(189 days)
No
The summary describes image processing and quantification based on angiography data, but there is no mention of AI, ML, or related concepts like training or test sets for model development.
No
This device is a software tool that assists during endovascular procedures by providing visualization and quantification of blood flow patterns. It is a diagnostic and procedural support tool, not a device that directly provides therapy.
Yes
AneurysmFlow is described as a software tool that provides relevant information on blood flow in a cerebral aneurysm and its parent artery based on angiography, including visualization and quantification of blood flow patterns. This information assists during endovascular procedures for treating saccular cerebral aneurysms, which implies aiding in understanding the condition and guiding treatment.
Yes
The device description explicitly states "AneurysmFlow is a software medical device" and describes it as a "software tool" and "software product". While it is intended to be used in combination with existing hardware (Philips interventional X-ray system), the device itself is presented as solely software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- AneurysmFlow's Function: AneurysmFlow analyzes imaging data (digital subtraction angiography and 3D rotational angiography) of blood flow within the body. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to assist during endovascular procedures by visualizing and quantifying blood flow patterns based on imaging, not by analyzing biological samples.
- Device Description: The description clearly states it's a software tool that works with imaging systems and data.
Therefore, AneurysmFlow falls under the category of medical imaging software or image processing software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
AneurysmFlow assists during endovascular procedures for treating of saccular cerebral aneurysms, by:
- Visualization of blood flow patterns in the aneurysm and parent vessel, based on digital subtraction angiography.
- Quantification of the blood flow in the aneurysm parent vessel, based on digital subtraction angiography and 3D rotational angiography.
- Comparison of blood flow, both visual and quantified between two acquisitions.
Product codes (comma separated list FDA assigned to the subject device)
OWB, LLZ
Device Description
AneurysmFlow is a software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. AneurysmFlow is a software medical device and is intended to be used in combination with the currently marketed Philips interventional X-ray system and 3D volume data from 3D Rotational Angiography. AneurysmFlow is a software product (Interventional Tool) that provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3D-RA data. It can visualize blood flow patterns in an aneurysm based on DSA data. It can also provide a side by side visual and quantitative comparison between two acquisitions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital subtraction angiography (DSA), 3D rotational angiography (3D-RA)
Anatomical Site
Cerebral aneurysms / cerebral vessels, parent vessel, parent artery, main feeding artery of the aneurysm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Assists during endovascular procedures; used in combination with Philips interventional X-ray system; user during interventional procedures.
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)
Software verification testing (functionality, interoperability, privacy and security, performance, reliability, safety, and Allura compatibility) has been performed to cover system level requirements and the risk control measures. Results demonstrated that all executed tests were passed.
Algorithm verification testing has been performed to support the accuracy of the algorithm used. Results demonstrated that the algorithm confirms to its specifications.
Non-clinical software validation testing has been performed to cover the intended use, commercial claims, service user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users. Results demonstrated that the AneurysmFlow conforms to its intended use and user needs and has proven to be safe and effective.
Sample clinical images of one case accompanied by signed statements from three board certified neuroradiologists were provided to demonstrate that after completing all worksteps, the presented data are consistent with the raw data (X-ray angiogram).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
Philips Medical Systems Nederland BV Image Guided Therapy (IGT) Systems Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 Best, 5684PC NETHERLANDS
Re: K160455
Trade/Device Name: AneurysmFlow Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, LLZ Dated: July 22, 2016 Received: July 25, 2016
Dear Jeanette 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.
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,
Jeff Balyua
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
2
Indications for Use
510(k) Number (if known)
Device Name AneurysmFlow
Indications for Use (Describe)
AneurysmFlow assists during endovascular procedures for treating of saccular cerebral aneurysms, by:
· Visualization of blood flow patterns in the aneurysm and parent vessel, based on digital subtraction angiography.
· Quantification of the blood flow in the aneurysm parent vessel, based on digital subtraction angiography and 3D rotational angiography.
· Comparison of blood flow, both visual and quantified between two acquisitions.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | February 15, 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: | |
| Device Name: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Primary Product code: | ||
| Secondary Product Code: | AneurysmFlow | |
| AneurysmFlow | ||
| Image-intensified fluoroscopic x-ray system | ||
| 21CFR §892.1650 | ||
| Radiology | ||
| Class II | ||
| OWB (Interventional x-ray system) | ||
| LLZ (system, image processing, | ||
| radiological) | ||
| Primary | ||
| Predicate | ||
| Device: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Primary Product code: | ||
| Secondary Product Code: | 2D Perfusion | |
| Philips Medical Systems Nederland B.V. | ||
| K132147 (Dec 16, 2013) | ||
| Image-intensified fluoroscopic x-ray system | ||
| 21 CFR, Part 892.1650 | ||
| Radiology | ||
| Class II | ||
| OWB | ||
| LLZ | ||
| Reference | ||
| Device 1: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | 3D Roadmap | |
| Philips Medical Systems Nederland B.V. | ||
| K121772 (March 21, 2013) | ||
| Reference | Trade Name: | EP Navigator |
| Device 2: | Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) Clearance: | K142126 (December 9, 2014) |
4
AneurysmFlow is a software tool intended to provide relevant Device description: information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. AneurysmFlow is a software medical device and is intended to be used in combination with the currently marketed Philips interventional X-ray system and 3D volume data from 3D Rotational Angiography. AneurysmFlow is a software product (Interventional Tool) that provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3D-RA data. It can visualize blood flow patterns in an aneurysm based on DSA data. It can also provide a side by side visual and quantitative comparison between two acquisitions.
AneurysmFlow assists during endovascular procedures for treating of Indications for Use: saccular cerebral aneurysms, by:
- Visualization of blood flow patterns in the aneurysm and parent vessel, based on digital subtraction angiography.
- Quantification of the blood flow in the aneurysm parent vessel, based on digital subtraction angiography and 3D rotational angiography.
- Comparison of blood flow, both visual and quantified between two . acquisitions.
The indications for use of AneurysmFlow are similar to the primary currently marketed and predicate device 2D Perfusion except that:
- The use of AneurysmFlow is limited to cerebral vessels instead of all vessels
- · AneurysmFlow also provides quantification of flow in addition to a color coded visualization
However, this difference does not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the predicate. Both devices have the same intended use: they are accessories to the currently marketed Philips interventional X-ray system and provide additional information derived from the time intensity curve of a digital subtraction angiography (DSA) run to support the user during interventional procedures.
Technological AneurysmFlow employs comparable technological characteristics as the characteristics: predicate device 2D Perfusion:
- . Both devices are accessories to the currently marketed Philips interventional X-ray system and use angiography X-ray images from this system as input.
- . Both devices run on the (separate) currently marketed Tools Workstation (Philips Interventional Interventional Workspot).
5
- Both devices use a dedicated real-time link with the Interventional ● X-ray system to acquire live 2D fluoroscopy images and exam data.
- . Both devices provide a mechanism to the user to mark a region of interest in which the flow parameters are derived.
- . Both devices provide color coded representation of parameters derived from a digital subtraction angiography (DSA).
- Both devices provide side by side comparison of information from two acquisitions.
- . Both devices provide visualization of contrast density over time in a time-graph and color image format.
- Both devices provide basic viewing operations to manipulate image data that is shown in the viewers.
- o Both devices provide a mechanism to the user to synchronize interactions (like changing the region of interest) across compared runs.
- . Both devices provide a mechanism to the user to take a snapshot of the main display area.
- . Both devices provide a mechanism to the user to export displayed information.
AneurysmFlow is different from the currently marketed and predicate device 2D Perfusion with regards to the following technological characteristics:
- The AneurysmFlow algorithm derives flow information from digital subtraction angiography (DSA) data using the modulation in contrast concentration resulting from the heart rhythm, whereas the currently marketed and predicate device 2D Perfusion uses time to peak and wash in rate parameters. This difference does not raise new questions on safety and effectiveness and existing verification methods showed both algorithms provide accurate results.
- AneurysmFlow provides a mechanism to the user to quantify the arterial flow in the user chosen arterial segment of the main feeding artery of the aneurysm, whereas the currently marketed and predicate device 2D perfusion visualizes the mean transit time. For calculation of volumetric flow in the artery, AneurysmFlow uses 3D volume data in conjunction with the DSA data. This does not raise new questions on safety and effectiveness since the flow calculation from DSA and 3D volume data only provides additional information to the user and the user can observe if the registration of DSA data with 3D volume data and segmentation within the 3D volume data is correct and reject / reselect a 3D volume. Furthermore, the technology to register 3D volume data with 2D images is identical to the technology used in reference device 3D Roadmap (K121772).
- AneurysmFlow provides the flow information not only in color image format but also as a vector field, time graph and in a
6
numerical representation. As these are only different representations of the derived parameters from the digital subtraction angiography (DSA), this difference does not raise new questions on safety and effectiveness.
- AneurysmFlow provides automatic position control (APC) to . recall C-arm orientations from previous acquisitions, whereas with the currently marketed and predicate device 2D Perfusion, users have to manually position the C-arm orientations from previous acquisitions. As the APC feature is only adding convenience, this difference does not raise new questions on safety and effectiveness. Furthermore, this technology is identical to the reference device EP Navigator (K142126).
Based on the information provided above. AneurysmFlow is considered substantially equivalent to the primary currently marketed and predicate device 2D Perfusion and references devices 3D Roadmap and EP Navigator in terms of technological characteristics.
The AneurysmFlow complies with the following international and FDArecognized consensus standards:
Summary of Non-Clinical Performance Data:
- IEC 62304 Medical device software Software life cycle ● processes (Ed. 1.0, 2006),
- IEC 62366-1 Medical devices Application of usability ● engineering to medical devices (Ed. 1.0, 2015),
- . ISO 14971 Medical devices - Application of risk management to medical devices (Ed. 2.0, 2007),
- NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011),
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005, document number 337)
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Software verification testing (functionality, interoperability, privacy and security, performance, reliability, safety, and Allura compatibility) has been performed to cover system level requirements and the risk control measures. Results demonstrated that all executed tests were passed.
Algorithm verification testing has been performed to support the accuracy of the algorithm used. Results demonstrated that the algorithm confirms to its specifications.
Non-clinical software validation testing has been performed to cover the intended use, commercial claims, service user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users. Results demonstrated that the AneurysmFlow conforms to its intended use and user needs and has proven to be safe and effective.
7
Therefore, AneurysmFlow is substantially equivalent to the primary currently marketed and predicate device 2D Perfusion in terms of safety and effectiveness.
AneurysmFlow did not require clinical studies since substantial Summary of equivalence to the primary currently marketed and predicate device 2D Clinical Performance Perfusion was demonstrated with the following attributes:
-
Indication for use; ●
Data: -
o Technological characteristics;
-
Non-clinical performance testing; and .
-
Safety and effectiveness. .
Sample clinical images of one case accompanied by signed statements from three board certified neuroradiologists were provided to demonstrate that after completing all worksteps, the presented data are consistent with the raw data (X-ray angiogram).
Substantial AneurysmFlow is substantially equivalent to the primary currently Equivalence marketed and predicate device 2D Perfusion (K132147) in terms of indications for use, technological characteristics and safety and Conclusion: effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366-1 and ISO 14971. The results of these tests demonstrate that AneurysmFlow met the acceptance criteria and is adequate for this intended use.