614 patients (302 for Allura Xper and 312 for AlluraClarity) undergoing neuroendovascular procedures.

[Söderman M, Mauti M, Boon S, Omar A, Marteinsdóttir M, Andersson T, Holmin S, Hoornaert B. Radiation dose in neuroangiography using image noise reduction technology: a population study based on 614 patients. Neuroradiology. 2013; 55:1365-1372]

In this 510(k) Premarket Notification no changes have been made to the indications for use, technological characteristics, and performance of the Allura Xper FD series and the Allura Xper OR Table series provided with the ClarityIQ technology when compared to the currently marketed device.

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The indications for use of the Allura Xper FD series and Allura Xper OR Table Indications for Use: series provided with ClarityIQ technology is identical to the currently marketed Allura Xper FD series and the Allura Xper OR Table series: The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and ● minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties . procedures. Additionallv: The Allura Xper and Allura Xper OR Table series is compatible with a hybrid ● Operating Room. . Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper OR Table . series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR. Therefore, the Allura Xper FD series and Allura Xper OR Table series provided with the marketing claims for the ClarityIO technology is substantially equivalent to the currently marketed device in terms of indications for use. Technological In this 510(k) Premarket Notification no changes have been made to the characteristics: technological characteristics of the currently marketed Allura Xper FD series and the Allura Xper OR Table series. Therefore, the Allura Xper FD series and Allura Xper OR Table series provided with the new marketing claims for the ClarityIO technology is substantially equivalent to the currently marketed device in terms of technological characteristics. The following performance data was provided in support of the substantial Performance Data: equivalence determination for the new marketing claims for the neuroendovascular indications for use. Clinical data A single center retrospective clinical study with 620 patients was conducted outside the United States. Of the 620 patients, 614 were eligible for analysis, 302 for Allura Xper system (without ClarityIO technology) and 312 for AlluraClarity system (with ClarityIQ technology). The purpose of this study was to quantify the procedural patient radiation dose reduction with the AlluraClarity system for neuroendovascular procedure and to assess its impact on the performances of the physician, in comparison to the Allura Xper system. Procedures were classified as either diagnostic or interventional. The primary endpoints were radiation dose measurements per procedure: Dose Area Product (DAP) fluoro, DAP exposure and DAP total (sum of DAP fluoro

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	and DAP exposure); Cumulative Air Kerma (CAK) values for frontal and lateralchannel. To evaluate the effect of the physician awareness of the system in use,secondary endpoints such as procedure time, fluoroscopy time, number ofacquired exposure images and number of acquired exposure runs, were collected.In conclusion, in routine diagnostic and interventional neuroendovascularprocedures, the AlluraClarity system reduced patient radiation dose by 62%(95%CI of 56%, 68%) and 65% (95%CI of 58%, 71%) respectively over the totalprocedure without affecting the procedural performances (fluoroscopy time andnumber of DSA images) compared to equivalent procedures on an Allura Xpersystem.The clinical performance data as documented in the clinical study supports the
	new marketing claims for the neuroendovascular indications for use.Therefore, the Allura Xper FD series and Allura Xper OR Table seriesprovided with the new marketing claims is substantially equivalent to thecurrently marketed device in terms of safety and effectiveness.
SubstantialEquivalenceConclusion:	The Allura Xper FD series and Allura Xper OR Table series with the newmarketing claims of the ClarityIQ technology for the neuroendovascularindications is substantially equivalent to the currently marketed Allura Xper FDseries and the Allura Xper OR Table series (K141979) in terms of indications foruse, technological characteristics and safety and effectiveness.
	The additional claims do not impact the device from a safety or performanceperspective. Therefore, substantial equivalence can be claimed in this 510(k)Premarket Notification. The clinical study demonstrates that the Allura Xper FDseries and Allura Xper OR Table series provided with the new marketingclaims of the ClarityIQ technology in the neuroendovascular indications does notraise 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.