The XperCT Rel. 3 reconstructs 3D volumes from rotational fluoroscopic acquisitions, and provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up. XperCT Rel. 3 helps to manually estimate the dimension of the lesion.

Device Description

The XperCT Rel. 3 is a software medical device intended to provide high-speed and high resolution 3D cross-sectional imaging in the angiography lab. The XperCT Rel. 3 generates a 3D image that visualizes soft tissue, which helps in identifying anatomy, for example cerebral, abdominal, and peripheral, etc., from a single rotational scan. The XperCT Rel. 3 includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of x-ray radiation.

AI/ML Overview

The provided text discusses the XperCT Rel. 3 device, but it does not contain specific acceptance criteria, study details (like sample sizes for test or training sets, data provenance), or performance metrics. The document states that "Non-clinical verification and validation tests were performed... The test results demonstrate that the XperCT Rel. 3 software medical device complies with international recognized standards as detailed in this premarket submission and met the acceptance criteria." However, it does not explicitly list these criteria or their fulfillment.

Therefore, the following table and information can only reflect what is explicitly stated or can be inferred from the provided text, and will highlight where information is missing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with international recognized standards (as detailed in the premarket submission).	The test results demonstrate that the XperCT Rel. 3 software medical device complies with international recognized standards as detailed in this premarket submission.
Meeting specific requirement specifications and risk management results for software verification, validation, and conformance testing.	The test results demonstrate that the XperCT Rel. 3 software medical device met the acceptance criteria for requirement specifications and risk management results.
(Specific numerical or functional performance criteria - e.g., accuracy, precision, image quality metrics)	Not reported in the provided text. The document states it "provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up" and "helps to manually estimate the dimension of the lesion."

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The document refers to "Non-clinical verification and validation tests" but does not indicate the source or nature of the data used in these tests (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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 is mentioned in the provided text. The device is a software medical device for imaging, which assists physicians, but there is no study described that compares human reader performance with and without its assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Non-clinical verification and validation tests" could imply standalone testing for the software's functionality and image reconstruction capabilities. However, specific details of such a standalone performance study (e.g., metrics, dataset) are not provided. The device is described as assisting the physician, implying it is not intended for fully autonomous use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the provided text. For image reconstruction, ground truth could refer to ideal reconstructed images or phantom data used for validation.
The sample size for the training set:
- Not specified in the provided text. Information about a training set is not explicitly mentioned as the document focuses on the validation of the device rather than its development or initial training.
How the ground truth for the training set was established:
- Not specified, as information about a training set or its ground truth is not provided.

Summary

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K130893
Page 1 of 2

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

Date Prepared: March 29, 2013

General Information

Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC, Best, The Netherlands Establishment Registration Number: 3003768277

Contact Person:

Ms. Liselotte Kornmann, PhD Regulatory Affairs Manager Philips Medical Systems Nederland B.V. Veenpluis 4-6, 5684 PC, Best, The Netherlands Phone: +31 6 11 621238 Fax: +31 40 2769100 E-mail: Liselotte. Kornmann@philips.com.

Device Name and Classification:

Device Trade Name: Device name: Classification Name: Classification Regulation: Classification Panel: Device Class: Product code:

XperCT XperCT Rel. 3 Image-intensified fluoroscopic x-ray system 21CFR §892.1650 Radiology Class II OWB, JAK

Legally Marketed Predicate Devices:

Trade Name: 510(k) Clearance: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

XperCT K060749 April 4, 2006 Angiographic x-ray system Radiology 21CFR §892.1600 Class II IZI

SEP 0 6 2013

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K130893
Page 2 of 2

Device description:

The XperCT Rel. 3 is a software medical device intended to provide high-speed and high resolution 3D cross-sectional imaging in the angiography lab.

The XperCT Rel. 3 generates a 3D image that visualizes soft tissue, which helps in identifying anatomy, for example cerebral, abdominal, and peripheral, etc., from a single rotational scan.

The XperCT Rel. 3 includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of x-ray radiation.

Indications for Use:

Technology:

The XperCT Rel. 3 is a software medical device, which is provided on the hosting software functionality platform of the currently marketed Interventional Workspot Rel. 1 (K121296 - Jan 2, 2013).

The XperCT Rel. 3 software medical device employs the same fundamental scientific technology as the currently marketed and predicate software medical devices, Philips XperCT Rel. 1.

Non-clinical Performance Data:

Non-clinical verification and validation tests were performed with regards to the requirement specifications and risk management results, specifically including software verification, validation conformance testing. The test results demonstrate that the XperCT Rel. 3 software medical device complies with international recognized standards as detailed in this premarket submission and met the acceptance criteria.

Conclusion:

The XperCT Rel. 3 software medical device is substantially equivalent to the currently marketed and predicate software medical devices, Philips XperCT Rel. 1 based on the design functionality, indications for use and fundamental scientific technology.

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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" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, with three horizontal lines above them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO066-G609 Silver Spring, MD 20993-0002

September 6. 2013

Philips Medical Systems Nederland B.V. % Ms. Liselotte Kornmann Regulatory Affairs Manager Veenpluis 4-6 5684 PC, Best THE NETHERLANDS

Re: K130893

Trade/Device Name: XperCT Rel. 3 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAK Dated: July 22, 2013 Received: July 24, 2013

Dear Ms. Kornmann:

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 10 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: CDRFI 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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Page 2-Ms. Kornmann

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/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2)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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.7)

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): K130893

XperCT Rel. 3 Device Name:

Indications for Use:

Indications For Use: The XperCT Rel. 3 reconstructs 3D volumes from rotational fluoroscopic acquisitions, and provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up. XperCT Rel. 3 helps to manually estimate the dimension of the lesion.

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

Over-The-Counter Use (21 CFR 801 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)

Sm. 7)

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

510(k)

Page 1 of 1 .

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.