The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: · The Allura Xper R9 series can be used in a hybrid Operating Room. · The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.

Device Description

The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 interventional fluoroscopic X-ray system include: - Real-time image visualization of patient anatomy during procedures - Imaging techniques and tools to assist interventional procedures - Post processing functions after interventional procedures ● - Storage of reference/control images for patient records ● - Compatibility to images of other modalities via DICOM ● - . Built in radiation safety controls This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper FD series / Allura Xper OR Table series R8.2.1. Configurations are composed of detector type, (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features: - . 12 inch Flat detector (FD12) - 15 inch Flat detector (FD15) ● - 20 inch Flat detector (FD20) . Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

AI/ML Overview

The provided document is a 510(k) summary for the Philips Medical Systems Nederland BV Allura Xper R9, an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device (Allura Xper FD series / Allura Xper OR Table series R8.2.1) rather than presenting a study to prove a device meets specific acceptance criteria based on its own reported performance.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set ground truth) are not detailed or applicable in the context of this 510(k) submission, which is primarily a comparative assessment.

However, I can extract the relevant information that is present:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" in this context is substantial equivalence to the predicate device, specifically in terms of:

Indications for Use: The modified device (Allura Xper R9) must have the same indications for use as the predicate.
Technological Characteristics: Despite modifications, the fundamental scientific technology must be the same, and changes must not raise new questions of safety or effectiveness.
Safety and Effectiveness: Performance testing (non-clinical) must demonstrate that the device is as safe and effective as the predicate device.

The "reported device performance" is a demonstration of this substantial equivalence.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (Allura Xper R9 vs. Predicate)
Indications for Use	The rewording of the indications for use statement does not impact substantial equivalence because the indications for use of both devices remain exactly the same.
Technological Characteristics	The Allura Xper R9 has the same technological characteristics compared to the predicate devices. Modifications (e.g., different flat detectors, software architecture, user interfaces, hardware, operating system update) do not raise any new questions regarding safety or effectiveness. The fundamental scientific technology is the same.
Safety and Effectiveness	Non-clinical performance testing (software verification, usability, imaging performance) demonstrated compliance with International and FDA-recognized consensus standards and FDA guidance documents, and revealed equivalent imaging performance when compared to the predicate device.

Other requested information:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified for non-clinical performance tests. The document refers to "software verification testing," "non-clinical validation testing," and "imaging performance metrics" but does not detail sample sizes, data provenance (e.g., country), or whether it was retrospective/prospective outside of referring to "sample clinical images" which were not required for substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified for the non-clinical performance tests that established substantial equivalence. The document mentions "Signed statements from a board certified radiologist demonstrate that sample clinical images are of adequate quality for use in diagnostic and interventional procedures." This was additional evidence, not the primary means of establishing substantial equivalence for the device's technical aspects.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. The non-clinical tests relate to engineering and technical performance (software verification, compliance with standards, imaging performance metrics). Expert adjudication in the traditional sense for diagnostic accuracy is not mentioned as a primary method for demonstrating substantial equivalence.
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 was done or reported. This device is an X-ray imaging system, not an AI-powered diagnostic tool. The submission is a 510(k) for an updated fluoroscopic X-ray system, demonstrating equivalence to an existing one.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of a general fluoroscopic X-ray system. The "standalone" performance here refers to the system's ability to capture and process images according to its specifications and regulatory standards. The non-clinical performance testing (software verification, imaging performance) served this purpose.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests, "ground truth" was established by compliance with recognized international standards (IEC, ISO), FDA guidance documents, and engineering specifications. For example, "Results demonstrated that all executed tests were passed" for software verification. "Equivalent imaging performance" was measured against the predicate device based on metrics outlined in specific FDA guidance.
The sample size for the training set
- Not applicable. This submission is for an imaging device, not an AI/machine learning algorithm requiring a "training set."
How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.

Summary

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

November 23, 2016

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

Re: K162148 Trade/Device Name: Allura Xper R9 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: October 20, 2016 Received: October 24, 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 D.'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) K162148

Device Name Allura Xper R9

Indications for Use (Describe)

· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

· The Allura Xper R9 series can be used in a hybrid Operating Room.

· The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.

Patient Population:

All human patients of all ages. Patient weight is limited to the specification of the patient table.

Type of Use (Select one or both, as applicable)

X 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:	July 28, 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 R9
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	Primary Code: OWBSubsequent Code: JAA
Predicate Device:	Trade Name:	Allura Xper FD series / Allura Xper OR Tableseries R8.2.1
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K141979 (Aug 19, 2014)
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	Primary Code: OWBSubsequent Code: JAA

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Device description: The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 interventional fluoroscopic X-ray system include:

Real-time image visualization of patient anatomy during procedures
Imaging techniques and tools to assist interventional procedures
Post processing functions after interventional procedures ●
Storage of reference/control images for patient records ●
Compatibility to images of other modalities via DICOM ●
. Built in radiation safety controls

This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.

The Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper FD series / Allura Xper OR Table series R8.2.1.

Configurations are composed of detector type, (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features:

. 12 inch Flat detector (FD12)
15 inch Flat detector (FD15) ●
20 inch Flat detector (FD20) .

Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

Indications for Use: The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform:

• Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.

· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

• The Allura Xper R9 series can be used in a hybrid Operating Room.

• The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.

Patient Population:

All human patients of all ages. Patient weight is limited to the specification of the patient table.

Although there is some rewording of the indications for use statement of the Allura Xper R9, this rewording of the indications for use statement does not

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impact substantial equivalence because the indication for use of both devices remain exactly the same.

Based on the information provided above, the Allura Xper R9 is considered substantially equivalent to the currently marketed and predicate device Allura Xper FD series / Allura Xper OR Table series R8.2.1 in terms of Indications for Use.

Technological The Allura Xper R9 has the same technological characteristics compared to the characteristics: predicate devices. Modifications implemented in the Allura Xper R9 include:

12 inch Flat detector (FD12)
. Removal of current (optional) Quantitative Analysis feature.
New software architecture (iEngine) which enables: ●
- New user interfaces (graphical and non-graphical) in control o room and exam room
  - Procedure based workflow in which Procedure Cards enable the o clinical user to select, manage and customize presets for the different performed medical procedures.
  - Video integration for exam and control room with seamless O mouse control
- Integrated electronic instructions for use and user guidance о
Introduction of:
- New Table Side Module (TSM) hardware (secondary O controller)
- Wide screen displays O
- Parallel working, which enables the operator in the Control o Room to schedule a new patient or review and export images of a previous case in parallel to progress of an interventional procedure in the examination room
- Integrated patient handling and administration O
- Graphical indication of table panning on Last Image Hold (LIH) O
- Easy USB import/export O
- O Integrated Bolus Chase Reconstruction
- Integration with IntelliSpace Portal o
- Improved serviceability/manufacturability O
- o IPv6 support
- Windows 7, which replaces Microsoft Windows XP operating O system used on the predicate device

The differences between the Allura Xper R9 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the Allura Xper R9 is considered substantially equivalent to the currently marketed predicate Allura Xper FD series / Allura Xper OR Table series R8.2.1 in terms of fundamental scientific technology.

Non-clinical performance testing has been performed on the Allura Xper R9 and Summary of Non-Clinical Performance demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents: Data:

IEC 62304 Medical device software Software life cycle processes . (Edition 1.0, 2006). FDA/CDRH recognition number 13-32.

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. ISO 14971 Medical devices – Application of risk management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
IEC 60601-2-28 Particular requirements for the basic safety and ● essential performance of X-ray tube assemblies for medical diagnosis (Edition 2.0, 2010). FDA/CDRH recognition number 12-204
IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.0, 2010). FDA/CDRH recognition number 12-202.
. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
Guidance for Industry and FDA Staff Applying Human Factors and ● Usability Engineering to Medical Devices, February 3, 2016 (document number 1757)
FDA Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices (document number 644).

Software verification testing of the functional, non-functional and user interface requirements as well as performance, reliability and safety has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed.

Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users.

The imaging performance metrics outlined in the FDA Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices revealed equivalent imaging performance when compared to the predicate device.

Therefore, Allura Xper R9 is substantially equivalent to the currently marketed Allura Xper FD series / Allura Xper OR Table series R8.2.1 in terms of safety and effectiveness.

Summary of Clinical The Allura Xper R9 did not require clinical study data since substantial Performance Data: equivalence to the currently marketed predicate device Allura Xper FD series / Allura Xper OR Table series R8.2.1 was demonstrated with the following attributes:

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

These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.

Signed statements from a board certified radiologist demonstrate that sample clinical images are of adequate quality for use in diagnostic and interventional procedures. These images were not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended.

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Substantial The Allura Xper R9 is substantially equivalent to the currently marketed predicate device Allura Xper FD series / Allura Xper OR Table series R8.2.1 in Equivalence Conclusion: terms of indications for use, technological characteristics and safety and effectiveness.

The modifications of the Allura Xper R9 are within the controls and predetermined specifications. Additionally, non-clinical performance tests provided in this 510(k) premarket notification demonstrated substantial equivalence to the predicate device and ensured that the modifications are properly introduced; verification and validation testing was conducted to ensure the proper introduction of the individual modifications listed; sample clinical images as well as conformance to IEC standards and guidance documents were provided. All of these components and tests were used to support substantial equivalence of the subject device and demonstrate that the Allura Xper R9 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.