Who is the manufacturer of ALLURA XPER FD; OR TABLE?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for ALLURA XPER FD; OR TABLE (K133292).

What is the FDA product code for ALLURA XPER FD; OR TABLE?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ALLURA XPER FD; OR TABLE?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for ALLURA XPER FD; OR TABLE?

AlluraClarity Xper FD series X-ray system (K130638); Allura Xper FD OR Tables Series (K102005).

Who can help prepare an FDA 510(k) submission like ALLURA XPER FD; OR TABLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ALLURA XPER FD; OR TABLE

K133292 · Philips Medical Systems Nederland B.V. · OWB · Mar 5, 2014 · Radiology

Device Facts

Record ID	K133292
Device Name	ALLURA XPER FD; OR TABLE
Applicant	Philips Medical Systems Nederland B.V.
Product Code	OWB · Radiology
Decision Date	Mar 5, 2014
Decision	SESE
Submission Type	Abbreviated
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, 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. 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 (Allura Xper FD R8.2) for vascular, cardiovascular, neurovascular, and non-vascular imaging. Inputs: X-ray radiation; outputs: diagnostic images. Features ClarityIQ technology using XRES4 noise reduction algorithms to reduce quantum noise. Used in clinical settings, including hybrid operating rooms, by physicians. System includes FD20 X-ray detector with passive cooling and high-voltage X-ray generator. Supports single and biplane configurations. Output used by clinicians for real-time guidance during interventional procedures; aids in diagnostic and therapeutic decision-making. Benefits include improved image quality and reduced noise for minimally invasive procedures.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing and compliance with international/FDA-recognized consensus standards (IEC 60601-2-43, IEC 60601-2-28, ISO 14971, IEC 62304). Sample clinical images provided to demonstrate diagnostic quality.

Technological Characteristics

Modular angiographic X-ray system. Components: FD20 X-ray detector (passive cooling, high DQE), high-voltage X-ray generator. Software: XRES4 noise reduction algorithm. Standards: IEC 60601-2-43, IEC 60601-2-28, ISO 14971, IEC 62304. Connectivity: Hybrid OR integration, magnetic navigation compatibility.

Indications for Use

Indicated for human patients requiring vascular, cardiovascular, neurovascular, and non-vascular diagnostic, interventional, and minimally invasive imaging procedures, including angiography, stent placement, embolization, thrombolysis, PTCA, atherectomy, pacemaker implantation, EP, 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

AlluraClarity Xper FD series X-ray system (K130638)
Allura Xper FD OR Tables Series (K102005)

Related Devices

K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES · Philips Medical Systems Netherland BV · Aug 19, 2014
K162859 — Allura Xper FD series and Allura Xper OR Table series · Philips Medical Systems Nederland B.V. · Dec 2, 2016
K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEM · Philips Medical Systems Nederland B.V. · Jun 28, 2013
K161563 — Allura Xper FD series and Allura Xper OR Table series · Philips Medical Systems Nederland B.V. · Jul 29, 2016
K172822 — Azurion series R1.2 · Philips Medical Systems Nederland B.V. · Nov 22, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ **MAR 0 5 2014** HILIPS K'133292 Page 1 of 3 # 510(k) Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | January 27, 2014 | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer: | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684-PC, Best, The Netherlands Establishment Registration Number: 3003768277 | | | Contact: | Mr. Klien van Dam, PhD Regulatory Affairs Manager +3140 2795225 | | | Device Trade Names: | Allura Xper FD series Allura Xper OR Table series | | | Classification | Classification Name: Image-intensified fluoroscopic X-ray system Classification Regulation: 21 CFR 892.1650 Classification Panel: Radiology Device Class: II Primary product code: OWB Secondary product code JAA | | | Predicate Device #1 | Device Name AlluraClarity Xper FD series X-ray system Manufacturer Philips Medical Systems Nederland B.V. 510(k) number K130638 Classification Regulation 21 CFR 892.1650 Device Class: II Product Code: OWB | | | Predicate Device #2 | Device Name Allura Xper FD OR Tables Series Manufacturer Philips Medical Systems Nederland B.V. 510(k) number K102005 Classification Regulation 21 CFR 892.1650 Device Class: 11 Product Code: Primary code: OWB Subsequent code: JAA | | | Device Description: | The Allura Xper family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2. The Allura Xper FD R8.2 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table. the Allura Xper FD R8.2 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. | | | Indications for 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. 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. 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. Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR. | | | Technology: | The Allura Xper FD R8.2 has the same technological characteristics compared to the predicate devices. Modifications implemented in the Allura Xper FD R8.2 include the introduction of a new, state of the art FD20 X-ray detector with passive cooling, and a higher DQE. Additionally, a new high voltage X-ray generator with reduced size is introduced. | | | | Based on the information provided in this premarket notification, the Allura Xper FD R8.2 is considered substantially equivalent to the currently marketed and predicate devices in terms of: Design and functionality Indications for use Fundamental Scientific Technology Performance specifications and testing | | | Non-clinical Performance Data: | The Allura Xper R8.2 complies with the following international and FDA recognized consensus standard and FDA Guidance Documents: IEC 60601-2-43. IEC 60601-2-28. ISO 14971: IEC 62304. FDA Guidance document entitled, "Guidance for the | | {1}------------------------------------------------ # PHILIPS {2}------------------------------------------------ | | Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. FDA Guidance document entitled, "General Principals of ♥ software Validation: Final Guidance for Industry and FDA Staff' issued January 11, 2002. FDA Guidance document entitled, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Devices" issued August 6, 1999. The test results demonstrate that the Allura Xper FD R8.2: Complies with the aforementioned international and FDA- recognized consensus standards and/or FDA guidance documents Meets the acceptance criteria and is adequate for its intended use. Therefore, the Allura Xper FD R8.2 is substantially equivalent to the | | Clinical Performance Data: | currently marketed and predicate devices in terms of safety and effectiveness. The subject of this premarket submission, the Allura Xper FD R8.2. did not require clinical studies to support substantial equivalence. Sample clinical images that demonstrate diagnostic quality of the images are provided. | | Conclusion: | The Allura Xper FD R8.2 is substantially equivalent to the predicate devices in terms of design features, fundamental scientific technology, indications for use and safety and effectiveness. The changes implemented in the Allura Xper FD R8.2 System do not render the system to be Not Substantial Equivalent. | {3}------------------------------------------------ HUMAN SERVI Public Health Service Food and Diug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002 March 5. 2014 Philips Medical Systems Nederland B.V. % Klien van Dam, Ph.D. Veenpluis 4-6 5684 PC Best THE NETHERLANDS Rc: K133292 Trade/Device Name: Allura Xper FD scries; Allura Xper OR Table series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: 11 Product Code: OWB, JAA Dated: January 27, 2014 Received: February 7. 2014 Dear Dr. van Dam: 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 cither 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Klien van Dam, Ph.D. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Sm.p) for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. #### 510(k) Number (if known) # K133292 # Device Name Allura Xper 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 use on human patients to perform: • Vascular, cardiovascular and neurovascular imaging diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, choracic and abdominal angiography, as well as PT As. stent placements, embolisations and thrombolysis. · Cardiac imaging applications including diagnosics, interventional and minimally invasive procedures (such as not 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 Allurs 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) [x] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | FOR FDA USE ONLY | | |------------------------------------------------------------------------------|-----| | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | | | Smh | FORM FDA 3881 (9/13)