(51 days)
No
The summary mentions "advanced XRES4 noise reduction algorithms" and "ClarityIQ technology," but there is no mention of AI, ML, or related terms like neural networks or deep learning. The description of the performance study focuses on radiation dose reduction and procedural performance metrics, not on AI/ML-specific performance metrics.
No.
The device is described as a modular angiographic X-ray system used for imaging applications, interventional, and minimally invasive procedures. Its primary function is imaging and facilitating procedures, not directly treating a disease or condition. While used in therapeutic procedures, the device itself is an imaging and guidance tool.
Yes
The device's intended use explicitly states "Cardiac imaging applications including diagnostics," indicating its capability for diagnostic procedures.
No
The device description explicitly states it is a "modular angiographic X-ray system," which is a hardware device. While it includes software components for image processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for imaging and interventional procedures directly on human patients. This involves visualizing internal structures and guiding medical interventions.
- Device Description: The description confirms it's an angiographic X-ray system. X-ray systems are used for imaging the body, not for testing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. IVDs are designed to analyze these samples.
The device is a medical imaging and interventional system used in vivo (within the body) for diagnosis and treatment guidance.
N/A
Intended Use / Indications for Use
The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:
· Vascular, cardiovascular and neurovascular imaging applications, 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 Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.
- · Allura Xper FD10 is compatible with specified magnetic navigation systems.
· Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
Product codes
OWB, JAA
Device Description
The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Peripheral, cerebral, thoracic, abdominal, cardiac
Indicated Patient Age Range
human patients
Intended User / Care Setting
Interventional cardiologist, Hybrid Operating Room
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
A single center randomized, unblinded parallel study with 127 patients conducted outside the United States. Of the 127 patients randomized, 122 patients were evaluable for radiation dose analysis, 80 for AlluraClarity system (with ClarityIQ technology), and 42 in Allura Xper system (without ClarityIQ technology). Procedures were classified as either diagnostic or interventional.
Summary of Performance Studies
Clinical study: A single center randomized, unblinded parallel study with 127 patients conducted outside the United States. 122 patients were evaluable for radiation dose analysis (80 for AlluraClarity system, 42 for Allura Xper system).
The purpose of this study was to quantify the patient radiation dose reduction with the AlluraClarity system for cardiovascular procedure and to assess its impact on the performances of the physician, in comparison to the Allura Xper system. Procedures were classified as either diagnostic or interventional.
The primary endpoints were radiation dose measurements per procedure: Dose Area Product (DAP) fluoro, DAP exposure and DAP total (sum of DAP fluoro and DAP exposure); Cumulative Air Kerma (CAK) values for frontal and lateral channel. Secondary endpoints such as procedure time, fluoroscopy time, number of acquired exposure images and number of acquired exposure runs, were collected.
In conclusion, for interventional cardiology, the AlluraClarity system reduced patient radiation dose by 67% (95% CI of 53%, 77%) over the total procedure without affecting the procedural performances (fluoroscopy time and number of images) compared to equivalent procedures on an Allura Xper system.
Key Metrics
Patient radiation dose reduction by 67% (95% CI of 53%, 77%) for the total procedure without affecting the procedural performance (fluoroscopy time and number of exposure images).
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2016
Philips Medical Systems Nederland BV % Ms. Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS
Re: K162859
Trade/Device Name: Allura Xper FD series and Allura Xper OR Table series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: October 7, 2016 Received: October 12, 2016
Dear Ms. Becker:
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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 Industry and Consumer Education 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.
Michael O'Hara
For
Robert Ochs. Ph.D. 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) K162859
Device Name
Allura Xper FD series and Allura Xper OR Table series
Indications for Use (Describe)
The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:
· Vascular, cardiovascular and neurovascular imaging applications, 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 Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.
- · Allura Xper FD10 is compatible with specified magnetic navigation systems.
· Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | October 07, 2016 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Ms. Jeanette Becker | |
| Regulatory Affairs Manager | ||
| Phone: +31 611386380 | ||
| E-mail: jeanette.becker@philips.com | ||
| Secondary Contact | ||
| Person: | Ms. Liselotte Kornmann, PhD | |
| Senior Manager Regulatory Affairs | ||
| Phone: +31 611621238 | ||
| E-mail: liselotte.kornmann@philips.com | ||
| Device: | Trade Name: | Allura Xper FD series and Allura Xper OR Table |
| series | ||
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | OWB (Interventional Fluoroscopic x-ray system) | |
| Secondary Product Code: | JAA (System, x-ray, fluoroscopic, image-intensified) | |
| Predicate Device: | Trade Name: | Allura Xper FD series and Allura Xper OR Table |
| series | ||
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K161563 (July 29, 2016) | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB |
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The basis for this 510(k) Premarket Notification is to expand the marketing claims Device description: of the currently marketed Allura Xper FD series and the Allura Xper OR Table series (K161563, July 29, 2016) provided with the ClarityIQ technology with the following marketing claim for the cardiovascular indications:
In routine coronary procedures*, the AlluraClarity system with ClarityIQ technology may reduce patient radiation dose (as total dose-area product) by 67%** for the total procedure without affecting the procedural performance (fluoroscopy time and number of exposure images) as compared to equivalent procedures on an Allura Xper system, as demonstrated in one single-center studv. ***
- Routine coronary interventions comprise of fluoroscopy and exposure usage.
** (95% CI of 53%, 77% for all diagnostic and interventional coronary procedures). The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional cardiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task.
*** Results based on total dose area product from a single center prospective controlled randomized study (University Hospital Gent, Belgium) on 122 patients (42 for Allura Xper and 80 for AlluraClarity) undergoing coronary procedures. Of the 122 patients, 102 (83.6%) had a diagnostic procedure without intervention and 51 (41.8%) resulted in a diagnosis of no coronary disease. Patient radiation exposure was quantified using cumulative dose area product as collected from Radiation Dose Structured Reports and/or Allura Reports. Baseline dose was maintained by configuring both systems to power up with the lowest dose settings as default and default procedure settings for cardio were used. Exam duration and fluoro time was consistent between the systems and an increase in number of exposure images and runs with the AlluraClarity was attributed to the biplane configuration compared to the monoplane configuration of the Allura Xper.
In this 510(k) Premarket Notification no changes have been made to the indications for use, technological characteristics, and performance of the Allura Xper FD series and the Allura Xper OR Table series provided with the ClarityIQ technology when compared to the currently marketed device.
The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.
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| | series provided with ClarityIQ technology is identical to the currently marketed
Allura Xper FD series and the Allura Xper OR Table series: |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Allura Xper series and the Allura Xper OR Table series (within the limits of
the used OR table) are 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 Allura Xper and Allura Xper OR Table series is compatible with a hybrid
Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper OR Table
series 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 standalone for surgical use in the OR. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series
provided with the marketing claim for the ClarityIQ technology is substantially
equivalent to the currently marketed device in terms of indications for use. |
| Technological
characteristics: | In this 510(k) Premarket Notification no changes have been made to the
technological characteristics of the currently marketed Allura Xper FD series and
the Allura Xper OR Table series. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series
provided with the new marketing claim for the ClarityIQ technology is
substantially equivalent to the currently marketed device in terms of technological
characteristics. |
| Performance Data: | The following performance data was provided in support of the substantial
equivalence determination for the new marketing claim for the cardiovascular
indications for use. |
| | Clinical data
A single center randomized, unblinded parallel study with 127 patients conducted
outside the United States. Of the 127 patients randomized, 122 patients were
evaluable for radiation dose analysis, 80 for AlluraClarity system (with ClarityIQ
technology), and 42 in Allura Xper system (without ClarityIQ technology).
The purpose of this study was to quantify the patient radiation dose reduction with |
| | and DAP exposure); Cumulative Air Kerma (CAK) values for frontal and lateral
channel. Secondary endpoints such as procedure time, fluoroscopy time, number
of acquired exposure images and number of acquired exposure runs, were
collected.
In conclusion, for interventional cardiology, the AlluraClarity system reduced
patient radiation dose by 67% (95% CI of 53%, 77%) over the total procedure
without affecting the procedural performances (fluoroscopy time and number of
images) compared to equivalent procedures on an Allura Xper system. |
| | The clinical performance data as documented in the clinical study supports the
new marketing claim for the cardiovascular indications for use. |
| | Therefore, the Allura Xper FD series and Allura Xper OR Table series
provided with the new marketing claim is substantially equivalent to the currently
marketed device in terms of safety and effectiveness. |
| Substantial
Equivalence
Conclusion: | The Allura Xper FD series and Allura Xper OR Table series with the new
marketing claim of the ClarityIQ technology for the cardiovascular indications is
substantially equivalent to the currently marketed Allura Xper FD series and the
Allura Xper OR Table series (K161563) in terms of indications for use,
technological characteristics and safety and effectiveness. |
| | The additional claims do not impact the device from a safety or performance
perspective. Therefore, substantial equivalence can be claimed in this 510(k)
Premarket Notification. The clinical study demonstrates that the Allura Xper FD
series and Allura Xper OR Table series provided with the new marketing claim
of the ClarityIQ technology in the cardiovascular indications does not raise any
new safety and/or effectiveness concerns. |
The indications for use of the Allura Xper FD series and Allura Xper OR Table
the AlluraClarity system for cardiovascular procedure and to assess its impact on the performances of the physician, in comparison to the Allura Xper system. Procedures were classified as either diagnostic or interventional.
The primary endpoints were radiation dose measurements per procedure: Dose Area Product (DAP) fluoro, DAP exposure and DAP total (sum of DAP fluoro
Indications for Use:
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