(109 days)
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, 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.
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.
This device is an X-ray system, and the provided documentation focuses on its software validation and clinical performance based on questionnaires and dose reports, rather than a typical AI/ML-driven diagnostic device with specific performance metrics like sensitivity and specificity. Therefore, the questions related to ground truth, expert adjudication, MRMC studies, and separate training/test sets are not directly applicable in the conventional sense for this type of submission.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to "clinically acceptable" performance and successful utilization of the system for its indicated uses, as determined by physicians. There are no quantitative performance metrics such as sensitivity, specificity, or AUC provided in the document for the device's diagnostic capabilities, as the focus is on radiation dose reduction and image processing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Clinically acceptable performance for fluoroscopy and acquisitions | All physicians indicated performance was "clinically acceptable" in questionnaires. |
| Successful utilization for intended clinical procedures | System was "successfully utilized" during clinical procedures covered by indications for use. |
| Ability to perform clinical tasks for all indicated applications | Physicians were "able to perform clinical tasks" with the system on all clinical applications. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of images or cases. The clinical performance data is based on "retrospective collected and analyzed clinical data," specifically "DICOM structured dose reports and customer satisfaction questionnaires." The number of questionnaires or dose reports reviewed is not provided.
- Data Provenance: Retrospective clinical data. The country of origin is not specified, but the manufacturer is Philips Medical Systems Netherlands B.V., so the data could originate from various international sites where Philips systems are used.
3. Number of Experts and Qualifications for Ground Truth
This question is not directly applicable in the context of this submission. The "ground truth" here is the physician's subjective assessment of the system's clinical acceptability and utility, rather than external verification of a disease state.
- Number of "Experts": Not specified. The document mentions "all physicians indicated...", implying multiple physicians participated in the questionnaires, but an exact number is not given.
- Qualifications of "Experts": The "experts" are the physicians who utilized the AlluraClarity System during clinical procedures and completed the satisfaction questionnaires. Their specific qualifications (e.g., area of specialty, years of experience) are not detailed.
4. Adjudication Method for the Test Set
Not applicable. There was no formal adjudication process for a "test set" in the sense of verifying diagnostic accuracy or discrepancies between readers. The assessment was based on individual physician feedback via questionnaires.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe an MRMC comparative effectiveness study, nor does it quantify the improvement of human readers with or without AI assistance. The study focuses on the overall perceived clinical performance of the system as a whole, including its new image processing algorithms.
6. Standalone (Algorithm Only) Performance Study
No. The clinical performance data describes the performance of the integrated AlluraClarity Xper FD Series X-ray System, which includes the new image processing software (XRES4/ClarityIQ technology), not the algorithm in isolation.
7. Type of Ground Truth Used
The "ground truth" for the clinical performance assessment was expert consensus in the form of physician feedback/satisfaction questionnaires. This feedback directly addressed the "clinical acceptability" and "successful utilization" of the device for its indicated uses. While DICOM structured dose reports were also analyzed, they primarily provide objective data on dose, not clinical decision-making ground truth.
8. Sample Size for the Training Set
Not applicable. This device is an X-ray system with a new image processing algorithm, not a machine learning model that relies on a distinct "training set" in the conventional sense of supervised learning for classification or detection. The algorithms themselves would have been developed and tuned using various image data, but this is not characterized as a "training set" in the context of a clinical validation study's sample size.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a distinct "training set" for the purpose of a clinical validation study with established ground truth. The XRES4 algorithms are described as "noise reduction algorithms," implying their development would involve signal processing and image quality metrics, rather than labeled clinical outcomes or pathology for training a diagnostic AI model.
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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 4-65684-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 (AlluraClaritysystem) is a modular angiographic X-ray system, based on a set ofcomponents that can be combined into different single and biplaneconfigurations to provide specialized angiography. Combined with aqualified, compatible OR table, the AlluraClarity system can also beused for imaging in the Hybrid OR. The AlluraClarity system isprovided with ClarityIQ technology, which utilizes the advancedXRES4 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 useon human patients to perform:Vascular, cardiovascular and neurovascular imaging-applications, including diagnostic, interventional and minimallyinvasive procedures. This includes, e.g., peripheral, cerebral,thoracic and abdominal angiography, as well as PTAs, stentplacements, embolisations and thrombolysis.Cardiac imaging applications including diagnostics,1interventional and minimally invasive procedures (such asPTCA, 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 characteristicscompared to the predicate device, with the exception of the imageprocessing software. The AlluraClarity system uses the advancedXRES4 (ClarityIQ) noise reduction algorithms to reduce quantumnoise in X-ray images. |
| Non-clinicalPerformance Data: | The modifications implemented in the AlluraClarity system arelimited to the software components of the image processingpipeline. As such, the AlluraClarity System complies with thefollowing international and FDA recognized consensus standard andFDA Guidance Documents with respect to software validation:• IEC 62304:2006 entitled, "Medical Device Software –Software Life-Cycle Processes."• FDA Guidance document entitled, "Guidance for thePremarket Submissions for Software Contained in MedicalDevices" issued May 11, 2005.• FDA Guidance document entitled, "General Principals ofsoftware Validation; Final Guidance for Industry and FDAStaff" issued January 11, 2002. |
| The results of the software validation demonstrate that the softwarefor AlluraClarity System comply with the aforementionedinternational and FDA recognized consensus standard and FDAGuidance Documents and that the software is adequate for itsintended purpose. | |
| ClinicalPerformance Data: | Clinical performance of the AlluraClarity system is based onretrospective collected and analyzed clinical data.Retrospective data originated from DICOM structured dose reportsand customer satisfaction questionnaires demonstrate the following:• The AlluraClarity System was successfully utilized duringclinical procedures that are covered by the indications foruse for both fluroroscopy and acquisitions• In the completed questionnaires all physicians indicated thatthe performance of the AlluraClarity System was clinicallyacceptable. |
| The results of this analysis demonstrated that physicians were ableto perform clinical tasks with the AlluraClarity system on all clinicalapplications noted in the indications of use of the product, andtherefore support a determination of substantial equivalence. | |
| Conclusion: | The AlluraClarity system is substantially equivalent to the predicatedevices in terms of indications for use, technology, design, principleof operations and performance. |
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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.
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· 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
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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
§ 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.