Allura Xper FD series and Allura Xper OR Table series

K162859 · Philips Medical Systems Nederland B.V. · OWB · Dec 2, 2016 · Radiology

Device Facts

• Record ID: K162859
• Device Name: Allura Xper FD series and Allura Xper OR Table series
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: OWB · Radiology
• Decision Date: Dec 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

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 Story

Modular angiographic X-ray system; provides specialized angiography in single/biplane configurations. Utilizes ClarityIQ technology with XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. Used in interventional suites and hybrid operating rooms; operated by physicians (interventional cardiologists/radiologists). Inputs: X-ray radiation; Outputs: fluoroscopic and radiographic images. Healthcare providers use output for real-time guidance during minimally invasive procedures. ClarityIQ technology enables significant reduction in patient radiation dose (DAP) during coronary procedures without compromising procedural performance. Benefits include reduced radiation exposure for patients and staff.

Clinical Evidence

Single-center, prospective, randomized, unblinded study (n=122 evaluable patients: 80 AlluraClarity, 42 Allura Xper) conducted outside the U.S. Primary endpoint: radiation dose reduction (DAP). Results: AlluraClarity reduced total procedure radiation dose by 67% (95% CI: 53%, 77%) compared to Allura Xper, with no significant difference in procedural performance (fluoroscopy time, number of images).

Technological Characteristics

Modular angiographic X-ray system; X-ray energy source; includes ClarityIQ technology with XRES4 noise reduction algorithms. Compatible with hybrid OR environments and magnetic navigation systems. No changes to hardware or materials from predicate.

Indications for Use

Indicated for human patients undergoing vascular, cardiovascular, neurovascular, and non-vascular diagnostic, interventional, and minimally invasive procedures, including angiography, stent placement, embolization, thrombolysis, pacemaker implantation, electrophysiology, drainage, biopsy, and vertebroplasty.

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 and Allura Xper OR Table series (K161563)

Submission Summary (Full Text)

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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 [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 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:

· 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial, sans-serif; font-size: 10pt;">☑</span> 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.<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 FD series and Allura Xper OR Table<br>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 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 Table<br>series |
| | 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.

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.

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| | series provided with ClarityIQ technology is identical to the currently marketed<br>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<br>the used OR table) are intended for use on human patients to perform:<br>Vascular, cardiovascular and neurovascular imaging applications, including<br>diagnostic, interventional and minimally invasive procedures. This includes, e.g.,<br>peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent<br>placements, embolisations and thrombolysis.<br>Cardiac imaging applications including diagnostics, interventional and<br>minimally invasive procedures (such as PTCA, stent placing, atherectomies),<br>pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties<br>procedures. |
| | Additionally:<br>The Allura Xper and Allura Xper OR Table series is compatible with a hybrid<br>Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper OR Table<br>series can be used for imaging in the Hybrid OR within the applications<br>domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also<br>be used standalone for surgical use in the OR. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series<br>provided with the marketing claim for the ClarityIQ technology is substantially<br>equivalent to the currently marketed device in terms of indications for use. |
| Technological<br>characteristics: | In this 510(k) Premarket Notification no changes have been made to the<br>technological characteristics of the currently marketed Allura Xper FD series and<br>the Allura Xper OR Table series. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series<br>provided with the new marketing claim for the ClarityIQ technology is<br>substantially equivalent to the currently marketed device in terms of technological<br>characteristics. |
| Performance Data: | The following performance data was provided in support of the substantial<br>equivalence determination for the new marketing claim for the cardiovascular<br>indications for use. |
| | Clinical data<br>A single center randomized, unblinded parallel study with 127 patients conducted<br>outside the United States. Of the 127 patients randomized, 122 patients were<br>evaluable for radiation dose analysis, 80 for AlluraClarity system (with ClarityIQ<br>technology), and 42 in Allura Xper system (without ClarityIQ technology).<br>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 lateral<br>channel. Secondary endpoints such as procedure time, fluoroscopy time, number<br>of acquired exposure images and number of acquired exposure runs, were<br>collected.<br>In conclusion, for interventional cardiology, the AlluraClarity system reduced<br>patient radiation dose by 67% (95% CI of 53%, 77%) over the total procedure<br>without affecting the procedural performances (fluoroscopy time and number of<br>images) compared to equivalent procedures on an Allura Xper system. |
| | The clinical performance data as documented in the clinical study supports the<br>new marketing claim for the cardiovascular indications for use. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series<br>provided with the new marketing claim is substantially equivalent to the currently<br>marketed device in terms of safety and effectiveness. |
| Substantial<br>Equivalence<br>Conclusion: | The Allura Xper FD series and Allura Xper OR Table series with the new<br>marketing claim of the ClarityIQ technology for the cardiovascular indications is<br>substantially equivalent to the currently marketed Allura Xper FD series and the<br>Allura Xper OR Table series (K161563) in terms of indications for use,<br>technological characteristics and safety and effectiveness. |
| | The additional claims do not impact the device from a safety or performance<br>perspective. Therefore, substantial equivalence can be claimed in this 510(k)<br>Premarket Notification. The clinical study demonstrates that the Allura Xper FD<br>series and Allura Xper OR Table series provided with the new marketing claim<br>of the ClarityIQ technology in the cardiovascular indications does not raise any<br>new 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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