(158 days)
No
The summary describes standard image reconstruction and filtering techniques, with no mention of AI or ML terms or methodologies.
No
The device aids in diagnosis, surgical planning, interventional procedures, and treatment follow-up by providing imaging, but it does not directly perform or deliver therapy.
Yes.
Explanation: The "Intended Use / Indications for Use" section states that the device "provides CT-like images that assist the physician with diagnosis".
No
The device description explicitly states that the software generates a 3D image from rotational fluoroscopic acquisitions, which are produced by hardware (an angiography system). While the device itself is software, its function is directly tied to and dependent on a hardware imaging modality. The summary also mentions "conformance testing" which could imply testing with the associated hardware.
Based on the provided information, the XperCT Rel. 3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- XperCT Rel. 3 Function: The XperCT Rel. 3 processes imaging data (rotational fluoroscopic acquisitions) acquired directly from the patient's body to create 3D images. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it assists with diagnosis, surgical planning, interventional procedures, and treatment follow-up based on the generated images. This is consistent with an imaging device, not an IVD.
Therefore, the XperCT Rel. 3 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
rotational fluoroscopic acquisitions
Anatomical Site
cerebral, abdominal, and peripheral, etc.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / angiography lab
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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:
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.
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.
2
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.
3
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
4
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 .