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-ray 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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Allura Xper FD series and Allura Xper OR Table series with ClarityIQ technology

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Primary Endpoints (Radiation Dose Reduction)
Reduce patient radiation dose (total dose-area product) by 67% for total procedure in routine coronary procedures.	Patient radiation dose was reduced by 67% (95% CI of 53%, 77%) over the total procedure.
Secondary Endpoints (Procedural Performance)
Not affecting procedural performance (fluoroscopy time)	Fluoroscopy time was consistent between the systems.
Not affecting procedural performance (number of exposure images)	Number of exposure images was consistent between the systems (though an increase in AlluraClarity was attributed to biplane vs. monoplane configuration).
Not affecting procedural performance (number of exposure runs)	Number of exposure runs was consistent between the systems (though an increase in AlluraClarity was attributed to biplane vs. monoplane configuration).

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

Sample Size: 122 patients (80 for AlluraClarity system, 42 for Allura Xper system) were evaluable for radiation dose analysis out of 127 randomized patients.
Data Provenance: Prospective, controlled, randomized single-center study conducted at University Hospital Gent, Belgium.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set beyond the general context of the "interventional cardiologist assisted by a physicist." This study primarily focuses on quantifying dose reduction and procedural performance, which are objective measurements rather than subjective interpretations by multiple experts. The "ground truth" here is the objective measurement of radiation dose (DAP, CAK) and procedural metrics like fluoroscopy time and image count.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Since the primary endpoints are objective measurements (radiation dose, fluoroscopy time, etc.), a formal adjudication process (like 2+1 or 3+1) for subjective interpretations would not be applicable or necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the device's technical performance in terms of dose reduction and procedural metrics, not on human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The study assesses the performance of the "AlluraClarity system with ClarityIQ technology" which utilizes advanced XRES4 noise reduction algorithms. While it is implied the algorithm is functioning "standalone" from a human interpretational perspective, the study is comparing this system (used by interventional cardiologists) against an older system. The direct performance of only the algorithm's output quality (e.g., image clarity metrics) without human interaction is not explicitly detailed as a primary outcome. However, the study aims to show that the dose reduction achieved by the algorithm does not negatively impact procedural performance, indirectly addressing the algorithm's effectiveness in a clinical workflow context.

7. Type of Ground Truth Used

The ground truth used consists of objective physiological measurements and procedural metrics:

Radiation dose measurements: Cumulative Dose Area Product (DAP) fluoro, DAP exposure, DAP total (sum of DAP fluoro and DAP exposure), and Cumulative Air Kerma (CAK) values. These were collected from Radiation Dose Structured Reports and/or Allura Reports.
Procedural metrics: Procedure time, fluoroscopy time, number of acquired exposure images, and number of acquired exposure runs.

8. Sample Size for the Training Set

The document does not specify a separate training set for the ClarityIQ technology. The study described is a clinical study to validate the dose reduction claim, not a study for training the algorithm itself. The ClarityIQ technology with its XRES4 noise reduction algorithms was previously cleared (K130638), implying its development and potential training were done prior to this specific study.

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

Since no training set is explicitly mentioned or detailed in this document, the method for establishing its ground truth is not provided. The "ground truth" in this context refers to the basis for the clinical claim being made using the already developed ClarityIQ technology.

Summary

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

December 2, 2016

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

Re: K162859

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, JAA Dated: October 7, 2016 Received: October 12, 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) K162859

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.
· 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.

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:	October 07, 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 OR Tableseries
	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 Fluoroscopic x-ray system)
	Secondary Product Code:	JAA (System, x-ray, fluoroscopic, image-intensified)
Predicate Device:	Trade Name:	Allura Xper FD series and Allura Xper OR Tableseries
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K161563 (July 29, 2016)
	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 (K161563, July 29, 2016) provided with the ClarityIQ technology with the following marketing claim for the cardiovascular indications:

In routine coronary procedures*, the AlluraClarity system with ClarityIQ technology may reduce patient radiation dose (as total dose-area product) by 67%** for the total procedure without affecting the procedural performance (fluoroscopy time and number of exposure images) as compared to equivalent procedures on an Allura Xper system, as demonstrated in one single-center studv. ***

Routine coronary interventions comprise of fluoroscopy and exposure usage.

** (95% CI of 53%, 77% for all diagnostic and interventional coronary 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 cardiologist 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 prospective controlled randomized study (University Hospital Gent, Belgium) on 122 patients (42 for Allura Xper and 80 for AlluraClarity) undergoing coronary procedures. Of the 122 patients, 102 (83.6%) had a diagnostic procedure without intervention and 51 (41.8%) resulted in a diagnosis of no coronary disease. Patient radiation exposure was quantified using cumulative dose area product as collected from Radiation Dose Structured Reports and/or Allura Reports. Baseline dose was maintained by configuring both systems to power up with the lowest dose settings as default and default procedure settings for cardio were used. Exam duration and fluoro time was consistent between the systems and an increase in number of exposure images and runs with the AlluraClarity was attributed to the biplane configuration compared to the monoplane configuration of the Allura Xper.

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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	series provided with ClarityIQ technology is identical to the currently marketedAllura Xper FD series and the Allura Xper OR Table series:
	The Allura Xper series and the Allura Xper OR Table series (within the limits ofthe used OR table) are intended for use on human patients to perform:Vascular, cardiovascular and neurovascular imaging applications, includingdiagnostic, interventional and minimally invasive procedures. This includes, e.g.,peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stentplacements, embolisations and thrombolysis.Cardiac imaging applications including diagnostics, interventional andminimally invasive procedures (such as PTCA, stent placing, atherectomies),pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplastiesprocedures.
	Additionally:The Allura Xper and Allura Xper OR Table series is compatible with a hybridOperating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper OR Tableseries can be used for imaging in the Hybrid OR within the applicationsdomains Neuro, Vascular, Non Vascular and Cardiac. The OR table can alsobe used standalone for surgical use in the OR.
	Therefore, the Allura Xper FD series and Allura Xper OR Table seriesprovided with the marketing claim for the ClarityIQ technology is substantiallyequivalent to the currently marketed device in terms of indications for use.
Technologicalcharacteristics:	In this 510(k) Premarket Notification no changes have been made to thetechnological characteristics of the currently marketed Allura Xper FD series andthe Allura Xper OR Table series.
	Therefore, the Allura Xper FD series and Allura Xper OR Table seriesprovided with the new marketing claim for the ClarityIQ technology issubstantially equivalent to the currently marketed device in terms of technologicalcharacteristics.
Performance Data:	The following performance data was provided in support of the substantialequivalence determination for the new marketing claim for the cardiovascularindications for use.
	Clinical dataA single center randomized, unblinded parallel study with 127 patients conductedoutside the United States. Of the 127 patients randomized, 122 patients wereevaluable for radiation dose analysis, 80 for AlluraClarity system (with ClarityIQtechnology), and 42 in Allura Xper system (without ClarityIQ technology).The purpose of this study was to quantify the patient radiation dose reduction with
	and DAP exposure); Cumulative Air Kerma (CAK) values for frontal and lateralchannel. Secondary endpoints such as procedure time, fluoroscopy time, numberof acquired exposure images and number of acquired exposure runs, werecollected.In conclusion, for interventional cardiology, the AlluraClarity system reducedpatient radiation dose by 67% (95% CI of 53%, 77%) over the total procedurewithout affecting the procedural performances (fluoroscopy time and number ofimages) compared to equivalent procedures on an Allura Xper system.
	The clinical performance data as documented in the clinical study supports thenew marketing claim for the cardiovascular indications for use.
	Therefore, the Allura Xper FD series and Allura Xper OR Table seriesprovided with the new marketing claim is substantially equivalent to the currentlymarketed device in terms of safety and effectiveness.
SubstantialEquivalenceConclusion:	The Allura Xper FD series and Allura Xper OR Table series with the newmarketing claim of the ClarityIQ technology for the cardiovascular indications issubstantially equivalent to the currently marketed Allura Xper FD series and theAllura Xper OR Table series (K161563) in terms of indications for use,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 marketing claimof the ClarityIQ technology in the cardiovascular indications does not raise anynew safety and/or effectiveness concerns.

The indications for use of the Allura Xper FD series and Allura Xper OR Table

the AlluraClarity system for cardiovascular 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

Indications for Use:

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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.