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. .

Combined with a qualified, compatible Operating Room (OR) table, the Allura Xper FD OR Table X-ray imaging systems can be used for imaging in the hybrid OR within the application domains neuro, vascular, non-vascular and cardiac. The OR table can also be used stand-alone for surgical use in the OR.

Device Description

The proposed Allura Xper FD X-ray imaging systems with the SSD spacer removed are identical to the currently marketed and predicate Allura Xper FD X-ray imaging systems with the source-skin distance spacer (SSD spacer) mounted onto the X-ray tube housing, except that the SSD spacer is removed. Removal of the SSD spacer allows the execution of electrophysiology (EP) surgical procedures that require mounting of a special frame of currently marketed mapping systems (such as BioSense Webster's CARTO frame or Location Pad, etc.) underneath the patient table. With the BioSense Webster's CARTO frame mounted underneath the patient table, the SSD spacer mounted onto the X-ray tube housing of the currently marketed and predicate Allura Xper FD X-ray imaging systems interferes with the C-arc rotations during EP procedures, thus necessitating the removal of the SSD spacer. By construction, the source-skin distance cannot become smaller than 30 cm when the SSD spacer is removed. This minimum SSD complies with the international product safety standards IEC 60601-2-43 and IEC 60601-2-54 and with the minimum distance of 20 cm as required per 21 CFR, Part 1020.32(g) for certain specific surgical procedures.

AI/ML Overview

This document is a 510(k) summary for a modification to an existing X-ray system, specifically the Allura Xper FD X-ray imaging systems with the SSD spacer removed. The core of the submission is to demonstrate that the modified device is substantially equivalent to its predicate device (the same system with the SSD spacer mounted). Therefore, the acceptance criteria and supporting "study" are primarily focused on proving this substantial equivalence, rather than establishing de novo performance benchmarks as a new device would.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device: The modified device (with SSD spacer removed) must demonstrate performance equivalent to the predicate device (with SSD spacer mounted) in terms of X-ray tube, collimator, flat solid-state X-ray detector, hardware, and software.	"The performance of the proposed Allura Xper FD X-ray systems with the SSD spacer removed is equivalent to the performance of the currently marketed and predicate Allura Xper FD X-ray imaging systems, since the removal of the SSD spacer has no effect on the performance of the X-ray tube, the collimator, the flat solid-state X-ray detector, the hardware and the software."
Minimum Source-Skin Distance (SSD) Compliance: The device, with the SSD spacer removed, must still comply with relevant safety standards and regulations for minimum SSD.	"By construction, the source-skin distance cannot become smaller than 30 cm when the SSD spacer is removed. This minimum SSD complies with the international product safety standards IEC 60601-2-43 and IEC 60601-2-54 and with the minimum distance of 20 cm as required per 21 CFR, Part 1020.32(g) for certain specific surgical procedures."

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

This submission does not involve a traditional "test set" with patient data in the way an AI algorithm submission would. Instead, the "test" is a technical comparison/analysis.

Sample Size for Test Set: Not applicable in the context of imaging data. The evaluation is based on the system's design and mechanical/electrical components.
Data Provenance: Not applicable. The "data" used for evaluation is primarily engineering specifications, design documentation, and regulatory standards. The submission highlights that the predicate devices are manufactured by Philips Medical Systems Nederland B.V. (The Netherlands).

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

Not applicable for this type of submission. This is not a study requiring expert clinical assessment of images or outcomes to establish ground truth. The "ground truth" here is compliance with engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous clinical data requiring adjudication. The evaluation relies on direct comparison of technical specifications and regulatory compliance.

5. 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 comparative effectiveness study was done. This device is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers. The change is a physical modification (removal of an SSD spacer).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not a standalone algorithm. It is a modification to a physical medical imaging device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Engineering Specifications and Design Intent: The manufacturer's assurance that the removal of the SSD spacer does not alter the performance of the core X-ray components (tube, collimator, detector, hardware, software).
Regulatory Standards: Compliance with international (IEC 60601-2-43, IEC 60601-2-54) and US federal (21 CFR, Part 1020.32(g)) minimum source-skin distance requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not involve a training set.

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

Not applicable, as there is no training set.

Summary

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尺 130 84 2

MAY 2 1 2013

510(k) Summary of Safety and Effectiveness

Device Name:	The proposed Allura Xper FD X-ray imaging systems with the SSD spacerremoved include the following:• Allura Xper FD OR Table series;• Allura Xper FD10 series;• Allura Xper FD20 series;• Allura Xper FD Biplane series.
Classification:	Classification Name: 21 CFR, Part 892.1600 - Angiographic x-ray systemClassification: Class IIClassification Panel: RadiologyProduct Code: IZI
Date Prepared:	January 18, 2013
Sponsor:	Philips Medical Systems Nederland B. V.Veenpluis 4-65684PC BestThe Netherlands
Contact:	Dr. Jos van VroonhovenStandardization manager
Predicate Devices:	The predicate devices of the proposed Allura Xper FD X-ray imaging systemswith the SSD spacer removed include the following Allura Xper FD X-rayimaging systems with the SSD spacer mounted (also manufactured and marketedby Philips Medical Systems Nederland B.V.):• Allura Xper FD OR Table series (K102005 - cleared by FDA on August9, 2010);• Allura Xper FD10 series (K041949 - cleared by FDA on July 30, 2004);• Allura Xper FD20 series (K033737 - cleared by FDA on December 9,2003);• Integris Series Release 2 (K984545 - cleared by FDA on February 25,1999). Note: the Integris Series Release 2 systems are currently marketedas Allura Xper FD Biplane series.
Device Description:	The proposed Allura Xper FD X-ray imaging systems with the SSD spacerremoved are identical to the currently marketed and predicate Allura Xper FDX-ray imaging systems with the source-skin distance spacer (SSD spacer)mounted onto the X-ray tube housing, except that the SSD spacer is removed.Removal of the SSD spacer allows the execution of electrophysiology (EP)surgical procedures that require mounting of a special frame of currentlymarketed mapping systems (such as BioSense Webster's CARTO frame orLocation Pad, etc.) underneath the patient table. With the BioSense Webster'sCARTO frame mounted underneath the patient table, the SSD spacer mountedonto the X-ray tube housing of the currently marketed and predicate Allura Xper

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FD X-ray imaging systems interferes with the C-arc rotations during EP procedures, thus necessitating the removal of the SSD spacer. By construction, the source-skin distance cannot become smaller than 30 cm when the SSD spacer is removed. This minimum SSD complies with the international product safety standards IEC 60601-2-43 and IEC 60601-2-54 and with the minimum distance of 20 cm as required per 21 CFR, Part 1020.32(g) for certain specific surgical procedures.

Intended Use:

The proposed Allura Xper FD X-ray imaging systems with the SSD spacer removed and the currently marketed and predicate Allura Xper FD X-ray imaging systems with the SSD spacer mounted are indicated 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.

Combined with a qualified, compatible Operating Room (OR) table, the Allura Xper FD OR Table X-ray imaging systems 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 stand-alone for surgical use in the OR. .

Non-clinical Test Data: The performance of the proposed Allura Xper FD X-ray systems with the SSD spacer removed is equivalent to the performance of the currently marketed and predicate Allura Xper FD X-ray imaging systems, since the removal of the SSD spacer has no effect on the performance of the X-ray tube, the collimator, the flat solid-state X-ray detector, the hardware and the software.

Substantial Equivalence

The proposed Allura Xper FD X-ray imaging systems with the SSD spacer to Predicate Devices: removed are substantially equivalent to the currently marketed and predicate Allura Xper FD X-ray imaging systems with the SSD spacer mounted, in terms of design, indications for use, principle of operations, performance, hardware and software.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three lines instead of one.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 21, 2013

Philips Medical Systems Nederland B.V. % Dr. Jos Van Vroonhoven Veenpluis 4-6 5684 PC Best NETHERLANDS

Re: K130842

Trade/Device Name: Allura Xper FD series with the SSD spacer removed Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: January 29, 2013 Received: April 22, 2013

Dear Dr. Vroonhoven:

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

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Page 2 - Dr. Vroonhoven

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.

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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.

Michael D. O'Hara for

Janine M. Morris 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): K130842

Device Name:

Allura Xper FD series with the SSD spacer removed

Indications for Use:

The Allura Xper FD X-ray imaging systems are indicated 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. .

Prescription Use YES . (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130842 510(k)

Page 1 of 1

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.