2D PERFUSION
Device Facts
| Record ID | K132147 |
|---|---|
| Device Name | 2D PERFUSION |
| Applicant | Philips Medical Systems Nederland B.V. |
| Product Code | OWB · Radiology |
| Decision Date | Dec 16, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
2D Perfusion assists in the diagnosis of perfusions of issues, based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series.
Device Story
2D Perfusion is a software medical device accessory to Philips X-ray imaging systems. It processes digital subtraction angiography (DSA) input runs to visualize blood perfusion in tissues. The device analyzes the time-intensity curve of the DSA input to calculate functional parameters: arrival time, time to peak, wash-in rate, width, area under the curve, and mean transit time. It generates color-coded parametric images representing these values, allowing clinicians to compare pre-, peri-, and post-procedural states. Used in interventional settings, the software runs on the Philips Interventional Workspot platform. By providing visual representations of vascular flow characteristics, it assists physicians in diagnosing perfusion alterations, potentially improving clinical decision-making during interventional procedures.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via non-clinical software verification and validation testing, including compliance with IEC 62304, IEC 62366, and ISO 14971 standards.
Technological Characteristics
Software-based medical device hosted on Philips Interventional Workspot. Analyzes time-intensity curves from DSA input. Outputs color-coded parametric images. Complies with IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 14971 (risk management).
Indications for Use
Indicated for use by clinicians to assist in the diagnosis of tissue perfusion alterations based on digital subtraction angiography (DSA) imaging. Prescription use only.
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
- Allura Xper FD20 X-Ray Imaging Systems (K033737)
- Allura Xper FD OR Table Series (K102005)
- AW VolumeShare 5 with AngioViz Option (K110834)
Reference Devices
- Philips Interventional Workspot (K121296)
Submission Summary (Full Text)
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KB2147
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EC 1 6 2013
## 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR \$807.92.
Date Prepared: July 8, 2013 Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277 Contact Person: Ms. Liselotte Kornmann. PhD Regulatory Affairs Manager Phone: +31 40 2791111 Fax: +31 40 2769100 E-mail: Liselotte.Kornmann@philips.com Device Name: 2D Perfusion Classification Name: Image-intensified fluoroscopic x-ray system Classification: Classification Regulation: 21CFR 8892.1650 Radiology Classification Panel: Device Class: Class II Primary Product Code: OWB (Interventional x-ray system) Secondary Product Code: I_LZ (svstem, image processing, radiological) Primary Predicate Device 1: Trade Name: Allura Xper FD20 X-Ray Imaging Systems Manufacturer: Philips Medical Systems Nederland B.V. K033737 (December 9, 2003) 510(k) Clearance: Classification Regulation: 21 CFR, Part 892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Device Class: Class II OWB (interventional fluoroscopic x-ray system) Product Code: Primary Predicate Device 2: Trade Name: Allura Xper FD OR Table Series Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K102005 (August 9. 2010) Classification Regulation: 21 CFR. Part 892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Device Class: Class II Product Code: OWB (interventional fluoroscopic x-ray system)
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# Secondary Predicate Device:
| Secondary Predicate Device: | Trade Name:<br>Manufacturer:<br>510(k) Clearance:<br>Classification Regulation:<br>Classification Name:<br>Classification Panel:<br>Device Class:<br>Product Code: | AW VolumeShare 5 with AngioViz Option<br>GE Healthcare<br>K110834 (April 26. 2011)<br>21CFR §892.1600<br>Picture archiving and communications system<br>Radiology<br>Class II<br>LLZ (system, image processing, radiological) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note: The 2D Perfusion software medical device is considered an accessory to the following currently marketed and predicate devices and thus designated with the primary product code of OWB:<br>Philips Allura Xper FD20 X-Ray Imaging Systems (K033737): and Philips Allura Xper FD OR Table Series (K102005). Since the 2D Perfusion is a software medical device and is an accessory to the currently marketed Philips Allura Xper X-ray Systems, substantial equivalence demonstration is not warranted. | | |
| Device description: | The 2D Perfusion software medical device is a tool that assists the physician in the diagnosis of perfusion (i.e., passage of blood through blood vessels to an organ or a tissue) alterations by providing a color coded representation of a digital subtraction angiography (DSA) run. The 2D Perfusion software medical device can visualize multiple functional parameters related to the time-density function and also provides a comparison between pre-, peri-, and post-procedural color coded images. | |
| Indications for Use: | 2D Perfusion assists in the diagnosis of perfusion alterations of tissues, based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series. | |
| | Note: The indication for use of the 2D Perfusion software medical device and the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) are similar as follows:<br>Produces / provides parametric images from a DSA series to enable the user to more easily visualize vascular flow. | |
| | The differences between the 2D Perfusion software medical device and the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) are:<br>The currently marketed and secondary predicate AngioViz Option produces from a DSA series parametric images representing maximum (peak) opacification, time to peak, and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow. The 2D Perfusion software medical device provides the following | |
:
- parameters to enable the user to more easily visualize characteristics related to vascular flow; arrival time, time to peak. wash-in rate, width. area under the curve, and means transit time.
.
:
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The parameters provided with the 2D Perfusion does not affect the safety or effectiveness since they provide a different representation of information already present in the input DSA images to enable the user to more easily visualize characteristics related to vascular flow as compared to the parameters provided by the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 (GE Healthcare, K110834). Thus, the differences in the indications for use do not impact the safety and effectiveness of this product.
Based on the information provided above. 2D Perfusion is considered substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) in terms of indication for use.
The fundamental scientific technology of both the currently marketed and Technology: secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) and 2D Perfusion software medical device, is as follows:
- Execution on and comnection to an independent software hosting platform ! . workstation, which supports functions for image display, manipulation, and selective recording, import, export and data handling.
The 2D Perfusion software medical device is provided on the independent hosting software platform. Philips Interventional Workspot (K121296. January 2, 2013). The currently marketed Philips Interventional Workspot software platform. which support 510(k) cleared Philips Interventional Tools. provides common functionalities (e.g., import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the Interventional procedure.
- . Provide visualization of parameters derived from the time intensity curve of a DS.4 input run.
Based on analysis of the time intensity curve of the input DSA. the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healtheare, K110834) provides images of the following derived parameters:
- Peak opacification: the maximum intensity of the ime intensity . curve:
- . Time to peak, the time between the first arrival of contrast medium and the moment it reaches its maximum concentration; and
- . Peak opacification to time to peak ratio.
Based on analysis of the time intensity curve of the input DSA. 2D Perfusion provides images of the following derived parameters:
- Time to peak: the time between the first arrival of contrast medium � and the moment it reaches its maximum concentration. This yields the same information as the time to peak provided by the predicate
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AngioViz Option; and
- Wash-in rate: the slope of the time intensity curve between arrival . time and time to peak. This yields similar information as the peak opacification to time to peak ratio provided by the predicate AngioViz Option.
In addition. 21) Perfusion provides images of the following derived parameters which are not provided by the predicate AngioViz Option:
- Arrival time: the time between the start of the DSA run and the . moment of arrival of contrast medium;
- Width: the time during which the time intensity curve is at least at . half its maximum intensity:
- Area under the curve: the total accumulated intensity between the . first of arrival of contrast medium and the moment of leveling off after the contrast bolus has passed; and
- Mean transit time: the time between the first of arrival of contrast . medium and the moment of leveling off after the contrast bolus has passed.
The additional parameters visualized by 2D Perfusion as well as the absence of the Peak opacification visualization do not affect the safety or effectiveness since both the predicate AngioViz Option and 21) Perfusion provide visualization of parameters derived from the time intensity curve. Thus. the differences in the technology do not impact the safety and effectiveness of this product.
Based on the information provided above. 2D Perfusion is considered substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of technology.
The 2D Perfusion software medical device complies with the following Summary of Noninternational and FDA-recognized consensus standards: clinical Performance
Data:
- . IEC 62304 Medical device software – Software life cvcle processes (2006):
- IEC 62366 Application of usability engineering to medical devices (2007): .
- ISO 14971 Application of risk management to medical devices (2007). .
Non-clinical software verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device complies with international and FDA-recognized consensus standards and meets the acceptance criteria and is adequate for its intended use. Therefore, the 2D Perfusion software medical device is substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of safety and effectiveness.
#### The 2D Perfusion software medical device did not require clinical studies since Summary of Clinical substantial equivalence to the currently marketed and predicate device was Data:
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K132147
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demonstrated with the following attributes:
- . Design features:
- . Indication for use:
- . Fundamental scientific technology:
- . Non-clinical performance testing: and
- . Safety and effectiveness.
Substantial Equivalence Conclusion:
The 2D Perfusion software medical device is substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with nonclinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that the 2D Perfusion software medical device met the acceptance criteria and is adequate for this intended use.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
Philips Medical Systems Nederland B.V. % Liselotte Kornmann, Ph.D. Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K132147
Trade/Device Name: 2D Perfusion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: November 5, 2013 Received: November 7, 2013
Dear Dr. Kornmann:
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 - Liselotte Kornmann, 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.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.lda.gov/McdicalDevices/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 vours,
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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### 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) K132147
### Device Name 2D Perfusion
#### Indications for Use (Describe)
2D Perfusion assists in the diagnosis of perfusions of issues, based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series.
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)
FORM FDA 3881 (9/13)
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