(279 days)
No
The document describes image processing and 3D reconstruction techniques, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance study focuses on segmentation validation by experts, not on the performance of an AI/ML model.
No
The device is described as assisting physicians in diagnosis and treatment and providing image guidance for catheter maneuvering, not directly performing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations." This directly indicates a diagnostic purpose.
Yes
The device is explicitly described as "software medical devices" and "software product" multiple times in the "Device Description" section. While it is intended to be used in combination with an Allura X-ray system, the submission focuses on the software components and their functionalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device (Allura 3D-RA Rel. 6 and its extensions) is a software medical device that processes medical images (X-ray, MRA, CTA) to create 3D visualizations and provide image guidance for medical procedures. It does not analyze biological samples.
- Intended Use: The intended use is to assist physicians in analyzing X-ray images, creating 3D views, assisting in the diagnosis and treatment of endovascular diseases, and providing image guidance during interventions. This is focused on image processing and procedural assistance, not laboratory testing of biological samples.
Therefore, the device falls under the category of medical imaging software and image-guided surgery tools, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Allura 3D-RA Rel. 6:
- The Allura 3D-RA Rel. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs.
- The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
- The Allura 3D-RA Rel.6 also supports measurement of lesion dimensions and anatomical distances.
3D Roadmap Rel. 1:
- The 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
MR-CT Roadmap Rel. 1:
- The MR-CT Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
Note: The summary of indications for use on page 3 repeats the indication for Allura 3D-RA Rel. 6 under 3D Roadmap Rel. 1 and MR-CT Roadmap Rel. 1. The specific Indications for Use forms for each device have been used for clarity.
Product codes
OWB, JAK, LLZ
Device Description
The device description of the 3D Interventional Tools software medical devices that are subject of this 510(k) submission are as follows:
Allura 3D-RA Rel. 6 software medical device (Allura 3D-RA Rel. 6)
The Allura 3D-RA Rel. 6 is a software product (Interventional Tool) intended to provide high-speed and high resolution 3D visualization of vessels and bones anatomy. Allura 3D-RA is intended to be used in combination with an Allura X-ray system.
The Allura 3D-RA Rel. 6 generates a 3D reconstruction from 2D X-ray images to visualize vascular anatomy, and helps to identify vascular pathologies from a single contrast-enhanced rotational angiogram. It can be used during anv angiography procedure and can cover any anatomical area including cerebral, abdominal, and peripheral. It also allows for 3D visualization of the spine.
3D Roadmap Rel. 1 software medical device (3D Roadmap Rel. 1)
The 3D Roadmap Rel. 1 is a software product intended (Interventional Tool) to assist the physician during complex interventions by providing live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body. 3D Roadmap is intended to be used in combination with an Allura X-ray system.
The 3D Roadmap Rel. 1 overlays live 2D fluoroscopic images on a 3D reconstruction of the vessel tree processed by Allura 3D-RA Rel. 6 and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including cerebral, abdominal, and peripheral vasculature.
MR-CT Roadmap Rel. 1 software medical device (MR-CT Roadmap Rel. 1)
The MR-CT Roadmap Rel.1 is a software product intended to provide live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body, reusing segmented MRA or CTA data that has been acquired previously. The MR-CT Roadmap Rel.1 is intended to be used in combination with an Allura X-ray system.
The MR-CT Roadmap Rel.1 overlays live 2D fluoroscopic images on a previously acquired MRA or CTA volume, which is registered by the Allura 3D-RA Rel. 6 with the X-ray system using a rotational scan and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including for example cerebral, abdominal, and peripheral vasculature.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, MRA, CTA
Anatomical Site
vessels and bones, vascular anatomy, cerebral, abdominal, peripheral, spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, during any angiography procedure, during any endovascular intervention.
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)
This premarket submission included an in-house validation study to assess the performance of the aneurysm tool in segmentation of the aneurysm. In this retrospective study performed on 3DRA clinical datasets with aneurysms, the performance of the tool was validated by three experts; one of the experts was an interventional neuro radiologist. The aneurysm tool can be used successfully for aneurysms between 2 and 22 mm that are not located on crossing vessels. According to the validation study, the average success rate of segmentation is 73% with a 95% confidence interval of (60%, 100%].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average success rate of segmentation is 73% with a 95% confidence interval of (60%, 100%].
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.
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Page 1 of 4
MAR 2 1 2013
510(k) Summary of Safety and Effectiveness
3D Interventional tools software medical device
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
Date prepared: March, 1 2013
ldentification of manufacturer
| Company: | Philips Medical Systems Nederland B.V |
|---|---|
| Address: | Veenpluis 4-6, |
| 5684-PC, Best, The Netherlands | |
| Registration number: | 3003768277 |
Identification of U.S. designated agent
| Company: | Philips Medical Systems |
|---|---|
| Address: | 22100 Bothell Everett Highway |
| Bothell, WA 98021-8431, U.S.A. | |
| Registration number: | 1217116 |
Identification of official correspondent
| Name: | Liselotte Kornmann, PhD
Regulatory Affairs Manager |
|----------|--------------------------------------------------------------------------------------------|
| Address: | Philips Medical Systems Nederland B.V.
Veenpluis 4-6,
5684-PC, Best, The Netherlands |
| Phone: | +31 6 11 621238 |
| Fax: | +31 40 2769100 |
| E-mail: | Liselotte.Kornmann@philips.com. |
Device identification
Regulation description: Regulation number:
Trade name: Device name:
Product code:
Class:
Allura 3D-RA, 3D Roadmap, MR-CT Roadmap Allura 3D-RA. Rel. 6, 3D Roadmap Rel. 1, MR-CT Roadmap Rel. 1 Image-intensified fluoroscopic x-ray system 21CFR 892.1650 OWB, JAK, LLZ
Legally marketed devices
| Trade names: | Allura 3D-RA Rel. 4.2 |
|---|---|
| Manufacturer: | Philips Medical Systems |
| 510(k) numbers: | K040254 - Feb 19, 2004 |
| Trade names: | Innova Vision Applications |
| Manufacturer: | GE Medical Systems |
| 510(k) numbers: | K092639 - Dec 2, 2009 |
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Device description
The device description of the 3D Interventional Tools software medical devices that are subject of this 510(k) submission are as follows:
Allura 3D-RA Rel. 6 software medical device (Allura 3D-RA Rel. 6)
The Allura 3D-RA Rel. 6 is a software product (Interventional Tool) intended to provide high-speed and high resolution 3D visualization of vessels and bones anatomy. Allura 3D-RA is intended to be used in combination with an Allura X-ray system.
The Allura 3D-RA Rel. 6 generates a 3D reconstruction from 2D X-ray images to visualize vascular anatomy, and helps to identify vascular pathologies from a single contrast-enhanced rotational angiogram. It can be used during anv angiography procedure and can cover any anatomical area including cerebral, abdominal, and peripheral. It also allows for 3D visualization of the spine.
3D Roadmap Rel. 1 software medical device (3D Roadmap Rel. 1)
The 3D Roadmap Rel. 1 is a software product intended (Interventional Tool) to assist the physician during complex interventions by providing live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body. 3D Roadmap is intended to be used in combination with an Allura X-ray system.
The 3D Roadmap Rel. 1 overlays live 2D fluoroscopic images on a 3D reconstruction of the vessel tree processed by Allura 3D-RA Rel. 6 and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including cerebral, abdominal, and peripheral vasculature.
MR-CT Roadmap Rel. 1 software medical device (MR-CT Roadmap Rel. 1)
The MR-CT Roadmap Rel.1 is a software product intended to provide live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body, reusing segmented MRA or CTA data that has been acquired previously. The MR-CT Roadmap Rel.1 is intended to be used in combination with an Allura X-ray system.
The MR-CT Roadmap Rel.1 overlays live 2D fluoroscopic images on a previously acquired MRA or CTA volume, which is registered by the Allura 3D-RA Rel. 6 with the X-ray system using a rotational scan and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including for example cerebral, abdominal, and peripheral vasculature.
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K12/772
Page 3 of 4
Indications for Use:
The indications for use of the 3D Interventional Tools software medical devices are as follows:
Allura 3D-RA Rel. 6
- The Allura 3D-RA Rel. 6 is intended to assist physicians in analyzing two . dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs.
- The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of . endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
- The Allura 3D-RA Rel. 6 also supports measurement of lesion dimensions and . anatomical distances.
3D Roadmap Rel.1
- 3D Roadmap Rel. 1 is an extension of Allura 3D-RA. which provides image . quidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
- The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of . endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
MR-CT Roadmap Rel.1
- MR-CT Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image . guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
- The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of . endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
Technological characteristics
The technological characteristics of the 3D Interventional Tools software medical devices are as follows:
The Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1 and MR-CT Roadmap Rel. 1 software medical device applications are extensions of the currently marketed and predicate Allura 3D-RA rel 4.2 with new functionality that are built re-using the same technology. They are provided on the hosting software functionality platform of the currently marketed and predicate Allura 3D-RA Rel 4.2. Please note that upon receiving 510(k) clearance (K121296) from FDA for the independent hosting software functionality platform, Interventional Workspot, which is currently pending with FDA, the Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1 and MR-CT Roadmap Rel. 1, will be provided as separate software medical devices.
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Image /page/3/Picture/0 description: The image shows a handwritten string of characters, "K121772". The characters are written in a cursive style, with the "K" being the largest and most distinct character. Below the string of characters, the text "Page 4 of 4" is printed in a smaller font size.
Summary of testing
Verification and validation tests were performed with reqards to Intended Use. Claims, Requirement specifications and Risk management requirements. The test results demonstrate that the Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1 and MR-CT Roadmap Rel. 1 software medical devices comply with all the requirements, including international recognized standards as detailed in this premarket submission and met the acceptance criteria.
This premarket submission included an in-house validation study to assess the performance of the aneurysm tool in segmentation of the aneurysm. In this retrospective study performed on 3DRA clinical datasets with aneurysms, the performance of the tool was validated by three experts; one of the experts was an interventional neuro radiologist. The aneurysm tool can be used successfully for aneurysms between 2 and 22 mm that are not located on crossing vessels. According to the validation study, the average success rate of segmentation is 73% with a 95% confidence interval of (60%, 100%].
Conclusion:
The 3D Interventional Tools software medical devices are substantially equivalent to the currently marketed and predicate devices, based on the similar design functionality, indications for use and software requirements.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Philips Medical Systems Nederland B.V. % Liselotte Kornmann, Ph.D. Regulatory Affairs Manager Veenpluis 4-6 5684-PC, BEST THE NETHERLANDS
Re: K121772
Trade/Device Name: Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1, MR-CT Roadmap Rel. 1 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAK, LLZ Dated: February 28, 2013 Received: March 05, 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. Iisting 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
5
Page 2 - Dr. Kornmann
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K121772
Device Name: 3D Roadmap Rel. 1
Indications For Use:
The 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Radiological Health 510(k): K121772
Page 1 of 1
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Indications for Use
510(k) Number (if known): K121772
Device Name: Allura 3D-RA Rel. 6
Indications For Use:
The Allura 3D-RA Rel. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs.
The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
The Allura 3D-RA Rel.6 also supports measurement of lesion dimensions and anatomical distances.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Radiological Health 510(k): K121772
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Indications for Use
510(k) Number (if known): K121772
Device Name: MR-CT Roadmap Rel. 1
Indications For Use:
The MR-CT Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
್ತು
Division of Radiological Health 510(k): K121772
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