(168 days)
Yes
The summary mentions "EmboGuide automatic feeder detection (AFD)" and provides performance metrics (sensitivity, agreement among readers) specifically for this AFD functionality, which strongly suggests the use of an automated algorithm, likely AI/ML, for identifying feeding vessels.
No
Explanation: This device is a post-processing software that assists physicians in planning and guiding embolization procedures. It does not directly perform a therapeutic function on the patient.
Yes
The device assists physicians in the analysis of 3D rotational angiography images and helps with the planning and guidance of embolization procedures by identifying and annotating blood vessels. This involves analyzing medical images to provide information for diagnosis or treatment planning.
Yes
The device is explicitly described as a "post processing software medical device" and its function is to provide tools and guidance based on image analysis, not to directly interact with or control hardware in a way that would classify it as a hardware device. While it is used in conjunction with an X-ray system, its regulatory classification appears to be based on its software functionality.
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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- EmboGuide's Function: EmboGuide is a software device that processes medical images (3D rotational angiography, CT, MR, XperCT) to assist physicians in planning and guiding embolization procedures. It works with imaging data acquired from the patient's body, but it does not directly examine biological specimens in vitro.
- Intended Use: The intended use clearly states it's for assisting physicians in performing embolization procedures using interventional X-ray and analyzing imaging data. This is an in vivo procedure (performed within the living body) supported by image processing.
Therefore, EmboGuide falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The relevant text section says "Not Found" for PCCP authorization.
Intended Use / Indications for Use
EmboGuide is a post processing software medical device intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure. It provides real time overlay of 3D rotational angiography images of the same anatomy to support device/catheter guidance.
Product codes (comma separated list FDA assigned to the subject device)
OWB, LLZ, JAK
Device Description
EmboGuide is a post processing software medical device intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. EmboGuide is an extension of XperCT and intended to be used in combination with an Allura interventional X-ray system. Like the primary predicate device 3D Roadmap, EmboGuide adds specific functionality to the Allura system but does not change the overall intended use of the Allura system or the overall risk profile.
EmboGuide uses a 3D volume reconstructed from 3D rotational angiography images acquired on the Allura X-ray system and the segmentation of lesions on previously acquired CT, MR or XperCT datasets as input data for the planning of the embolization. The physician can use this input data to analyze the vasculature of lesions, and to identify and annotate the blood vessels that shall be embolized (feeding vessels). The real-time overlay and registration of the 3D volume on live 2D X-ray images from the Allura X-ray system of the same anatomy can be used as additional 3D image guidance to support the navigation of the device/catheter. Planning data, like the earlier annotated feeding vessels and/or 3D landmarks can be displayed on 2D-3D fused images as supporting information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D rotational angiography images, CT, MR, XperCT, 2D X-ray images, 2D angiography, Cone Beam CT (CBCT)
Anatomical Site
Liver (hypervascular tumors)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians (interventional radiologists) / Interventional X-ray suite
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
The clinical validation study of EmboGuide was based on a retrospective image collection of 63 patients (outside the United States) and included a prospective review of randomized images; 44 subjects were included in the study and 19 were excluded. First, feeding vessels of the lesions were defined by consensus of two experienced interventional radiologists (located outside the United States) who also performed the procedures by using all available information (2D angiography, MR and /or CT, Cone Beam CT (CBCT) and EmboGuide). This was used as the "ground truth". Another three independent interventional radiologists (located out- and inside the United States) determined the feeding vessels based on CBCT, EmboGuide automatic feeder detection (AFD) and by subsequent review i.e., adding and deleting feeding vessels. Finally, the "ground truth" was compared with the determination of feeding vessels by the three independent readers for CBCT, EmboGuide AFD alone, and EmboGuide used in normal clinical practice (i.e., adding or removing vessels).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Validation Study (retrospective image collection with prospective review)
Sample Size: 44 subjects (patients) included
Key Results:
- the sensitivity of EmboGuide in clinical routine use for identification of tumor feeding vessels is 83+/- 8% with a CI of 95% for HCC patients with diagnostic quality CBCT images and no tumors or feeding vessels outside the volume imaged with CBCT.
- EmboGuide as it will be used in normal clinical practice provides for a higher sensitivity to identify feeding vessels compared to CBCT,
- EmboGuide AFD alone provides for a higher sensitivity to identify feeding vessels compared to CBCT,
- the overall agreement among readers for identification of feeding vessels using both the EmboGuide AFD and EmboGuide as it will be used in clinical practice was greater than the pre-selected acceptance criteria of 0.7 (i.e., 70%) indicating that for both approaches results in a consistent identification of feeding vessels for different readers,
- the agreement among readers for identification of feeding vessels using the EmboGuide AFD alone was close to one (i.e., 0.99 with the lower bound of the 95% CI of 0.986), and
- the overall agreement among readers for identification of feeding vessels using the CBCT (i.e., 0.69 with lower 95%CI of 0.648) was less than the preselected acceptance criteria of 0.7 (i.e., 70%) indicating that identification of feeding vessels using this method may not be consistent for different readers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, agreement among readers.
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 tex. 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
Philips Medical Systems Nederland B.V. % Ms. Liselotte Kornmann Regulatory Affairs Manager Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS
Re: K142273
Trade/Device Name: EmboGuide Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ, JAK Dated: December 16, 2014 Received: January 12, 2015
Dear Ms. 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.
1
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/Resourcesfor You/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,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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
EmboGuide
Indications for Use (Describe)
EmboGuide is a post processing software medical device intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure. It provides real time overlay of 3D rotational angiography images of the same anatomy to support device/catheter guidance.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: | December 16, 2014 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Contact Person: | Mr. Hans Venings | |
| Director of Regulatory Affairs | ||
| Phone: +31 611348827 | ||
| E-mail: hans.venings@philips.com | ||
| Device: | Trade Name: | EmboGuide |
| Device Name: | EmboGuide Rel. 1.0 | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | OWB (Interventional x-ray system) | |
| LLZ (system, image processing, radiological), | ||
| JAK (system, x-ray, tomography, computed) | ||
| Primary Predicate | ||
| Device: | Trade Name: | 3D Roadmap Rel. 1 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K121772 (March 21, 2013) | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | OWB (Interventional x-ray system) | |
| LLZ (system, image processing, radiological), | ||
| JAK (system, x-ray, tomography, computed) |
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| Reference Device: | Trade Name:
Manufacturer:
510(k) Clearance:
Classification Regulation:
Classification Name:
Classification Panel:
Device Class:
Product Code: | FlightPlan for Liver
GE Healthcare
K121200 (November 2, 2012)
21 CFR, Part 892.2050
Picture Archiving and Communications System
Radiology
Class II
LLZ |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description: | EmboGuide is a post processing software medical device intended to assist
physicians in performing embolization of hypervascular tumors in the liver using
interventional X-ray. EmboGuide is an extension of XperCT and intended to be
used in combination with an Allura interventional X-ray system. Like the
primary predicate device 3D Roadmap, EmboGuide adds specific functionality
to the Allura system but does not change the overall intended use of the Allura
system or the overall risk profile.
EmboGuide uses a 3D volume reconstructed from 3D rotational angiography
images acquired on the Allura X-ray system and the segmentation of lesions on
previously acquired CT, MR or XperCT datasets as input data for the planning of
the embolization. The physician can use this input data to analyze the vasculature
of lesions, and to identify and annotate the blood vessels that shall be embolized
(feeding vessels). The real-time overlay and registration of the 3D volume on live
2D X-ray images from the Allura X-ray system of the same anatomy can be used
as additional 3D image guidance to support the navigation of the device/catheter.
Planning data, like the earlier annotated feeding vessels and/or 3D landmarks can
be displayed on 2D-3D fused images as supporting information. | |
| Indications for Use: | EmboGuide is a post processing software medical device intended to assist
physicians in performing embolization of hypervascular tumors in the liver using
interventional X-ray. It provides tools to help the user with the analysis of 3D
rotational angiography images. Its output is intended as an adjunct means to
help with the planning and guidance of the embolization procedure. It provides
real time overlay of 3D rotational angiography images on live 2D X-ray images
of the same anatomy to support device/catheter guidance.
EmboGuide has similar indications for use as its primary predicate device 3D
Roadmap:
Similar to 3D Roadmap, EmboGuide is a supportive tool to help the
physician with performing an interventional procedure on the Allura X-ray
Xper system.Similar to 3D Roadmap, EmboGuide provides the real time overlay of 3D
rotational angiography images on live 2D X-ray images of the same anatomy
to support device/catheter guidance. | |
| • | Both EmboGuide and 3D Roadmap are extensions of the Allura interventional X-ray system (K133292). | |
| • | Both EmboGuide and 3D Roadmap use 3D volumes reconstructed from 3D rotational angiography images as input. | |
| • | Both EmboGuide and 3D Roadmap provide the overlay of 3D volume on live fluoroscopic images acquired from the Allura X-ray system. | |
| • | Both EmboGuide and 3D Roadmap provide dynamic update to changes of the position of the X-ray equipment; the 3D volume is automatically adjusted to any gantry changes and any lateral or longitudinal table movements. | |
| • | EmboGuide provides additional functionality to assist the clinical user with identifying arteries that are feeding into hypervascular tumors and to plan for the embolization treatment of these tumors. This is functionality to further support the clinician in performing interventions and does not raise new questions related to safety and effectiveness. Furthermore, the scientific method is comparable to reference device FlightPlan for Liver which also implements an algorithm for detecting vessels leading to a lesion. | |
| Summary of Non-clinical Performance Data: | Non-clinical performance testing has been performed on EmboGuide and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document: | |
| • | IEC 62304 Medical device software – Software life cycle processes (Ed. 1.0, 2006), | |
| • | IEC 62366 Medical devices – Application of usability engineering to medical devices (Ed. 1.0, 2007), | |
| • | 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), and | |
| • | 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). | |
| | Verification and validation tests have been performed to address intended use, the technical claims, requirement specifications and the risk management results. The test results in this 510(k) premarket notification demonstrate that | |
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Technological characteristics:
EmboGuide employs the same fundamental scientific technology as its primary predicate device 3D Roadmap.
EmboGuide:
- complies with the aforementioned international and FDA-recognized ● consensus standards and FDA guidance document, and
- . meets the acceptance criteria and is adequate for its intended use.
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Summary of Clinical Performance Data:
Clinical testing of EmboGuide included an initial reading study to validate the user interaction in the embolization planning workstep and a clinical validation study to validate the correctness and consistency of EmboGuide to identify feeding vessels leading to previously segmented lesions. Substantial equivalence was based in part on the clinical validation study of the EmboGuide software. Clinical Validation Study
The clinical validation study of EmboGuide was based on a retrospective image collection of 63 patients (outside the United States) and included a prospective review of randomized images; 44 subjects were included in the study and 19 were excluded. First, feeding vessels of the lesions were defined by consensus of two experienced interventional radiologists (located outside the United States) who also performed the procedures by using all available information (2D angiography, MR and /or CT, Cone Beam CT (CBCT) and EmboGuide). This was used as the "ground truth". Another three independent interventional radiologists (located out- and inside the United States) determined the feeding vessels based on CBCT, EmboGuide automatic feeder detection (AFD) and by subsequent review i.e., adding and deleting feeding vessels. Finally, the "ground truth" was compared with the determination of feeding vessels by the three independent readers for CBCT, EmboGuide AFD alone, and EmboGuide used in normal clinical practice (i.e., adding or removing vessels). The performance of EmboGuide was evaluated by the sensitivity. The study also evaluated whether consistent results could be obtained across multiple users. The study showed that:
- the sensitivity of EmboGuide in clinical routine use for identification of . tumor feeding vessels is 83+/- 8% with a CI of 95% for HCC patients with diagnostic quality CBCT images and no tumors or feeding vessels outside the volume imaged with CBCT.
- . EmboGuide as it will be used in normal clinical practice provides for a higher sensitivity to identify feeding vessels compared to CBCT,
- EmboGuide AFD alone provides for a higher sensitivity to identify feeding vessels compared to CBCT,
- . the overall agreement among readers for identification of feeding vessels using both the EmboGuide AFD and EmboGuide as it will be used in clinical practice was greater than the pre-selected acceptance criteria of 0.7 (i.e., 70%) indicating that for both approaches results in a consistent identification of feeding vessels for different readers,
- . the agreement among readers for identification of feeding vessels using the EmboGuide AFD alone was close to one (i.e., 0.99 with the lower bound of the 95% CI of 0.986), and
- the overall agreement among readers for identification of feeding vessels using the CBCT (i.e., 0.69 with lower 95%CI of 0.648) was less than the preselected acceptance criteria of 0.7 (i.e., 70%) indicating that identification of feeding vessels using this method may not be consistent for different readers.
The clinical performance data as documented in the clinical validation study demonstrate that EmboGuide performs comparably to the reference device FlightPlan for Liver that is currently marketed.
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Substantial Equivalence Conclusion:
Based on the information and comparison presented in the aforementioned sections, the proposed EmboGuide Rel. 1.0 software medical device is considered substantially equivalent to the currently marketed predicate device: 3D Roadmap, in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
For specific functionality to assist the clinical user in analyzing the 3D images of the vascular tree to plan for the embolization treatment, EmboGuide Rel. 1.0 is comparable to the currently marketed reference device FlightPlan for Liver. The (non-)clinical performance tests provided in this 510(k) premarket notification demonstrates that the proposed EmboGuide Rel. 1.0 is as safe and effective as its predicate device without raising any new safety and/or
effectiveness concerns