(109 days)
No
The document describes advanced noise reduction algorithms (XRES4, ClarityIQ) for image processing, but does not mention or imply the use of AI or ML technologies.
No.
The device is an angiographic X-ray system used for imaging and diagnostic purposes, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic" procedures in various imaging applications, including vascular, cardiovascular, neurovascular, and cardiac imaging.
No
The device description explicitly states it 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." This indicates the presence of hardware components beyond just software. While it mentions software modifications for image processing, the core device is an X-ray system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The AlluraClarity Xper FD Series X-ray System is an imaging system that uses X-rays to visualize internal structures of the human body in vivo (within the living organism). It does not analyze specimens in vitro.
- Intended Use: The intended use clearly describes imaging procedures performed directly on patients for diagnostic and interventional purposes.
- Device Description: The description focuses on the X-ray system components and its function in generating and processing X-ray images.
Therefore, the AlluraClarity Xper FD Series X-ray System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AlluraClarity Xper FD Series C-ray System is 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 AlluraClarity Xper FD Series X-ray System is compatible with a hybrid Operating -Room.
- FD10 is compatible with specified magnetic navigation systems.
Product codes
OWB
Device Description
The AlluraClarity Xper FD Series X-Ray System (AlluraClarity system) 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 AlluraClarity system can also be used for imaging in the Hybrid OR. The AlluraClarity system is provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Peripheral, cerebral, thoracic, abdominal (for angiography); Cardiac (for PTCA, stent placing, atherectomies, pacemaker implantations, electrophysiology); General (for drainages, biopsies, vertebroplasties).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical performance of the AlluraClarity system is based on retrospective collected and analyzed clinical data. Retrospective data originated from DICOM structured dose reports and customer satisfaction questionnaires demonstrate the following:
- The AlluraClarity System was successfully utilized during clinical procedures that are covered by the indications for use for both fluroroscopy and acquisitions
- In the completed questionnaires all physicians indicated that the performance of the AlluraClarity System was clinically acceptable.
The results of this analysis demonstrated that physicians were able to perform clinical tasks with the AlluraClarity system on all clinical applications noted in the indications of use of the product, and therefore support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Allura Xper FD OR Tables Series (K102005), Allura Xper FD10 (K041949), Allura Xper FD20 (K033737)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
:
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
JUN 2 8 2013
.
| Date Prepared: | June 10, 2013 |
|---|---|
| Manufacturer: | Philips Medical Systems Netherlands B.V. |
| Veenpluis 4-6 | |
| 5684-PC, Best, The Netherlands | |
| Contact: | Klien van Dam, PhD |
| Device Trade Name: | AlluraClarity Xper FD Series X-ray System |
| Regulation Number: | Regulation Number: 21 CFR 892.1650 |
| Regulation Name: | Image Intensified fluoroscopic x-ray system |
| Regulatory Class: | Class II |
| Product Code: | OWB |
| Predicate Devices: | Allura Xper FD OR Tables Series (K102005) |
| Allura Xper FD10 (K041949) | |
| Allura Xper FD20 (K033737) | |
| Device Description: | The AlluraClarity Xper FD Series X-Ray System (AlluraClarity |
| system) 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 AlluraClarity system can also be | |
| used for imaging in the Hybrid OR. The AlluraClarity system is | |
| provided with ClarityIQ technology, which utilizes the advanced | |
| XRES4 noise reduction algorithms to reduce quantum noise in X- | |
| ray images. | |
| Indications for Use: | The AlluraClarity Xper FD Series X-ray System is 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,
1
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 AlluraClarity Xper FD Series X-ray System is compatible
with a hybrid Operating Room.
FD10 is compatible with specified magnetic navigation systems.
-
|
| Technology: | The AlluraClarity system has the same technological characteristics
compared to the predicate device, with the exception of the image
processing software. The AlluraClarity system uses the advanced
XRES4 (ClarityIQ) noise reduction algorithms to reduce quantum
noise in X-ray images. |
| Non-clinical
Performance Data: | The modifications implemented in the AlluraClarity system are
limited to the software components of the image processing
pipeline. As such, the AlluraClarity System complies with the
following international and FDA recognized consensus standard and
FDA Guidance Documents with respect to software validation:
• IEC 62304:2006 entitled, "Medical Device Software –
Software Life-Cycle Processes."
• FDA Guidance document entitled, "Guidance for the
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. |
| | The results of the software validation demonstrate that the software
for AlluraClarity System comply with the aforementioned
international and FDA recognized consensus standard and FDA
Guidance Documents and that the software is adequate for its
intended purpose. |
| Clinical
Performance Data: | Clinical performance of the AlluraClarity system is based on
retrospective collected and analyzed clinical data.
Retrospective data originated from DICOM structured dose reports
and customer satisfaction questionnaires demonstrate the following:
• The AlluraClarity System was successfully utilized during
clinical procedures that are covered by the indications for
use for both fluroroscopy and acquisitions
• In the completed questionnaires all physicians indicated that
the performance of the AlluraClarity System was clinically
acceptable. |
| | The results of this analysis demonstrated that physicians were able
to perform clinical tasks with the AlluraClarity system on all clinical
applications noted in the indications of use of the product, and
therefore support a determination of substantial equivalence. |
| Conclusion: | The AlluraClarity system is substantially equivalent to the predicate
devices in terms of indications for use, technology, design, principle
of operations and performance. |
1
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Page 2 of 2
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2013
Philips Medical Systems Nederland B.V. % Klien van Dam, Ph.D. Regulatory Affairs Manager Veenpluis 4-6 5684-PC. Best NETHERLANDS
Re: K130638
Trade/Device Name: AlluraClarity Xper FD Series X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: March 28, 2013 Received: April 01, 2013
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 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 - Dr. van Dam
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/Resourcesfor You/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/Reportal?roblem/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,
Flaming M. Mendo
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): K130638
Device Name:
AlluraClarity Xper FD Series X-ray System
Indications for Use:
The AlluraClarity Xper FD Series C-ray System is 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 AlluraClarity Xper FD Series X-ray System is compatible with a hybrid Operating -Room.
- FD10 is compatible with specified magnetic navigation systems.
Prescription Use (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)
(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130638