(131 days)
Not Found
No
The document mentions "advanced XRES4 noise reduction algorithms," which are image processing techniques, but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies section also focuses on compliance with standards and guidance documents, not on AI/ML specific performance metrics or validation.
No
The device is an imaging system used for diagnostic and interventional procedures, but it does not directly provide therapy. It aids in procedures such as PTAs, stent placements, embolizations, and thrombolysis, which are therapeutic, but the device itself is for imaging and guidance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications. including diagnostic, interventional and minimally invasive procedures."
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 Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Allura Xper series is an angiographic X-ray system. It uses X-rays to create images of the inside of the body, primarily for vascular, cardiovascular, and neurovascular applications. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use clearly describes procedures performed directly on human patients, such as angiography, PTAs, stent placements, etc. These are not tests performed on specimens outside the body.
Therefore, the Allura Xper series falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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. 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.
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. The Allura Xper FD R8.2 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 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2 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 related to angiography. Neuro, Vascular, Non Vascular and Cardiac applications in a hybrid OR setting.
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)
The Allura Xper FD R8.2 did not require clinical studies to support substantial equivalence. Sample clinical images that demonstrate diagnostic quality of the images are provided.
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.
0
MAR 0 5 2014
HILIPS
K'133292
Page 1 of 3
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | January 27, 2014 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684-PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Contact: | Mr. Klien van Dam, PhD | |
| Regulatory Affairs Manager | ||
| +3140 2795225 | ||
| 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 AlluraClarity Xper FD series X-ray system | |
| Manufacturer Philips Medical Systems Nederland B.V. | ||
| 510(k) number K130638 | ||
| Classification Regulation 21 CFR 892.1650 | ||
| Device Class: II | ||
| Product Code: OWB | ||
| Predicate Device #2 | Device Name Allura Xper FD OR Tables Series | |
| Manufacturer Philips Medical Systems Nederland B.V. | ||
| 510(k) number K102005 | ||
| Classification Regulation 21 CFR 892.1650 | ||
| Device Class: 11 | ||
| 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. The Allura Xper FD R8.2 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 can also be used for imaging in the Hybrid | ||
| OR. The Allura Xper FD R8.2 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, 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. | ||
| Technology: | The Allura Xper FD R8.2 has the same technological characteristics | |
| compared to the predicate devices. Modifications implemented in | ||
| the Allura Xper FD R8.2 include the introduction of a new, state of | ||
| the art FD20 X-ray detector with passive cooling, and a higher DQE. | ||
| Additionally, a new high voltage X-ray generator with reduced size | ||
| is introduced. | ||
| Based on the information provided in this premarket notification, the | ||
| Allura Xper FD R8.2 is considered substantially equivalent to the | ||
| 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 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 |
1
PHILIPS
2
| | 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:
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 is substantially equivalent to the |
| Clinical
Performance Data: | currently marketed and predicate devices in terms of safety and
effectiveness.
The subject of this premarket submission, the Allura Xper FD R8.2.
did not require clinical studies to support substantial equivalence.
Sample clinical images that demonstrate diagnostic quality of the
images are provided. |
| Conclusion: | The Allura Xper FD R8.2 is substantially equivalent to the predicate
devices in terms of design features, fundamental scientific
technology, indications for use and safety and effectiveness.
The changes implemented in the Allura Xper FD R8.2 System do
not render the system to be Not Substantial Equivalent. |
3
HUMAN SERVI
Public Health Service
Food and Diug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
March 5. 2014
Philips Medical Systems Nederland B.V. % Klien van Dam, Ph.D. Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Rc: K133292
Trade/Device Name: Allura Xper FD scries; Allura Xper OR Table series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: 11 Product Code: OWB, JAA Dated: January 27, 2014 Received: February 7. 2014
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 cither 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Klien van Dam, Ph.D.
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.lda.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/Safetv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sm.p)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K133292
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 use on human patients to perform:
• Vascular, cardiovascular and neurovascular imaging diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, choracic and abdominal angiography, as well as PT As. stent placements,
embolisations and thrombolysis.
· Cardiac imaging applications including diagnosics, interventional and minimally invasive procedures (such as not 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 Allurs 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)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Smh |
FORM FDA 3881 (9/13)