ALLURA XPER OR TABLE SERIES
Device Facts
| Record ID | K102005 |
|---|---|
| Device Name | ALLURA XPER OR TABLE SERIES |
| Applicant | Philips Medical Systems North America, Inc. |
| Product Code | OWB · Radiology |
| Decision Date | Aug 9, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform: • Vascular 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 electrophysiclogy (EP). · Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures, Combined with a qualified, compatible OR table, the Allura Xper FD 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.
Device Story
Modular X-ray system for specialized angiography; consists of X-ray generator, tube/housing, beam limiter, image receptor, control, stands, patient support, and monitor suspension. Identical to Allura Xper FD series with addition of qualified, compatible OR table. Operated by trained healthcare professionals in OR/hybrid OR settings. Provides real-time imaging for diagnostic and interventional procedures (vascular, neurovascular, cardiac, non-vascular). Output displayed on monitors to guide clinicians during minimally invasive interventions; facilitates precise placement of stents/devices and procedural navigation. Benefits include integrated imaging and surgical capabilities in hybrid OR environment.
Clinical Evidence
No clinical performance test was required. Evidence consists of non-clinical verification and validation testing performed to verify system functionality relative to specifications and risk management requirements.
Technological Characteristics
Modular X-ray system; components include X-ray generator, tube/housing, beam limiter, image receptor, control, stands, patient support, and monitor suspension. Conforms to IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-43, IEC 62304, IEC 62366, and ISO 14971.
Indications for Use
Indicated for human patients requiring vascular, neurovascular, cardiac, or non-vascular diagnostic and interventional imaging procedures, including angiography, stent placement, embolization, thrombolysis, pacemaker implantation, electrophysiology, drainage, biopsy, and vertebroplasty. Used in hybrid OR settings or standalone surgical environments.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Philips Integris Allura series (K002016)
- Philips Allura Xper FD10 (K041949)
- Philips Allura Xper FD20 (K033737)
- Siemens Axiom Artis (K021021)
- Siemens Artis Zee family (K073290)
- Siemens Artis Zee / Zeego family (K090745)
Submission Summary (Full Text)
{0}------------------------------------------------
Philips Medical Systems Nederland B.V. eenpluis 4-8, 5684-PC, Best The Netherlands
KID2005
# D P
## 510(k) summary
AUG - 9 2010
The following information is submitted in accordance with the requirements of 21 CFR 807.92.
### ldentification of manufacturer
Company:...................................................................................................................................................................... Address: ..................................................................................................................................................................... 5684-PC, Best, The Netherlands Registration number:............................ 3003768277
### Identification of U.S. designated agent
| Company: | Philips Medical Systems |
|----------------------|-----------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>Bothell, WA 98021-8431, U.S.A. |
| Registration number: | 1217116 |
### Identification of official correspondent
Name:...................................................... Lynn Harmer Position: ................................................. Senior Manager, Regulatory Affairs Telephone:.................................................................................................................................................................... Date prepared:................................................................................................................................................................
### Device identification
| Trade name: | Philips |
|-------------------------|--------------------------------|
| Device name: | Allura Xper FD OR Table series |
| Regulation description: | Angiographic X-ray System |
| Regulation number: | 21CFR 892.1600 |
| Class: | II |
| Product code: | 90IZI |
### Legally marketed devices
| Trade names: | Philips Integris Allura series, Philips Allura Xper FD10,<br>Philips Allura Xper FD20,<br>Siemens Axiom Artis, Siemens Artis Zee family,<br>Siemens Artis Zee / Zeego family |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips and Siemens |
| 510(k) numbers: | K002016, K041949, K033737, K021021, K073290,<br>K090745 |
Page 1 of 3
{1}------------------------------------------------
### Intended Use:
The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform:
• Vascular 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 electrophysiclogy (EP).
· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures,
Combined with a qualified, compatible OR table, the Allura Xper FD 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.
### Device description:
The Allura Xper FD OR Table series is a modular X-ray systems series, based on a set of components that can be combined into different single and biglane configurations to provide specialized anglography. It is identical to the Allura Xper FD systems series, to which a qualified, compatible OR table component is added.
These Allura Xper FD OR Table series X-ray systems are Angiographic X-ray Systems consisting of 1 or more of the following components: X-ray generator, X-ray tubelhousing assembly, beam limiting device, image receptor. X-ray control, frontal/lateral stand, patient support and a monitor ceiling suspension.
### Substantial equivalence:
The Allura Xper FD OR Table series was compared to its predicate devices. Evaluations were carried out based on the comparison of the intended uses and device descriptions from 510(k) summaries of the predicate devices versus the new Allura Xper FD OR Table series.
Philips Healthcare believes that the Allura Xper FD OR Table series is as safe and effective, and performs in a substantially equivalent manner to the predicate devices.
{2}------------------------------------------------
### Summary of Non-Clinical and Clinical performance tests:
Non-clinical verification and validation tests were performed to verify and validate the system functionally for the intended use reiative to the specifications and risk management requirements. Results of the conducted tests conclude that the Allura Xper OR Table series is substantial equivalent to its predicate device. The following standards were used in the development of the product: or we could say the system conforms tot the following standards:
| Standard: | Title |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1, 2nd Ed.<br>+ Amendment No. 1<br>+ Amendment No. 2 + Corrigendum | General requirements for safety |
| IEC 60601-1-1, 2nd Ed. | Collateral standard: Safety requirements for medical<br>electrical systems |
| IEC 60601-1-2, ed 2.1 | Collateral standard: Electromagnetic compatibility –<br>Requirements and tests |
| IEC 60601-1-3, 1st Ed. | Collateral standard: General requirements for radiation<br>protection in diagnostic X-Ray equipment |
| IEC 60601-1-4 Ed 1.1 | Collateral standard: Safety requirements for program-<br>mable electronic systems |
| IEC 60601-2-7 2nd Ed. | Particular requirements for the safety of high voltage<br>generators |
| IEC 60601-2-28, 1st Ed. | Particular requirements for the safety of X-ray source<br>assemblies and X-ray tube assemblies for medical diag-<br>nosis |
| IEC 60601-2-32 1st Ed. | Particular requirements for the safety of associated<br>equipment of X-ray equipment |
| IEC 60601-2-43, 1st Ed | Particular requirements for the safety of X-Ray equip-<br>ment for Interventional procedures |
| IEC 62304, 1st Ed.+ Corrigendum NEN-EN-<br>IEC 62304:2006/C11:2008 | Medical device software – Software life cycle processes |
| IEC 62366, 1st Ed | Medical devices. Application of usability engineering to<br>medical devices |
| ISO 14971: 2007-10-01 | Medical devices – Application of risk management to<br>medical devices |
No clinical performance test was required to show safety and effectiveness of the Allura Xper FD OR Table series in the intended clinical environment.
### Conclusion:
The testing reported in this 510(k) establishes that the Allura Xper FD OR Table series is safe and effective for its intended use and is substantially equivalent to the currently legally marketed devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems North America c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
JUL 1 9 2013
Re: K102005
Trade/Device Name: Allura Xper OR Table Series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB. JAA Dated: July 14, 2010 Received: July 15, 2010
Dear Mr. Job:
This letter corrects our substantially equivalent letter of August 5, 2010.
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 subiect 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
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, which is a common representation of the department's mission to protect and promote the health of all Americans.
{4}------------------------------------------------
Page 2 - M. Job
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.
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Flaming M. Menge
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
{5}------------------------------------------------
### Indications for Use
### 510(k) Number
### Device Name
Allura Xper OR Table Series
### Indications for Use
The Allura Xper OR Table Series is intended for use on human patients (within the limits of the used OR table) to perform:
• Vascular and neurovascular imaging applications, including diagnostic, interventional and minimally Invasive procedures. This includes, e.g., perigheral, cerebral, thoracic and abdominal anglography, 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, blopsies and vertebroplasties procedures.
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 Cardlac. The OR table can also be used standalone for surgical use in the OR.
### Device description:
The Allura Xper OR Table Series is a modular X-ray systems family, based on a set of components that can be combined into different single and biplane configurations to provide specialized anglography. It is identical to the Allura Xper Series, to which a qualified, compatible OR table component is added.
### General Safety and Effectiveness:
To facilitate safe and efficacious operation of the system by a trained healthcare professional, instructions for use are provided as part of the device labelling, as well as a basic training at system handover.
AND/OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
office of in Vitro Dlagnostic Device
510(k) K02005
Appendix 005_Indications for Use Statement.docm
1/1
AUG - 9 2010
