Allura Xper R9

K162148 · Philips Medical Systems Nethrlands BV · OWB · Nov 23, 2016 · Radiology

Device Facts

• Record ID: K162148
• Device Name: Allura Xper R9
• Applicant: Philips Medical Systems Nethrlands BV
• Product Code: OWB · Radiology
• Decision Date: Nov 23, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Interventional fluoroscopic X-ray system; provides real-time visualization of patient anatomy during minimally invasive procedures. Inputs: X-ray radiation; outputs: real-time images, post-processed images, and reference/control images. Used in hybrid ORs and interventional suites by physicians (radiologists, surgeons). Features include flat detectors (FD12, FD15, FD20), ClarityIQ image processing, and iEngine software architecture. System supports procedure-based workflows via 'Procedure Cards', parallel processing (scheduling/reviewing while imaging), and integration with IntelliSpace Portal. Provides clinicians with visual guidance for catheter placement, device navigation, and anatomical assessment; facilitates minimally invasive interventions, potentially reducing patient trauma and recovery time compared to open surgery.

Clinical Evidence

No clinical study data required. Substantial equivalence established via non-clinical performance testing, including software verification, validation of user needs, and imaging performance metrics per FDA guidance. Board-certified radiologist statement provided confirming sample image quality for intended diagnostic and interventional use.

Technological Characteristics

Interventional fluoroscopic X-ray system; monoplane C-arm geometry. Features 12, 15, or 20-inch flat detectors. Connectivity: DICOM, IPv6 support, IntelliSpace Portal integration. Software: iEngine architecture, Windows 7 OS. Hardware: New Table Side Module (TSM), wide-screen displays. Radiation safety controls included. Complies with IEC 60601-2-43, IEC 60601-2-28, and IEC 62304.

Indications for Use

Indicated for image guidance in diagnostic, interventional, and minimally invasive surgery procedures including vascular, non-vascular, cardiovascular, and neuro applications. Applicable to all human patients of all ages, subject to operating room table weight limits.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Allura Xper FD series / Allura Xper OR Table series R8.2.1 (K141979)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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.

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

## Indications for Use

510(k) Number (if known) K162148

Device Name Allura Xper R9

Indications for Use (Describe)

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.

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)

### 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}------------------------------------------------

# 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.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | |
| Primary Contact<br>Person: | Ms. Jeanette Becker<br>Regulatory Affairs Manager<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact<br>Person: | Ms. Liselotte Kornmann, PhD<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] | |
| 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: OWB<br>Subsequent Code: JAA |
| Predicate Device: | Trade Name: | Allura Xper FD series / Allura Xper OR Table<br>series 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: OWB<br>Subsequent Code: JAA |

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

#### 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

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

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.

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

- . 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.

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

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.