(29 days)
Not Found
No
The document mentions "advanced XRES4 noise reduction algorithms" but does not explicitly state or imply the use of AI or ML. The focus is on image processing algorithms, which are not necessarily AI/ML.
No.
The device is an angiographic X-ray system primarily used for imaging, including diagnostic, interventional, and minimally invasive procedures. While it aids in procedures that lead to therapy, its direct function is imaging, not delivering therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures" and "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures." The mention of "diagnostic" applications confirms its function as a diagnostic device.
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". This indicates it is a hardware system with integrated software, not a software-only device.
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 used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that the Allura Xper series is an angiographic X-ray system used for imaging applications on human patients. It performs procedures like angiography, stent placements, biopsies, etc., which involve imaging the inside of the body using X-rays.
- Lack of In Vitro Testing: There is no mention of the device being used to analyze samples taken from the body or performing any tests on biological specimens. Its function is entirely focused on generating and processing X-ray images of the patient's internal structures.
Therefore, the Allura Xper series falls under the category of medical imaging devices rather than In Vitro Diagnostics.
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 family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2.1. The Allura Xper FD R8.2.1 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 Allura Xper FD R8.2.1 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2.1 is optionally 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, cardiac
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)
Non-clinical Performance Data:
The Allura Xper R8.2.1 complies with the following international and FDA recognized consensus standard and FDA Guidance Documents:
- IEC 60601-2-43.
- IEC 60601-2-28,
- ISO 14971:
- IEC 62304,
- . 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.
- FDA Guidance document entitled: "Guidance for the submission of 510(k)'s for solid state X-ray Imaging Devices" issued August 6, 1999
The test results demonstrate that the Allura Xper FD R8.2.1.
- Complies with the aforementioned international and FDA-● recognized consensus standards and/or FDA guidance documents
- . Meets the acceptance criteria and is adequate for its intended use.
Clinical Performance Data:
The subject of this premarket submission, the Allura Xper FD R8.2.1., did not require clinical studies to support substantial equivalence. Sample clinical images accompanied by a signed statement of a board certified radiologist are included in this 510(k) premarket notification to demonstrate that the images made with the FD15" (PX2630SV) X-ray detector of the Allura Xper FD R8.2.1 are of adequate quality for use in neuroradiological procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 consists of the department's name in a circular arrangement around a stylized symbol. The symbol features three overlapping profiles facing right, representing the department's focus on people and health. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2014
Philips Medical Systems Netherland, B.V. % Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best The Netherlands
Re: K141979
Trade/Device Name: Allura Xper FD series / 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: July 16, 2014 Received: July 21, 2014
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
1
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.
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/ResourcesforYou/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,
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)
Device Name
Allura Xper 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: | July 10, 2014 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684-PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Contact: | Mrs. Jeanette Becker | |
| Regulatory Affairs Manager | ||
| +31 6 113 86380 | ||
| Device Trade | ||
| Names: | Allura Xper FD series | |
| Allura Xper OR Table series | ||
| Classification | Classification Name: | Image-intensified fluoroscopic x-ray |
| system | ||
| Classification Regulation: | 21 CFR 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | II | |
| Primary product code: | OWB | |
| Secondary product code: | JAA | |
| Predicate Device #1 | Device Name | Allura Xper FD series |
| Manufacturer | Philips Medical Systems Nederland | |
| B.V. | ||
| 510(k) number | K133292 | |
| Classification Regulation | 21 CFR 892.1650 | |
| Device Class: | II | |
| Product Code: | Primary code: OWB | |
| Subsequent code: JAA | ||
| Predicate Device #2 | Device Name | Allura Xper OR Tables Series |
| Manufacturer | Philips Medical Systems Nederland | |
| B.V. | ||
| 510(k) number | K133292 | |
| Classification Regulation | 21 CFR 892.1650 | |
| Device Class: | II | |
| Product Code: | Primary code: OWB | |
| Subsequent code: JAA | ||
| Device Description: | The Allura Xper family consists of the Allura Xper FD series and | |
| the Allura Xper OR Table series and is identified as Allura Xper FD | ||
| R8.2.1. The Allura Xper FD R8.2.1 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 | ||
| Allura Xper FD R8.2.1 can also be used for imaging in the Hybrid | ||
| OR. The Allura Xper FD R8.2.1 is optionally provided with | ||
| ClarityIQ technology, which utilizes the advanced XRES4 noise | ||
| reduction algorithms to reduce quantum noise in X-ray images. | ||
| 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, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolization 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. | ||
| Technology: | The Allura Xper FD R8.2.1 has the same technological characteristics compared to the predicate devices. Modifications implemented in the Allura Xper FD R8.2.1 include: The addition of a FD15" (PX2630SV) X-ray detector, which has been cleared on July 10, 2014, as part of Philips' Veradius system with 510(k) number K133819, A Low Load Uninterruptable Power Supply (UPS) has been added as an option to the system, and Software updates for: Use of FD15" (PX2630SV) X-ray detector, Change in windows Host OS from XP to Windows Embedded Standard (WES) 2009, Elimination of unexpected C-arm movement during startup of the system, Enhancement of an overlay functionality on an XtraVision 3D-workstation for 3D-image guidance software applications, Support of non-US language keyboard layouts, and Sorting Photo files of a Biplane system when they |
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Based on the information provided in this premarket notification, the Allura Xper FD R8.2.1 is considered substantially equivalent to the
System (PACS).
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currently marketed and predicate devices in terms of:
- Design and functionality
- · Indications for use
- · Fundamental Scientific Technology
- · Performance specifications and testing
Non-clinical Performance Data:
The Allura Xper R8.2.1 complies with the following international and FDA recognized consensus standard and FDA Guidance Documents:
- IEC 60601-2-43. ●
- IEC 60601-2-28, ●
- ISO 14971: ●
- IEC 62304,
- . 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.
- FDA Guidance document entitled: "Guidance for the submission of 510(k)'s for solid state X-ray Imaging Devices" issued August 6, 1999
The test results demonstrate that the Allura Xper FD R8.2.1.
- Complies with the aforementioned international and FDA-● recognized consensus standards and/or FDA guidance documents
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, the Allura Xper FD R8.2.1 is substantially equivalent to the currently marketed and predicate devices in terms of safety and effectiveness.
The subject of this premarket submission, the Allura Xper FD Clinical Performance Data: R8.2.1., did not require clinical studies to support substantial equivalence. Sample clinical images accompanied by a signed statement of a board certified radiologist are included in this 510(k) premarket notification to demonstrate that the images made with the FD15" (PX2630SV) X-ray detector of the Allura Xper FD R8.2.1 are of adequate quality for use in neuroradiological procedures.
Conclusion: The Allura Xper FD R8.2.1 is substantially equivalent to the predicate devices in terms of design features, fundamental scientific technology, indications for use and safety and effectiveness.
- The modifications of the Allura Xper FD R8.2.1 are within ● the design controls and specifications;
- . A system verification test was performed to ensure that the modifications are properly introduced;
- Verification and validation testing was conducted to ensure the proper introduction of the individual modifications
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listed;
- . Sample clinical images as well as conformance to IEC standards and guidance documents were provided. All of the aforementioned components and tests were used to support substantial equivalence of the Allura Xper FD R8.2.1.